(90 days)
The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the device is accomplished through arthroscopy or arthrotomy.
The Meniscal Repair Device is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.
The provided document is a 510(k) summary for a Meniscal Repair Device (Bone Screw) and details its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/machine learning performance.
The study referenced is a non-clinical comparative pull-out strength test, which is a biomechanical test for a physical device, not an evaluation of an AI or algorithmic device.
Therefore, I cannot extract the requested information (points 1-9) as it pertains to AI/machine learning acceptance criteria and studies from this document. The document describes a traditional medical device (a bone screw) and its safety and effectiveness in comparison to existing devices.
§ 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.