(196 days)
The WishBone Medical Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis.
Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.
Not Found
The provided text is a 510(k) premarket notification letter and the "Indications for Use" for the WishBone Medical Plate and Screw System. It is a regulatory document concerning a bone fixation device, not a study report for an AI/algorithm-driven medical device. Therefore, it does not contain information on acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or comparative effectiveness studies typically associated with AI device evaluations.
The document primarily states that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices.
Missing Information:
The document lacks all the requested details regarding acceptance criteria and the study proving the device meets them because it is not a study report for an AI/algorithm device. Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications.
- Adjudication method.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information on standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.