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The TopLock Anchor System is intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation, Rotator Cuff Repair, Capsule Repair, Biceps Tenodesis. Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction, Bicep Tendon Reconstruction, Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction, Ulnar / Radial Collateral Ligament Reconstruction, Extensor Tendon Repair, Flexor Tendon Repair
The Knee:
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Tendon Repair
The Ankle and Foot:
Lateral Ligament Stabilization Repair, Medial Ligament Stabilization Repair.
Achilles Tendon Repair / Reconstruction, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Mid and Rear Foot Reconstruction

The TopLock Anchor System consists of a collection of barbed suture anchors, manufactured from medical grade Polyetheretherketone or PEEK (ASTM F2026). The anchors are offered from diameters of 3.5mm to 5.0mm with each size offering two eyelet size options to accommodate suture and suture tape. The size range and configurations are offered for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

This document is a 510(k) premarket notification for a medical device (TopLock Anchor System). It describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence.

Crucially, this document explicitly states that no clinical studies were performed to prove the device meets acceptance criteria. Instead, non-clinical tests (mechanical testing, cleaning, packaging, sterilization, pyrogenicity) were conducted to demonstrate design equivalence to predicate devices.

Therefore, I cannot provide the detailed information requested in the prompt regarding acceptance criteria, study design, ground truth, or expert involvement for clinical performance. The information provided in the document pertains to non-clinical acceptance criteria and testing for mechanical and material equivalence.

Based on the provided text, here's what can be extracted regarding the device's validation:

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Regarding the specific questions about clinical performance and AI-related studies:

1. A table of acceptance criteria and the reported device performance: Covered above for non-clinical aspects. No clinical performance criteria or data are provided.
2. Sample size used for the test set and the data provenance: Not applicable to clinical performance as no clinical studies were performed. For non-clinical tests, specific sample sizes are not detailed, but standard validation protocols would have been followed for mechanical and material testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical outcomes was not established as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a surgical implant, 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 device is a surgical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical performance. For non-clinical testing, the "ground truth" would be established engineering and material specifications, and regulatory standards.
8. The sample size for the training set: Not applicable. No training set for an AI/algorithm was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, the TopLock Anchor System received 510(k) clearance based on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing (mechanical, material, and sterility validations), rather than through clinical performance studies. The document explicitly states: "No clinical studies were performed."

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