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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."

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The Salto Talaris ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.

The Salto XT ankle prosthesis is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only.

The cleared Salto Talaris and the new Salto XT are intended for total ankle replacement. Both are a semiconstrained anatomical design, which reproduces the kinematics of the ankle joint. And both consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar component.

The submission seeks clearance for:

• the addition of new components to the Salto XT (tibial and talar components).
• the addition of a new size and new thicknesses to the cleared range of Salto Talaris tibial inserts.

The tibial inserts are compatible with both Salto Talaris (K060544, K090076, K130533) and the new Salto XT. The new device Salto XT has been designed to be compatible with the cleared and the new Salto Talaris tibial inserts. All Salto XT components are compatible with cleared Salto Talaris components.

The provided document is a 510(k) premarket notification for two medical devices, Salto XT and Salto Talaris ankle prostheses. This document details the FDA's decision of substantial equivalence to predicate devices, but does not describe acceptance criteria for software performance or a study proving that a device meets such criteria.

The document describes non-clinical testing for mechanical performance, such as tibial fatigue, insert locking mechanism strength, talar stability, contact pressure, and wear. These are physical tests of the prosthesis components, not software performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to software performance from this document.

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Intended Use: The INFINITY™ Total Ankle 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.

Indications For Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The 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 INFINITY™ Total Ankle System is a fixed-bearing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial insert, and talar dome) that are assembled to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.

The provided text is a 510(k) summary for the INFINITY™ Total Ankle System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the medical device is at least as safe and effective as a legally marketed device (predicate device).

However, the information provided does not contain details about acceptance criteria, a study proving device performance against those criteria, or any of the specific reader study methodologies requested.

The document primarily focuses on:

• Device Description: What the INFINITY™ Total Ankle System is made of and how it functions.
• Intended Use and Indications for Use: For whom and under what conditions the device is designed to be used.
• Technological Characteristics Comparison: A high-level statement that its features are similar to predicate devices.
• Non-Clinical Evidence: A list of types of non-clinical analyses performed (Bone interface stability, Component stability, Fatigue testing, Contact area/stress testing) and a conclusion that these results show the device performs "at least as well as" predicate devices. No specific performance metrics, acceptance criteria, or detailed study results are given.
• Clinical Evidence: Explicitly states "N/A", meaning no clinical evidence was presented for this 510(k) submission.
• Substantial Equivalence Conclusion: A general statement of safety and effectiveness based on non-clinical evidence and comparison to predicate devices.

Therefore, I cannot populate the requested table and answer the specific questions because the necessary data is not present in the provided text. The document aims to demonstrate substantial equivalence to existing devices through non-clinical testing and design comparison, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/software device.

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