(209 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 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 sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Exactech Alteon HA femoral stems are intended for press-fit fixation.
The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V with a polished neck region, grit blast surface and HA coating on the stem body. The stem has a 12/14 taper. The Alteon HA Femoral Stems Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.
The Alteon HA Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.
This FDA 510(k) summary for the Exactech® Alteon® HA Femoral Stem focuses on demonstrating substantial equivalence to an existing predicate device (Exactech Novation Element Press-Fit Femoral Stem), rather than proving the device meets specific performance criteria through a clinical study or an AI-driven evaluation.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance is not included in this document. This type of information is typically associated with the evaluation of artificial intelligence/machine learning (AI/ML) devices, diagnostics, or other devices requiring direct performance validation against clinical outcomes or expert labels.
The provided document describes a traditional 510(k) submission for a Class II medical device (hip joint prosthesis). For such medical devices, "acceptance criteria" primarily relate to:
- Mechanical performance: Ensuring the device can withstand physiological loads and wear over time.
- Biocompatibility: Confirming the materials are safe for implantation.
- Sterility: Verifying the device is sterile when packaged.
- Design and manufacturing controls: Ensuring consistent quality.
The "study that proves the device meets the acceptance criteria" in this context refers to benchtop engineering testing, not clinical trials or diagnostic performance studies involving human subjects' data interpretation.
Summary of what is present in the document related to "acceptance criteria" and "proof":
Acceptance Criteria and Proof (as per this 510(k) document)
The document outlines engineering analyses conducted to prove the device's mechanical properties. These are the de facto acceptance criteria for this type of device in a 510(k) submission seeking substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Type of Testing) | Reported Device Performance (Implied "Meets Standards") |
|---|---|
| Distal Fatigue Testing | Results demonstrate substantial equivalence |
| Proximal Fatigue Testing | Results demonstrate substantial equivalence |
| Range of Motion Analysis | Results demonstrate substantial equivalence |
| Pyrogen Testing | Met recommended limits per FDA's Guidance Document |
Note: The document states "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Alteon HA Femoral Stems are substantially equivalent to the cleared Exactech Novation Element Press-Fit Femoral Stem." This implies that the performance in these tests was comparable to or better than the predicate device, thus meeting the unstated acceptance thresholds for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified for the engineering tests. For mechanical testing, this typically refers to the number of physical samples of the device tested, not patient data.
- Data Provenance: The tests are inherently prospective as they are specifically conducted for the regulatory submission. The "data" are generated in a laboratory setting (benchtop testing), not from patient populations. Country of origin for data is not applicable in the sense of patient demographics; the tests would be performed in a controlled environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. Ground truth in the context of diagnostic AI/ML algorithms relies on human expert consensus or clinical outcomes. For this mechanical device, "ground truth" is established by standard engineering principles, test methodologies (e.g., ISO standards, ASTM standards), and regulatory guidelines. The "experts" would be the engineers and technicians conducting the tests and the regulatory specialists evaluating the data.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication is relevant for conflicting interpretations of clinical data, especially in image-based diagnostics. For mechanical engineering tests, results are typically quantitative and objective measurements (e.g., cycles to failure, deflection, etc.).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- No. An MRMC study is specific to evaluating the diagnostic performance of human readers, often comparing performance with and without AI assistance. This device is a mechanical implant, not a diagnostic tool, so such a study is not relevant.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No. This refers to the standalone performance of an AI algorithm. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used:
- Engineering Standards and Predicate Device Performance. The "ground truth" for this submission is established by demonstrating that the new device performs mechanically at least as well as the legally marketed predicate device when tested according to recognized engineering standards and methods. It's a comparative performance, not a clinical outcome or pathological diagnosis.
8. The Sample Size for the Training Set:
- Not Applicable. "Training set" refers to data used to train AI/ML algorithms. This is a traditional medical device, not an AI/ML product.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
In conclusion, this document demonstrates that the Exactech® Alteon® HA Femoral Stem meets the requirements for substantial equivalence for a 510(k) submission based on benchtop engineering testing, not clinical study data for diagnostic performance.
§ 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.