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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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The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total shoulder arthroplasty are as follows:

• Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• Congenital abnormalities in the skeletally mature
• Primary and secondary necrosis of the humeral head.
• Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
• To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).

This FDA 510(k) premarket notification for the Exactech® Equinoxe® Stemless Shoulder device does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria, AI/ML study design, ground truth, and sample sizes for training/testing sets are not applicable in this context.

This submission is for a medical implant (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to previously approved predicate devices through non-clinical (mechanical) testing, material comparisons, and similar indications for use.

Instead of AI/ML performance metrics, the document presents mechanical performance criteria.

Here's a breakdown of the relevant information provided:

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 for AI/ML device. The "test set" here refers to mechanical test samples, not clinical data for an algorithm. The document does not specify the number of mechanical samples used for each test. Data provenance is not relevant as it's mechanical testing of a physical device.

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 for AI/ML device. Ground truth, in the context of AI/ML, refers to labels or diagnoses. For a physical implant, ground truth would be established through engineering specifications and standards.

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

• Not applicable for AI/ML device. Adjudication methods are used to resolve disagreements in expert labeling for AI/ML ground truth.

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/ML device, so no MRMC studies or human reader improvement with AI assistance were performed.

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

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

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

• Not applicable for AI/ML device. For this physical device, "ground truth" equates to the established engineering specifications, performance standards (e.g., ISO, ASTM for fatigue, pull-out strength), and material properties that the device must meet to function safely and effectively.

8. The sample size for the training set:

• Not applicable for AI/ML device. There is no training set for a physical implant.

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

• Not applicable for AI/ML device. There is no ground truth or training set in the AI/ML sense for this device.

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The Optetrak Logic Metaphyseal Cones are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The augments are intended for press-fit fixation with the proximal tibial or distal femur. The final implant construct is completed by cementing a tibial tray or femoral component in place.

Optetrak Logic Metaphyseal Cones are designed to fill tibial and femoral bone voids during revision or complex primary surgery in the case of severe bone loss. Specifically, Optetrak Logic Metaphyseal Cones are designed to enhance fixation in primary or revision total knee arthroplasty (TKA) patients who have Anderson Orthopaedic Research Institute (AORI) type II and III tibial and femoral defects by providing stability to total knee implants via the metaphysis.

The provided text is a 510(k) premarket notification document for a medical device called "Optetrak Logic Metaphyseal Cones" by Exactech Incorporated. It details the regulatory review process and concludes that the device is substantially equivalent to existing predicate devices.

However, the document does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device. The text describes the device as knee system augments for total knee replacement and lists non-clinical testing such as fatigue testing, mating analysis, cadaveric implantation, biocompatibility assessment, compressive plastic deformation testing, abrasion resistance, static tensile strength testing, shear resistance, and porous structure characterization. These are typical engineering and material property tests for an orthopedic implant, not studies for an AI/ML-driven device's performance against clinical acceptance criteria.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about an AI/ML device study, acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for such a device.

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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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