(26 days)
The AcuMatch L-Series Unipolar Endoprosthesis is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture.
The AcuMatch L-Series Unipolar is a modular endoprosthesis consisting of a truncated spherical head and interchangeable neck sleeves. The device is fully machined from cobalt chrome alloy conforming to ASTM F1537-94. The size offerings include 15 head sizes (38 mm - 62 mm) with four available offset options (-5, +0, +5 and +10).
The Exactech® AcuMatch™ Integrated Hip System L-Series Unipolar Endoprosthesis is a modular endoprosthesis consisting of a truncated spherical head and interchangeable neck sleeves for hip hemiarthroplasty.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity under anticipated in-vivo loading | Functional testing and engineering analysis (FEA, fatigue testing, material certifications) demonstrated adequate performance for anticipated in vivo loading. |
| Substantial equivalence to predicate device (Exactech Opteon Unipolar device #K960538) in terms of materials and design. | The device is made of similar materials (cobalt chrome) and has similar design features (spherical design, offset sizing options) to the predicate. Functional testing and engineering analysis confirmed substantial equivalence. |
| Material composition adheres to ASTM F1537-94. | The device is fully machined from material conforming to ASTM F1537-94. |
| Sterilization Assurance Level (SAL) of 10-6 achieved. | Sterilization by Gamma radiation (25-37 kGy Cobalt 60 source) achieves an SAL of 10-6. |
2. Sample size used for the test set and the data provenance:
This document describes a submission for a medical device (hip endoprosthesis) and does not involve AI software or a "test set" in the context of clinical data for AI model validation. The "testing" referred to is mechanical and engineering testing, not clinical data analysis. The data provenance is from the manufacturer's internal engineering and material testing processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the submission pertains to a physical medical device and its mechanical and material properties, not an AI model requiring human experts for ground truth establishment.
4. Adjudication method for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used:
The "ground truth" in this context refers to established engineering standards, material specifications (ASTM F1537-94), and the performance characteristics of the predicate device (Exactech Opteon Unipolar device #K960538). These are based on published standards and previous regulatory approvals of the predicate device.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.