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The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.

The CoLink® Mfx Plating System is a line extension to the current CoLink® plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).

The provided text describes a 510(k) premarket notification for a medical device called the CoLink Mfx Implant System. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering analysis and performance testing of a physical implant system. The "performance testing" mentioned is mechanical testing (four-point bend testing per ASTM F382) to compare the subject plates to predicate plates, and also references previous validations for sterilization, biocompatibility, shelf life, and pyrogenicity for the broader CoLink® Afx System.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or studies related to AI/ML performance because the provided text is for a physical orthopedic implant and not an AI/ML-based device.

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The In2Bones USA LLC, CoLink® Cfx System is indicated for stabilization of fractures, revision procedures, osteotomies and reconstruction of the small bones in the foot and ankle including the calcaneus in both pediatric and adult patients.

The In2Bones CoLink® Cfx Plating System is a system of plates and screws and surgical instruments intended for stabilization of calcaneal fractures and osteotomies. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® Cfx Plating System.

The provided FDA document, K200762, is a 510(k) premarket notification for a medical device (CoLink® Cfx Plating System) that aims to demonstrate substantial equivalence to previously cleared predicate devices. This type of submission relies on comparisons to existing devices rather than new clinical effectiveness or performance studies against specific acceptance criteria.

Therefore, the document does not contain the information required to populate the fields in your request, as it does not describe a study proving the device meets specific acceptance criteria in the way you've outlined.

Here's why and what information is available (and what is not):

• Acceptance Criteria & Reported Performance: Not applicable. The document focuses on demonstrating similarity to already approved devices.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies: Not applicable. These relate to studies designed to evaluate a device's performance against a ground truth, which is not the purpose of this 510(k) submission.
• Training Set Sample Size & Ground Truth: Not applicable. This refers to AI/ML model development, which is not relevant to this mechanical implant device.

However, the document does provide the following relevant information about comparisons to predicate devices:

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

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

• Not applicable. This document describes a 510(k) submission for a mechanical implant, not an AI/ML product or a product requiring a clinical "test set" in the context of effectiveness studies. The evaluations were based on engineering analysis and comparison to predicate devices, not patient data sets.

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)

• Not applicable. No ground truth established by experts for a test set is mentioned or required for this type of submission.

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

• Not applicable. No test set or adjudication process is described.

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 a mechanical bone fixation system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• Not applicable. The "ground truth" in this context is the FDA's determination of substantial equivalence based on the provided engineering analysis and comparison to predicate devices.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/ML product that uses a training set.

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

• Not applicable. No training set is involved.

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