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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 proposed Exactech Alteon 6.5mm Bone Screws represent a modification to the predicate Exactech 6.5mm Cancellous Bone Screws cleared in K993082. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only differences between the predicate and the proposed devices are the following dimensional modifications:

• 1. Deeper hex The hexagonal driver feature depth was increased by .013 inches to provide additional driver engagement when installing the screws.
• 2. Tapered/lengthened shank The shank was lengthened by .016" and tapered.
• 3. Thread form modification The thread form was modified to conform to the dimensions for HB 6.5 screws as outlined in ASTM F543-13.
• 4. Modified tip geometry The tip distal to the screw head transitions to a smaller diameter with a smaller minor thread diameter.
• 5. Self-Tapping Flutes The self-tapping flutes were lengthened to intersect one full thread.

These modifications are proposed to provide surgeons with screws that provide improved self-tapping abilities, and are easier to insert than the predicate screws.

The proposed hip screws are intended to mate with the following Exactech implants:

• . Exactech Novation Crown Cups (K070479, K100269)
• Exactech Novation Crown Cups with InteGrip (K102975) .
• Exactech InteGrip Acetabular Shells (K122798)

The provided text describes a 510(k) submission for the Exactech® Alteon™ 6.5mm Bone Screws, which are a modification of a previously cleared device. However, the document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that such a device meets those criteria.

The information provided is for a traditional medical device (bone screws) and focuses on demonstrating substantial equivalence to a predicate device through engineering analyses. It does not involve any AI/ML components, therefore, it cannot address the specific points requested regarding AI/ML device performance, ground truth, expert review, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text, as it pertains to a non-AI/ML device.

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The Empire Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The Empire Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with Empire Acetabular Augments. The assembled construct is intended for press-fit fixation. The construct may also be used with bone cement at the discretion of the surgeon.

The proposed acetabular augments are manufactured by an additive manufacturing process from titanium alloy to create a porous structure designed to provide initial mechanical fixation in addition to the potential for long-term biological fixation. The augments feature holes that allow for the use of 4.5mm bone screws for adjunct fixation of the acetabular augment and the surrounding bone. The acetabular augments are available in 3 heights (8mm, 11mm, and 13mm) and cover acetabular shell outer diameter sizes 48-58mm.

The proposed augments mate with the following devices:

• Novation Crown Cup acetabular shells (K070479) .
• Exactech Bone Screws (K896601). .

The provided text describes a medical device, the Exactech® Novation® Empire™ Acetabular Augments, and its 510(k) submission for substantial equivalence to a predicate device. This document is a regulatory submission, not a study report, and therefore does not contain the detailed information typically found in a study focused on establishing acceptance criteria and proving performance through rigorous testing and analysis as requested by the prompt.

Specifically, the document does not describe an AI/ML-based device, nor does it detail a study with acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence of a physical medical implant to a legally marketed predicate device through engineering analyses and mechanical/animal studies.

Therefore, many of the requested fields cannot be directly extracted or are not applicable to the provided text. I will fill in what can be inferred and explicitly state when information is not available or not applicable.

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

The document does not explicitly state acceptance criteria in terms of numerical thresholds for performance metrics for a diagnostic or AI device. Instead, it relies on demonstrating substantial equivalence to a predicate device (Zimmer Hedrocel Acetabular Augment) through material, design, sterilization, and, critically, performance specifications and mechanical tests, animal studies, simulated-use tests, and engineering analyses. The "reported device performance" is essentially that it conforms to recognized performance standards for total hip replacement devices and is substantially equivalent to the predicate device.

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

• Test Set Sample Size: Not explicitly stated with a specific numerical value. The "test set" in this context refers to the samples used in mechanical tests, simulated-use tests, and animal studies. These types of studies often use a limited number of physical samples (e.g., a few augments for mechanical testing, a cohort of animals for an animal study), but the exact numbers are not provided.
• Data Provenance: Not specified. The document is a 510(k) summary from Exactech®, Inc., located in Gainesville, FL, USA. The studies would likely have been conducted in a similar regulated environment, but specific countries of origin for the data are not mentioned. The studies can be considered prospective in the sense that they were conducted for the purpose of this submission (e.g., the animal study comparing biological fixation characteristics).

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. This device is a physical implant, not an AI/ML diagnostic tool requiring expert ground truth for interpretation of images or patient data. The "ground truth" here is based on objective measurements from mechanical tests, biological responses in animal models, and engineering analyses, rather than expert interpretation.

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

• Not Applicable. As above, this is not a diagnostic study requiring inter-reader agreement or adjudication for ground truth establishment.

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. This is not an AI/ML device, and no MRMC comparative effectiveness study was conducted or is applicable here.

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

• No. This is not an AI/ML algorithm.

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

The "ground truth" in this context is established through scientific and engineering methods:

• Mechanical Test Data: Objective measurements of mechanical properties (e.g., strength, durability, fixation).
• Animal Study Data: Biological responses (e.g., bone ingrowth, inflammation) in animal models, compared against historical data.
• Engineering Analyses: Calculations and simulations based on design specifications and material properties.
• Cadaver Lab Validation: Demonstrating design features and fit.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device requiring a training set.

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

• Not Applicable. This is not an AI/ML device requiring a training set.

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