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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. Compared to predicate Alteon Monobloc Revision Stems implants, proposed Alteon Monobloc Revision Stem line extension implants offer a longer stem length option, a reduced neck offset option, and options for intermediately sized stem diameters to accommodate an array of patient anatomies.

This document describes the Exactech® Alteon® Monobloc Revision Stem and its line extensions. It is a 510(k) premarket notification, indicating that the device is being submitted for clearance based on its substantial equivalence to a predicate device, not through a study proving it meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. This submission focuses on comparing the new device to a previously cleared device (K150066) to demonstrate substantial equivalence based on design, materials, and non-clinical testing, rather than a clinical study evaluating diagnostic performance.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

This document does not specify general "acceptance criteria" in the way one would for a diagnostic or AI device's performance (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device through non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This document does not refer to a "test set" in the context of clinical data or AI performance evaluation. The "testing" refers to non-clinical, bench-top engineering tests (fatigue, range of motion, pyrogenicity). The sample sizes for these engineering tests are not specified in this summary.
• Data Provenance: Not applicable as no clinical data or patient-specific data is involved in this summary for demonstrating substantial equivalence. The data comes from internal laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. "Ground truth" usually refers to a definitive diagnosis or outcome for clinical data. This submission is based on non-clinical engineering testing, not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This concept applies to clinical data review by experts, not to non-clinical engineering tests.

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 device is an orthopedic implant, not a diagnostic imaging device or an AI-powered tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is an orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this submission are the accepted engineering standards for performance and material properties (e.g., USP , USP , ANSI/AAMI ST72 for pyrogen testing, and general industry standards for fatigue strength and range of motion for hip implants). This is not clinical ground truth.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI device.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set ground truth."

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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.

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