Search Results

This femoral component of the hip is indicated for use in patients with: 1 - Osteoarthritis - 2 Rheumatoid Arthritis - 3 Traumatic Arthritis and when the use of a more conservative procedure has failed or is unacceptable.

The Signal Medical Corporation Femoral Component of the Hip is manufactured with cobalt chromium alloy (ASTM F-75). The design is made available in four (4) sizes ranging from 10.5mm to 15mm. The stem portion of the femoral component is essentially identical to the DePuv AML Femoral Component (K852198) and the BioPro Horizon Femoral Component (K962769). The collar will be available in two different angular settings of 20 degrees to the horizontal and 35 degrees to the horizontal. The device will be offered with and without a sintered beaded surface, as depicted on the engineering drawings. The taper on the trunnion is a standard 5.708 degree angle as found on the Whiteside Biomechanics (K961625) and the StelKast Proform Cemented Femoral Component (K951083). The device has a circumfrential collar to load the bone on the cortical arc and distribute the compressive load of the implant as proximally as possible. The stems distal to the collar are essentially identical in geometry and size as the DePuy AML (K852198) and the BioPro Horizon (K962769). The non-sintered beaded surface device will have a 5mm hole in the distal tip of the implant to accommodate a cement centralizer from the StelKast Corporation (K951083). This device is designed for cemented use only in the non-porous coated version. With the porous sintered beaded surface, the device is designed for both cemented and non-cemented press-fit use.

The provided text is a 510(k) summary for a medical device (SMC Femoral Component) and does not describe any acceptance criteria or a study proving the device meets them in the context of an AI/ML medical device. This document is a regulatory submission for a traditional medical implant, a hip femoral component, seeking substantial equivalence to predicate devices. It focuses on the physical design, materials, and intended uses of the implant.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because these concepts are not applicable to the content of this 510(k) submission.

The document implicitly states the acceptance criteria were met by the FDA's determination of substantial equivalence to predicate devices (DePuy AML Femoral Component K852198, BioPro Horizon Femoral Component K962769, Whiteside Biomechanics K961625, and StelKast Proform Cemented Femoral Component K951083). This determination is based on the device's design, materials, and indications for use being similar to those legally marketed devices. However, this is a regulatory acceptance, not a performance study as would be conducted for an AI/ML device.

Ask a specific question about this device