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ZPS Plates are indicated for temporary internal fixation of osteotomies and fractures. 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 Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

The Zimmer Plates and Screws System (ZPS) is a non- locking, 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 ZPS screws for temporary fixation to the bone.

This document is a 510(k) premarket notification for the Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates. It describes the device, its intended use, and substantial equivalence to predicate devices, along with performance data.

Here's a breakdown of the requested information based on the provided text, focusing on the study conducted and its findings:

1. A table of acceptance criteria and the reported device performance

2. 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 the test set: The document states that the "weakest (worst-case) ZPS plate within each of the groups was selected as the representative sample for comparison." This implies a selection of specific plates from different groups for testing, rather than a large numerical sample size. The exact number of representative plates tested is not specified but is implied to be a small, worst-case selection from each group.
   • Data provenance: The performance data is non-clinical. It is based on laboratory testing (mechanical testing) of the device. There is no information about the country of origin of the data or whether it is retrospective or prospective, as it's not patient data.

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 question is not applicable to this study. The "ground truth" for this engineering performance study is based on objective mechanical properties (static and fatigue bending moments) and calculations, not expert interpretation of medical images or conditions. The assessment was based on physical property measurements and calculations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • This question is not applicable to this study. Adjudication methods are typically used in clinical studies for interpretation of medical data by multiple experts. For this engineering study, the "adjudication" is inherent in the objective measurements and calculations of mechanical properties.

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

   • No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a non-clinical, mechanical performance evaluation of a medical device (plates and screws). There is no AI component or human-in-the-loop performance involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No. A standalone algorithm-only performance study was not done. This study focuses on the mechanical performance of a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for this study is based on objective mechanical measurements and calculations of static and fatigue bending strength/moments. Specifically, it involves:
     • Beam bending cross-sectional analysis.
     • Calculations of static and fatigue bending moments.
     • Comparison to mechanical properties of predicate devices.

8. The sample size for the training set

   • This question is not applicable to this study. There is no "training set" as this is not a machine learning or AI study. The study involves direct mechanical testing and calculation on physical device samples.

9. How the ground truth for the training set was established

   • This question is not applicable as there is no training set or AI component. The "ground truth" for the performance evaluation was established through engineering principles, standardized testing (ISO 10993-1 for biocompatibility), and calculation methods.

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