(82 days)
The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
The DePuy Advantage Fixation screw is a fully threaded titanium alloy cancellous bone screw available in 7mm and 9mm diameters. Each diameter is available in six (6) lengths (15, 20, 25, 30, 35, and 40mm) in a cannulated version, and in five (5) lengths (20, 25, and 40mm) in a non-cannulated version. The Advantage screw has a polished satin finish, a 29 degree included angle tapered tip, a round body thread, and a radius on the socket end of the screw. Each screw has an internal hex fitting for instrument insertion during surgery.
The provided document is a summary effectiveness statement for a medical device, the DePuy Advantage™ Fixation Screw System. It describes the device, its intended use, and provides a basis for its substantial equivalence to another device (DePuy M. Kurosaka™ Interference Screws).
However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria, especially in the context of typical clinical performance metrics like accuracy, sensitivity, or specificity. It is for a bone screw, not an AI/imaging device, so the requested information (like multi-reader, multi-case studies, ground truth establishment by experts, etc.) is not applicable to this type of device.
Therefore, I cannot fulfill the request as the necessary data is not present in the provided text.
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JUN 19 1996 SUMMAI EFFECTIVENESS
Image /page/0/Picture/1 description: The image shows a document exhibit label. The word "EXHIBIT" is printed in large, bold, black letters at the top of the label. Below the word "EXHIBIT" is the roman numeral "II". There is a horizontal line between the word "EXHIBIT" and the roman numeral.
| NAME OF FIRM: | DePuy Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988 |
|---|---|
| FIRM CONTACT: | Sally FoustClinical Research Specialist |
| TRADE NAME: | DePuy Advantage™ Fixation Screw System |
| COMMON NAME: | Bone Screw |
| CLASSIFICATION: | 888.3040 Smooth or threaded metallic bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC |
SUBSTANTIALLY EQUIVALENT DEVICES:
Depuy M. Kurosaka™ Interference Screw DePuy M. Kurosaka™ Fixation Screw Arthrex TranstibialTM System
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Advantage Fixation screw is a fully threaded titanium alloy cancellous bone screw available in 7mm and 9mm diameters. Each diameter is available in six (6) lengths (15, 20, 25, 30, 35, and 40mm) in a cannulated version, and in five (5) lengths (20, 25, and 40mm) in a non-cannulated version. The Advantage screw has a polished satin finish, a 29 degree included angle tapered tip, a round body thread, and a radius on the socket end of the screw. Each screw has an internal hex fitting for instrument insertion during surgery.
The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Advantage Fixation Screw System screws are substantially equivalent to the DePuy M. Kurosaka Interference Screws cleared for fixation of bone-tendon-bone grafts in ACL reconstruction. All of the DePuy Advantage screws and the M. Kurosaka Interference screws are manufactured from Ti-6A1-4V alloy. All are available in 7mm and 9mm diameters in numerous lengths in cannulated and non-cannulated versions.
§ 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.