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The ExsoMed INnate Nano™ Lag Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The purpose of this Special 510(k) is to add additional sizes and geometry to InFrame™ Cannulated Fixation System. The ExsoMed INnate Nano Lag Screw System includes cannulated stainless screws with a diameter of 1.5mm and lengths ranging from 6 mm to 26 mm.

This document describes the FDA 510(k) clearance for the ExsoMed INnate Nano™ Lag Screw System. This is a medical device for orthopedic fixation, not an AI/ML powered device. Therefore, the information requested about acceptance criteria, study design (sample size, data provenance, experts for ground truth, adjudication, MRMC studies, standalone performance), ground truth type, and training set details for an AI/ML device is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (ExsoMed InFrame Cannulated Fixation System (K201430)) based on similar indications for use, materials, design, method of fixation, and performance characteristics.

The "Technology Comparison and Non-Clinical Performance Testing" section mentions:

• Acceptance Criteria: "The information summarized in the Design Control Activities Summary demonstrates that the additional sizes meet the predetermined acceptance criteria for the verification activities." (However, the specific acceptance criteria are not detailed in this public summary.)
• Study Proving Device Meets Acceptance Criteria: "Testing, according to ASTM F543, and engineering analysis were used to evaluate the mechanical strength, screw fixation performance, and screw usability performance of the ExsoMed INnate Nano Lag Screw System implants."

In summary, based on the provided text, it's impossible to create the table and answer the detailed questions regarding AI/ML device performance validation as the device is a mechanical orthopedic implant.

If this was an AI/ML powered device, the information would typically be found in detailed performance studies submitted as part of the 510(k), often in the "Performance Evaluation - Clinical" or "Performance Evaluation - Non-Clinical" sections, which are not fully provided in this public summary.

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