(23 days)
The CHARLOTTE™ CLAW® 3.5 is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The CHARLOTTE™ CLAW® 3.5 consists of curved 4-hole plates and locking screws of various lengths. All plates and screws are manufactured from stainless steel.
I am sorry, but the provided text is a 510(k) summary for a medical device (CHARLOTTE™ CLAW® 3.5), which is a compression plate used for bone fixation. This type of document is for regulatory approval and does not contain any information about acceptance criteria, study design, or performance metrics typically associated with AI/ML-based medical devices.
Therefore, I cannot extract the requested information such as:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document focuses on establishing substantial equivalence to a predicate device based on design features, materials, and analysis data, not on clinical performance studies or AI/ML model 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.