(139 days)
Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The DYNASTY® Acetabular System with Ceramic is manufactured from alumina matrix composite. The components are offered in sizes ranging from 32mm to 40mm.
The provided text describes a 510(k) summary for the DYNASTY® Acetabular System with Ceramic, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to an AI/ML algorithm.
Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance for an AI/ML device, nor can I answer questions regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The document states:
- "Clinical data was not provided for the subject devices." This explicitly indicates that no clinical study was performed to assess the device's performance in humans.
- "The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically, tribologically, and chemically." This suggests non-clinical (laboratory) testing was conducted, but the details of acceptance criteria for these tests and their results are not provided in a summary format. The document mentions that the testing "shows that it can be concluded that the subject ceramic material can be expected to perform well under normal physiological chemical and mechanical conditions," implying the tests were successful in demonstrating performance without specifying the criteria or results.
- The entire submission hinges on "Substantial Equivalence Information" to predicate devices. This means the device is considered safe and effective because it is very similar to devices already cleared by the FDA, rather than proving its effectiveness through new clinical trials against specific performance criteria.
In summary, the provided text does not contain the information needed to answer your questions regarding acceptance criteria and performance studies for an AI/ML device.
§ 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.