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The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder (Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs), Foot and Ankle (Hallux Valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions), Elbow, Wrist and Hand (Scapholunate ligament reconstructions, Ulnar or radial collateral ligament reconstructions, Lateral and Medial Epicondylitis, Biceps tendon reattachment), Knee (Extracapsular repairs and reattachments of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia, joint capsule closure to anterior proximal tibia; Extracapsular reconstruction, iliotibial band tenodesis; Patellar realignment and tendon repairs), Bladder Neck Suspension (Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility).

The BioRC Anchor is a cannulated, threaded, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly(L-lactide acid), which is used to attach soft tissue to bone. The device is preloaded on a disposable driver used to insert it into the bone.

The provided text describes the BioRC Anchor, a bioabsorbable soft tissue anchor, and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. Therefore, it does not contain the information required to populate all the requested fields about acceptance criteria and a study proving those criteria.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Not Applicable (N/A) based on the provided text:

• Specific quantitative acceptance criteria for performance (e.g., tensile strength, degradation rate, pull-out strength). The document states "Testing has been done to prove safety and effectiveness," but it does not report the specific results of these tests or explicit numerical acceptance criteria.
• A "study" in the sense of a clinical trial or a detailed engineering performance study with sample sizes, ground truth, experts, adjudication, or AI components. This document is a 510(k) Summary of Safety and Effectiveness, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance study results with the requested metrics.

Given this, the following sections will mostly be marked as N/A or "Not specified."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (test set): Not specified.
• Data Provenance: Not specified. (The document implies engineering and materials testing, but details are absent).
• Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this document does not describe a study involving expert-established ground truth on a test set (e.g., for image analysis or diagnostic accuracy). The "ground truth" for a medical device like this would typically involve engineering specifications, material properties, and potentially animal or cadaveric testing, but details are not provided.

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

• Not applicable. This document does not describe a study that would involve an adjudication method for a test set.

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 (surgical anchor), not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study with human readers and AI assistance is not relevant or described.

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, so standalone performance in that context is not relevant.

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

• The implicit "ground truth" for proving safety and effectiveness of a device like this would involve adherence to material specifications, mechanical performance benchmarks (e.g., pull-out strength, fatigue life), biocompatibility standards, and potentially successful histological outcomes in animal models for bioabsorption. However, the exact types of ground truth and how they were established are not specified in this summary. It states "Testing has been done to prove safety and effectiveness," which generically refers to these types of evaluations.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As above, this is not an AI model.

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