(266 days)
The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis.
The HKT Anatomical Locking Trauma System consists of metallic bone fixation plates and metallic screw fasteners. The bone plates and screws are composed of titanium alloy Ti-6Al-4V and commercially pure (Cp) titanium. The devices are used for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis. The bone plates are anatomically pre-contoured and offered in various shapes and sizes to allow for the orthopedic surgeon or equivalent medical professional to choose which device best fits each patient within the indication for use.
The provided text is a 510(k) premarket notification for a medical device called the "HKT Anatomical Locking Trauma System." This document aims to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market.
However, the request asks about
- acceptance criteria and the study that proves the device meets the acceptance criteria.
- The details pertain to AI/ML-based medical devices, particularly focusing on aspects like sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment.
The provided regulatory filing (K231213) is for a hardware medical device (metallic bone fixation appliances and accessories) and does NOT contain information related to AI/ML software. Therefore, it does not describe acceptance criteria or a study proving performance for an AI/ML device.
The document states:
- "No clinical data was provided to demonstrate substantial equivalence."
- "Based on the testing performed, including biocompatibility and performance testing per recognized consensus standards, it can be concluded that the subject devices are substantially equivalent to the predicate devices."
- "The following tests were performed to demonstrate performance and safety based on current industry standards:
- Biocompatibility: Cytotoxicity per ISO 10993-5, Irritation per ISO 10993-23, Acute and Subacute/Subchronic Systemic Toxicity per ISO 10993-11
- Performance Testing: Standard Specification and Test Method for Metallic Bone Plates per ASTM F382, Standard Specification and Test Methods for Metallic Medical Bone Screws per ASTM F543"
In summary, none of the requested information (acceptance criteria for AI/ML, sample sizes for AI/ML test/training sets, expert details, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, how ground truth for training was established) can be extracted from this document, as it pertains to a hardware device (bone plates and screws) and not an AI/ML software device.
§ 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.