(21 days)
The Synthes Ti-15Mo Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The Synthes Ti-15Mo Locking Distal Radius Plating System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal end of the radius.
The provided text is a 510(k) summary for the Synthes Ti-15Mo Locking Distal Radius Plating System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance-based acceptance criteria for AI/ML-enabled software.
Therefore, this document does not contain the information requested in the prompt regarding acceptance criteria and performance studies for an AI/ML device. The device described is a physical implant (bone plate and screws), not a software or AI/ML product.
Here's why the requested information is absent:
- Acceptance Criteria and Performance: The document aims to establish that the new device is as safe and effective as a previously marketed predicate device. It doesn't define quantitative performance acceptance criteria or report performance against such criteria.
- Sample Sizes (Test/Training Data), Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth: These are all concepts relevant to the validation of AI/ML algorithms using clinical data. A physical implant like a bone plate does not undergo these types of studies for 510(k) clearance. Its equivalence is typically based on material properties, design, and intended use compared to the predicate.
In summary, the provided text describes a medical device, but it is not an AI/ML device, and thus the requested information regarding acceptance criteria and studies for AI/ML performance is not present.
§ 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.