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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. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Total Hip Arthroplasty (THA) is the replacement of the acetabular and femoral portions of the hip joint. The acetabular aspect of THA includes the replacement of a portion of the pelvis called the acetabulum with a prosthetic cup or an assembly of a modular shell and liner.

The proposed no-hole and cluster hole modular Crown Cups are manufactured from titanium allov (Ti-6A1-4V) and are available with commercially pure (CP) titanium plasma-spray coating or CP titanium plasma-spray with hydroxylapatite coating applied to the exterior. The CP titanium plasma spray provides initial mechanical fixation and bony on growth. The holes allow for the use of 6.5 mm screws that will enhance the primary fixation, if needed.

The proposed Crown Cup liners are available in cross-linked Connection GXL Ultra High Molecular Weight Polyethylene (UHMWPE) (ASTM F648) and come in neutral, lipped, lateralized +5mm, and 10 degrec face-changing lateralized +5mm configurations.

The proposed cups mate with the following devices:
Novation Crown Cup GXL Liners (proposed -subject of this review) .
Novation · Crown Cup GXL and Std, Group 3 Liner (K070479) .
Exactech Bone Screws (K993082) ◆

The proposed liners mate with the following devices:
Novation Crown Cup acetabular shells (proposed -subject of this review) .
Exactech CoCr Femoral Heads (#K041906, #K862334) .
Exactech Zirconia Femoral Heads (#K050398, #K060107) ◆
Exactech BioloxForte Alumina Femoral Heads (#K032964, #K051682)

Here's an analysis of the provided text regarding the Exactech® Novation® Crown Cup® and Liners Special 510(k) submission, structured to answer your questions about acceptance criteria and the supporting study:

Exactech® Novation® Crown Cup® and Liners Special 510(k)

Analysis of Acceptance Criteria and Study

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance against specific, pre-defined acceptance criteria for a new device. Therefore, the "acceptance criteria" here are primarily related to showing that the modified device performs comparably to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" for a test set in the way one would for a clinical study with human subjects or a large image dataset. The studies described are primarily mechanical tests and engineering analyses.

• Sample Size: Not specified in terms of number of devices tested for each mechanical test (lever-out, push-out, torsional resistance). It mentions "the proposed worst-case scenario," implying a focused testing approach rather than a large statistical sample.
• Data Provenance: The data is technical/engineering in nature, originating from internal product development and testing at Exactech, Inc. The document does not specify a country of origin for the data beyond the company's location in Gainesville, FL, USA. It is prospective in the sense of being performed specifically for this 510(k) submission on the newly modified devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of submission or the studies described. The "ground truth" for mechanical testing is based on established engineering principles, recognized industry standards (e.g., ASTM F648 for UHMWPE), and performance metrics defined for total hip replacement devices. It does not involve expert consensus in the typical sense of medical image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against predefined engineering specifications, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study would involve human readers (e.g., radiologists, clinicians) evaluating cases, often with and without AI assistance, to measure diagnostic/treatment recommendation improvement. The device in question is a physical implant, not a diagnostic or a treatment planning software that would benefit from an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical medical implant, not an algorithm or AI software. The "standalone" performance here refers to the device's inherent mechanical properties, which were tested as described.

7. The Type of Ground Truth Used

The "ground truth" for this submission consists of:

• Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate device (K070479).
• Engineering Specifications/Standards: Recognized industry standards and performance specifications for total hip replacement devices (e.g., for lever-out, push-out, torsional resistance).
• Material Specifications: Conformance to recognized material standards (e.g., ASTM F648).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI. The design and manufacturing process for the device would be developed through engineering and design iterations, but these are not referred to as a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned or implied by the nature of the device and submission type, this question is not relevant.

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