(379 days)
The Polypin is intended for use in the fixation of small bone fragments in cases of lowload fractures, such as apical fragments, osteochondral fragments and cancellous/nonload-bearing fragments. Specific applications include the following:
| Apical fragments: | radial head
patellar rim
navicular
metacarpal/metatarsal (proximal or distal ends) |
|---------------------------------------|---------------------------------------------------------------------------------------------|
| Osteochondral fragments: | talus vault
femoral condyle |
| Spongy/non-load bearing
fragments: | talus |
The Polypin is a 2 mm diameter pin of high molecular weight absorbable poly (L/D-lactide). The Polypin is provided with a length of 35 mm, which can be shortened intraoperatively to as little as 10 mm. Eleven ring-shaped ribs, placed at intervals of 2.5 mm on the pin, prevent the implanted pin from slipping out. The small, lens-shaped head of the Polypin permits the pin to be pushed down until it is completely below the surface of the cartilage or bone, permitting low load compression of the bone fragments. The Polypin is provided presterilized by gamma radiation and is not intended to be resterilized by the user.
It appears the provided text describes a medical device (SYNTHES (U.S.A.) POLYPIN) and its characteristics, intended use, and substantial equivalence to other devices. However, the document does not contain information about acceptance criteria, device performance testing against those criteria, or details regarding a study to prove the device meets acceptance criteria as requested in the prompt.
Therefore, I cannot extract the information to populate the requested table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.
The "substantial equivalence" section mentions "extensive in-vitro and in-vivo testing," but it does not provide any results, acceptance criteria, or details about these tests.
§ 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.