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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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Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).

The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

The implanted screw is made of poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source.

Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies. Therefore, the typical information sought for AI/CADe devices (like ground truth establishment, reader studies, effect size with AI assistance, training set details, etc.) is not applicable here because this is a mechanical medical device, not an AI/CADe system.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by adherence to referenced standards and successful completion of specific mechanical tests. The reported device performance is simply "PASS" for all tested criteria, indicating it met the established benchmarks.

2. Sample size used for the test set and the data provenance

The document states "All specimens selected (worst-case) to verify the performance of the test criteria established based on literatures and comparison with the predicate device." However, specific numerical sample sizes for each test are not provided. The provenance of the test samples (e.g., country of origin, retrospective/prospective) is also not specified, though it is implied these are manufactured device samples undergoing bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes bench testing for a mechanical device. The "ground truth" here is determined by objective mechanical measurements against established ASTM and ISO standards, not expert interpretation of medical images or conditions.

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

This information is not applicable as the document describes bench testing for a mechanical device. There is no human adjudication process involved in these mechanical performance tests.

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 information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system.

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

The "ground truth" for the device's performance is established by objective mechanical measurements against recognized international standards (ASTM and ISO) for medical device performance (e.g., axial pullout strength, torsional yield strength, driving torque, degradation testing, fatigue).

8. The sample size for the training set

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system requiring a training set.

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

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system.

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