(156 days)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral 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; elderly, 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; nonumon 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 femoral stem is for cementless use only.
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 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 coating.
The provided text is a 510(k) summary for the Zimmer M/L Taper Hip Prosthesis, which describes its indications for use, technological characteristics, and a summary of performance data. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the detailed elements requested in your prompt.
Therefore, many of the requested elements (e.g., specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in this document.
This submission relies on non-clinical tests (performance testing, fatigue testing, range of motion testing) and states that clinical test data is not provided. The purpose is to show that the modified device is substantially equivalent to existing, legally marketed predicate devices, implying that if the predicates met their safety and effectiveness requirements, this device, being substantially equivalent, also meets them.
Here's a breakdown of what can be extracted or inferred, and what is explicitly not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from non-clinical tests) | Reported Device Performance |
|---|---|
| Equivalence to legally marketed devices (functional) | Performance testing showed equivalence to legally marketed devices. |
| Compatibility and safe/effective use with acquired devices | Fatigue testing and range of motion testing conducted to show compatibility and safe and effective use. |
| Non-inferiority in fatigue properties | Fatigue testing was conducted. (Specific metrics not provided) |
| Acceptable range of motion | Range of motion testing was conducted. (Specific metrics not provided) |
Note: The document does not provide specific quantitative acceptance criteria (e.g., "fatigue strength must exceed X MPa") or detailed performance metrics (e.g., "fatigue strength was Y MPa"). It broadly states that tests were completed to "determine equivalence" and "show compatibility and safe and effective use."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified, but likely from in-house laboratory testing given it's non-clinical. No mention of country of origin or retrospective/prospective nature as this is not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For non-clinical, mechanical tests, "ground truth" is typically established by engineering standards and measurement techniques, not human expert consensus.
4. Adjudication Method for the Test Set:
- Not Applicable. This is not a clinical or imaging study requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical test data is not provided for the subject device." Therefore, no MRMC study was performed or reported here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not Applicable. This is a physical medical device (hip prosthesis), not an algorithm or AI system.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and mechanical performance standards, measured through established laboratory methods.
8. Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It reports on non-clinical engineering tests to show the new device's performance aligns with legally marketed predicate devices. It does not contain the detailed clinical study information or AI algorithm validation data that your prompt is designed to elicit.
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