(38 days)
1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals;
2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities.
3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
Biomet OrthoSorb LS resorbable fixation devices include straight and tapered pins. Biomet OrthoSorb LS resorbable fixation devices are made of a resorbable copolymer, polyester derivative of L-lactic and glycolic acids. Poly L-lactic/polyglycolic acid copolymer degrades and resorbs in-vivo by hydrolysis into L-lactic and glycolic acids which are then metabolized by the body.
This is not an AI/ML device, therefore, the requested information is not applicable.
This is a medical device submission for the OrthoSorb LS, a resorbable fixation device (pin) made of a polyester derivative of L-lactic and glycolic acids. The document describes the device, its indications for use, and a summary of substantial equivalence to predicate devices based on mechanical testing.
Here's a breakdown of why an AI/ML device report is not appropriate:
- Device Description: The OrthoSorb LS is a physical pin. AI/ML devices typically refer to software algorithms that perform tasks like image analysis, diagnosis, or prediction.
- Technological Characteristics: The characteristics mentioned are "design, dimensions, and material," which are typical for physical implants.
- Summary of Substantial Equivalence: The equivalence is demonstrated through "mechanical testing that was performed to ASTM D6272" and "Single Shear testing." These are physical tests, not evaluations of algorithmic performance.
- No mention of AI/ML or Software: The document makes no reference to any artificial intelligence, machine learning, software, data processing, or algorithmic components.
Therefore, the requested fields related to acceptance criteria, ground truth, training sets, and expert evaluations for AI/ML performance are not present because the device described is a physical implant, not an AI/ML product.
§ 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.