(217 days)
Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.
Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. It is manufactured from commercially pure titanium. The plate is T-shaped, with the head 10° from perpendicular to the shaft, is precontoured, and is available in right and left versions. The head can be cut to size; it has up to six threaded holes, and accepts either 2.4 mm Cortex Screws or 1.8 mm Buttress Pins. The shaft can also be cut to size, and has up to five compression holes, two being elongated shaft holes to facilitate positioning, and accepts 2.7 mm Cortex Screws.
This document describes a medical device, the Synthes Volar Distal Radius Plate, and compares it to an existing device, the Synthes Small T-Plate. However, it does not contain information about acceptance criteria or a study related to device performance in terms of diagnostic accuracy or clinical effectiveness for AI/ML or imaging-based devices.
The document focuses on:
- Intended Use: Fixation of fractures and osteotomies of the distal radius.
- Material: Commercially pure titanium for the new device, 316L stainless steel for the comparator.
- Design Features: T-shaped, precontoured, dimensions, screw types accepted.
- Sterilization: Gamma radiation for sterile versions, steam sterilization guidelines for non-sterile.
- Performance Claim: Based on mechanical testing, the Synthes Volar Distal Radius Plate is at least equivalent to the Synthes Small T-Plate.
Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:
- A table of acceptance criteria and the reported device performance (in terms of diagnostic accuracy/clinical outcomes).
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
This document describes a traditional medical implant, and the "study" mentioned is "mechanical testing" to demonstrate equivalence in physical properties, not clinical or diagnostic performance.
§ 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.