(71 days)
Synthes Ti External Fixator Clamps are used in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation.
Synthes Ti External Fixator Clamps are manufactured from Titanium-6% Niobium (Ti-6A1-7Nb) or a Titanium-6% Aluminum-4% Vanadium (Ti-6A1-4V) alloy.
This document is a summary of safety and effectiveness information for Synthes Ti External Fixator Clamps, submitted to the FDA in 1996. It details a comparison against other Synthes clamps and specifies the material used. However, it does not contain any information regarding acceptance criteria, study methodologies, or performance results in the context of a statistical study with a device and ground truth, as typically required in modern AI/medical device evaluations.
Therefore, I cannot extract the requested information. The provided text is a regulatory submission for a physical medical device (external fixator clamps) in 1996, and not a study report or a "Summary of Safety and Effectiveness Data" that would include performance metrics against acceptance criteria using a test set with ground truth, as implied by your request for AI/diagnostic device-like information.
To elaborate on why each of your requested points cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The text states "Based on the mechanical properties for the Ti-6A1-7Nb material, the External Fixator Clamps will perform at least equivalent to Ti-6Al-4V External Fixator Clamps." This is a general statement about anticipated equivalency based on material properties, not a measured performance against specific acceptance criteria.
- Sample size used for the test set and the data provenance: Not present. No test set or data provenance is mentioned.
- Number of experts used to establish the ground truth... and qualifications: Not present. "Ground truth" as a concept for a diagnostic or AI device is not applicable here.
- Adjudication method: Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not present. This type of study is for diagnostic/AI devices, not for mechanical fixation clamps in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.