(180 days)
The Au/RA™ Cemented Femoral Stem and Cemented Long Femoral Stem are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstruction where sufficient bone stock is present. FOR CEMENTED USE ONLY
The AuRA The femoral stem is manufactured of forged Cobalt Chromium , ASTM F-799-95. The stem body has a trapezoid cross section with a lateral flange in the proximal half and has a grit and bead blast finish. The medial aspect of the stem is defined by broad radii in both planes and the stem body is tapered over the entire length in both the anterior/ posterior and the medial/lateral direction. The neck and collar region of the stems features anterior and posterior neck flats for a maximized range of motion. A wide collar maximizes load transmission to the calcar. Each stem body has a proximal, longitudinal cement interdigitation groove on the anterior and posterior face. There are also locating holes to accept optional centralizers.
The Proximal Centralizer is an injection molded polymethylmethacrylate modular component for use exclusively with the AuRA™ Hip System. It is similar to the Exactech Distal Centralizer previously released for use with the Exactech Cemented Hip. The Proximal Centralizer is a cement spacer which provides a mechanism by which the surgeon can centrally position the proximal aspect of the stem body in the prepared femoral canal.
This is a premarket notification for a medical device (AuRA™ Hip System Cemented Femoral Stem Cemented Long Femoral Stem), not a study assessing the performance of an AI/ML powered device. As such, the input document does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets these criteria.
The provided text describes the device, its materials, mechanical testing, biocompatibility, sterilization, indications, and contraindications. It does not include:
- Acceptance criteria and reported device performance in a table: There are no specific quantitative performance metrics or acceptance criteria for the device described.
- Sample size for the test set and data provenance: No test set is mentioned.
- Number of experts and their qualifications for establishing ground truth: Ground truth is not applicable in this context.
- Adjudication method for the test set: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned as this device is a physical implant, not an AI system.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to existing devices based on design, material, and intended use, rather than presenting a performance study against predefined criteria for a novel AI/ML application.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.