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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.

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

The INBONE Total Ankle System and INFINITY Total Ankle 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™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.

This is a 510(k) premarket notification for a medical device (INFINITY and INBONE Total Ankle Systems) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates substantial equivalence to predicate devices, focusing on design, materials, and non-clinical performance.

Therefore, many of the requested points cannot be answered from the provided text. I will address the points that can be inferred or directly stated.

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

The document does not present acceptance criteria or reported device performance in the form of a table with numerical values for metrics like sensitivity, specificity, or image quality, as would be expected for a diagnostic or AI-driven device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

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The INBONE and INFINITY Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE and INFINITY Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

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

The Inbone® and Infinity® Total Ankle Systems consist of tibial trays, talar domes and tibial inserts. The tibial trays and talar domes have modular stem connections. The tibial trays are manufactured from titanium alloy; the talar domes are manufactured from cobalt chrome; and the tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE).

The Inbone® and Infinity® Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

The design features of the Inbone® and Infinity® Total Ankle Systems are substantially equivalent to the design features of other-devices previously cleared for market.

This document is a 510(k) premarket notification for the INBONE and INFINITY Total Ankle System. It does not describe a study involving an AI device or present acceptance criteria in the typical format for AI performance. Instead, it is for a medical implant and focuses on demonstrating substantial equivalence to previously marketed predicate devices. Therefore, a direct answer to your request in the context of an AI device and its acceptance criteria as proven by a study is not possible from the provided text.

However, I can extract information related to the device and its intended use, which might be analogous to general "acceptance criteria" for a physical medical device. Also, I can explain why other requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone studies, etc.) is not applicable here.

Here's a breakdown based on the provided document:

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

The document does not specify "acceptance criteria" in the format of quantitative performance metrics for the device itself, as would be expected for an AI algorithm. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices. The "performance" is described in terms of its intended function and safety under specific conditions.

2. Sample size used for the test set and the data provenance

• Not Applicable: This document describes a medical implant, not an AI device. There is no "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to physical and environmental testing (e.g., MR compatibility), not data-driven performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: As there is no "test set" for an AI algorithm, there are no experts establishing ground truth in this context. The "ground truth" for the device's safety and effectiveness is established through adherence to recognized standards, predicate device comparison, manufacturing quality systems, and clinical experience with similar devices, rather than expert labeling of data.

4. Adjudication method for the test set

• Not Applicable: No test set or associated adjudication method for an AI algorithm is 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

• Not Applicable: This is a physical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance are involved in its evaluation as described in this document. The document explicitly states "N/A" under "Substantial Equivalence - Clinical Evidence."

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 AI system.

7. The type of ground truth used

• For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence relies on:
  • Predicate Device Comparison: The primary "ground truth" is the established safety and effectiveness of legally marketed predicate devices (K123059 Inbone® II Total Ankle System, K123954 and K140749 Infinity® Total Ankle System).
  • Material Science and Engineering Principles: The physical and mechanical properties of the device components.
  • Environmental Testing: Specifically, MR compatibility testing to ensure safety under those conditions.

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not an AI system. There is no "training set."

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

• Not Applicable: No training set or associated ground truth establishment is applicable to this medical implant device.

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The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The INBONE® Total Ankle is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The ankle prosthesis is intended for cemented use only.

The INBONE® implant is a total ankle replacement (TAR) that is made of several specific components. A key concept of the INBONE® device is its modularity. Based on patient anatomy, a number of component sizes can be optioned for best fit. These components include the tibial stem components, the tibial tray, the poly bearing, the talar dome, and the talar stem.

This document is a 510(k) summary for the INBONE® Total Ankle System Line Extension. It's a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices. It does not describe a study involving algorithms, AI, or human readers, nor does it provide acceptance criteria for such a system.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance
• Sample sizes for a test set or training set
• Data provenance
• Number/qualifications of experts to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used

The document focuses on the physical characteristics and safety/effectiveness of a medical implant (an ankle prosthesis). The substantial equivalence is based on:

• Non-Clinical Evidence: Performance testing and engineering analysis related to articular shear stability, contact pressure, and lock detail.
• Technological Characteristics Comparison: Addition of a Size 1 Talar Dome and Size 1+ Poly Bearing, thicker poly bearings for revisions, trials for new poly bearings and the size 1 talar dome, and mid and top tibial stem pieces with plasma coating removed.

In summary, this document is about a mechanical medical device, not an AI or algorithm-based device.

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Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery.

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

The INBONE™ Total Ankle System consists of tibial trays, talar domes, poly inserts, tibial stems and talar stems.

The design features of the INBONE™ Total Ankle System device modification are substantially equivalent to the design features of the predicate INBONE™ Total Ankle System devices.

This document describes a 510(k) premarket notification for a modified INBONE™ Total Ankle System. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove performance against specific acceptance criteria in the context of typical AI/medical device efficacy studies.

Here's an analysis of the provided information based on your requested points, highlighting that this is a device modification approval and not a de novo device efficacy study:

1. Table of Acceptance Criteria and the Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Criterion: Perform at least as well as the legally marketed predicate device. This is implicitly based on:

• Material equivalence
• Identical indications for use
• Similar design features (despite slight difference in overall length of new size)
• Mechanical integrity (specifically fatigue life) | Performance:
• The modified device utilizes the same materials as the predicate.
• The indications for use are identical to the predicate device.
• The design features are similar; the modification is the addition of a new size, differing only in overall length from existing sizes.
• Fatigue testing was performed. The results show that the additional size "can be expected to perform at least as well as the legally marketed predicate." This is the key "performance" reported to meet the substantial equivalence claim.
• Conclusion: "the subject devices can be expected to perform at least as well as the predicate devices." |

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

   • Sample Size: Not applicable. This approval is based on a fatigue test for a mechanical device, not a performance study on a "test set" of patients or data in the context of AI/diagnostic devices. The sample size would refer to the number of devices or components tested in the fatigue assessment. This specific number is not provided in a way that relates to clinical "test sets."
   • Data Provenance: Not applicable in the traditional sense of patient data. The data originates from mechanical fatigue testing performed on the device or its components. The location of testing is not specified, nor is whether it was prospective (new tests for this submission) or retrospective (re-analysis of previous test data, though unlikely for a new size).

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" derived from expert consensus on a test set of clinical cases. The "ground truth" for mechanical testing is typically defined by engineering specifications and standards for device breakage or wear, with evaluation performed by engineers or testing laboratories.

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

   • Not applicable. This concept is relevant for clinical or diagnostic studies requiring expert review, which is not the nature of this 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 is not an AI-assisted diagnostic device, nor does it involve human readers interpreting data. It's a mechanical implant. The document explicitly states "B.2. Substantial Equivalence - Clinical Evidence N/A".

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

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

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

   • As this is a mechanical device, the "ground truth" for its performance is established by engineering standards and specifications for mechanical integrity and fatigue life, demonstrated through fatigue testing. The comparison is to a predicate device's established performance under similar testing conditions.

8. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device requiring a training set.

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

   • Not applicable.

Summary of the K103374 Submission:

This 510(k) submission is for a device modification (addition of a new size) to an existing orthopedic implant (INBONE™ Total Ankle System). The primary method used to demonstrate substantial equivalence, rather than meeting specific performance criteria against a clinical "ground truth," was:

• Comparison of Technological Characteristics: Showing identical indications, similar design features (with minor modification for size), and use of the same materials.
• Non-Clinical Evidence: Specifically, fatigue testing of the new size. The acceptance criterion was that the new size performs "at least as well as the legally marketed predicate" in terms of mechanical fatigue. The study essentially involved a direct comparison to the predicate's known or expected fatigue performance, implied to be successful if it met industry standards for such devices.
• Absence of Clinical Evidence: The submission explicitly states "N/A" for clinical evidence, indicating that no new human clinical trials were conducted or deemed necessary for this specific device modification.

Therefore, the "study" proving the device meets the (implied) acceptance criteria is the fatigue testing that demonstrated equivalent mechanical performance to the predicate device.

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