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The CoLink® NeoFuse MIS Plating System is a fusion plate indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.

The CoLink® NeoFuse MIS Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are a line extension of the CoLink® NeoFuse Plating System.

The provided text describes a medical device, the "CoLink® NeoFuse MIS Plating System," which is a fusion plate used for anterior fixation of ankle arthrodesis and fractures. This document is a 510(k) Pre-market Notification from the FDA, indicating a review of the device's substantial equivalence to existing legally marketed devices.

Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI-powered diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various performance tests and comparisons.

The primary acceptance criteria for this type of medical device (a bone fixation system) revolve around:

• Mechanical Performance: The device must meet sufficient mechanical strength and fatigue properties to perform its intended function.
• Biocompatibility: The materials used must be safe for implantation in the human body.
• Sterility: The device must be sterile and maintain its sterility.
• Packaging Integrity: The packaging must protect the device and maintain sterility until use.
• Dimensional and Material Equivalence: The subject device's geometry, dimensions, and materials should be comparable to predicate devices.

Table of Performance (Based on provided text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide numerical sample sizes for mechanical testing (e.g., number of plates tested). It states "Testing was conducted per a modified ASTM F382 set up for the plates...". For biocompatibility, sterilization, and packaging, it refers to validation according to international standards (ISO, ANSI/AAMI), which implies that appropriate sample sizes were used as dictated by those standards for validation studies, but these specific numbers are not detailed in this summary.

There is no mention of data provenance (e.g., country of origin or retrospective/prospective nature) as this is not a clinical study involving human patient data, but rather performance testing of the device itself.

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 is not applicable. The device is a physical bone fixation system, not a diagnostic AI device requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for the mechanical performance testing would be the physical properties and failure points observed during the standardized tests, compared against established engineering and regulatory benchmarks.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., of medical images) where discrepancies need to be resolved. This document details engineering and performance testing, not clinical interpretation.

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

This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The CoLink® NeoFuse MIS Plating System is a surgical implant, not an AI diagnostic tool.

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

This is not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance testing is based on:

• Standardized Test Methods: Adherence to and performance within established engineering standards (e.g., ASTM F382, ISO 10993-1, ISO 11137-2, ISO 11607-1, ANSI/AAMI ST72).
• Predicate Device Performance: The underlying assumption of substantial equivalence is that the predicate devices are safe and effective, and thus the subject device, performing comparably, is also considered safe and effective.

8. The sample size for the training set

This is not applicable. There is no "training set" as this device is not an AI algorithm requiring machine learning.

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

This is not applicable for the same reason as above.

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