(113 days)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disoular necrosis of thefemoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head: pathological fractures of the femoral neck: and osteoarthritis in which the femoral head is primarily affected.
The Zimmer M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is flat, collarless and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the porous coating.
Please note that the provided text is a 510(k) summary for a medical device (Zimmer M/L Taper Hip Prosthesis), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a novel AI/software medical device.
Therefore, the requested information elements related to AI/software performance studies (such as acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes a traditional medical device (hip prosthesis) and its non-clinical performance testing.
However, I can extract the information that is present in the document which aligns with your request for device performance and study details, interpreting "acceptance criteria" through the lens of device validation for mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 7206-6 & ISO 7206-4) | Reported Device Performance (M/L Taper Hip Prosthesis) |
|---|---|
| Meets requirements for proximal fatigue testing | Meets performance requirements |
| Meets requirements for distal fatigue testing | Meets performance requirements |
| Meets endotoxin limits (USP39-NF34 Chapter 161) | Met the endotoxin limits |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the proximal and distal fatigue testing or bacterial endotoxin testing.
The data provenance is non-clinical testing, performed by the manufacturer, Zimmer, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable as the document describes non-clinical mechanical and biological testing for a hardware device, not an AI/software medical device requiring expert-established ground truth. The "ground truth" here is the physical performance of the device against established standards.
4. Adjudication Method for the Test Set
This is not applicable for mechanical and biological non-clinical testing. Performance is assessed against quantitative standards outlined in the ISO and USP guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI/software devices, not for a hip prosthesis.
6. If a Standalone Performance Study was done
Yes, standalone (non-clinical) performance testing was done on the device itself. This included:
- Proximal fatigue testing to ISO 7206-6
- Distal fatigue testing to ISO 7206-4
- Bacterial endotoxin testing to USP39-NF34 Chapter 161
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" was defined by:
- Engineering performance standards (ISO 7206-6, ISO 7206-4) for mechanical properties.
- Biological safety limits (USP39-NF34 Chapter 161) for endotoxin levels.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical hip prosthesis, not an AI/software algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical 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.