(182 days)
The Arthrex TRIMit™ Family, made of polylactide (PLLA), are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts of the foot, ankle, hand, wrist, elbow, and shoulder in the presence of appropriate brace and/or immobilization. More specific surgeries include:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valqus Reconstruction (proximal and chevron), Midfoot Reconstruction, Metacarpal and Metatarsal fusions and Ligament Repair, Tendon transfer in the foot/ankle such as Posterior Tibial Tendon Transfer for Posterior Tibial Tendon Dysfunction, Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Dysfunction, Kidner transfer, Extensor Hallucis Longus transfer, Flexor Hallucis Longus for Achilles Tendon reconstruction, Weber A and B fractures, Lateral and Medial Malleolus Ankle Fracture, Osteochondritis Dissecans, Fractures of the Distal Radius, tibial tubercle avulsions in adolescence
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, phalangeal fracture and fusion, metacarpal fracture and fusion, carpal fusion and fracture, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures
The Arthrex TRIMit™ Family of screws are manufactured using poly(L-lactide). They are threaded, fully cannulated implants. The TRIMit™ implants are available with a reusable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a drill of the appropriate size.
The provided text describes a 510(k) summary for the Arthrex TRIMit™ Family of bone fixation fasteners. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
The information provided does not contain any details about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established. This type of information is typically found in supporting documentation for a 510(k) submission, such as a study report or clinical data summary, which is not part of the provided text.
Based on the provided text, the device is a physical bone fixation fastener (an implant) and not a software algorithm or AI device that would typically have performance metrics like sensitivity, specificity, or AUC. The "performance" of such a device would usually relate to mechanical properties (e.g., tensile strength, bending strength, fatigue life), biocompatibility, and degradation characteristics. These are assessed through bench testing and sometimes animal or clinical studies to demonstrate safety and effectiveness for its intended use, often in comparison to a predicate device.
Therefore, I cannot populate the requested tables or answer the specific questions related to acceptance criteria, study details, and AI/algorithm performance. The provided text is solely a regulatory submission summary focusing on the device description, indications for use, and a statement of substantial equivalence.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.