(85 days)
The Arthrex Bio-Compression Screw is intended for fixation of fractures, osteotomies and arthrodesis in:
- 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
where size of offered implant is patient appropriate.
The Arthrex Bio-Compression Family is currently comprised of enhanced Poly(I-Lactide) or PLLA implants in various lengths and diameters. They are offered sterile.
This 510(k) summary (K060478) describes the Arthrex Bio-Compression Family of implants, which are enhanced Poly(L-Lactide) or PLLA implants used for the fixation of fractures, osteotomies, and arthrodesis in various anatomical locations.
Based on the provided text, the submission does not contain information regarding an AI/ML powered device or a study involving acceptance criteria and device performance in the context of an AI/ML solution.
This document is a traditional 510(k) submission for a physical medical device (bone fixation screw) and, as such, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, and ground truth for training are not applicable to this type of submission.
The "studies" mentioned relate to "in house test data" and "articles cited" to support the use of the device in the same manner as a competitor, indicating traditional engineering and biomechanical testing for device safety and effectiveness.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as these concepts, as framed in the request, are not present in the provided 510(k) for this specific type of physical medical implant.
§ 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.