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The TriMed Tenodesis Cross Screw and Interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include:

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand and wrist.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment.

The TriMed Suture Bead is not indicated for use within intra-articular sites.

The TriMed Tenodesis Cross Screw and Interference Screw are cannulated single use bone screws. The screws are made of implant grade stainless steel, titanium or PEEK, the suture beads are made of implant grade stainless steel or titanium. All products will be available sterile and non-sterile. Variations in implant size, diameter, shape and materials for all components are intended to allow the implants to accommodate variations in patient size, graft size and sites of application.

This document is a 510(k) Pre-Market Notification for the TriMed Tenodesis Cross Screw, Interference Screw, and Suture Bead. It describes the intended use, device description, and substantial equivalence to previously cleared devices.

Crucially, this document does NOT contain any information about acceptance criteria or a study proving the device meets those criteria. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data or formal clinical trials with acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Here is what I can extract from the document, but it does not fulfill the prompt's requirements regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available in the provided text. The submission focuses on substantial equivalence, not performance against specific acceptance criteria.

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

Not applicable. No performance study data is presented.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No performance study data requiring expert ground truth is presented.

4. Adjudication Method:

Not applicable. No performance study data requiring adjudication is presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document does not present any MRMC studies nor compare human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

No. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used:

Not applicable. No performance study data is presented.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

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