(63 days)
The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps.
The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device called the "Synthes SSEF" and compares it to another device, the "EBI's Orthofix Penning Dynamic Wrist Fixator," based on mechanical testing.
However, it does not discuss:
- Acceptance criteria or reported device performance in the context of a study involving AI or diagnostic accuracy. The "performance" mentioned refers to mechanical performance, not diagnostic.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods. These are typical elements of studies evaluating AI or diagnostic tools, which is not the subject of this document.
- MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot populate the table or provide the detailed information requested based on this text.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A small circle with a dot in the center is located to the upper right of the word.
NOV 1 2 1996
Summary of Safety and Effectiveness Information Attachment IX:
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647 - 9700 Contact: Angela J. Silvestri September 1996
Synthes SSEF is compared to the EBI's Orthofix Penning Dynamic Wrist Fixator.
The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. It is anticipated that the most common use of the device would be as follows:
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- A small incision is made over the second metacarpal and radius.
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- Using the Parallel Drill Guide for soft tissue protection and positioning, a pair of Self-Drilling Schanz Screws are inserted into the second metacarpal and radius.
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- An adjustable clamp is slid over each pair of Schañz Screws and tightened to lock on the pins.
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- An appropriately sized rod is slid through each clamp.
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- End caps are applied to each end of the rod to captivate the clamps.
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- The fracture is reduced.
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- The remaining screws on both adjustable clamps are tightened to hold the reduction.
The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride.
The EBI's Orthofix Penning Dynamic Wrist Fixator also stabilizes fractures of the distal radius. It is manufactured from stainless steel and anodized aluminum.
Based on the results of the mechanical testing, Synthes SSEF is at least equivalent to the EBI's Orthofix Pennig Dynamic Wrist Fixator in 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.