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Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.

This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.

The provided text is a 510(k) premarket notification for a medical device called "Fix2Lock (PEEK Self Punching)". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the detailed acceptance criteria and study results for a new, AI-powered device's performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, and training set specifics cannot be extracted from this document. This type of information is typically found in study reports or technical documentation submitted for devices that involve AI/ML components requiring performance validation against defined metrics.

The document primarily discusses:

• Device Identification: Fix2Lock (PEEK Self Punching), a Class II device for orthopedic surgery.
• Intended Use: Fixation of soft tissue to bone using suture (shoulders, knees, foot/ankle, hand/wrist, elbow).
• Substantial Equivalence (SE) Claim: The subject device (K231322) is substantially equivalent to a predicate device (K202763), and a reference device (K081511).
• Non-Clinical Tests: Bench tests were conducted to verify design specifications and SE to the predicate device, citing compliance with various ASTM and ISO standards for material, mechanical performance, sterilization, shelf life, packaging, and bacterial endotoxin (e.g., ASTM F2026, F543, ISO 11135, 11607, USP ).
• Comparison Table: Details similarities and differences in product code, regulatory class, intended use, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf life between the subject, predicate, and reference devices.

In essence, this document is a regulatory submission for a traditional medical device demonstrating equivalence, not a performance study for an AI/ML diagnostic or assistive device that would have the requested acceptance criteria and study design details.

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