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Aesculap's Bipolar Coagulator (GN160) is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.

Aesculap's Bipolar HF Device is a non-sterile, reusable electrosurgical generator capable of generating high frequency electrical current, driven through a software based program, for coaqulation with existing Aesculap bioolar instruments (e.g. forceps). It is equipped with a bipolar outlet. The device is fitted with a universal power adapter for mains voltages 100-120V and 220-240V. All software and electrical components are housed within a combination metallic and thermoplastic enclosure. A bipolar cord connects the instruments to the unit. The unit is activated by means of a foot control.

The provided document, K110695, describes the Aesculap Bipolar High Frequency (HF) Device. Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical or large-scale performance testing with human subjects or a dataset. The evaluation for this device focused on non-clinical bench testing and comparison to predicate devices. Therefore:

• Sample Size for Test Set: Not applicable in the context of human subject or image-based test sets. The "test set" would refer to the specific device units built and tested against engineering specifications and international standards.
• Data Provenance: The data provenance is from internal engineering and regulatory compliance testing of the Aesculap Bipolar HF Device. There is no indication of country of origin of data in terms of patient or clinical records, as no clinical testing was performed. All testing appears to be retrospective in the sense that it was conducted on manufacturing units to demonstrate compliance with pre-existing standards and equivalence to predicate devices.

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

This section is not applicable to the K110695 submission. The "ground truth" for this type of device (an electrosurgical unit) is established through:

• Engineering specifications and performance metrics: The device must generate a specific electrical output within defined parameters.
• Adherence to recognized safety and performance standards (IEC standards): These standards define acceptable performance limits.
• Comparison to predicate devices: The "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices.

There is no mention of human experts establishing a "ground truth" for a test set in the way one would for diagnostic imaging or a medical AI algorithm.

4. Adjudication Method for the Test Set

This is not applicable. Since there's no "test set" involving subjective human interpretation or a need for consensus among experts for a diagnostic task, no adjudication method was used. The evaluation involved objective measurements and comparisons to engineering specifications and standards.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which is not what the Aesculap Bipolar HF Device is. The device is a electrosurgical generator, not a diagnostic tool with human readers.

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

This is not applicable. The device is an electrosurgical unit, not an AI algorithm. Its performance is inherent to its electrical output and safety features, which are tested in a standalone capacity (the device itself) against engineering specifications and standards. There is no distinction between "algorithm only" and "human-in-the-loop" performance in this context.

7. The Type of Ground Truth Used

The "ground truth" for the Aesculap Bipolar HF Device was established by:

• Engineering specifications: The device must produce electrical currents within defined parameters (e.g., frequency, power output for coagulation).
• Compliance with international safety and performance standards (IEC 60601-1, 60601-2-2, 60601-1-2, 62304): These standards define the acceptable range of performance and safety characteristics.
• Performance of legally marketed predicate devices: The fundamental "ground truth" for substantial equivalence is that the new device performs "similarly" to these already cleared devices for their intended use.

This is a form of regulatory and engineering ground truth, not a clinical ground truth derived from pathology, expert consensus on images, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. The Aesculap Bipolar HF Device is an electrosurgical generator, not an AI/ML algorithm. There is no "training set" in the machine learning sense. The device's operation is based on pre-programmed software and hardware, not learned from data.

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

This is not applicable for the reasons stated in point 8.

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