(22 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; - A vascular necrosis of the femoral head; ● - Acute traumatic fracture of the femoral head or neck; ● - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; - . Certain cases of ankylosis.
The Summit Basic Press-Fit Hip Stem is a collared, tapered Titanium femoral stem with a grit blasted finish. The Summit Basic Press-Fit Hip Stem is offered in 7 sizes with a constant neck offset. The stem is intended for cementless, press-fit fixation and is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.
This document is a 510(k) summary for a medical device called the DePuy Summit Basic Press-Fit Hip Prosthesis. It does not describe an AI or software-driven device. Therefore, it does not contain the information required to answer your questions about acceptance criteria and a study proving device performance in the context of AI.
The provided text focuses on:
- Device Description: What the hip prosthesis is made of, its features, and intended fixation method.
- Intended Use and Indications: The medical conditions for which the hip replacement is designed.
- Basis of Substantial Equivalence: How this new device is similar to a previously cleared device (the DePuy Response 2000 Hip Stems), primarily comparing materials and design variations.
- FDA Clearance Letter: Official communication from the FDA confirming substantial equivalence to a predicate device.
To reiterate, there is no mention of acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training/test sets as these concepts apply to the evaluation of AI/software in medical devices.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.