(49 days)
The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System/CoLink® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The In2Bones CoLink® Mini Plating System is a system of plates and screws and surgical instruments intended for stabilization of forefoot and midfoot fractures. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® Mini Plating System.
This document is a 510(k) premarket notification from In2Bones USA, LLC for their CoLink® Mini Plating System. The FDA's letter and the company's 510(k) Summary confirm that the device is a metallic bone fixation appliance used for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of small bones in the hand, wrist, foot, and ankle for both pediatric and adult patients.
However, the provided text does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device. The document is for a traditional medical device (metallic bone plates and screws), and the "Performance Testing" section explicitly states that "No additional mechanical testing was required for the CoLink® Mini Plating System." Instead, it relies on engineering analysis and comparison to previously cleared predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with defined acceptance criteria and human or algorithmic performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these concepts are not relevant to the type of device and submission described in the provided text. The "Conclusion" section within the 510(k) Summary explicitly states: "Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices." This highlights that the basis for clearance is substantial equivalence to existing devices, not a new performance study against specific acceptance criteria.
§ 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.