(149 days)
The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies.
Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.
The High Tibial Osteotomy System is a fracture fixation system used to perform closing wedge osteotomies. It consists of L-plates, cortical and cancellous bone screws, and offset staples.
Materials: The devices are manufactured from CoCrMo ( cast or Wrought ), Ti-6A1-V, and 316 LVM stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following osteotomy.
This looks like a 510(k) premarket notification for a medical device. The provided text is a "Summary of Safety and Effectiveness" which is a high-level overview. It does not contain the detailed information required to describe acceptance criteria and associated study results for AI/ML device performance.
This document specifically states: "Fracture Fixation System" and then describes components like L-plates, bone screws, and staples made from CoCrMo, Ti-6A1-V, and 316 LVM stainless steel. This is clearly a surgical implant/instrument system, not a software or AI/ML-driven diagnostic or therapeutic device.
Therefore, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/ML performance metrics (like sample size for test sets, data provenance, ground truth, MRMC studies, standalone performance, training set details) is not applicable to this specific K963700 submission.
Explanation of why the requested information is not present and cannot be inferred:
- Device Type: The Metagen High Tibial Osteotomy System is a mechanical orthopedic implant and surgical instrument system. Its safety and effectiveness are established through material testing, mechanical testing (e.g., fatigue, static strength), biocompatibility testing, and comparison to existing predicate devices based on design, materials, and intended use.
- No AI/ML Component: There is no mention of any artificial intelligence, machine learning, software algorithm, imaging analysis, or diagnostic function in the provided summary.
- Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to predicate devices. For mechanical devices, this typically involves comparing design specifications, materials, manufacturing processes, and sometimes bench testing results to show similar performance characteristics. It does not involve clinical studies with AI performance metrics.
- Missing Information: All bullet points in your request (acceptance criteria table, sample sizes, ground truth, expert adjudication, MRMC, standalone performance, training set details) are relevant to the evaluation of AI/ML-driven devices. Since this is not an AI/ML device, such information would not be part of its submission or evaluation.
In summary, the provided document K963700 does not describe an AI/ML device, and thus cannot fulfill the request for information pertaining to AI/ML device acceptance criteria and study details.
§ 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.