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The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.

The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation, and seal). The shape and duration of waveforms are comparable between the generator and the predicate device. The Generator functions in any of the following user selectable modes: Pure Cut, Blend Mode 1, Blend Mode 2, Blend Mode 3, Special Cut, Laparoscopic Cut, Pinpoint Coagulation, Gentle Coagulation, Spray Coagulation, Laparoscopic Coagulation, Macro Bipolar, Micro Bipolar, Gentle Bipolar, Auto Stop Bipolar, Vessel Seal with Optional Power Cut. The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. Like the predicate device, the ICON VS incorporates an ergonomically designed user interface screen for the selection of device settings. The ICON VS uses identical technology to the predicate device and the waveform profiles for all cut, coagulation, and bipolar modes are identical. The ICON VS differs from the predicate device in that 1) it is designed to work with Bovie Seal and Cut Instruments (K-092208 pending review), 2) the vessel sealing mode on the ICON VS is less aggressive than the predicate device (90 watts of power versus 400 watts of power), and 3) the power cut mode on the ICON VS delivers 100 watts of power versus the predicate device which delivers 80 watts of power.

The provided text is a 510(k) summary for the Bovie ICON VS Electrosurgical Generator. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results. Therefore, I cannot extract the requested information as it is not present in the document.

Here's why I cannot fulfill your request based on the provided text:

• No Acceptance Criteria or Reported Performance Data: The document does not specify any quantitative acceptance criteria (e.g., "device must achieve 90% accuracy" or "power output must be within +/- 5% of target"). Similarly, it does not present reported device performance in terms of metrics like sensitivity, specificity, accuracy, or power output measurements compared against specific targets.
• No Formal Study Design or Results: The text describes the device, its operation, and its intended use, and compares it to a predicate device. It states that "The ICON VS uses identical technology to the predicate device and the waveform profiles for all cut, coagulation, and bipolar modes are identical." It also notes differences in power output for vessel sealing and power cut modes. However, these are descriptive comparisons, not the results of a formal study with statistical analysis, sample sizes, ground truth establishment, or expert reviews as you've outlined for AI/diagnostic devices.
• Focus on Substantial Equivalence: The primary objective of a 510(k) submission, as reflected in this summary, is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and performance characteristics qualitatively or through engineering tests, rather than clinical trials or reader studies that would generate the type of data you're asking for.
• Device Type: This is an electrosurgical generator, a medical device that cuts and coagulates tissue using electrical current. The "acceptance criteria" and "study" framework you've described (e.g., MRMC studies, ground truth establishment by experts, pathology, training/test sets) are highly relevant for diagnostic devices, particularly those involving image analysis or AI. For electrosurgical generators, performance evaluation typically involves electrical safety testing, electromagnetic compatibility (EMC) testing, power output accuracy measurements, and functional testing to ensure the device performs its intended cutting and coagulation actions effectively and safely, often through bench testing or animal studies, not reader studies.

In summary, the provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence by comparing technological features and intended use, not a detailed report of a performance study with the specific metrics and methodologies you have requested for a diagnostic or AI-driven device.

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