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The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. The Integrated Monopolar L-Hook (H/S)™ is available with of 32cm. It is intended to be introduced via standard 5mm surgical trocars as long as their internal diameter is 5.70mm or greater. The device is for prescription use only.

The provided text is a 510(k) summary for the Ultravision2™ System Integrated Monopolar L-Hook (H/S)™. It details the device's characteristics, comparison to predicate devices, and a summary of non-clinical testing.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a software-driven AI device. The device described is a surgical instrument that combines visual field clearing and monopolar HF tissue cutting/coagulation. The "visual field clearing" mechanism is stated as "electrostatic precipitation," which is a physical principle, not an AI algorithm.

Therefore, many parts of your request, specifically those related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, or training sets, cannot be answered from the provided text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics comparison and non-clinical bench testing for safety and performance of the surgical instrument itself.

Here is what can be extracted from the provided text regarding device acceptance and performance through non-AI related testing:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance:

• The document does not specify sample sizes for the various tests.
• Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as the testing relates to the physical device and its biocompatibility/electrical safety, not clinical study data for AI.

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):

• This is not applicable as the device is not an AI/software device requiring expert interpretation of medical images or data. Ground truth for the described tests would be established by validated measurement techniques and laboratory protocols based on the specified ISO and ASTM standards.

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

• Not applicable for the type of testing described (bench testing, biocompatibility).

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. The device is a surgical instrument, not an AI-assisted diagnostic tool.

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 (expert consensus, pathology, outcomes data, etc):

• For biocompatibility tests, ground truth is established by the specific chemical and biological reactions/observations as defined by the ISO and USP standards (e.g., cell viability for cytotoxicity, skin reaction for irritation, hemolysis levels).
• For electrical safety and mechanical tests, ground truth is established by direct physical measurements against engineering specifications and international standards (IEC, EN, ASTM).
• For "Visual field clearing" and "Design validation under simulated use conditions," the ground truth is against internal performance specifications, aiming for equivalence to predicate devices, implying practical demonstration of effectiveness.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device.

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

• Not applicable as this is not an AI/machine learning device.

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