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The ArthroCare ENT Coblator Surgery System is 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 ArthroCare ENT Coblator Surgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

This document is a 510(k) summary for the ArthroCare ENT Coblator Surgery System, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device after modifications to performance and dimensional specifications, and labeling.

Therefore, the document does not contain the kind of detailed study information (like acceptance criteria, sample sizes, expert qualifications, or MRMC studies) that would typically be found in a clinical trial report or a comprehensive validation study for a new, non-substantially equivalent device.

Here's why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable / Not provided. The document states that the "proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System." This implies that the device is expected to meet the existing performance and safety standards established for the predicate device (K021364), rather than defining new, explicit acceptance criteria and then presenting new performance data against them. The phrase "performance specifications" refers to the device's technical characteristics, not clinical performance metrics.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This document is a 510(k) submission, not a new clinical study report. It relies on the substantial equivalence to a previously cleared device (K021364) for safety and effectiveness. There is no mention of a new "test set" in the context of clinical or performance data to prove efficacy for the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. As no new test set or clinical study is described, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not provided. No specific test set with ground truth is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable / Not provided. This device is an electrosurgical system, not an AI-assisted diagnostic tool. Such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable / Not provided. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable / Not provided. No clinical ground truth data is presented for this 510(k) submission. The safety and effectiveness are based on substantial equivalence to the predicate device.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/machine learning device; thus, there is no "training set."

9. How the ground truth for the training set was established:
* Not applicable / Not provided. As there is no training set, this information is not relevant.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a modified medical device to a predicate device, rather than a report on a new clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present. The core claim is that the modifications "do not significantly affect the safety or efficacy of the System" compared to the predicate, K021364.

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