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The Yasargil Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied with Aesculap clip appliers, which contain titanium alloy or phynox jaws.

The Yasargil Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are manufactured from either titanium alloy according to ISO 5832/3 or phynox (cobalt alloy) per ISO 5832/7. The clips range in size from 3 mm to 40 mm and are available in straight, curved, angled, bayonet. T-bar, offset T-bar, concave T-bar, fenestrated, and non-fenestrated styles.

The Yasargil Clip Appliers are manufactured from stainless steel (body) with either a titanium allov or phynox jaw. The appliers are available in short (50mm), standard (90 mm) and long (110 mm) lengths, as well as straight, angled and bayonet shapes.

The provided text describes a 510(k) summary for Aesculap Yasargil Aneurysm Clips and Clip Appliers (K131500). This document is a premarket notification for a medical device, asserting its substantial equivalence to previously marketed devices. It focuses on the manufacturing and biomechanical properties of the clips and appliers, rather than a clinical study evaluating diagnostic accuracy or a human-in-the-loop AI system. Therefore, many of the requested categories for AI/diagnostic device studies are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "test set" here refers to physical components of the device (clips and appliers) that underwent biomechanical and MRI compatibility testing, not a dataset of patient information. The document does not specify the number of individual clips or appliers tested.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed on manufactured devices.

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 diagnostic or AI studies (e.g., expert consensus on medical images) is not relevant here. The "truth" for this device's performance is established by compliance with engineering and material science standards (ISO, ASTM). The expertise involved would be in manufacturing, materials science, and biomedical engineering.

4. Adjudication method for the test set

• Not applicable. There was no expert adjudication process for this type of device performance testing. Performance was measured against predefined engineering and material standards.

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. It is a surgical instrument.

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

• Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for this device is based on pre-defined engineering standards (ISO 9713, ASTM F2119, F2182, F2213, F2052, F2503) and the physical properties of the materials and design of the device. The testing aimed to demonstrate that the device met these established standards for biomechanical performance and MRI compatibility.

8. The sample size for the training set

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

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

• Not applicable.

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