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The Hintermann Series H2 Total Ankle (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint.

The Hintermann Series H2 is indicated as a total ankle replacement in primary of ankle joints damaged bv:

• Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)

• Primary arthritis (e.g., degenerative disease)

• Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present.

Note: In the United States, this device is intended for cemented use only.

The Hintermann Series H2 Total Ankle System is a total ankle prosthesis designed to replace the ankle joint. The Hintermann Series H2 Total Ankle System includes the following implantable components.

• H2 Tibial Component
• H2 Tibial Polyethylene (PE) Inlay
• Hintermann Series Talar Component

The tibial and talar components are coated with plasma spray titanium on the cement contacting surfaces. These components are used together to address the indications as outlined.

The provided text is a 510(k) summary for the Hintermann Series H2 Total Ankle System, a medical device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, rather than providing an acceptance criteria table and detailed study results typical of an AI/ML medical device submission.

As such, the information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria (especially in the context of AI/ML performance) is not present in the provided text.

The document describes non-clinical testing/performance data for the ankle system, which refers to mechanical and material tests to ensure the physical properties and safety of the implant, not the performance of an AI/ML algorithm.

Here's why the document doesn't contain the requested information:

• Device Type: The Hintermann Series H2 Total Ankle System is a physical orthopedic implant (an ankle joint prosthesis), not an AI/ML-driven diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission for a physical device like this primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis, material characterization, and mechanical testing (e.g., wear, fatigue, range of motion). It does not involve AI/ML performance metrics, ground truth establishment, or human reader studies.

Therefore, for each of your points, the answer based solely on the provided text would be:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document lists mechanical tests (e.g., Range of Motion per ASTM F2665-09, Locking Mechanism Testing per ASTM F1814) that were performed, but it does not present a table of specific quantitative acceptance criteria or the numerical results of these tests. It simply states that testing was done to support substantial equivalence.
2. Sample sizes used for the test set and the data provenance: Not applicable in the context of AI/ML. For mechanical testing, sample sizes would refer to the number of prostheses tested, but this information is not detailed in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts are establishing ground truth for an AI/ML algorithm in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical device would be established by standardized testing protocols (e.g., ASTM standards) measuring physical parameters, not by expert consensus on clinical cases.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is for a physical medical device (an ankle prosthesis) and not an AI/ML-driven device. As such, it does not contain the information related to acceptance criteria, test sets, ground truth, or human reader studies typically associated with AI/ML medical device performance evaluation.

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The Hintermann Series H2 Total Ankle Replacement (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint.

The Hintermann Series H2 is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by:

· Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)

· Primary arthritis (e.g., degenerative disease)

· Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present.

Note: In the United States, this device is intended for cemented use only.

The Hintermann Series H2 Total Ankle System includes a metal tibial component, polyethylene inlay, and metal talar component. The tibial and talar components are coated with plasma spray titanium on the bone contacting surfaces. The system is a semiconstrained device used for the indications as follows.

This document is a 510(k) summary for the Hintermann Series H2 Total Ankle System, asserting its substantial equivalence to previously marketed predicate devices. It focuses on the device's design, materials, and nonclinical testing to demonstrate safety and effectiveness.

Here's an analysis of the provided text in relation to your request about acceptance criteria and supportive studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a clear table of specific, quantitative acceptance criteria with corresponding reported device performance values. Instead, it lists types of non-clinical tests performed and states that the comparisons confirmed substantial equivalence to predicate devices. It implies that meeting the standards of ASTM F2665 and FDA guidance constitutes the acceptance criteria, but doesn't quantify results against specific thresholds.

Here's a conceptual representation, though explicit numeric values are missing from the text:

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

The document details non-clinical testing, which refers to laboratory or bench testing, not human-subject clinical trials. Therefore, concepts like "test set" in the context of patient data, data provenance (e.g., country of origin), or retrospective/prospective studies are not applicable to the information provided. The "sample size" for the non-clinical tests would refer to the number of physical device units or components tested for each specific test (e.g., 5 units for fatigue testing), but this information is not specified in the provided text.

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

Since this is a non-clinical device clearance based on substantial equivalence, there is no "test set" of patient data and therefore no experts used to establish ground truth in the way you might find in an AI/diagnostic device submission. The "ground truth" here is adherence to engineering standards and material specifications, verified through laboratory testing.

4. Adjudication Method for the Test Set

As there is no patient data test set or expert review, an adjudication method is not applicable to this submission.

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 conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. The Hintermann Series H2 Total Ankle System is an implantable medical device, and its clearance is based on non-clinical engineering and material performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the Hintermann Series H2 Total Ankle System is a physical implant, not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

For this non-clinical submission, the "ground truth" is defined by:

• Established engineering standards: Specifically, ASTM F2665 ("Standard Specification for Total Ankle Replacement Prosthesis").
• FDA guidance documents: Such as the "FDA Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements dated February 2, 2000" and general FDA guidance for endotoxin testing.
• Material specifications: For titanium alloy, UHMWPE, and CoCr alloy.

The "ground truth" is that the device, when subjected to these tests, performs within the acceptable parameters defined by these standards and demonstrates properties comparable to legally marketed predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. The device is an implant and does not involve machine learning or AI, and therefore has no "training set."

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

This question is not applicable as no training set exists for this device.

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