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The Synthes Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.

The Synthes Ankle Arthrodesis Plates are minimally contoured metal plates that utilize traditional internal plate/screw fixation to promote fusion or "arthrodesis" of the ankle.

This document is a 510(k) summary for the Synthes Ankle Arthrodesis Plates. It describes a medical device, its intended use, classification, and a determination of substantial equivalence to a predicate device by the FDA. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not a performance study report for a novel AI/software medical device.

Therefore, I cannot provide the requested information in the format specified because the provided text does not contain the details of a study on device performance against acceptance criteria. The document is for a traditional medical device (metal plates) and focuses on regulatory clearance based on substantial equivalence, not on performance metrics of a software or AI algorithm.

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The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle and the distal tibia.

The Synthes Ankle Arthrodesis Plate is a minimally contoured metal plate that utilizes traditional internal plate/screw fixation to promote fusion or “arthrodesis” of the ankle.

The provided document is a 510(k) premarket notification for the Synthes Ankle Arthrodesis Plate. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness against specific acceptance criteria.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical trial would. Instead, it refers to documentation provided to the FDA that demonstrated substantial equivalence to an existing device.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria & Device Performance Table: Not applicable for a 510(k) submission focused on substantial equivalence. This document doesn't define performance metrics or provide a table showing how the device met them.

2. Sample Size, Test Set Data Provenance: Not applicable. There's no mention of a test set of human subjects or data from such a study.

3. Number of Experts & Qualifications: Not applicable. This type of submission doesn't involve expert establishment of ground truth for a test set.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable. This isn't a study comparing human readers with and without AI assistance.

6. Standalone Performance Study: Not applicable. There is no algorithm, and therefore no standalone performance study in the context of AI/medical image analysis.

7. Type of Ground Truth: Not applicable. There is no ground truth established for this type of device.

8. Sample Size for Training Set: Not applicable. There's no machine learning algorithm, and thus no training set.

9. Ground Truth for Training Set Establishment: Not applicable.

In summary, the provided document is a regulatory filing for a medical device (an ankle arthrodesis plate) based on substantial equivalence, not a study evaluating an AI/software device against predefined acceptance criteria.

Ask a specific question about this device