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The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System has been cleared under K192994. The purpose of this submission is to introduce a new diffusion bonded talar dome to the APEX 3D Total Ankle Replacement System. The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided document is an FDA 510(k) clearance letter for the APEX 3D Total Ankle Replacement System. This document does not describe AI/ML-driven medical devices or related acceptance criteria studies.

The 510(k) summary explains that the submission is to introduce a new diffusion-bonded talar dome to an already cleared total ankle replacement system. The performance testing described is focused on the physical and mechanical properties of the implant materials and manufacturing processes, such as:

• Porous Structure Characterization
• Diffusion Bonded Tensile Strength
• Diffusion Bonded Static Shear Strength
• Diffusion Bonded Fatigue Shear Strength
• Diffusion Bonded Abrasion Resistance
• Metallurgical Analysis
• Accelerated Corrosion Soak

The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device."

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and studies for an AI/ML-driven device, as this document pertains to a mechanical orthopedic implant, not an AI/ML product.

To answer your request, I would need a different source document that details the performance study of an AI/ML-driven medical device.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided document is a 510(k) summary for a medical device (APEX 3D Total Ankle Replacement System), which focuses on demonstrating substantial equivalence to a predicate device. It addresses the device's indications for use, description, and the performance testing conducted to assure substantial equivalence.

However, the document does NOT contain information related to software or AI device performance, acceptance criteria, or ground truth establishment relevant to the questions asked about AI/software validation.

Therefore, I cannot extract the requested information from the provided text. The document explicitly states:

• "Clinical data are not needed to support the safety and effectiveness of the subject device." This indicates that there was no clinical study, including any involving AI or human readers, performed for this submission.
• The tests listed are all non-clinical performance tests on the physical components of the ankle replacement system (e.g., fatigue, material characterization, micromotion, magnetic resonance compatibility). None of these involve software or AI performance metrics.

To answer your request, if this were an AI/software device submission, the acceptance criteria and study details would typically involve metrics like sensitivity, specificity, AUC, human reader performance studies (MRMC), ground truth assessment by experts, sample sizes for training and testing, and adjudication methods. None of this information is present in the provided document.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided text is a 510(k) summary for the APEX 3D Total Ankle Replacement System. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing detailed acceptance criteria and performance studies for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device meets acceptance criteria cannot be extracted from this document.

The document states that the APEX 3D Total Ankle Replacement System is "substantially equivalent" to a predicate device (K192994). This means that the FDA has determined it is as safe and effective as a legally marketed device, but it doesn't involve the kind of rigorous performance testing against specific acceptance criteria that would be conducted for a new, unproven technology, especially software or AI.

The "Performance Data" section mentions "engineering analysis" to show that "the original testing and subsequent performance is not adversely affected by the modifications". This included "talar stability assessment and bacterial endotoxin testing." This is related to the physical device's integrity and biocompatibility, not software performance.

In summary, the provided text does not contain the information requested in your prompt as it pertains to a traditional medical device (total ankle replacement system) demonstrating substantial equivalence, not a software or AI-based device with specific performance metrics and acceptance criteria.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

The Paragon 28 Laser Alignment Guide is a line extension to the APEX 3D Total Ankle Replacement System instrumentation (K192994). The Paragon 28® APEX 3D™ Total Ankle Replacement System Laser Alignment Guide is designed to provide a visual guide to verify alignment of the instrumentation associated with the APEX 3D™ Total Ankle Replacement System. Once inserted into the proper instrumentation, the Laser projects a line onto the patient to be used by surgeons as a visual reference for alignment. The Laser Alignment Guide is a singleuse electrical device.

This document describes the APEX 3D Total Ankle Replacement System Laser Alignment Guide, a line extension to the APEX 3D Total Ankle Replacement System instrumentation. The information provided is sufficient to answer some, but not all, of your questions regarding acceptance criteria and the study proving device performance, especially concerning clinical study details, as this submission primarily focuses on substantial equivalence based on non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the Laser Alignment Guide specifically and its substantial equivalence to predicate devices, rather than establishing new performance criteria or providing a direct table of acceptance criteria and performance for the overall APEX 3D Total Ankle Replacement System itself. The "acceptance criteria" for the Laser Alignment Guide are inferred from the non-clinical tests performed to demonstrate its intended function and safety.

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

• Sample Size: The document mentions "a cadaveric design evaluation" and "stability assessment" but does not specify the sample size (e.g., number of cadavers, number of stability tests).
• Data Provenance: The cadaveric study would imply human anatomical data. The provenance (e.g., country of origin) is not specified.
• Retrospective or Prospective: These non-clinical tests would be considered prospective in nature, as they were conducted specifically for this submission.

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

This information is not provided in the document. The cadaveric design evaluation and stability assessment would likely involve technical and possibly surgical experts, but their numbers and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the non-clinical tests (cadaveric evaluation, stability, electrical safety), a formal "adjudication method" in the sense of consensus among multiple human readers of medical images is unlikely to apply directly. The "assessment" mentioned suggests an evaluation against pre-defined criteria, but the specific method is not detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission for the Laser Alignment Guide is based on substantial equivalence demonstrated through non-clinical testing. It does not involve a study comparing human reader performance with and without AI assistance.

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

The Laser Alignment Guide is a physical medical device that provides a visual guide for human surgeons. It is not an algorithm or an AI system, so the concept of "standalone performance" for an algorithm does not apply. Its function is inherently "human-in-the-loop" as it assists a surgeon.

7. The Type of Ground Truth Used

For the non-clinical tests mentioned:

• Cadaveric Design Evaluation: The "ground truth" would be the anatomical landmarks and the intended alignment as determined by surgical principles. The laser's projection would be evaluated against this anatomical reality.
• Stability Assessment: The "ground truth" would be the engineering specifications for stability and secure attachment.
• Electrical Safety Testing: The "ground truth" would be the applicable electrical safety standards and regulations.

8. The Sample Size for the Training Set

The Laser Alignment Guide is a hardware device, not an AI/ML system that utilizes a "training set." Therefore, discussions of a training set sample size are not applicable.

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

As there is no "training set" for this hardware device, this question is not applicable.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided FDA 510(k) summary for the Paragon 28 APEX 3D Total Ankle Replacement System does not contain information related to AI/ML device performance or clinical studies using AI/ML. The document describes a traditional medical device (an ankle replacement system) and focuses on its mechanical performance testing and substantial equivalence to predicate devices based on physical properties, materials, and design.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are specific to the evaluation of AI/ML-driven medical devices, not the type of device described in this document.

The document details:

• Device Type: Total Ankle Replacement System (mechanical implant).
• Performance Testing: Focuses on mechanical characteristics like range of motion, contact stress, fatigue strength, polyethylene wear, etc.
• Substantial Equivalence: Based on intended use, indications, design, materials, and size range compared to predicate mechanical devices.

Thus, all specific questions regarding AI/ML device evaluation (e.g., test set, ground truth, experts, MRMC, standalone performance, training set) are not applicable to the content provided.

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