(87 days)
The "new" I.CO.S Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of bone fragments, in long bones or small bones fractures.
- · Fractures management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
The size of the chosen screw should be adapted to the specific indication.
The "new" I.CO.S" Screw is a cannulated compression screw with non-theaded shaft, allowing optimal compression. The head of this screw can be driven forward and translated along the body in order to increase the compression controled by the surgeon. It also has a self-tapping screw tip. It comes in diameters from 4.0 mm to 6.5 mm and in length from 26 to 90. It is identical in design to the I.CO.S® Screw (K993762)
The provided document is a 510(k) summary for the I.CO.S® Screw, a bone fixation device. It describes the device, its intended use, and claims substantial equivalence to predicate devices already on the market. However, this document does not contain information about acceptance criteria, detailed study designs, sample sizes, or expert involvement as typically found in a clinical or performance study report for AI/CAD devices.
The "Summary of Studies" section (Section O) only briefly mentions that the "rupture torque of the 'new' I.CO.S® Screw is the same as for the device cleared, since the design has not changed. It was compared with requirements of the French Standard NºNF-S -90414 and found to have a resistance torsion in compliance with the selected standard." This is a purely mechanical performance test against a standard, not a study of device performance in a clinical setting or its effectiveness with human readers.
Therefore, I cannot provide the requested information from the provided text. The questions posed relate to the evaluation of AI/CAD devices, which involve performance metrics like sensitivity, specificity, reader studies, and ground truth establishment, none of which are present in this 510(k) summary for a mechanical bone screw.
§ 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.