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CONMED CleanSeal Vessel Sealers are intended to be used in open and mimimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for ubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.

CleanSeal Advanced Bipolar Vessel Sealer Maryland is designed to be used, with a compatible MEP-1 electrosurqical generator, in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm arteries and veins. They are sterile, single use bipolar vessel sealing hand pieces featuring double action non-stick coated jaws, three shaft length options, a one-hand controlled handle with latchable lever. The instrument creates a seal by application of radio frequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between the jaws.

The provided text describes a 510(k) premarket notification for a medical device called "CleanSeal Advanced Bipolar Vessel Sealer Maryland." This document is a regulatory submission to the FDA, demonstrating the device's substantial equivalence to previously cleared predicate devices.

However, the information provided does not contain any details about acceptance criteria, study design for a test set, sample sizes for training or test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML device performance.

The document primarily focuses on:

• Device Description and Intended Use: Explains what the device is, how it works, and its surgical applications for sealing and dividing tissue and vessels.
• Performance Testing: Mentions that the device has been tested according to FDA guidance for electrosurgical devices.
• Biocompatibility Testing: States that biocompatibility testing was conducted and met acceptance criteria.
• Chronic Animal Studies: Describes two chronic animal studies (porcine and canine models) comparing the performance of the CleanSeal Maryland with its predicate devices for effective vessel sealing. These are biological/physiological studies, not studies of an AI/ML algorithm's performance.
• Shelf Life Study: Indicates a shelf-life study was performed.
• Substantial Equivalence Argument: Compares the new device's features (Model numbers, intended use, polarity, dimensional design, rated voltage, shelf-life, sterilization method, and disposability) to its predicate and reference devices to argue for substantial equivalence.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML device. The document refers to a physical electrosurgical device, and the "performance testing" and "chronic animal studies" relate to its mechanical and biological effectiveness, not an AI/ML algorithm's analytical performance on data.

If this device were an AI/ML device, the required information (acceptance criteria for AI metrics, test set details, ground truth, etc.) would be explicitly mentioned in sections describing its software performance and validation. Since those details are absent, it confirms that this is not an AI/ML device submission from which such information could be extracted.

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