(90 days)
The Smith & Nephew ACCORD Cable System is indicated for use in general orthopaedic repair procedures including general cerclage of the femur, trochanteric reattachment, fixation of fractures in conjunction with intramedullary prosthesis (i.e., femoral stem) and screw fixation techniques.
The ACCORD Cable System includes cables (with or without clamps), trochanteric grips, and plates. (K223762).
The Smith & Nephew ACCORD Cable System consists of Cobalt Chrome cables (without clamps) to be used with the ACCORD Titanium trochanteric grips or ACCORD Titanium plates and also Stainless Steel and Cobalt Chrome cables with clamps to be used alone. These materials are identical to the material that has been previously cleared in K223762, K031162, and K993106.
The implants within this system are single-use and are Gamma sterilized.
The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the Smith & Nephew ACCORD Cable System. It does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
Instead, this submission is for labeling updates to an existing, previously cleared medical device (ACCORD Cable System). The core assertion is that there are no significant changes in design, technological characteristics, function, sterilization, or packaging as a result of these labeling updates. Therefore, no performance testing (bench, animal, clinical) was required for this specific 510(k) submission (K233949).
Consequently, I cannot extract the information required to answer your prompt, as the prompt is designed for a study demonstrating the performance of a new or significantly modified device, particularly one involving AI/ML and associated acceptance criteria. The document explicitly states:
- "There is no significant change in design, technological characteristics, function, sterilization or packaging of the devices as a result of this submission."
- "The subject Smith & Nephew ACCORD Cable System devices are identical in function, design features, materials, packaging, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared (K223762, K031162). These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled."
- "Therefore, since there are no changes to the design features, or manufacturing methods of the subject ACCORD Cable System devices, no performance testing (bench, animal, clinical) was required."
This 510(k) relies on the substantial equivalence to its predicate devices (K223762, K031162, K993106), which would have had their own studies to demonstrate safety and effectiveness at the time of their clearance. However, those studies are not detailed in this document.
Therefore, I cannot provide the requested information based on the provided text. The document describes a regulatory filing for a non-AI/ML device that did not require new performance studies due to the nature of the submission (labeling updates only).
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.