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The Xomed ENT RF system is for use by qualified surgeons familiar with radiofrequency electrosurgery techniques. The system produces monopolar and bipolar cutting and coagulation, and may provide fluid irrigation.

Indications in general surgery are for cutting, removal, and coagulation of tissues.

Indications in otorhinolaryngology (ENT) are for cutting, removal, and coagulation of tissues and for the destruction of tissue by thermal ablation in ENT procedures including, but not limited to snoring procedures, submucosal palatal and turbinate shrinkage, and traditional uvulopalatoplasty.

The Xomed ENT RF System consists of a radio frequency electrosurgical generator with a footswitch and/or fingerswitch to activate the generator RF output, various scissors, forceps, and probe electrosurgical instruments, and accessories including electrical cables to attach various electrosurgical instruments.

The system may be provided with an RF output current indicator, and a built-in peristaltic pump and associated footswitch for fluid irrigation.

This submission is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore clinical performance studies, acceptance criteria, multi-reader multi-case studies, and ground truth information are not applicable.

The submission focuses on establishing substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a study as would be done for novel or AI/ML-driven devices.

Here's why the requested information isn't present in the document and what the document does provide:

• Acceptance Criteria and Reported Device Performance: Not applicable. The submission does not define specific performance metrics like sensitivity, specificity, accuracy, or report on clinical study results against such criteria.
• Sample Size, Data Provenance, Number of Experts, Adjudication Method: Not applicable. These details are relevant for clinical trials or studies assessing device performance (especially AI/ML models), which are not required for a 510(k) submission seeking substantial equivalence for this type of device.
• MRMC Comparative Effectiveness Study: Not applicable. This type of study is typically done for diagnostic devices or AI algorithms where human reader performance is compared with and without AI assistance. This device is a surgical tool.
• Standalone Performance: Not applicable. "Standalone performance" usually refers to the performance of an algorithm without human intervention, which is not relevant for an electrosurgical system.
• Type of Ground Truth: Not applicable. Ground truth, such as pathology or outcomes data, is used to validate the output of diagnostic or predictive algorithms. This device is a surgical instrument.
• Sample Size for Training Set, How Ground Truth for Training Set was Established: Not applicable. This device is not an AI/ML algorithm that requires training data and ground truth establishment.

What the document does provide regarding "proof" of the device:

The "study" for this type of device is the demonstration of Substantial Equivalence to a legally marketed predicate device.

• Section 8.0 Substantial Equivalence: States that "The Xomed ENT RF system is substantially equivalent to the Surgitron IEC marketed by Ellman (K990146 and K980177) in its intended use, materials, and overall design."
• The FDA's decision letter (starting on page 2) confirms this: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

In summary, for this 510(k) submission, the "proof" is the demonstration and FDA's acceptance of substantial equivalence to a predicate device, based on comparable intended use, technology, and safety/effectiveness profiles, rather than a clinical study with specific acceptance criteria.

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