(90 days)
Deformity of the great toe when it is bent to the outside toward the other toes. Commonly referred and to as: Hallux Valgus
Osteotomy or fracture fixation of the small bones of the hand or foot.
Not Found
I am sorry, but based on the provided text, I cannot provide the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Plaquagrafe and P4V Agrafe". It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the letter does not contain any information regarding:
- Specific acceptance criteria or reported device performance metrics.
- Details about a study to prove the device meets acceptance criteria.
- Sample sizes, data provenance, number or qualifications of experts, or adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
- The type of ground truth used or details about the training set.
The document primarily focuses on the regulatory clearance for the device, not the technical details of its performance validation.
§ 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.