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The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.

The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The implants of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial F MTP) contain implants and instruments or instruments only provided sterile by gamma sterilization.

This document is a 510(k) premarket notification for the Footmotion Plating System. As such, it does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML performance evaluation. This device is a medical implant system, not a software or AI-driven diagnostic tool.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of submission. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical safety, rather than evaluating performance against a specific clinical metric.

Here's a breakdown of the information that is applicable or discernible from the provided text, along with an explanation for why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria for performance in the typical sense of accuracy, sensitivity, or specificity that would apply to an AI/ML device. Instead, "acceptance criteria" are implied through the demonstration of substantial equivalence to legally marketed predicate devices. The performance is assessed through engineering analyses and material testing to ensure the device is safe and effective for its intended use, similar to its predicates.

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

• Not Applicable in the traditional sense for an AI/ML device. This is a physical implant system. The "test set" would refer to samples of the device components undergoing various engineering and material tests.
• The document mentions "Engineering analyses," which would involve testing physical samples (e.g., fatigue testing, tensile strength testing). The specific number of samples for each type of engineering analysis is not provided in this summary.
• Data Provenance: The analyses and testing appear to be conducted by or for Newclip Technics, a French company. The nature of the analyses (e.g., bench testing, material characterization) means the "data provenance" is derived from these tests. These are prospective tests conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. For a physical device like this, there isn't a "ground truth" to be established by clinical experts in the same way there would be for an AI diagnostic. The "ground truth" is derived from engineering principles, material science standards, and established surgical practices for similar devices.
• The "experts" involved would be materials scientists, biomechanical engineers, and regulatory specialists designing and evaluating the device and its testing protocols. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

• Not Applicable. As there's no "ground truth" requiring expert consensus adjudication for clinical interpretations, no such method is described. The evaluation relies on objective engineering measurements against predefined standards.

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/ML device, nor is it a device that is 'read' by human readers in the context of diagnostics. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This is a physical medical device (implants and instruments), not an algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" is based on:
  • Engineering Standards: Conformance to material standards (e.g., ASTM F136, ISO 5832-3 for Titanium alloy).
  • Biomechanical Principles: The "engineering analyses" would establish that the device's mechanical properties (e.g., strength, fatigue resistance for fixation of osteotomies, fractures, arthrodeses) are appropriate for its intended use, likely by comparison to predicate devices' known performance.
  • Regulatory Compliance: Meeting endotoxin limits through LAL testing.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical device and does not have a "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable.

In summary, this 510(k) submission for the Footmotion Plating System demonstrates substantial equivalence to predicate devices through engineering analyses, material testing, and confirmation of intended use rather than through clinical performance metrics and studies typical of AI/ML software.

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