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Tornier® Insite™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The devices described in this 510(k) Notice are exactly the same device as the predicate Axya Medical Suture anchors described in the 510(k) Notices listed above. The various anchors are fabricated from titanium, PLLA absorbable polymer and acetal polymer. They are provided in diameters of 3mm, 5mm and 6.5mm to facilitate the attachment of soft tissue to bone.

No changes have been made to the devices.

This document is a 510(k) summary for a medical device called Insite™ Suture Anchors. It does not describe a study involving acceptance criteria or device performance in the way a clinical trial or AI model validation would. Instead, it argues for "substantial equivalence" to previously cleared predicate devices.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense of a clinical trial or AI model. The "acceptance criteria" here is that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and performs as safely and effectively. The "performance" is implicitly deemed equivalent to the predicates.

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

Not applicable. This is a claim of substantial equivalence for a physical medical device, not a data-driven study with a test set. There is no "test set" in the context of an algorithm or diagnostic accuracy study.

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

Not applicable. There is no ground truth establishment in the context of a data analysis or diagnostic accuracy study. The "ground truth" for the predicate devices' safety and effectiveness would have been established through their initial clearances and post-market surveillance.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication in this context.

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 physical suture anchor, not an AI or diagnostic imaging system that would involve human readers.

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

Not applicable in the sense of a data-driven study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Axya Medical Suture anchors) based on their prior 510(k) clearances, their established history of use, and testing performed according to FDA guidelines. The claim is that the Insite™ Suture anchors are identical and therefore have the same "ground truth" performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for physical device equivalence.

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

Not applicable. There is no "training set" for physical device equivalence.

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