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The Endoscopic Clip Appliers with clip magazine are intended for use in endoscopic surgery for ligating, marking vessels and tubular structures wherever a ligating clip is used/indicated.

Aesculap's Endoscopic Clip Appliers consists of two types of clip appliers (multifire (manual) or pneumatic (used CO2 cartridge). The clip appliers are reusable instruments that have either a 5 or 10 mm diameter and range in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The new clip magazine cartridge hold 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.

The provided text does not contain detailed information regarding specific acceptance criteria, a formal study proving device performance against such criteria, or data related to AI/algorithm performance. The document is a 510(k) summary for an Endoscopic Clip Applier line extension, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." Therefore, there is no table of acceptance criteria or reported device performance against such criteria in the provided text. The submission relies on demonstrating substantial equivalence based on similar technological characteristics and materials to a predicate device (Aesculap Endoscopic Clip Appliers, K962493).

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

Not applicable. The document does not describe a performance study with a test set. The substantial equivalence argument is based on design and material similarities.

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

Not applicable. No test set was described to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No test set was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document does not describe a comparative effectiveness study involving human readers or AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. This device is a mechanical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable. Ground truth is not relevant in the context of this 510(k) submission, which focuses on substantial equivalence of a physical device.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical medical instrument, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device is a mechanical medical instrument, not an AI algorithm.

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