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The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures whenever ligating clips are used/indicated.

Aescular's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in laparoscopic surgery. The clip appliers are available in 12mm diameter with a length of 330mm. The clip appliers are a non-modular, one-piece design for single fire use. These appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge holds 4 clips.

The provided text is a 510(k) Premarket Notification for an endoscopic clip system, specifically a line extension for Aesculap's Endoscopic Clip Appliers with Disposable Clip Magazine.

Based on the information provided, no specific acceptance criteria or a study proving that the device meets acceptance criteria are detailed in the document.

The document states:

• "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." This indicates that there are no specific, formally established performance standards that the device needs to meet for regulatory approval.
• The submission focuses on establishing substantial equivalence to an existing predicate device (K080753). This means the primary argument for approval is that the new device is as safe and effective as a legally marketed device, rather than a demonstration of meeting new, specific performance criteria through a dedicated study.

Therefore, the following points, which would typically be included in a description of acceptance criteria and study results, cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: No test set or associated study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
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 device is a mechanical surgical tool, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily describes the device, its intended use, and argues for substantial equivalence to a predicate device based on similar technological characteristics (shape, size, materials). Regulatory approval in this case relies on demonstrating that the modified device does not raise new questions of safety or effectiveness compared to the already approved predicate device.

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