(74 days)
Synthes 7.0/7.3 mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments.
Synthes 7.0/7.3 mm Cannulated Screws are available in multiple thread length configurations (16 mm, 32 mm or fully threaded). Both Screws feature reverse cutting flutes and cancellous threads. Additionally, the 7.3 mm Cannulated Screw features self-drilling/self-tapping flutes. Both screws are used in conjunction with a guide wire for precise placement in bone. Synthes 7.0/7.3 mm Cannulated Screws are manufactured from stainless steel. The 7.3 mm Cannulated Screw is also available in a titanium alloy.
This document is a summary of safety and effectiveness information for a medical device (Synthes 7.0/7.3 mm Cannulated Screws). It does not contain information about a study that uses Artificial Intelligence (AI) or machine learning to meet acceptance criteria through device performance.
Therefore, I cannot provide the requested information, such as acceptance criteria and device performance in an AI context, sample sizes for test and training sets, expert qualifications, adjudication methods, or ground truth types, because the document describes a traditional mechanical medical device and its mechanical testing, not an AI-powered device.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters, with a circled "R" symbol to the left and a registered trademark symbol to the right. To the right of the word "SYNTHES" is the text "K 96 2011" in a handwritten style. The text is black and the background is white.
Summary of Safety and Effectiveness Information Attachment VI:
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647 - 9700 Contact: Angela J. Silvestri May 21, 1996
Synthes Sterile 7.0/7.3 mm Cannulated Screws are compared to Synthes 6.5 mm Cancellous Screws.
Synthes 7.0/7.3 mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments. Synthes 7.0/7.3 mm Cannulated Screws are available in multiple thread length configurations (16 mm, 32 mm or fully threaded). Both Screws feature reverse cutting flutes and cancellous threads. Additionally, the 7.3 mm Cannulated Screw features self-drilling/self-tapping flutes. Both screws are used in conjunction with a guide wire for precise placement in bone. Synthes 7.0/7.3 mm Cannulated Screws are manufactured from stainless steel. The 7.3 mm Cannulated Screw is also available in a titanium alloy.
Additionally, the Ace 6.5 mm Ti Cannulated Cancellous Screw System, the Richards 8.0 mm Cannulated Screw, and Zimmer Magna-Fx Cannulated Screw Fixation System are commercially available devices that are also similar to the 7.0/7.3 mm Cannulated Screws.
Synthes 7.0/7.3 mm Cannulated Screws will be provided sterile; Gamma radiation will be used to sterilize the device.
Based on mechanical testing, Synthes 7.0/7.3 mm Cannulated Screws are at least equivalent to Synthes 6.5 mm Cancellous Screws.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.