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The RASL Repair Kit is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

The Radicle Orthopaedics RASL Repair Kit is an implant and instrument system designed to treat scapholunate ligament ("SLIL") ruptures. The RASL Repair Kit implants are made from titanium alloy, Ti-6Al-EV ELI, per ASTM F136. Instruments are made from surgical-grade stainless steel according to ASTM F899. The entire kit is supplied non-sterile. Instruments are meant to be reusable.

The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Radicle Orthopaedics RASL Repair Kit. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, design, material, and performance testing.

This document describes a medical device (a bone fixation fastener) and its performance through physical (mechanical) testing, not an AI/ML-based device that would require the type of studies and criteria (e.g., accuracy, sensitivity, specificity, human reader improvement, ground truth establishment) typically associated with AI/ML evaluation.

Therefore, I cannot extract information to fill out the requested template as it pertains to AI/ML device performance. The information requested, such as 'acceptance criteria based on computational metrics,' 'sample sizes for test and training sets using patient data,' 'number of experts for ground truth,' and 'MRMC studies,' are not applicable to the mechanical testing described in this document.

The document discusses the following types of performance data (mechanical testing):

• Torsional Testing per ASTM F543
• Insertion/Removal and Axial Pullout Testing per ASTM F543
• Assembly Strength Testing
• Static and Fatigue Bending Testing per ASTM F1264
• Corrosion Testing per ASTM F2129
• Wear Debris Testing per ASTM F1877

These tests compare the physical properties and strength of the RASL Repair Kit to its predicate devices (Acumed SLIC Screw Repair System and Zimmer HBS Screw System) to demonstrate substantial equivalence, rather than clinical performance based on patient data and AI algorithms.

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