(30 days)
AcuMatch Press-Fit Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of the AcuMatch Integrated Hip System.are.also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
AcuMatch Press-Fitt Femoral Components are intended to be used in press fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.
AcuMatch Press-Fit Stems are made of similar materials and are of a similar design to other legally marketed femoral components, most notably the Exactech MCS femoral components. The proposed AcuMatch models are composed of titanium alloy (Ti-6Al-4V), have a trapezoidal crosssectional geometry, secondary distal tapers, optional calcar collars and optional hydroxyapatite (HA) coatings. The HA coating available on the AcuMatch models is identical to the one used for the predicate MCS component.
The Exactech AcuMatch™ Integrated Hip System Press-Fit Femoral Components underwent performance testing to establish substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria by comparing the performance results of the AcuMatch Press-Fit stems to those of the predicate Exactech MCS design, which has a positive clinical history. The acceptance criterion is that the AcuMatch results must "exceed those of the predicate MCS design."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adequate for anticipated in vivo loading | AcuMatch results exceeded those of the predicate MCS design. |
| No reported stem failures (reference MCS) | Predicate MCS design has a clinical history in excess of 7 years with no reported stem failures. |
| Material specifications met | Vendor material certifications were part of the performance data. |
| Design considerations met |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: The document mentions "production quality parts" were used for fatigue testing, but a specific number is not provided.
- Data Provenance: The tests appear to be prospective in nature, conducted specifically for the AcuMatch device. The country of origin of the data is implied to be within the United States, given the sponsor (Exactech Inc., Florida, USA).
3. Number of Experts and Qualifications for Ground Truth:
- This information is not applicable as the study focuses on mechanical performance testing, not human expert interpretation for establishing ground truth.
4. Adjudication Method for Test Set:
- This information is not applicable as the study focuses on mechanical performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not performed/applicable. This study is for a medical device (hip implant) and involves mechanical performance testing, not a diagnostic imaging study that would typically utilize an MRMC design.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Not applicable. This device is a physical implant, not a software algorithm with or without human-in-the-loop performance. The "performance" here refers to the mechanical integrity of the implant itself.
7. Type of Ground Truth Used:
The ground truth for the performance claims appears to be:
- Mechanical Testing Results: This includes fatigue testing of the device and material properties.
- Predicate Device Clinical History: The successful 7-year clinical history of the similar MCS design without reported stem failures serves as a form of "ground truth" to establish the safety and effectiveness of the design principles.
8. Sample Size for Training Set:
- Not applicable. This study does not involve machine learning or a "training set" in the conventional sense.
9. How Ground Truth for Training Set was Established:
- Not applicable. As there is no training set for a machine learning model, this question is irrelevant to the provided document.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.