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The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies and osteopenic bone.

The Synthes 3.5 mm VA-LCP Proximal Tibia Plate System consists of pre-contoured bone fixation plates intended for the treatment of fractures of the proximal tibia. Variable angle screws can be angled up to 15 degrees from the normal trajectory prior to locking the screw to the plate. Percutaneous instrumentation will allow the variable angle plates and screws to be applied through minimally invasive techniques.

The provided text describes the Synthes 3.5 mm VA-LCP Proximal Tibia Plate System and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. This is not a study that evaluates an AI/ML powered device, therefore, many of the requested criteria are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The text mentions "Static and dynamic construct testing" and "mechanical testing," but it does not specify the sample size for these tests (e.g., number of plates or screws tested).

The data provenance is from laboratory mechanical testing conducted by the manufacturer, Synthes. It is not human-derived data and therefore not retrospective or prospective in the medical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This criterion is not applicable as the study is a mechanical validation of a physical medical device, not a diagnostic or AI-powered device requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This criterion is not applicable for the same reason as point 3. Mechanical testing results are objective measurements, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This criterion is not applicable. The device is a physical bone fixation system, not a software or AI-assisted diagnostic tool that would involve human readers or an AI-enabled workflow.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This criterion is not applicable. The device is a physical implant, not an algorithm, and therefore does not have a "standalone" algorithmic performance. The mechanical testing implicitly represents "standalone" performance of the physical device under simulated conditions.

7. Type of Ground Truth Used

The ground truth used was mechanical engineering standards and predicate device performance. The goal was to demonstrate that the novel device's mechanical properties (fatigue strength, bending moment) were comparable to those of existing, legally marketed predicate devices.

8. Sample Size for the Training Set

This criterion is not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing processes are informed by engineering principles and prior device knowledge, but not in the same way an AI model is "trained."

9. How the Ground Truth for the Training Set Was Established

This criterion is not applicable for the same reason as point 8.

Summary of the Study and Acceptance Criteria from the document:

The study described is a mechanical performance evaluation aimed at demonstrating the substantial equivalence of the Synthes 3.5 mm VA-LCP Proximal Tibia Plate System to its predicate devices.

Acceptance Criteria: The device was expected to show comparable mechanical performance in terms of fatigue strength and bending moment when compared to the predicate devices.

Study Description:

• Study Type: Static and dynamic construct mechanical testing.
• Purpose: To assess the fatigue strength and bending moment of the subject device.
• Conclusion: "The results of the mechanical evaluation confirm that the subject device is substantially equivalent to the predicate."

In essence, the "acceptance criteria" here were met by showing that the new device's mechanical behavior was not inferior to the established, safe, and effective predicate devices.

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