Search Results

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are additionally indicated for patients with a failed previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INBONE™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.

This is a 510(k) summary for a medical device (an ankle replacement system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not applicable in the context of AI/ML performance evaluation.

However, I can extract the information that is present regarding the non-clinical performance and a general conclusion of equivalency:

Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System

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

The document lists "Applicable Standard" for various non-clinical performance bench tests. The specific acceptance criteria (e.g., minimum tensile strength value) are not explicitly stated within this summary, nor are the reported performance values. The study concludes that the device performs "at least as well as the predicate devices," implying it met the standards.

Ask a specific question about this device

The INVISION™ Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INVISION™ Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The INVISION Total Ankle Revision System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

The INVISION Total Ankle Revision System is a fixed-bearing ankle replacement prosthesis that restores mobility to a failing ankle joint. This modular system is comprised of a tibial tray, talar domes, talar plates, and a poly insert. These components are assembled together to create the two-piece prosthesis. Based on patient anatomy, a number of component sizes and design configurations can be selected.

This document describes the INVISION™ Total Ankle Revision System, a medical device, and its substantial equivalence to predicate devices, which is a regulatory pathway for approval. The information provided does not pertain to an AI device or a study that evaluates the performance of a device against acceptance criteria in the context of an AI system. Instead, it focuses on the safety and efficacy of the ankle implant and its components through non-clinical testing.

Therefore, many of the requested categories related to AI device acceptance criteria and study details cannot be fulfilled from the provided text.

Here's an attempt to extract relevant information and note the missing parts:

1. Table of Acceptance Criteria and 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)

This information is not applicable as the document describes non-clinical engineering tests (fatigue, shear, torsion, pyrogen, MR safety) for a physical medical implant, not a data-driven AI device. There is no mention of a "test set" in the context of data for an algorithm.

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)

This information is not applicable. The ground truth for engineering tests is typically defined by industry standards, material properties, and design specifications, not by human experts in a clinical data review setting.

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

This information is not applicable. This refers to a method used in clinical data annotation or review, which is not relevant to the non-clinical tests described.

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

This information is not applicable. The document explicitly states "SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A," indicating no human clinical studies were performed for this 510(k) submission. Therefore, an MRMC study for AI assistance is entirely outside the scope of this document.

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

This information is not applicable. This describes a physical ankle implant, not an algorithm or AI device.

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

For the non-clinical tests described (Fatigue, Shear, Torsion, Pyrogen, MR Safety Labeling), the "ground truth" or acceptance criteria would be based on established engineering standards, material specifications, and regulatory requirements for medical implants, not clinical data from pathology or outcomes.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this document is about a physical medical device approval process via substantial equivalence, not an AI model.

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

This information is not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of what the document does provide regarding the device approval:

The document, K180730, describes a 510(k) premarket notification for the INVISION™ Total Ankle Revision System. This system is a fixed-bearing ankle replacement prosthesis. The submission seeks to demonstrate "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective as existing approved devices.

Instead of clinical trials demonstrating specific acceptance criteria against, for example, a disease diagnosis or patient outcome, the document focuses on non-clinical evidence to support safety and efficacy. This includes:

• Fatigue Testing
• Shear Testing
• Torsion Testing
• Pyrogen Testing
• MR Safety Labeling Evaluation

The conclusion drawn is that "The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case." It states that "the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent."

Ask a specific question about this device

The INVISION Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INVISION Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The INVISION Total Ankle Revision System is a fixed-bearing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes multiple tibial and talar components that are assembled together to create the two-piece prosthesis. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

This document is a 510(k) summary for the INVISION™ Total Ankle Revision System. It describes the device and its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, there is no acceptance criteria or study that proves device performance against specific acceptance criteria in the context of an AI/algorithm-based medical device. This document is for a physical medical device (an ankle prosthesis), not a software or AI device.

Therefore, many of the requested points are not applicable to this document. I will answer the applicable points based on the information provided.

Not Applicable for an AI/Algorithm-based Device:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

Applicable Information from the Document:

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

   • N/A. This document does not present acceptance criteria for a software/AI device or a study demonstrating performance against such criteria. The "Substantial Equivalence - Non-Clinical Evidence" section mentions engineering analysis and rationale for shear strength, fatigue strength, and torsional stability, as well as MR testing for displacement force, torque, artifact, and RF heating, and pyrogenicity testing. However, specific numerical acceptance criteria or performance metrics are not provided in this summary.

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

   • N/A. This is a physical orthopedic implant. There is no "test set" in the context of an AI/algorithm. Non-clinical evidence was gathered through engineering analysis and rationale, and MR testing. The document does not specify sample sizes for these tests, nor data provenance in the way it would for clinical data or AI training/test 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):

   • N/A. Ground truth for AI/algorithm is not applicable here.

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

   • N/A. Adjudication method for AI/algorithm is not applicable here.

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:

   • N/A. This is not an AI device, so MRMC studies are not relevant. The document explicitly states under "(b)(2). Substantial Equivalence- Clinical Evidence": "N/A".

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

   • N/A. Not an AI/algorithm device.

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

   • N/A. Ground truth for AI/algorithm is not applicable here. Non-clinical evidence was based on engineering analysis, material properties, and specific performance tests (shear strength, fatigue strength, torsional stability, MR compatibility and RF heating, pyrogenicity).

8. The sample size for the training set:

   • N/A. Not an AI/algorithm device, so there is no training set.

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

   • N/A. Not an AI/algorithm device, so there is no training set or its associated ground truth establishment.

Ask a specific question about this device

The INVISION® Total Ankle Revision System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

The INVISION® Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INVISION® Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INVISION® Total Ankle Revision System is a fixed-bearing system that is specifically designed considering revision procedures. Based on the INBONE® Total Ankle System platform, INVISION® Total Ankle Revision System includes tibial stems, talar domes, talar plates, and tibial trays.

The provided text describes the INVISION® Total Ankle Revision System, a medical device, and its FDA 510(k) summary of safety and effectiveness. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-based diagnostic or prognostic device.

The document is a traditional 510(k) submission for a physical medical implant (an ankle prosthesis). The "acceptance criteria" and "study" mentioned in your request, along with details like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set sample size," are all relevant to the evaluation of AI/Machine Learning-based medical devices, particularly those that generate diagnostic or prognostic outputs.

The information provided in the document focuses on:

• Device Description: What the total ankle revision system is.
• Intended Use and Indications for Use: The conditions for which the device is intended.
• Technological Characteristics Comparison with Predicate Devices: Comparing the new system to previously approved ankle prostheses, noting similarities in indications, instrumentation, materials, and sterilization, and a minor difference in talar plate fixation.
• Non-Clinical Evidence for Substantial Equivalence: This includes mechanical testing (fatigue, shear, wear, torsional, torque-off, pull-off testing) to show the new device performs at least as well as or better than predicate systems.
• Clinical Evidence: Stated as "N/A," indicating no new human clinical trials were conducted for this 510(k) submission to demonstrate substantial equivalence, likely relying on the established performance of the predicate devices.
• Conclusion: The device is substantially equivalent to predicate devices based on the submitted non-clinical evidence.

Therefore, I cannot provide the requested table or detailed answers for an AI/algorithm study as the document describes a physical medical implant approval.

Ask a specific question about this device

The INVISION™ Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The INVISION™ Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cement use only.

The subject INVISION™ Total Ankle Revision System is a fixed-bearing system that is specifically designed considering revision procedures. Based on the INBONE® Total Ankle System platform, INVISION™ Total Ankle Revision System includes tibial trays that are compatible with the INBONE® Total Ankle System talar stems and INBONE® Sulcus Poly Inserts. To accommodate various patients' boney defects, the INVISION™ tibial trays are available in two heights: +4 mm and +8 mm, which are an additional 4 mm or 8 mm above the current INBONE® height.

This document is a 510(k) premarket notification for the INVISION™ Total Ankle Revision System. It describes the device, its intended use, and its equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to the requested information:

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

Based on the provided text, there are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI/software medical devices. This document concerns a physical orthopedic implant.

The document states "Dimensional comparisons were used to demonstrated that the tibial trays of the INVISION™ Total Ankle Revision System does not present a new worst-case compared to the tibial trays of the INBONE® Total Ankle System." This can be interpreted as the performance criteria.

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 refers to an orthopedic implant, and the primary evidence for substantial equivalence is based on dimensional comparisons to predicate devices, not on data from a "test set" in the context of diagnostic or AI performance.

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. The ground truth, in this context, would be the design specifications and established safety/performance of the predicate devices. Expert consensus for performance metrics is not mentioned as part of this submission.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of this device's submission.

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 device is an ankle prosthesis, not an AI-powered diagnostic tool. Hence, no MRMC study involving human readers and AI assistance was conducted.

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

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

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

The "ground truth" implicitly used for establishing substantial equivalence for a physical device like this is primarily engineering specifications and established performance characteristics of the predicate devices. Dimensional comparisons are used to show the new device is within the safe and effective range established by the predicate.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. As above, no training set is mentioned or relevant to this device.

Ask a specific question about this device