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To coagulate tissue.
The Cosman Coagulator (CC-1) and accessories  વે઼઼ indicated for gene

The Radionics CC-1 Cosman Coagulator is an electrosurgical device with a microprocessor and accessory electrodes. The features of the CC-1 are included in one or more of the predicate devices. The system and unit testing results provided in this premarket notification verify that the CC-1 is accurate and reliable. Audio and visual indicators and displays inform the user regarding the proper function of the CC-1. In addition, self-test routines check the software and front panel LEDs upon power-up.
The CC-1. addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available Radionics CBC-1, Codman Malis CMC-III, Fischer G50 and Valleylab Force 40 devices. Like these devices, the CC-1 is comprised of a radiofrequency generator with a microprocessor and accessory electrodes. The features of the generator include manual, timed, automatic temperature and automatic power control. The CC-1 also displays and/or monitors: impedance, temperature, power and current. The maximum power output is 200 Watts. Electrodes include monopolar, bipolar, reusable, disposable, irrigating and non-irrigating types. These features are all included in one or more of the predicate devices.

The provided text is a 510(k) premarket notification for a medical device, the Cosman Coagulator CC-1. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than robust clinical performance studies with acceptance criteria, sample sizes, and ground truth establishment as would be typical for a novel device or AI/ML algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of an AI/ML algorithm's performance.

Specifically, the document states:

• "The features of the CC-1 are included in one or more of the predicate devices."
• "The system and unit testing results provided in this premarket notification verify that the CC-1 is accurate and reliable."
• "The CC-1...has the same intended use and technological characteristics as the commercially available Radionics CBC-1, Codman Malis CMC-III, Fischer G50 and Valleylab Force 40 devices."
• "Radionics believes that the information and testing provided in this premarket notification clearly describe the CC-1 Cosman Coagulator and accessories and demonstrate that it is equivalent to the mentioned commercially marketed predicate devices."

This indicates that the "study" proving the device meets criteria is primarily a comparison to existing, legally marketed predicate devices and internal system/unit testing for accuracy and reliability, not a clinical trial with specific performance metrics against a defined ground truth as would be evaluated for an AI/ML diagnostic tool.

Therefore, I cannot populate the table or answer the subsequent questions in the requested format based on the provided text. The document's purpose is to demonstrate substantial equivalence, not to provide detailed performance metrics from a clinical study as typically described for AI/ML devices.

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