TX Q&A

The performance metrics for posterior spinal rod and screw internal fixation systems usually include key dimensions and tolerances of pedicle screws (e.g., diameter), key dimensions and tolerances of connecting rods (e.g., diameter), hardness of parts other than the connecting rod, tensile strength of connecting rods and cross-links, surface quality (appearance, surface roughness, surface defects), compatibility performance, sterility (if applicable), and residual ethylene oxide levels (if applicable).

Endoscopic power equipment refers to devices driven by a power source to provide mechanical power to a tool head for grinding or cutting tissues during endoscopic surgeries. These devices can be categorized based on the tool head's functions such as shaving, grinding, and drilling. For example, there are devices for soft tissue shaving, devices for bone tissue grinding/drilling, and devices that combine both functionalities. The main performance metrics for these products should reference national and industry standards, taking into account clinical needs and the specific technical characteristics of the product. Equipment designed for shaving should comply with industry standard YY/T 0955 "Medical Endoscopes—Endoscopic Surgical Devices—Shavers." For other uses such as grinding and drilling, the metrics can be determined by referencing this standard combined with the product's characteristics.

You need to outline the production and processing technologies for making metal powders, specifying key procedures, special processes, control points, and corresponding parameters. For the base material used in powder making, you should detail its common name, chemical name, standards and grades, material supplier, incoming inspection standards, and quality control requirements. Clearly define the main powder production processes like electrode induction melting gas atomization, plasma inert gas atomization, vacuum induction melting gas atomization, and plasma rotating electrode atomization. Specify critical process parameters like gas pressure, flow rate and temperature, the nozzle's inner diameter and spray angle, tower pressure and oxygen content during gas atomization, and current and rotation speed for the rotating electrode atomization process, along with the basis for determining these parameters. You should also define the processes for screening, mixing, and packaging the powder after making it, describing how to control these processes. Considerations should include how fine powder is removed during screening, atmospheric protection, pollution control, and explosion prevention measures. Additionally, study the compatibility of metal powder with key process parameters of the printing equipment. Essential parameters include laser power, scanning speed, spot diameter, scan spacing, scanning strategy, powder layer thickness, atmospheric protection, support structure, printing direction, and chamber temperature. Clearly define the worst-case performance of the metal powder and the parameter settings for the printing process.

The main unit and ablation needle of a microwave ablation device can be registered as a single unit or split into separate registration units. The compatibility requirements between the main unit, cables, and ablation needle of microwave ablation devices are very high. Random changes in the combination can affect the safety and effectiveness of microwave output. Therefore, development, production, and usage must be in conjunction with a specified main unit or accessories. For separately registered microwave ablation device main units and ablation needles, it is essential to specify the related products they must be used with. The separately registered main unit must clearly specify in its scope of application that it is to be used with approved ablation needles compatible with the device. Separately registered microwave ablation needles must specify the model and software version of the compatible main unit in their scope of application.

In vitro diagnostic reagents usually need supporting instruments to complete sample detection. If the supporting instruments have not yet been approved for market release, both the reagent and the instrument can use the same clinical trial data and documentation for their registration applications when tested together in clinical trials. However, it's important to note that the regulations for reagents and instruments are different, so they should be registered as separate units. When designing the clinical trial and preparing documentation, the following should be noted: The ethical approval documents should clearly state that the approved clinical trial project includes both the reagent and the instrument. The titles and content of the clinical trial protocol, summary, and report should include both the reagent and the instrument. The main text should clearly specify detailed information about both the reagent and the instrument. The clinical trial protocol should include all evaluation indicators and methods for both the reagent and the instrument. The clinical trial summary and report should cover the complete clinical evaluation content for both the reagent and the instrument to support their market release requirements.

For products listed in the catalog of in vitro diagnostic reagents exempt from clinical trials, clinical evaluations should involve a study with no fewer than 100 samples. Quantitative test reagents with different reference intervals due to known physiological variations (such as menstrual cycle, gender, age, etc.) — for example, luteinizing hormone test reagents — should include samples from the intended applicable population and interference samples, covering the concentration range across the linear/measuring interval. It is not necessary to stratify statistics for different reference intervals in these populations. For test reagents with significantly different clinical decision-making implications in different population reference intervals, such as full-range C-reactive protein (CRP) test reagents, at least 100 samples should be included for the intended population in each of the high-sensitivity and routine-use reference intervals. Stratified statistics should be conducted for these different populations.

The software security level should be comprehensively determined based on the intended use, usage scenarios, and core functions of the software. The software security levels are categorized by the degree of risk into three levels: minor, moderate, and severe. Minor level means the software is unlikely to cause harm, moderate level means the software may cause minor (non-severe) harm directly or indirectly, and severe level means the software may cause severe harm or death directly or indirectly. Applicants must determine the product risk and software security level by considering the specific intended use of the IVD device and the possible harm it could cause and submit software research materials according to the respective security level. Generally, the network security level of IVD devices matches the software security level of the device. In special cases, the network security level may be lower than the software security level, in which case detailed reasons must be provided. Applicants should provide network security research materials corresponding to the level. For vulnerability assessment, besides providing a self-assessment report on network security vulnerabilities, severe network security level also requires a report from a qualified network security assessment agency that outlines maintenance plans for known residual vulnerabilities to ensure the overall residual risk of the product is acceptable. Examples of IVD device security levels: Gene sequencing products intended for fetal chromosomal aneuploidy screening and tumor gene companion diagnostics should be classified as severe level due to the potential for severe harm or death based on the auxiliary diagnostic results. PCR analyzers intended for pathogen gene detection and human gene mutation detection should have software classified at least as moderate level.

YY 0861 "Ophthalmic Optics: Ophthalmic Viscoelastic Agents" specifies that coordinate charts need to be drawn for the four performance indicators: spectral transmittance, elasticity, shear viscosity, and absolute complex viscosity. Applicants must provide these coordinate charts in their research data. It is not necessary to draw these performance coordinate charts or define chart indicators in the product technical requirements.

Knee joint prosthesis products typically specify in their product technical requirements performance indicators such as appearance, surface defects (for non-coated metal and ceramic components), surface roughness of joint surfaces, surface roughness of non-articulating surfaces exposed to soft tissues, surface roughness of coatings (if applicable), dimensions and tolerances of various parts, minimum thickness of load-bearing areas of tibial components/meniscal components (limited to conventional ultra-high molecular weight polyethylene), relative angular range of motion (if the declared product includes both femoral and tibial components), sterility performance (if applicable), and ethylene oxide sterilization residue (if applicable). If the product surface is a hydroxyapatite coating, the adhesion strength between the hydroxyapatite coating and the substrate must be specified; if the product surface is a plasma-sprayed metal coating, the surface morphology, shear strength, and tensile strength of the metal coating must also be specified.

Hip joint prosthesis products typically specify in their product technical requirements performance indicators such as appearance, surface defects (for non-coated metal and ceramic components), surface roughness of joint surfaces, surface roughness at the taper connection site, surface roughness of coatings (if applicable), dimensions and tolerances of taper connections and joint surfaces, diameter tolerance and sphericity radial deviation of ceramic-to-ceramic joint surfaces, minimum thickness of acetabular components (limited to conventional ultra-high molecular weight polyethylene), minimum thickness of bipolar head liners, fixation anti-torque performance testing of handle femoral components, static load resistance of modular femoral heads, deformation resistance of metal acetabular components, minimum and maximum angles (if the declared product includes both femoral heads and femoral stems), sterility performance (if applicable), and ethylene oxide sterilization residue (if applicable). If the product surface is a hydroxyapatite coating, the adhesion strength between the hydroxyapatite coating and the substrate must be specified; if the product surface is a plasma-sprayed metal coating, the surface morphology, shear strength, and tensile strength of the metal coating must also be specified.