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The O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator used to supply the RF signals to electrosurgical handpieces used on soft tissues where a wide range of tissue types, patient conditions and load impedances are encountered.

The OR Pro 300™ is a full powered electrosurgical generator with separate monopolar and bipolar sections. The monopolar section is designed for cutting and coagulation outputs, is intended for use with a patient return electrode, and is a floating, isolated output. The bipolar section incorporates a separate output from the monopolar output and has independently controlled power. The Bipolar section is a floating isolated output and is intended to be used with bipolar instruments. AC power mains is applied to the generator from a detachable line cord. This power mains voltage is converted to a DC voltage and applied to a single RF amplifier. An RF amplifier utilizes power MOSFETs to convert the DC voltage into a RF energy that is suitable for electrosurgical procedures. The generator is activated by either handswitching or footswitching active accessories. Three different types of CUTTING, Pure, Blend 1 and Blend 2, can be selected by the push buttons on the front panel. Two different types of COAG, Pinpoint and Spray, can also be selected on the front panel. In addition, BIPOLAR COAG is provided through the bipolar output jacks.

The provided text is a 510(k) summary for the Medtrex O.R.Pro 300™ Electrosurgical Generator. It details the device's technical specifications, indications for use, and its claim of substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance evaluation.

The only study mentioned is testing to "all applicable requirements of AAMI HF18-R-10/93 - American National Standard for Electrosurgical Devices." This standard focuses on the electrical and functional safety and performance of electrosurgical generators, not on the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information because the input document does not contain data related to AI/ML device performance, acceptance criteria for such, or studies involving human readers, ground truth establishment, or training/test sets as would be relevant for an AI/ML medical device.

The document confirms that the device "met all the applicable requirements of the Standard" for the AAMI HF18-R-10/93. This implicitly means that the acceptance criteria defined within that standard were met for electrical and functional performance, but those are not related to the AI/ML specific criteria you've asked for.

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