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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.

Exactech Alteon HA femoral stems are intended for press-fit fixation.

The proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty.

The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V ELI (per ASTM F136, ASTM F620) with a grit blast surface and HA coating (per ISO 13779-2). The stem has a 12/14 taper. The Alteon HA 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 compatible with the same femoral components as the predicate:

• Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392)

• Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)

• Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682)

• Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392)

• AcuMatch L-series Unipolar endoprostheses (K010081)

• AcuMatch L-Series Bipolar Endoprostheses (K013211) .
  The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate:

• AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906)

• AcuMatch A-Series Acetabular GXL Liners (K051556)

• AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313)

• Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, K141960)

• Novation Crown Cup Acetabular Shells with InteGrip (K102975)

• Novation Crown Cup Constrained Liners and Rings (K071676)

• Exactech Integrip Acetabular Shells (K122798)

• Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583)

• Exactech Alteon Acetabular Cup System (K182502)

This document is a 510(k) premarket notification from the FDA for a medical device called "Alteon® HA Femoral Stems." It's important to understand that a 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device, not a study proving device performance against specific acceptance criteria in the context of an AI/software device.

Therefore, the requested information pertaining to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/software device is not applicable to this FDA submission. This submission is for a physical orthopedic implant (a femoral stem for hip replacement), not a "device" in the sense of an AI algorithm or diagnostic software.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving performance against specific acceptance criteria for a new, innovative diagnostic or AI-driven capability.

Here's a breakdown based on the context of the provided document, addressing why many of the requested fields cannot be filled:

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

   • Acceptance Criteria: Not explicitly stated in the context of performance metrics for an AI/software device. The "acceptance" here is the FDA's determination of substantial equivalence.
   • Reported Device Performance: The document describes non-clinical testing performed to show the new HA coating does not negatively impact the device's essential characteristics, maintaining equivalence to the predicate. Performance is demonstrated through engineering analyses (Range of Motion, Stem Neck Fatigue, Distal Stem Fatigue) and characterization of the new HA coating, ensuring it meets standards like ISO 21535:2007, ASTM F2068-2015, ISO 7206-6:2013, ISO 7206-4:2010, ISO 13779-2, and USP , USP , ANSI/AAMI ST72. No quantitative performance metrics in the sense of sensitivity, specificity, etc., for a diagnostic task are provided or relevant.

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

   • This is not applicable. The "test set" in the context of this 510(k) refers to the physical devices undergoing mechanical and chemical testing. There's no data set of patient images or information from which "data provenance" would be relevant.

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. There is no ground truth, expert consensus, or image review involved for this type of medical device submission. The "ground truth" for a mechanical implant is its physical and chemical properties and mechanical integrity, which are assessed through engineering tests, not expert medical review.

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

   • Not applicable. This refers to adjudication of medical image interpretations, which is not part of this submission. Mechanical testing results are objective measurements against established standards.

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 for AI-powered diagnostic devices. The device in question is a physical orthopedic implant.

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

   • Not applicable. This is for AI algorithms.

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

   • Not applicable in the sense of a clinical ground truth for a diagnostic device. The "truth" for this device's performance is adherence to established engineering and material standards.

8. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this physical implant.

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

   • Not applicable. There is no AI model or "training set" for this physical implant.

Summary of Relevant Information from the Document (Re-framed to align with the FDA 510(k) context):

The submission is for the Alteon® HA Femoral Stems, demonstrating substantial equivalence to the predicate device K162732 Exactech® Alteon® HA Femoral Stems. The key difference is the hydroxyapatite (HA) coating material/process.

The "study" conducted for this submission involves non-clinical testing and engineering analyses to demonstrate that the proposed device performs as intended and is substantially equivalent to the predicate.

Non-Clinical Tests and Analyses Done:

• Engineering analysis of Range of Motion (ROM): Per ISO 21535:2007.
• Engineering analysis of Stem Neck Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-6:2013.
• Engineering analysis of Distal Stem Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-4:2010.
• HA coating characterization: Per ISO 13779-2 and FDA Guidance document, "510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants," dated February 1997.
• Bacterial endotoxins: Per USP , USP , and ANSI/AAMI ST72.

Conclusion from Testing:
The non-clinical testing and analysis found that the difference in the applied HA coating does not change the intended use, safety, or performance requirements of the proposed devices, nor does it adversely affect their safety or effectiveness. This supports the claim of substantial equivalence to the predicate device. No clinical testing was submitted.

To reiterate, the framework provided in the request is designed for evaluating AI/software-as-medical-device (SaMD) products, which is not what the Alteon® HA Femoral Stems are.

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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 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 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 Novation LPI Prime Femoral Stem is a titanium press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The proximal region of the stem is coated with porous titanium plasma spray for uncemented, biological fixation.

The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:

• Exactech Cobalt Chromium Alloy Femoral Heads (K041906) .
• Exactech Ziramic Zirconia Femoral Heads (K050398, K060107) .
• Exactech BIOLOX®forte Alumina Femoral Heads (K032964, K051682) .
• Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
• AcuMatch L-series Unipolar endoprosthesis (K010081)

The proposed femoral stems are intended to mate with the following bipolar components:

• AcuMatch L-Series Bipolar Endoprosthesis (K013211) .

The provided document is a 510(k) summary for the Exactech® Novation® LPI Prime Femoral Stem, a medical device. It does not describe an AI/ML device or present a study comparing AI performance against acceptance criteria in the typical sense of a diagnostic or predictive algorithm.

Therefore, the requested information about acceptance criteria, device performance in terms of metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance is not applicable to this document.

Instead, this document describes the regulatory submission for a physical medical implant (a femoral stem for hip replacement) and establishes its substantial equivalence to previously marketed devices based on technological characteristics and mechanical testing.

Here's a breakdown of the relevant information from the document, rephrased to fit the context of a medical device submission, rather than an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Context)

• Clinical Literature Review of similar femoral prostheses.
• Cadaver lab validation for design features.
• Finite Element Analyses for worst-case size.
• Range of Motion testing per EN ISO 21535.
• Distally Fixed Fatigue Worst case Press-fit Fatigue Testing per FDA guidance.
• Femoral Neck Fatigue Worst case Press-fit Fatigue Testing per FDA guidance.
• Femoral Head Modular Junction Burst Testing and Axial pull-off Testing on the taper specification. |
  | Intended Use is similar to predicate devices. | Similar indications for use as predicate devices (e.g., hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, fractures). |

2. Sample size used for the test set and the data provenance:

• This is not applicable as it's not an AI/ML study. The "test set" here refers to mechanical and cadaveric testing.
• Mechanical Testing: The document mentions "worst case size for testing" for fatigue tests, implying specific sample selections rather than a broad 'test set' in the data sense.
• Cadaver Lab: Used for "validation demonstrating the design features," implying a limited number of cadavers for physical fit and design assessment.
• Data Provenance: Not explicitly stated as "data provenance" but the clinical literature review would draw from existing medical literature, likely international. Cadaver labs and mechanical testing are typically conducted in-house or by contract labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of AI/ML. The "ground truth" for a medical device like this is established through engineering principles, adherence to recognized standards, and clinical experience of surgeons.
• The "experts" involved would be biomechanical engineers, materials scientists, regulatory specialists, and orthopedic surgeons (for cadaver lab validation and clinical input) but their number or specific qualifications are not detailed in this summary.

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

• Not applicable as it's not an AI/ML study involving expert consensus on data. The "adjudication" in this context would be regulatory review by the FDA.

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:

• No, an MRMC comparative effectiveness study was not done, as this is a physical medical device, not an AI/ML algorithm for image interpretation or diagnosis.

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

• Not applicable. This is a physical implant, not an algorithm.

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

• The closest equivalent to "ground truth" for this device would be established engineering principles, international performance standards for hip implants (e.g., EN ISO 21535), and clinical practice guidelines, validated through mechanical testing and cadaveric studies. The objective is to demonstrate safety and effectiveness for its intended use, primarily through mechanical integrity and functional fit.

8. The sample size for the training set:

• Not applicable as this is a physical medical device, not an AI/ML algorithm. There is no "training set" in this context. The design of the device would be informed by biomechanical principles, prior device designs, and clinical experience.

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

• Not applicable.

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