(111 days)
The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the biomechanical reduction of abnormal intermetatarsal angle.
The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the correction of Hallux Valgus deformities by providing reduction of the 1st intermetatarsal angle.
Not Found
This device, the Instratek HAV-Lok Bunion Correction System, is a traditional 510(k) submission and does not include any studies related to AI/algorithm performance or acceptance criteria in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving the device meets those criteria, as no such information is present in the provided document.
The document states:
- "The technological characteristics between the predicate and proposed devices are the same."
- "There are no significant differences between the proposed and predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness."
- "The HAV-Lok Bunion Correction System, as designed, is as safe and effective as the predicate devices. Comparisons have been made to a legally marketed predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."
This indicates that the device's acceptance was based on its similarity to an already approved device, not on new performance studies with specific acceptance criteria that would typically be associated with AI or novel diagnostic technologies.
§ 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.