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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.

Ask a specific question about this device

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 Exactech BIOLOXdelta femoral heads and Biolox Option femoral heads and adapters are modifications to the existing Exactech 12/14 Alumina heads previously cleared in K032964 and K051682. The proposed femoral heads and adapters have the same general design features as the predicate device. The proposed femoral heads are manufactured from an alumina/zirconia based ceramic material known as Delta per ISO 6474-2. The Biolox Option adapters are comprised of titanium alloy per ISO 5832-3 and are intended for use with the Biolox Option femoral heads for primary and revision applications in which the taper remains intact.

The proposed femoral heads mate with the following devices:
12/14 Femoral Stems
Novation Press-Fit Femoral Stems (K042842)
Novation Splined RDD Femoral Stem (K063279)
Novation Element Press-Fit Femoral Stem (K080980)
Novation Cemented Stems (K052787)
Novation Cemented Plus (K083392)
AcuMatch Press Fit Stems (K041906, K051335)
AcuMatch Cemented Stems (K052787)
AcuMatch M-Series (K032964, K051858)
Acetabular Liners
Novation Crown Cup Standard and GXL UHMWPE Liners (K070479, K100269)
Novation Crown Cup Constrained Liners (K071676)
AcuMatch A-Series Standard and GXL UHMWPE Liners (K993082, K000242, K040613, K051556)
AcuMatch Constrained Liners (K040601)

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
similar indications for use
similar design features
incorporate similar materials
the same shelf life
are packaged and sterilized using the same materials and processes

This document is about the 510(k) summary for BIOLOX® Delta and BIOLOX® Option Femoral Heads, which are medical devices. It primarily details the substantial equivalence to predicate devices based on non-clinical performance data (engineering evaluations). Therefore, the request for information related to clinical studies, human readers, ground truth establishment, and training/test set sizes for an AI/algorithm-based device is not applicable to this document.

However, I can extract the acceptance criteria and the (non-clinical) performance reported for this medical device from the provided text.

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

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

Not applicable. This document describes non-clinical engineering evaluations, not clinical test sets or patient data.

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 for clinical data is not relevant for non-clinical engineering evaluations. The "ground truth" here would be the established international standards (ISO) and regulatory guidance, which are met by the engineering tests.

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

Not applicable. No clinical test set or human adjudication was involved.

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 not an AI/algorithm-based device, and no MRMC study was performed.

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

Not applicable. This is not an AI/algorithm-based device.

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

For the engineering evaluations, the "ground truth" or reference points are established international standards (ISO 7206-10) and specific industry/regulatory guidance (Ceramtec specifications and FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems).

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and does not involve training sets.

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

Not applicable. This is not an AI/algorithm-based device.

Ask a specific question about this device

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.

Ask a specific question about this device

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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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 Cemented Plus femoral stem is a modification to the existing Novation Cemented femoral stem devices previously cleared in K052787. The proposed stem has the same general design features (collar, cement groove, and "cobra" flange) as the predicate stem. but incorporates a more trapezoidal distal geometry. Additionally, the proposed device includes 5 additional sizes (standard offset Size 10, standard and extended offset Size 12 and 14) to the scope. The proposed stems mate with previously cleared 12/14 CoCr (#K041906), Zirconia ceramic (#K060107), and Alumina ceramic (#K032964 and #K051682) femoral heads.

The provided text describes a 510(k) submission for the Exactech® Novation® Cemented Plus Femoral Stems, focusing on its substantial equivalence to a predicate device. This type of submission is for medical devices and does not involve AI or machine learning. Therefore, the concepts of "acceptance criteria," "study proving the device meets acceptance criteria," "sample sizes," "ground truth," "MRMC studies," or "standalone performance" as they relate to AI/ML device evaluation are not applicable to this document.

The document primarily demonstrates that the modified femoral stem (the new device) is substantially equivalent to a previously cleared device (the predicate device) based on design features, indications for use, materials, shelf life, packaging, and sterilization processes.

Here's how the information provided aligns with what would be in an AI/ML context, if it were applicable, but noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable for this type of device. For a traditional medical device like a femoral stem, "acceptance criteria" relate to engineering performance (e.g., strength, fatigue life, biocompatibility) rather than diagnostic accuracy or sensitivity/specificity of an algorithm. The reported "performance" is that it demonstrates substantial equivalence to the predicate device through "engineering studies."

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

• Not applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The evaluation relies on "engineering studies" of the physical implant. The document does not specify the sample size of these engineering studies or their provenance.

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

• Not applicable. No "ground truth" establishment in the AI/ML sense is needed for this type of device. The evaluation of a femoral stem is based on engineering principles and regulatory compliance, not expert consensus on image interpretation or similar tasks.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is used as there is no "test set" of AI/ML outputs to adjudicate.

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

• No, not applicable. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a physical implant.

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

• No, not applicable. This concept belongs to AI/ML device evaluation. The "device" here is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable in the AI/ML context. For this device, the "ground truth" (if analogies must be drawn) would be established engineering standards, material science principles, and clinical safety/efficacy data from the predicate device that inform the modified device's design and testing. The document states "Results of engineering studies" as the basis for substantial equivalence.

8. The Sample Size for the Training Set:

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

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

• Not applicable. Again, no AI/ML training set is involved.

In summary, the provided text pertains to a regulatory submission for a physical medical device (a femoral stem) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The criteria and study types relevant to evaluating AI/ML models are not found or necessary in this document.

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