(29 days)
The InteliFUSE, Inc. Warm System with StimuLinks are used as a system for the following indications:
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hand and foot bone fragment and osteotomy fixation and joint arthrodesis
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fixation of proximal tibial metaphysis osteotomy
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fixation of soft tissue to bone such as anterior cruciate reconstruction.
The system consists of two and four prong staples for use in various fixation techniques. The Nitinol staples have prongs which are parallel during insertion. Application of heat from the Warm System to the staple causes the prongs to deflect inward. This inward deflection results in staple compression and retention. The heat is applied through two electrodes in an autoclavable heating wire. The electrodes are applied to the back of the implanted staple to activate heating.
An accessory pack is provided with the Warm System and includes the resterilizable current source, drill bits of different sizes for creating proper hole diameters, a drill guide for depth gauging, an impactor for tapping the staples in place, forceps, and a locator pin. The accessory pack components are all commercially available finished devices.
The 2 prong StimuLink staples are available in wire thicknesses from 1.2 x 1.2 mm to 2mm x 3 mm, and in lengths and heights from 5 to 30 mm, including uneven prong heights. Four prong plates for multiaxial loads are available in ranges from 15 x 6 x 6 mm to 15 x 6 x 10 mm.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document describes a medical device (InteliFUSE, Inc. Warm System with StimuLinks) and its intended use, but does not include details of any studies or tests conducted to prove its performance against specific criteria.
§ 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.