(36 days)
The UNI-CLIP® STAPLE is implanted for fixation of bone fractures or for bone reconstructions.
The UNI-CLIP® STAPLE is indicated for:
- Mono or bi-cortical osteotomies in the forefoot
- Distal or proximal metatarsal osteotomies
- Fusion of the first metatarsophalongeal joint and the interphalangeal joint
- Fixation of the osteotomies for hallux valgus treatment (such as, Scarf, Chevron)
- Akyn type Osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Arthrodesis and osteotomy fixation in the Midfoot and Hindfoot
The UNI-CLIP® STAPLE is designed so that, by widening the "diamond", mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled, with many choices of size.
The provided text describes a medical device submission (K991482) for the UNI-CLIP® STAPLE, but it does not contain information related to acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications that would be found in a clinical or analytical performance study a for AI/ML device.
The document is a 510(k) summary for a traditional medical device (a bone fixation staple) and focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties and intended use. The "Summary of Studies" section only mentions:
- "Torque of divergence and strenght of compression the UNI-CLIP® STAPLE was studied and found to have a resistance to torsion in compliance with the selected standard."
This is a very general statement about a mechanical test and does not provide the detailed information requested for an acceptance criteria table or a study description as typically applied to AI/ML device evaluations.
Therefore, I cannot populate the table or answer the specific questions provided in the prompt based on the given text. The information required (e.g., acceptance criteria, reported performance values, sample sizes for test/training, ground truth methods, expert qualifications, adjudication, MRMC studies) is completely absent in this document.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.