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The ArthroCare Coblator IQ System is indicated for the following procedures:

• For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and
• 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 Coblator IQ System is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.

The provided text is a 510(k) summary for the ArthroCare Coblator IQ™ System, an electrosurgical device. It outlines the device's description, intended uses, and claims of substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all sections of your request.

Specifically, the document states: "performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Coblator IQ System to the predicate devices." However, it does not provide any specific acceptance criteria or the results of this performance testing in a quantifiable manner. It also does not define what "performance" specifically refers to in this context (e.g., coagulation efficacy, tissue ablation rate, etc.), nor does it provide the results of such tests or the methodology used to demonstrate the device meets any specific criteria.

Therefore, for many of your points, the answer will be that the information is not provided in the submitted text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Not specified	Not specified
   (The document states "performance testing has been completed to demonstrate the substantial equivalence," but does not list specific criteria or results.)	(The document claims "the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use" based on this testing, but provides no quantitative results.)

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample size: Not specified.
   • Data provenance: Not specified. (No information regarding the country of origin of data, or if it was retrospective or prospective.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not applicable and not provided. The device is an electrosurgical tool, and the "performance testing" mentioned likely refers to bench testing or animal studies, not interpretative studies requiring expert ground truth in the way medical imaging AI devices do.

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

   • Not applicable and not provided. See point 3.

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:

   • A MRMC study was not done. This type of study is relevant for diagnostic imaging AI, not for an electrosurgical device. The document does not describe AI assistance for human readers.

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

   • Not applicable. This is not an AI algorithm. The device is a physical electrosurgical system.

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

   • Not applicable. The concept of "ground truth" as used for AI/diagnostic devices doesn't directly apply here. The "performance testing" would likely involve objective measurements in a lab or animal model.

Training Set Details (Not applicable for this type of device)

8. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

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