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The indications for use for each product cleared under 510(K) remains the same. The only difference in the product is that it will now be available sterile.

Small Fragment Plates and Screws: Used as an aid to the healing of volar rim fractures of the distal radius. Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically: - Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone. - An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. - A combination of the above

Tension Band Wire: Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of the injury.

TriMed Bearing Plate: TriMed Volar Bearing Plate: 1. Fixation of fractures or non-unions of the distal radius 2. Osteotomies of the distal radius to correct malunion.

TriMed Ulnar Osteotomy Plate: The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

TriMed Bone Plates: The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

TriMed Tenodesis Cross Screw and Interference Screw: 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 Reconstruciton, Tendon Transfers in the foot and ankle.

TriMed Suture Bead: 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 products cleared in the 510(K)'s listed above will now be provided sterile by TriMed, Inc. No other changes have been made to the devices. Sterilization, packaging, aging and shipping validations have proven that the product can reach the end user while maintaining a sterility assurance level of 10-6.

The provided document is a 510(k) summary for the TriMed Sterile Product. It states that the product is a sterile version of previously cleared TriMed devices and does not include any studies or performance data related to AI/ML device performance or clinical outcomes.

Therefore, I cannot answer the questions regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, or any aspects of a comparative effectiveness study. The document explicitly states:

"The products cleared in the 510(K)'s listed above will now be provided sterile by TriMed, Inc. No other changes have been made to the devices. Sterilization, packaging, aging and shipping validations have proven that the product can reach the end user while maintaining a sterility assurance level of 10-6."

This indicates that the focus of this 510(k) is solely on the sterility of existing devices, not on new functionality or a new AI/ML algorithm.

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