(80 days)
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
Temporary internal fixation devices, such as the ZPS screws, are designed to stabilize fractures during the normal healing process.
This is a 510(k) premarket notification for a medical device (Zimmer® Plates and Screws System (ZPS) - Screws only) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through clinical trials. Therefore, much of the requested information regarding AI models, comparative effectiveness studies, and detailed ground truth establishment is not applicable to this type of submission.
However, I can provide the available information from the document that aligns with your request for acceptance criteria and study data related to the device's performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance / Conclusion |
|---|---|
| Sterilization Validation: Achieve a minimum gamma dose of 20kGy and a Sterility Assurance Level (SAL) of $10^{-6}$ or better. | The devices can be terminally sterilized to a SAL of $10^{-6}$ or better. |
| Shelf Life: Product has a specified shelf life. | Accelerated aging showed that the product has a shelf life of 10 years. |
| Sterile Packaging: Withstand normal distribution and storage conditions and maintain sterile barrier properties throughout the specified product shelf life. | (Implied to have met, as device is provided sterile) To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life. |
| Biocompatibility: Tested per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). | All testing passed. |
| Mechanical Performance (through engineering evaluations and nonclinical lab testing): Address differences in screw diameters, partial vs. full threads, starting load, material strength, and drive types. Include cross-sectional analysis, fatigue failure, insertion torque, and torque to failure. | The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. |
Note: The document explicitly states: "Clinical data and conclusions were not needed for this device." This immediately tells us that a clinical study as typically defined for efficacy or safety of a new drug or novel device was not performed. The focus is on non-clinical performance to show substantial equivalence.
Information on AI-specific questions (not applicable to this document):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, no clinical test set for AI. The non-clinical tests involved specific numbers of samples for each mechanical or biological test, but these are not reported in detail in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, no expert-based ground truth for AI.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no test set requiring adjudication in this context.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is a hardware device, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, this is a hardware device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For non-clinical tests, the "ground truth" is defined by the objective measurement criteria of the specific ASTM or ISO standards used (e.g., specific torque values, fatigue cycles, SAL values, cytocompatibility metrics).
- The sample size for the training set: Not applicable, no AI training set.
- How the ground truth for the training set was established: Not applicable, no AI training set.
Summary of the Study (Non-Clinical Performance):
The performance of the Zimmer® Plates and Screws System (ZPS) - Screws only, to demonstrate substantial equivalence, relied entirely on non-clinical performance testing and engineering evaluations. These included:
- Sterilization Validation: Demonstrated the device could be terminally sterilized to a SAL of $10^{-6}$ or better using a minimum gamma dose of 20kGy.
- Shelf Life Testing: Accelerated aging studies were conducted, concluding a 10-year shelf life.
- Sterile Packaging Testing: Designed to ensure the integrity of the sterile barrier under normal distribution and storage conditions for the specified shelf life.
- Biocompatibility Testing: Performed on the screw material according to ISO 10993-1 and 21 CFR § 58 (Good Laboratory Practices), with all tests passing.
- Engineering Evaluations and Mechanical Testing: This included analysis of various screw characteristics (diameters, thread types, starting load, material strength, drive types) and specific tests like cross-sectional analysis, fatigue failure, insertion torque, and torque to failure.
The conclusion drawn from these non-clinical studies was that the devices are safe and effective and substantially equivalent to the predicate devices. No clinical studies were deemed necessary due to the nature of the device (temporary internal fixation) and the demonstration of equivalence through non-clinical means.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.