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The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The Arthrex Bio-Corkscrew Suture Anchor is a 5.5 x 15mm fully threading anchor configured with suture or with suture and needles.

This K043337 submission for the Arthrex Bio-Corkscrew Suture Anchor is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device). For devices cleared via 510(k), especially for general orthopedic fixation devices like suture anchors, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to a predicate device's performance, rather than through a rigorous, AI-specific performance study with pre-defined acceptance criteria and ground truth validation. This clearance relies on the established safety and effectiveness of the predicate.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in a 510(k) submission for this type of device, as it does not involve an AI/ML algorithm or a new performance claim that requires such a study design.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (General to 510(k) process):

• Same Intended Use: The new device must have the same intended use as a legally marketed predicate device.
• Same Technological Characteristics: The new device must have the same technological characteristics as the predicate, OR different technological characteristics must not raise new questions of safety and effectiveness.
• No New Questions of Safety and Effectiveness: Any differences in technological characteristics must be demonstrated to be as safe and effective as the predicate.

Reported Device Performance (as per the 510(k) Summary):

2. Sample Size Used for the Test Set and the Data Provenance

• Not applicable: This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI/ML algorithm or a performance study requiring such a sample size. The substantial equivalence relies on comparison to a predicate device and potentially non-clinical bench testing (but details of such testing are not provided in the summary).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable: No "ground truth" was established for a test set in the context of an AI/ML or diagnostic performance study as described in the provided document.

4. Adjudication Method for the Test Set

• Not applicable: There was no test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: An MRMC comparative effectiveness study was not done, as this is a medical device for physical fixation, not an image analysis or diagnostic AI tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable: This device is a physical suture anchor, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable: No "ground truth" data of the type requested (expert consensus, pathology, outcomes data) was used in this 510(k) submission for the purpose of validating an AI/ML model or a new diagnostic claim. The "ground truth" for substantial equivalence is effectively the performance and safety profile of the predicate device.

8. The Sample Size for the Training Set

• Not applicable: This submission does not involve a "training set" for an AI/ML model.

9. How the Ground Truth for the Training Set Was Established

• Not applicable: This submission does not involve an AI/ML model or a training set requiring ground truth establishment.

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