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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 and knees.

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 document is a 510(k) summary for the medical device Fix2Lock (PEEK Self Punching). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. It primarily details a non-clinical bench study to verify design specifications and compliance with material and mechanical performance standards.

Therefore, many of the requested sections regarding clinical study design, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance are not applicable or not available in this type of submission.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The study described is a bench test, and the number of units tested to demonstrate compliance with the listed standards is not provided.
• Data Provenance: Not applicable, as this is a bench test for materials, mechanical properties, and sterilization, not a clinical study with patient data.

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

• Not applicable. Ground truth as typically understood in clinical studies (e.g., disease presence/absence determined by experts) is not relevant for this type of bench testing. Compliance with engineering standards and material specifications would be assessed by engineers and quality control personnel.

4. Adjudication method for the test set

• Not applicable. There is no mention of adjudication for the bench tests. Compliance is determined against established engineering and material standards.

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 medical device for orthopedic fixation, 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 physical medical device, not an algorithm.

7. The type of ground truth used

• For the bench tests, the "ground truth" is defined by the specifications and requirements stipulated in the referenced international and national standards (e.g., ASTM F2026 for PEEK, ISO 11135 for sterilization). The device's performance is compared against these quantitative and qualitative standard requirements.
• For the overall submission, the "ground truth" for demonstrating marketability is the substantial equivalence to the predicate device, Arthrex Corkscrew and SwiveLock Suture Anchors (K143745).

8. The sample size for the training set

• Not applicable. This is a physical medical device and not an AI/machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this device.

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