FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Aesculap Slim Clip Appliers are manufactured from stainless steel (body & jaw). The previously cleared appliers are available in lengths ranging from 50 mm to 110 mm in 10 mm increments. In addition to the straight jaw configuration (0%), the Clip Appliers are available with jaws angled up & down (5° to 15°), left & right (5° to 15°), in increments of 5° in all lengths. This submission intends to add additional lengths of 120 mm and 130 mm in these configurations. This submission intends to add additional jaw angulations of 20° to 45° up and down and 20° to 30° left and right in 5° increments and lengths ranging from 50-130 mm in 10 mm increments. In addition to these configurations, clip appliers with latches will be available in lengths ranging from 70 mm to 110 mm increments with jaw angulations ranging from straight, 5° to 45° up and down and 5° to 30° left and right in 5° increments. Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Aesculap Slim Clip Applier, a device used for opening, closing, and applying Aesculap YASARGIL aneurysm clips. The submission aims to add new lengths and jaw angulations, as well as an optional latch feature, to existing cleared appliers.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Methodology)	Reported Device Performance (Results)	Conclusion
Benchmark Functional Test	(1) Meet required interface and opening width of the aneurysm clip. (2) Successful release of designated aneurysm clip in the craniotomy. (3) Latch functionality.	Pass	The devices interfaced successfully with the aneurysm clips while providing the correct opening width. In addition, the devices successfully released the aneurysm clips within the craniotomy.
Predicate/Subject Device Comparison Test	Comparison between predicate and subject device ensuring: (1) Required interface and opening width of designated aneurysm clip. (2) Successful performance of the clip applier with the aneurysm clip. (3) Latch functionality.	Pass	The performance testing demonstrated that the subject devices are substantially equivalent to the predicate devices.
Usability Test	(1) Ensuring identification of designated clip type for the specific clip applier. (2) Legibility of additional Clip Applier identification features, i.e., company name, article number, and UDI information. (3) Ensuring visualization of surgical site. (4) Ability to grasp, hold, and apply YASARGIL Aneurysm Clip. (5) Latch usability test.	Pass	The usability test demonstrated that the subject devices were properly identified and met the usability requirements.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of appliers, number of clips, number of simulated craniotomies). It generally refers to "all required testing" being completed. The tests are bench tests, meaning they were conducted in a laboratory setting, not with human subjects. Thus, data provenance in terms of country of origin or retrospective/prospective medical data is not applicable here as the test data is generated in a controlled environment.

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

This information is not provided in the document. The tests performed are primarily functional and mechanical, suggesting that the "ground truth" is defined by engineering specifications and performance standards rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the bench testing (Pass/Fail results against predefined criteria), formal adjudication by multiple parties for each test outcome is unlikely to have been a primary method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (aneurysm clip applier), and the studies described are bench tests to confirm its mechanical and functional equivalence to predicate devices, not studies involving human readers interpreting imaging data or clinical outcomes. Therefore, an effect size of human readers improving with or without AI assistance is not applicable.

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

This question is not applicable to the Aesculap Slim Clip Applier. This device is a manual surgical instrument, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The ground truth for the acceptance criteria and testing appears to be based on:

Engineering Specifications: The required interface and opening width of the aneurysm clip, and the ability to release the clip successfully.
Functional Performance Standards: The successful performance of the clip applier with the aneurysm clip, and latch functionality.
Usability Requirements: Ensuring proper identification features, legibility, visualization of the surgical site, and the ability to grasp, hold, and apply the clip.

These are primarily objective, measurable criteria related to the device's design and intended function.

8. The Sample Size for the Training Set

This is not applicable. The Aesculap Slim Clip Applier is a mechanical medical device, not a machine learning or AI algorithm that requires training data.

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

This is not applicable, as there is no training set for a mechanical device.

Summary

Regulation Number and Section

§ 882.4175 Aneurysm clip applier.

(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).