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Intended Use: The Incompass 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 Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.

Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.

The provided text is a 510(k) clearance letter for the Incompass Total Ankle System. It outlines the device's indications for use, its classification, and declares its substantial equivalence to predicate devices based on non-clinical evidence.

However, the clearance letter explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

This means that the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies proving a device meets acceptance criteria, especially for AI/ML-based devices or those requiring clinical trials) is not included in this document. The clearance was based on non-clinical performance bench testing to demonstrate substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety, rather than clinical efficacy studies.

Therefore, I cannot provide the requested information from this document. If this were a submission for a device that required clinical performance data to demonstrate safety and effectiveness (e.g., an AI/ML device), this section would typically contain summaries of those studies.

Based on the provided document, here's what can be inferred or explicitly stated regarding the acceptance criteria and study proving adherence to them:

The device in question is a Total Ankle System, a type of orthopedic implant, not an AI/ML-based device or one that underwent a clinical efficacy study for its 510(k) clearance.

The "study" that proves the device meets acceptance criteria, in this context, refers to non-clinical performance bench testing.

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

Since no clinical efficacy study was conducted for this 510(k) clearance, there's no data to populate such a table detailing clinical performance metrics (like sensitivity, specificity, or human reader improvement).

The acceptance criteria for this device were related to substantial equivalence through bench testing. The document states:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified in the document, as it refers to engineering and materials testing (bench testing) rather than a dataset of patient cases. For bench testing, "samples" would refer to the number of devices or components tested.
• Data Provenance: Not applicable in the context of clinical patient data (e.g., country of origin, retrospective/prospective), as the evidence was non-clinical bench testing. The testing would have been conducted in a laboratory setting.

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

• Not applicable. Ground truth as typically defined for AI/ML or clinical studies (e.g., expert consensus on medical images) was not established. The "ground truth" for bench testing is determined by engineering standards, material science principles, and established testing methodologies.

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

• Not applicable. This is relevant for studies involving human reviewers or AI output, not for materials and mechanical bench testing.

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:

• No. This type of study is specifically for AI/ML-assisted diagnostic devices. The Incompass Total Ankle System is a physical medical implant.

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

• No. This is relevant for AI/ML algorithms.

7. The type of ground truth used:

• The "ground truth" for this clearance was established through engineering standards, material specifications, and validated bench testing protocols comparing the device's physical and mechanical properties against those of legally marketed predicate devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

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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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