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The ArthroCare ENT 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 ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.

Here's an analysis of the provided text regarding the ArthroCare ENT Plasma Wands, focusing on acceptance criteria and study details.

Based solely on the provided text, there is no information about a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a "Special 510(k)" submission. This type of submission is for modifications to a previously cleared device where the manufacturer attests that the changes do not significantly affect safety or efficacy. In such cases, a new clinical study to establish new acceptance criteria or performance is generally not required, as substantial equivalence to the predicate device is being claimed based on existing data and the minor nature of the changes.

Therefore, most of the requested fields cannot be answered definitively from this document.

Here's a breakdown of what can be extracted and what is explicitly not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not present in the document. The document states: "The indications for use, technology, principle of operation, performance specifications, materials, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)." This implies that the performance specifications (which would include acceptance criteria) reference the predicate a device (K030108), but the specifics are not detailed in this submission.

2. Sample Size Used for the Test Set and Data Provenance

Not present in the document. As no new performance study is described for this "Special 510(k)," there is no mention of a test set, sample size, or data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not present in the document. See point 2.

4. Adjudication Method for the Test Set

Not present in the document. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, one was not done (or at least not described in this document). This document primarily focuses on demonstrating substantial equivalence through design and material modifications, not through a new comparative effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/Not present in the document. This is a physical electrosurgical device, not an AI algorithm.

7. The Type of Ground Truth Used

Not present in the document. See point 2.

8. The Sample Size for the Training Set

Not applicable/Not present in the document. See point 6.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not present in the document. See point 6.

Summary of Device-Specific Information from the Text:

• Device Name: ArthroCare® ENT Plasma Wands
• Predicate Device: ArthroCare ArthroWands (K030108)
• Modifications: Dimensional specifications, materials, and labeling.
• Claim: These modifications are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
• Intended Use: Ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery, with a comprehensive list of specific ENT procedures.

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