(66 days)
The KLS Martin Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
The KLS Martin Hand Plating System consists of plates of various lengths and thickness from 0.6mm to 3.0mm and screws of various lengths having a diameter of 1.0mm to 2.7mm.
The provided text is a 510(k) summary for the KLS Martin Hand Plating System and the FDA's response. This type of regulatory document focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than conducting new clinical studies with acceptance criteria, ground truth establishment, or multi-reader multi-case studies for AI models.
Therefore, the input does not contain the information necessary to answer your request regarding acceptance criteria and study details for a device whose performance is being proven through a study. The document confirms that the KLS Martin Hand Plating System is substantially equivalent to existing predicate devices based on material, manufacturing processes, and intended use.
Specifically, there is no mention of:
- Acceptance criteria table or reported device performance metrics. The document compares the new device to predicates based on materials, manufacturing, and intended use, not performance metrics from a study.
- Sample size for test set, data provenance, number of experts, qualifications of experts, or adjudication method for a study designed to prove performance.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes for human readers with/without AI assistance.
- Standalone (algorithm only) performance study. The device is a physical plating system, not an AI algorithm.
- Type of ground truth used.
- Sample size for training set or how ground truth for the training set was established.
The core of this document is a regulatory submission demonstrating substantial equivalence to legally marketed predicate devices, not providing a performance study with detailed acceptance criteria and ground truth validation as would be expected for an AI/diagnostic 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.