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The subject device of this premarket notification submission is Indicated for use to cut and or coagulate during laparoscopical surgical procedures.

Solid Laparoscopic Electrodes

This document is a 510(k) premarket notification approval letter from the FDA for Solid Laparoscopic Electrodes manufactured by Aaron Medical Industries, Inc. As such, it does not contain the detailed study information typically found in a clinical trial report or a submission supporting AI-based device approval.

Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these aspects are not part of this type of regulatory correspondence for a traditional medical device (not an AI/ML device).

The letter confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, meaning its safety and effectiveness are considered comparable. The "Indications For Use" state: "The subject device of this premarket notification submission is indicated for use to cut and/or coagulate during laparoscopic surgical procedures."

For traditional medical devices, "acceptance criteria" are typically related to engineering specifications, biocompatibility, sterilization, and basic functional performance tests, rather than diagnostic accuracy metrics as would be seen for AI/ML devices. The "study that proves the device meets the acceptance criteria" would refer to the testing and documentation submitted to demonstrate compliance with these engineering and safety standards, not a clinical study in the sense of a multi-reader, multi-case assessment.

In summary, the provided document does not contain the information requested in your prompt because it is a regulatory approval letter for a traditional medical device, not a study report for an AI/ML diagnostic device.

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