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ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus.
ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

The Zimmer Plates and Screws System (ZPS) is a nonlocking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone. The ZPS Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation. The purpose of this submission is a line extension adding the sterile version of the 2.7mm cortical screws cleared under K143066.

This document describes the 510(k) premarket notification for the Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws. The submission is a line extension to add a sterile version of screws that were previously cleared as non-sterile. Therefore, the focus is on demonstrating that the sterile version is substantially equivalent to the predicate devices, primarily through non-clinical performance data related to sterility and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state a "test set" in the context of a clinical performance study with a specific sample size. The evaluation is primarily based on non-clinical testing and comparison to predicate devices, where the "test set" would refer to samples used in biocompatibility and shelf-life testing. The data provenance is from Zimmer, Inc.'s internal testing and regulatory submission processes (e.g., test reports for biocompatibility and shelf-life).

3. 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)
This information is not applicable. The device is a bone fixation fastener, not an AI/imaging device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is a non-clinical evaluation of a physical surgical device, not a diagnostic or prognostic system requiring expert adjudication.

5. 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 not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is established through recognized standards and testing methods for medical device performance and safety:

• Biocompatibility: Adherence to ISO 10993-1 and Good Laboratory Practices (21 CFR 58), with "passed" results indicating acceptable biological response.
• Sterility and Shelf Life: Adherence to ISO 11607-1:2006 and 11607-2:2006, with "10-year shelf life" indicating validated performance.
• Mechanical Equivalence: Demonstrated identity in design and material to mechanically tested and cleared predicate devices.

8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI models with a "training set."

9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.

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