(90 days)
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
- Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are line extensions to the Medacta Total Hip Prosthesis system family AMIStem H, Quadra S and Quadra H femoral stems (K093944), AMIStem C & Quadra C SN (K103189), AMIStem and Quadra - Line Extension (K121011), and AMIStem-H Proximal Coating (K161635).
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants subject of this submission are comprised of the following products:
- AMIStem-H Proximal Coating STD, Stem sizes 00 and 0; ●
- AMIStem-H Proximal Coating LAT, Stem size 0;
- AMIStem-P STD, Stem sizes 00 9; ●
- AMIStem-P LAT, Stem sizes 0 - 8;
- AMIStem-P Collared STD, Stem sizes 00 9; and ●
- AMIStem-P Collared LAT, Stem sizes 0 - 8.
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are part of the brand, Medacta Total Hip Prosthesis system for total and partial hip arthroplasty. The Medacta Total Hip Prosthesis system family consists of femoral stems, modular femoral heads, and acetabular components.
The provided text describes a 510(k) premarket notification for hip joint prostheses, specifically the AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared. It focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data.
However, the provided text does not contain any information regarding the acceptance criteria or study details for an artificial intelligence (AI) device. The "Performance Data" section solely lists non-clinical mechanical and pyrogenicity tests for the hip prostheses, which are physical medical devices, not AI software or algorithms.
Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device using the provided text.
Here's why I cannot fulfill your request:
- No AI Device Mentioned: The document is a 510(k) submission for physical hip implants, not an AI or software as a medical device (SaMD).
- Performance Data Irrelevant to AI: The performance tests listed (range of motion, fatigue testing, pull-off force, pyrogenicity) are standard for orthopedic implants, not for evaluating AI performance metrics like diagnostic accuracy, sensitivity, specificity, etc.
- Missing AI-Specific Details: All your specific questions (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are entirely related to AI model evaluation, which is absent from this document.
§ 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.