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The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.

MEMOMETAL Navis® Bone Plating System is single use bone fixation appliances intended to be permanently implanted. They are designed with anatomical shape plates made of biocompatible titanium alloy. The Bone Plating System use 2.5 mm locking, unlocking screws and 1.8 mm smooth locking pegs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different lengths, widths, number of plate holes, left and right shapes.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Key Takeaways:

• This document describes a 510(k) premarket notification for the Memometal Navis® Bone Plating System.
• The primary method for demonstrating substantial equivalence was mechanical testing comparing the new device to legally marketed predicate devices.
• No clinical tests were used or presented, meaning there's no information on human reader performance, AI assistance, or related clinical metrics.
• The focus is on mechanical properties of the implants themselves, not diagnostic or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in terms of number of plates/pegs tested. The document refers to "mechanical characterization of plates" and "mechanical characterization of pegs," implying a sample was used, but the exact number isn't stated.
• Data Provenance: The tests were "performed to demonstrate equivalence," indicating a controlled lab setting rather than clinical data. The ASTM F382-99 standard for the 3-point bending test suggests standardized laboratory conditions. No country of origin for the test data is explicitly mentioned, but the submitter is based in France. The data is entirely retrospective in the sense that it evaluates the manufactured device; there's no prospective patient follow-up mentioned.

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

• Not applicable. This study did not involve human experts establishing ground truth for a test set, as it was a mechanical performance study of an implantable device, not a diagnostic or AI-driven imaging study. The "ground truth" was established by the physical properties and performance metrics of the predicate devices as measured under standardized test conditions.

4. Adjudication Method for the Test Set

• Not applicable. There was no subject interpretation or clinical assessment requiring adjudication. The study involved objective mechanical measurements.

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, an MRMC study was NOT done. This document pertains to a bone plating system, which is an implantable device, not a diagnostic imaging AI tool. Therefore, there's no concept of human readers or AI assistance in this context.

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

• No. This is not an AI algorithm. It is a physical bone plating system.

7. The Type of Ground Truth Used

• The "ground truth" for this study was the established mechanical performance and design characteristics of legally marketed predicate devices (Medartis Aptus®, TRIMED Bone plates, and STRYKER variax®). The new device's mechanical properties were measured and compared against these established benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This study did not involve a training set as it was not an AI/machine learning study.

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

• Not applicable. As stated above, there was no training set.

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