(188 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.
- · Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Alteon Monobloc Revision Stem implants are made from titanium alloy and offer multiple stem lengths, offsets, and diameters to accommodate an array of patient anatomies.
This document describes a medical device called the Exactech Alteon Monobloc Revision Stem, which is a hip implant. The provided text is a 510(k) summary, a regulatory submission to the FDA, and it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with performance metrics.
Therefore, the requested information points regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment are not explicitly available in the provided document in the context of demonstrating specific performance outcomes.
The document discusses non-clinical testing performed, but it doesn't present a table of acceptance criteria versus reported device performance in a measurable way that would typically be associated with AI or diagnostic device studies.
Here's an analysis based on the information provided, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Not provided in the document.
- The document mentions "non-clinical testing" like fatigue testing, range of motion analysis, cadaveric implantation and surgeon assessment, and biocompatibility assessment. However, it does not specify quantitative acceptance criteria for these tests (e.g., "fatigue strength shall be X MPa") nor does it report specific performance values against such criteria. The conclusion simply states that "Results of engineering studies and comparison of key features... demonstrate the proposed Alteon Monobloc Revision Stem devices are substantially equivalent."
2. Sample size used for the test set and the data provenance
- Not explicitly provided.
- The document mentions "cadaveric implantation and surgeon assessment" but does not specify the number of cadavers used or the number of surgeons involved.
- Data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not explicitly provided.
- The "cadaveric implantation and surgeon assessment" implies expert involvement (surgeons), but the number and specific qualifications (e.g., years of experience) are not stated. The term "ground truth" as typically used in AI/diagnostic studies is not applicable here, as it's a mechanical device assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
- Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving multiple readers. This document describes testing for a mechanical implant, not a diagnostic device.
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.
- This is a mechanical hip implant, not an AI or diagnostic device. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant or performed for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable.
- This is a mechanical hip implant; there is no algorithm or standalone performance in the context of AI or diagnostics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly defined in the context of "ground truth" for a diagnostic study.
- For mechanical devices like this, "ground truth" might refer to engineering standards, material properties, biomechanical test results, or successful implantations. The document mentions "fatigue testing," "range of motion analysis," and "cadaveric implantation and surgeon assessment," which serve as forms of objective and expert-driven evaluation, but not "ground truth" in the AI/diagnostic sense.
8. The sample size for the training set
- Not applicable.
- This is a mechanical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
- As there is no training set for an AI model, this question is not relevant.
Summary of what the document does provide:
- Device Name: Exactech Alteon Monobloc Revision Stem
- Predicate Device: Zimmer Wagner SL Revision Stem (K043356)
- Purpose of Submission: To demonstrate substantial equivalence to the predicate device.
- Non-Clinical Testing Mentioned:
- Fatigue testing
- Range of motion analysis
- Cadaveric implantation and surgeon assessment
- Biocompatibility assessment
- Conclusion: "Results of engineering studies and comparison of key features included in this submission demonstrate the proposed Alteon Monobloc Revision Stem devices are substantially equivalent to cleared predicate Zimmer Wagner SL Revision Stem devices."
The provided text is a regulatory filing focused on substantial equivalence, which primarily involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically include the detailed performance metrics or study structures (like those for AI/diagnostic devices) that would answer the specific questions posed.
§ 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.