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The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during surgery, including laparoscopic surgery. The Ultravision™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.

The Ultravision™ Visual Clearing System removes surgical smoke and particulates from the visual field by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ultravision 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is intended for use only with the Ultravision™M Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.

The Ultravision Visual Field Clearing System is a surgical smoke precipitator. The study described in the provided text focuses on demonstrating the substantial equivalence of the updated Ultravision system to its predicate device, particularly concerning the addition of a new indication for use in open surgical procedures.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Tests (Cytotoxicity, Intracutaneous Irritation, Systemic Toxicity, Maximization Sensitization): The sample sizes for these tests are not explicitly stated in the provided text. These are typically standard tests conducted according to ISO 10993 guidelines, which would specify the number of samples/animals required. The provenance is likely laboratory-based testing.
• Performance Test 1 (Simulated Use): The text states a "human factors evaluation was also conducted during simulated surgery by actual users (surgeons)." The number of surgeons or simulated cases is not specified. The data provenance is from simulated surgical conditions.
• Performance Test 2 (Risk Assessment/Ozone Generation): This involved "empirical testing on ozone generation" in a "worst-case model." The specific sample size for these empirical tests (e.g., number of test runs, duration of tests) is not provided. The data provenance is laboratory testing.

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

• Biocompatibility Tests: Ground truth for these tests is established by standardized laboratory procedures and scientific assessment against predefined biological endpoints. No "experts" in the sense of clinical specialists establishing ground truth are mentioned.
• Performance Test 1 (Simulated Use): "Actual users (surgeons)" provided feedback to compare the Ultravision device to reference devices. The number of surgeons is not specified, nor are their specific qualifications (e.g., years of experience, subspecialty), beyond being "surgeons." Their feedback likely served as the "ground truth" for perceived performance metrics like workflow, ease of use, and risks in the simulated environment.
• Performance Test 2 (Risk Assessment): The ground truth for ozone generation is established by analytical measurements against regulatory limits (implied by "21 CFR"). The risk assessment for tissue damage risks was conducted internally by the manufacturer, comparing risks across different environments. The specific experts involved in designing or executing this risk assessment are not detailed, but it would involve experts in medical device safety, engineering, and possibly toxicology.

4. Adjudication Method for the Test Set

• Biocompatibility Tests: Adjudication is based on objective measurements and adherence to ISO 10993 standards and criteria.
• Performance Test 1 (Simulated Use): Feedback from "actual users (surgeons)" was synthesized to conclude equivalence. The method of synthesizing this feedback (e.g., individual reports, consensus meeting, voting) is not specified. It's unclear if a formal adjudication process beyond simple aggregation of feedback was used.
• Performance Test 2 (Risk Assessment): The risk assessment involves internal evaluation against predefined criteria and regulatory standards (for ozone). This is typically an internal process, so a specific external adjudication method is unlikely to have been used in the sense of a clinical read.

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

• No MRMC comparative effectiveness study was done. This device is a surgical smoke precipitator, not an AI diagnostic tool. The "Performance Test 1" involved human factors evaluation by surgeons, but it was not an MRMC study and did not involve AI.

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

• This device is a physical medical device (surgical smoke precipitator) and not an algorithm or AI-powered tool. Therefore, a standalone algorithm performance study is not applicable. The device's performance is intrinsically linked to its physical operation.

7. The Type of Ground Truth Used

• Biocompatibility Tests: Ground truth is established by standardized laboratory test results adhering to ISO 10993, which provide objective measurements of biological response (e.g., cell viability, irritation scores, systemic effects, sensitization).
• Performance Test 1 (Simulated Use): Ground truth is based on subjective feedback and comparative assessment from "actual users (surgeons)" regarding workflow, ease of use, and perceived risks in a simulated environment.
• Performance Test 2 (Risk Assessment): Ground truth for ozone generation is based on empirical measurement data compared against regulatory limits (21 CFR). For tissue damage assessment, it's based on an internal risk assessment methodology comparing scenarios.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The device was previously cleared (K182053), and the current submission is for an expanded indication, so the "development" or "training" of the device happened prior to or as part of the predicate device's clearance.

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

• Not applicable, as no training set for an AI/ML model is involved.

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