(131 days)
The Arthrex Compression FT Screws is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
- Osteochondral fragments (talar vault, femoral condyle)
- apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
- cancellous fragments (talus)
- Carpal, metacarpal, and small hand bone
- tarsal and metatarsals
- phalanges
- Intra-articular fractures
- ankle
- proximal and distal humerus
- proximal and distal radius
- proximal and distal ulna
- osteochondral fixation and fractures
- Osteochondritis Dissecans
- Fixation of fractures and osteotomies about the knee
- Oblique fractures of the fibula
- Reconstructive surgeries of the foot
- malleolar fixation
The Arthrex Compression FT Screws are a family of screws designed to provide fixation of fractures, osteotomies and arthrodesis. These titanium screws are cannulated with a tapering head. The screws will be offered in three diameters, 2.8mm, 3.7mm and 4.1mm, and will range in length from 8mm to 50mm.
The provided document is a 510(k) summary for a medical device, the Arthrex Compression FT Screws. However, it does not describe acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic AI/machine learning device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical screw used for bone fixation. The "study" mentioned is mechanical testing (insertion, pull-out, and compression) to show that the physical properties of the proposed screws are comparable to predicate devices. This is a common requirement for Class II medical devices seeking 510(k) clearance, where safety and effectiveness are established by showing similarity to currently marketed devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they would apply to an AI/machine learning diagnostic device (e.g., performance metrics like sensitivity, specificity, AUC, human reader improvement, ground truth establishment) because this document is about a different type of medical device entirely, a bone fixation screw, and its clearance process does not involve AI performance evaluation.
The categories you requested are relevant for AI/ML device evaluations. The information present in the document is about mechanical testing and regulatory classification of a physical orthopedic implant.
If you have a document detailing a study for an AI/machine learning diagnostic device, please provide that, and I would be happy to describe its acceptance criteria and study details.
§ 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.