(7 days)
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.
The provided text is a 510(k) premarket notification for a medical device (ArthroCare® ENT Plasma Wands) and does not describe a study that conducted testing with associated acceptance criteria. Instead, it describes a "Special 510(k)" submission for a material modification to a previously cleared device.
The key points from the text related to performance, acceptance criteria, and studies are:
- Substantial Equivalence: The document states that the modified ArthroCare ENT Plasma Wands are "substantially equivalent" to a predicate device (K033257). This is a regulatory pathway and not a performance study demonstrating new acceptance criteria.
- No new performance criteria: The submission explicitly states: "The indications for use, technology, principle of operation, dimensional specifications, performance specifications, labeling and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)."
- No new study presented: Because the performance specifications are stated to be the same, and the modification is primarily material, the document does not present a new study with acceptance criteria to demonstrate device performance. It relies on the substantial equivalence to the previously cleared device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this specific document, as those types of studies were not included in this Special 510(k) submission.
Summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria or specific reported device performance data from a new study. It asserts that the "performance specifications... remain the same as in the predicate cleared 510(k)" (K033257).
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new test set data is presented as part of this Special 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No new test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No new test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is an electrosurgical wand; it is not an AI algorithm.
7. The Type of Ground Truth Used
Not applicable. No new study requiring ground truth is described.
8. The Sample Size for the Training Set
Not applicable. This device is an electrosurgical wand; there is no AI algorithm with a training set discussed.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set discussed.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.