(134 days)
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
The Zimmer® Periarticular Plating System - Screws are similar in intended use, type of materials, and performance characteristics to the predicate devices (Zimmer Periarticular Locking Plate System - K042598, cleared 10/29/2004). The proposed screws are provided sterile vs. non-sterile.
The provided text is a 510(k) summary for the Zimmer® Periarticular Plating System - Screws. This document focuses on the non-clinical performance and substantial equivalence to predicate devices, rather than a study with a test set, experts, or ground truth as would be typical for an AI/ML medical device.
Therefore, many of the requested fields are not applicable to this type of regulatory submission. The device described is a physical surgical screw, not a software algorithm or an AI-enabled device.
I will fill in the available information and explicitly state when a requested field is not applicable based on the provided text.
Acceptance Criteria and Device Performance for Zimmer® Periarticular Plating System - Screws
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: | Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed. Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, bending or fatigue failure, material strength. |
| Sterilization Validation: | To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL greater than or equal to 10-6. |
| Shelf Life: | Accelerated aging showed that the product has a shelf life of 10 years. |
| Sterile Packaging: | To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life. |
| Mechanical Performance/Durability: | Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure. The new sterile screws are similar in intended use, type of materials, and performance characteristics to the predicate devices. |
Study Details:
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A table of acceptance criteria and the reported device performance: See table above.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. This submission is for a physical medical device (screws) and relies on non-clinical (lab) performance testing and engineering evaluations, not a "test set" of data in the context of an AI/ML device. The various tests (biocompatibility, sterilization, shelf life, mechanical testing) would have involved a sufficient number of samples for those specific tests.
- Data Provenance: Not applicable. This refers to laboratory testing and engineering evaluations.
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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. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant for the non-clinical testing of a physical device. Testing was conducted by qualified personnel in laboratories following established standards and good laboratory practices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for resolving disagreements in expert labeling of data, which is not part of this device's non-clinical performance evaluation.
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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 physical orthopedic screw, not an AI/ML diagnostic or assistive device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical orthopedic screw, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation is based on established engineering principles, material science standards (e.g., ISO 10993-1), and regulatory requirements (e.g., sterilization to a SAL ≥ 10^-6, accelerated aging for shelf life, mechanical properties testing). These are objective measurements and validations, not expert consensus on qualitative data.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.