(51 days)
The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
Not Found
The provided document is a 510(k) summary for a medical device called the "TriMed Ulnar Osteotomy Plate." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove effectiveness or meeting specific performance acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The 510(k) process for this device relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.
Here's why the requested information is absent:
- Acceptance Criteria & Device Performance: This document does not define specific performance metrics or acceptance criteria for the TriMed Ulnar Osteotomy Plate because its approval is based on substantial equivalence to existing devices (K952766 Rayhack Osteotomy System and K030310 Synthes 3.5/4.5 mm. LCP Metaphyseal Plates).
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone): No clinical trials or performance studies are described in this 510(k) summary. The submission relies on a comparison of the new device's characteristics to those of the predicate devices.
- Ground Truth: Since no performance study is detailed, there's no mention of how "ground truth" would be established.
- Training Set Information: This is relevant for machine learning or AI-driven devices, which this medical plate is not.
In summary, the provided K043263 document describes a traditional medical device submission through the 510(k) pathway, which primarily assesses substantial equivalence and does not typically include the detailed clinical or performance study data you've requested.
§ 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.