(87 days)
Components of the Ascendant Acetabular System are intended for use in total hip arthroplasty for treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty.
The Ascendant Acetabular System consists of two modular shell options which mate with currently marketed insert components for replacement of the acetabulum during total hip arthroplasty. They are designed to provide congruency with the ability to effectively seal the acetabulum, and may be implanted with or without bone cement. Press-fit fixation (e.g. cementless) to the bone is achieved by an oversized shell with a grit blasted, Chemtex (chemically textured process) surface.
The provided text is a 510(k) summary for the Sulzer Orthopedics Ascendant Acetabular Shell System, a medical device for total hip arthroplasty. It details the product description, its intended use, and claims substantial equivalence to previously marketed devices.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics or statistical analysis.
The text focuses on:
- Product Description: Materials, surface, locking mechanism, dome hole, and variations of the shell (Cluster-Hole and Multi-Hole).
- Intended Use/Indications for Use: Specific patient conditions and scenarios for total hip arthroplasty.
- Substantial Equivalence: A claim that the device is similar to existing legally marketed devices based on materials, general design features, and intended uses. This is a regulatory pathway to market for Class II and Class III devices, implying that if the new device is substantially equivalent to a predicate device, it is considered as safe and effective as the predicate.
Therefore, I cannot provide the requested information as it is not present in the given input. The input describes the device and its regulatory clearance, but not the specific studies and acceptance criteria related to its performance attributes (e.g., strength, durability, biocompatibility) that would typically be part of a design verification and validation report submitted to the FDA, but not necessarily summarized in the public 510(k) summary provided.
If this were a submission for an AI/ML a medical device, the types of studies and acceptance criteria mentioned in the prompt (e.g., sample size, ground truth, expert adjudication, MRMC studies) would be highly relevant. However, for a mechanical implant like the acetabular shell, the "acceptance criteria" and "study" would refer to engineering tests (e.g., fatigue testing, wear testing, material strength, biocompatibility tests) rather than reader studies or AI model performance metrics.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.