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The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).

Aesculap's Sovereign Bipolar Instruments are comprised of a variety of non-sterile, reusable endoscopic scissors and forceps. The modular instruments utilize standard bipolar cables (with flat plugs) connected to compatible electrosurgical generators that supply bipolar energy. The instruments may be sterilized by steam sterilization.

The provided document is a 510(k) summary for the SOVEREIGN™ Bipolar Instruments, which is a regulatory submission for a medical device. It focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving performance metrics for AI or software, or human readers. Therefore, much of the requested information regarding AI-specific acceptance criteria, test sets, ground truth establishment, or multi-reader studies is not applicable to this document.

However, I can extract information related to the device's conformance to a standard, which serves as a form of "acceptance criteria" in the context of device safety and effectiveness.

Here's a breakdown of the relevant information from the provided text:

1. A 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)

• Not applicable. This document describes a medical device (surgical instruments), not a software or AI algorithm that would typically have a "test set" in the context of performance evaluation with data samples. The performance evaluation here refers to conformance to an electrical safety standard, not data-driven performance metrics.

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)

• Not applicable. Ground truth establishment by experts is relevant for evaluating the performance of diagnostic or prognostic AI/software. This document concerns the safety and operational principles of physical surgical instruments.

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

• Not applicable. Adjudication methods are used in the context of resolving discrepancies in expert labeling or diagnoses, which is not relevant to the evaluation described for these bipolar instruments.

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. An MRMC study with AI assistance is not relevant for the type of device described (bipolar surgical instruments).

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

• Not applicable. This report is not about an algorithm or AI.

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

• Not applicable. The "ground truth" in this context is the established requirements of the IEC 60601-2-18 standard for electromedical devices, which the instruments are stated to conform to.

8. The sample size for the training set

• Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

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

• Not applicable. As there is no training set, there is no ground truth establishment for a training set.

Summary of what the document does provide regarding "performance":

The document states that:

• "No 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, legally mandated performance benchmarks for this type of device directly from the FDA for this submission.
• "The Sovereign Bipolar Instruments, however, conform to the following electromedical standard: IEC 60601-2-18." This is the key "performance data" provided. Conformance to this standard implies that the device meets generally accepted safety and essential performance requirements for electromedical equipment.

The entire 510(k) submission process is to demonstrate substantial equivalence to predicate devices. The "performance data" in this context refers to showing that the new device is as safe and effective as existing legally marketed devices, rather than establishing novel quantitative performance metrics against specific acceptance criteria for a new technology or AI.

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