(59 days)
All Exactech® Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 Exactech® Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where stock is present, and to restore mobility resulting from previous fusion.
Exactech® Highly Polished Femoral Stems are intended for cemented fixation.
The Exactech® Alteon® Highly Polished Femoral Stem implants are manufactured from forged Cobalt Chromium Alloy (Co-28Cr-6Mo) with a polished neck finish and polished surface finish. The Alteon® Highly Polished Femoral Stems are available in different combinations of stem length, neck offset, and diameter to accommodate an array of patient anatomies. The femoral stem has a 12/14 taper and has a trapezoidal cross-sectional stem geometry with a distal taper.
Alteon® Highly Polished Femoral Stem implants are collarless femoral stems and are intended for cemented use only.
The document provided is a 510(k) premarket notification for a medical device, the Exactech® Alteon® Highly Polished Femoral Stem. It is not an AI/ML device, and therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (such as MRMC studies, standalone performance, training set details, or expert ground truth adjudication) is not applicable.
The document discusses the device's substantial equivalence to a predicate device (Avenir Cemented Hip Stem, K131884) based on its indications for use, technological characteristics, and non-clinical testing.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the way one might for an AI device's performance metrics (e.g., specific sensitivity/specificity thresholds). Instead, it describes performance requirements through non-clinical testing designed to demonstrate that the device performs as intended and is substantially equivalent to predicate devices.
| Acceptance Criteria (Implied by testing) | Reported Device Performance (Demonstrated by testing) |
|---|---|
| Mechanical integrity under fatigue loads (distal and proximal) | Testing performed to demonstrate performance as intended. |
| Proper range of motion | Range of Motion Analysis performed. |
| Femoral head compatibility (burst strength, fatigue, post-fatigue burst, pull-off) | Femoral Head Compatibility Testing performed. |
| Geometric similarity to existing stems | Geometry Comparison of Alteon® HPS to Alteon® HA Femoral Stem performed. |
| Sterility and absence of pyrogens | Pyrogen testing conducted in accordance with USP , USP , and ANSI/AAMI ST72; meets recommended limits per FDA guidance. |
| Conformance to recognized performance standards for total hip replacement devices | Device conforms to recognized performance standards. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable as the studies described are non-clinical (mechanical and material testing), not clinical studies involving patient data or a "test set" in the context of AI. The tests involve physical samples of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable. Ground truth, in the context of device performance, is established through standardized engineering tests and material science principles, not expert consensus on diagnostic or prognostic classifications.
4. Adjudication Method:
Not applicable for non-clinical, engineering-based testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is not an AI algorithm. The performance described is for a physical medical prosthetic.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by engineering standards, material properties, and biomechanical principles. For instance, the pyrogen testing relies on established biological assay standards (USP, ANSI/AAMI ST72) to determine the absence of pyrogens. Mechanical tests like fatigue testing rely on established engineering methodologies to assess durability under simulated physiological loads.
8. Sample Size for the Training Set:
Not applicable. This is not an AI device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI 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.