(15 days)
Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The Piccolo Composite Nailing System includes nails, screws and a set of instruments.
The Piccolo Composite Nail, indicated for treatment of the tibia and femur, is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 400 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 160 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
The provided text is a 510(k) summary for the CarboFix Orthopedics Ltd. Piccolo Composite™ Nailing System. This document describes a medical device (intramedullary nailing system) and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance is not present in this document.
The document indicates that the company performed static 4-point bending evaluation, static torsion evaluation, dynamic evaluation, and evaluation supporting MR Conditional labeling, demonstrating that the device is safe and effective for its intended use. However, explicit acceptance criteria values and the detailed results of these evaluations are not provided in this summary.
Therefore, I cannot fulfill your request for the specific table and details related to AI/ML device performance and testing.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.