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The Herculon* Soft Tissue Reattachment System is indicated for the reapproximation of soft tissue.
SHOULDER: Bankart, Slap lesion, Rotator cuff, and Deltoid repair. Acromio-clavicular separation, capsular shift/capsulolabral reconstruction and Biceps tenodesis.
ELBOW: Tennis elbow repair, biceps tendon reattachment.
KNEE: Extra capsular repairs; reattachment of medial and lateral ligaments, posterior oblique ligament or joint capsule to tibia, and joint capsule closure to anterior proximal tibia; Extra capsular reconstruction, ITB tenodesis, Patellar ligament and tendon avulsions.
ANKLE: Lateral and medial instability, Achilles tendon repair/reconstruction.
PELVIS: Fixation in pubic bone for the purpose of bladder neck suspension.

The Herculon* Soft Tissue Reattachment System is a nonabsorbable repair device used to attach soft tissue to bone using sutures. The device is a self tapping, Ti-6Al-4V threaded implant that accommodates one or two sutures. The sterile package includes a Suture Anchor, Inserter, and polyester suture.

I apologize, but the provided text from the 510(k) summary (K040594) for the "Herculon* Soft Tissue Reattachment System" does not contain information about acceptance criteria or specific studies performed to prove device performance.

The document primarily focuses on:

• Device Description (suture anchor system)
• Classification Information
• Indications for Use
• Materials
• Predicate Device identification ("Ogden* Suture Anchor with Suture (K020352)")
• A declaration of substantial equivalence to the predicate device.
• The FDA's letter of clearance.

There is no mention of:

• A table of acceptance criteria or reported device performance metrics.
• Details of any specific studies (e.g., sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, training set information) that would typically be included to demonstrate device efficacy or safety.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive new clinical trials or performance studies that generate new acceptance criteria and detailed performance data, especially for devices like this which are often evaluated based on material safety and mechanical properties similar to existing devices.

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