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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 Stems are being re-branded as the Alteon Neck Preserving Femoral Stems.

The Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are titanium press-fit prostheses 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 titanium plasma sprayfor 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 (K023964, K051682) ●
• Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
• AcuMatch L-series Unipolar endoprostheses (K010081) ●

The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7are line extensions to the Novation LPI Prime Femoral Stems cleared in K121684. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7use the femoral neck geometry as the previously cleared Novation LPI Prime Femoral Stem Size 5.

The provided text describes the Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6 and 7, which are titanium press-fit prostheses for hip arthroplasty. The device is a "Special 510(k)" submission, indicating it's a modification of a previously cleared device. Therefore, the "study" proving acceptance is primarily based on engineering analyses rather than clinical trials with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds in a table within the document. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device through engineering analyses. The "reported device performance" is framed in terms of the results of these analyses showing equivalence.

Overall Conclusion: "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are substantially equivalent to cleared Novation LPI Prime Femoral Stem devices." This implies that the engineering analyses successfully showed the new device met the performance characteristics expected and exhibited no new safety or efficacy concerns compared to the predicate. |

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

• Sample Size for Test Set: Not applicable. This submission relies on engineering analyses rather than a clinical "test set" of patient data or samples. The testing involves simulations and calculations on the device designs.
• Data Provenance: Not applicable. Since it's an engineering analysis, there isn't data provenance in the sense of patient origin. The analyses are based on the design specifications of the device.

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

• Number of Experts: Not applicable. Ground truth for an engineering analysis of mechanical equivalence is typically established by engineering standards, validated simulation tools, and established theoretical models, not by human experts interpreting clinical data.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical test set or human interpretation requiring an adjudication process. The engineering analyses follow validated methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is not an AI-powered diagnostic device, but a medical implant. Therefore, MRMC studies and AI assistance metrics are not relevant or applicable.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI system. Its performance is evaluated through material science and biomechanical engineering principles.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on established engineering principles, validated simulation models (e.g., Finite Element Analysis), and the performance characteristics of the legally marketed predicate device (Exactech Novation LPI Prime Femoral Stem - K121684). The goal is to demonstrate that the new sizes maintain the safety and effectiveness profile established by the predicate.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning device and therefore does not have a "training set" in the computational sense. The "training" here would be the accumulated engineering knowledge and technical data related to similar implants.

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

• How Ground Truth for Training Set was Established: Not applicable. As described above, there is no "training set." The understanding of implant performance comes from historical data, biomechanical research, material science, and regulatory standards developed over time for orthopedic devices.

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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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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.

The proposed Novation CFS Press-Fit and Cemented Femoral Stems are modifications to the existing Novation Press-Fit and Novation Cemented Plus femoral stem devices previously cleared in K042842 and K083392, respectively. The proposed Novation CFS Press-Fit stem has the same general design features as the predicate device. The modifications include the addition of a calcar collar, grit-blast body, and a satin finish neck. The proposed CFS Cemented stem has the same general design features as the Novation Cemented Plus stem, but the proposed stems are cast instead of forged cobalt chrome alloy and the neck is a satin finish. Both proposed stems contain a modified 12/14 femoral head taper connection.
The proposed stems mate with previously cleared 12/14 Co-28Cr-6Mo femoral heads (K041906), Zirconia ceramic femoral heads (K050398 and K060107) and 12/14 Unipolar Sleeves (K010081). The proposed stems are not compatible with alumina ceramic femoral heads (K032964 and K051682).
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
· the same indications for use
· similar design features
· incorporate the same materials
· the same shelf life
· are packaged and sterilized using the same materials and processes.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as this document is a 510(k) summary for a medical device (femoral stems) and not a study on an AI/ML device:

Important Note: The provided document is a 510(k) Summary for a physical medical device (femoral stems), not an AI/ML device. Therefore, the questions regarding AI/ML performance, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone algorithm performance are not applicable to this document. The "study" mentioned refers to engineering studies to demonstrate substantial equivalence, not clinical or AI/ML performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a physical medical device. The "test set" in the context of this 510(k) refers to the modified femoral stems themselves undergoing engineering studies (e.g., mechanical testing), not a dataset for an AI/ML algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective clinical data) in the context of an AI/ML test set.

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

• Not Applicable. Ground truth, in the context of AI/ML, involves expert labeling of data. This document pertains to physical device design and engineering validation, not AI/ML.

4. Adjudication Method for the Test Set

• Not Applicable. This refers to AI/ML ground truth establishment.

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

• Not Applicable. This is specific to AI/ML devices assessing reader performance. The document describes a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is specific to AI/ML devices. The document describes a physical medical device.

7. The Type of Ground Truth Used

• Not Applicable. For a physical device like a femoral stem, the "ground truth" relates to material properties, mechanical integrity, and biological compatibility, which are assessed through engineering analyses, material testing, and preclinical/clinical data if required (though for a 510(k), often relies on equivalence to predicates) rather than expert consensus on data labels, pathology, or outcomes data in the AI/ML sense.

8. The Sample Size for the Training Set

• Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

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

• Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

Summary of Device and Evidence Presented in Document:

The document is a 510(k) summary for new Exactech® Novation® CFS™ Press-Fit and Cemented Femoral Stems. The "study" mentioned refers to engineering studies comparing these modified stems to previously cleared predicate devices (Novation® 12/14 Press-Fit Femoral Stems K042842 and Novation® Cemented Plus Femoral Stems K083392).

The primary acceptance criterion is substantial equivalence to the predicate devices. The device meets this by demonstrating, through engineering studies, that it has:

• The same intended use
• Basic fundamental scientific technology
• Same indications for use
• Similar design features (with specified modifications like calcar collar, grit-blast body, satin finish neck, and cast vs. forged material for cemented stems)
• Incorporates the same materials (except for the casting change)
• The same shelf life
• Packaged and sterilized using the same materials and processes.

The FDA reviewed the submission and concurred that the device is substantially equivalent to legally marketed predicate devices. The specific details of the "engineering studies" (e.g., number of tests, specific parameters measured, statistical analysis) are not provided in this public summary but would have been part of the full 510(k) submission.

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