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MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.

The device is a high frequency, bipolar ablation wand with suction capability that contains an integrated electrical cable and integrated saline delivery system.

The provided text is a 510(k) notification for MEDISISS Reprocessed ENT Ablation Wands (Coblators). This document is for a medical device (an ablation wand) and not for an AI/ML powered medical device. Therefore, the information requested such as "acceptance criteria and the study that proves the device meets the acceptance criteria", "sample size used for the test set and the data provenance", "number of experts used to establish the ground truth", "adjudication method", "multi reader multi case (MRMC) comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)", "type of ground truth used", "sample size for the training set", and "how the ground truth for the training set was established" are not applicable to this document. These questions are typically relevant for discussing studies related to the performance of AI/ML algorithms.

The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance specifications for regulatory clearance, rather than presenting a study with acceptance criteria in the manner requested for an AI/ML device.

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The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with Effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• Tonsillectomy
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring

The Wands are bipolar, single use, high frequency electrosurgical devices designed for a variety of ENT applications.

The provided document is a 510(k) summary for a medical device (ENTec® Plasma Wands) that refers to a modification in labeling for a previously cleared device. It explicitly states that the "indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s."

This type of submission (a Special 510(k)) does not typically involve new clinical studies to demonstrate device performance against acceptance criteria. Instead, it relies on demonstrating that the proposed changes do not significantly affect the safety or efficacy of the device, often by showing equivalence to a predicate device.

Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert ground truth, etc., for proving device performance for this particular 510(k) submission (K021364) is not applicable because a new performance study was not conducted or reported in this document. The submission is a "labeling modification" for an already cleared device.

The document states:

• "This Special 510(k) proposes a modification in labeling for the Wands, which were previously cleared under K014290 on March 28, 2002."
• "The indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s."
• "The proposed modification in labeling is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

In summary, based on the provided text, there is no information about new acceptance criteria, a study proving performance, sample sizes, expert ground truth, or MRMC/standalone studies because this 510(k) is for a labeling modification of an already cleared device, not for a new device requiring primary performance validation.

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