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The Sundt Slim-Line Aneurysm Clip Applier is designed for use only with Sundt Slim-Line Aneurysm Clips.

The subject Sundt Slim-Line Aneurysm Clip Applier is a stainless steel reusable hand-held instrument that is available in two configurations a fixed tip applier and a hinged tip applier. All three appliers consist of a handle grip with serrations, a two-piece spring, a shaft, and a v-grooved shape tip for grasping the aneurysm clip. The fixed tip Sundt Slim-Line Aneurysm Clip Applier and the Sugita appliers are designed with shaft that angles down and a thin tip profile to provide the surgeon a greater field of view during clip placement.

The provided document, a 510(k) summary for the Sundt Slim-Line Aneurysm Clip Applier, primarily focuses on demonstrating substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria for performance, a study proving those criteria were met, or any of the detailed aspects of a performance study (like sample sizes, ground truth establishment, or expert involvement) as typically required for AI/software-as-a-medical-device (SaMD) clearances today.

This submission is from 1998, a period predating widespread AI in medical devices and the current rigorous expectations for demonstrating AI/ML device performance. Devices like aneurysm clip appliers are mechanical instruments, and their clearance process historically relies on demonstrating substantial equivalence in design, materials, and intended use to predicate devices, rather than clinical performance metrics in the way AI algorithms are evaluated.

Therefore, most of the requested information cannot be extracted from this document. I will answer based on what is available in the document and state when information is not present.

1. Table of acceptance criteria and the 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 provided in the document. The clearance was based on substantial equivalence to predicate devices, not on a performance study with a test set.

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 provided in the document. No "ground truth" was established in the context of a performance study for this device's clearance.

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

This information is not provided in the document. No test set or adjudication method was described as part of this 510(k) submission for the device itself.

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 and not provided in the document. The device is a mechanical surgical instrument (aneurysm clip applier), not an AI-based diagnostic or assistive tool that would involve human readers or AI assistance.

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

This information is not applicable and not provided in the document. The device is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. No "ground truth" as typically understood in performance studies was used for the clearance of this mechanical device.

8. The sample size for the training set

This information is not applicable and not provided in the document. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided in the document. This device is not an AI/ML algorithm.

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