(101 days)
The In2Bones USA, CoLink Vallux Plating System is indicated for fixational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
The In2Bones CoLink Vallux Plating System includes a plate and screws and surgical instruments used to treat Hallux Valgus and reconstruction of bone for bunion corrections. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink Vallux Plating System.
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets them. The document is an FDA 510(k) clearance letter for the "CoLink Vallux Plating System," which is a metallic bone fixation device.
The document discusses:
- The FDA's determination of substantial equivalence to previously cleared predicate devices.
- The intended use of the device (fixation of osteotomies and corrective procedures of the hallux and associated disorders like hallux valgus).
- The materials used (Titanium Alloy).
- The fact that no additional mechanical testing was required because the screws are identical to previously cleared screws and no new worst-case plates or screws were added. A rationale was conducted to show substantial equivalence based on existing CoLink Plating System data.
- Adoption into previously provided sterilization, packaging, and endotoxin validations.
There is no mention of any study involving AI, human readers, ground truth establishment, training sets, or test sets. The entire document is focused on demonstrating substantial equivalence for a medical device (bone plates and screws), not a software or AI-based diagnostic tool.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text does not contain this information.
§ 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.