(305 days)
The Turbinator Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery involving nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage. The wand is designed to be used exclusively with the ArthroCare Coblator II (CII) controller and ArthroCare Irrigation pump. Other controllers/pumps must not be used.
The ArthroCare Turbinator Wand is a bipolar, single use, electrosurgical device designed for use with the ArthroCare Coblator II System Controller for specific turbinate indications in otorhinolaryngology (ENT) procedures.
This document describes the ArthroCare® Turbinator™ Wand, a bipolar electrosurgical device. The information provided heavily emphasizes its substantial equivalence to a predicate device, the ReFlex Ultra 45, implying that the acceptance criteria are met by demonstrating similar performance to this existing, approved device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Meet all design and performance specifications | Turbinator Wand meets all design and performance specifications. |
| Evaluate tissue effects similar to predicate device | Proposed device is substantially equivalent to the predicate device. |
| Perform as intended when used as labeled | Turbinator Wand performs as intended when used in accordance with its labeling. |
| Similar technological characteristics to predicate device (design, material, chemical composition, energy source) | Turbinator Wand has similar technological characteristics as compared to the predicate ArthroCare ReFlex Ultra 45 Wand. |
| Modifications do not raise new questions of safety or effectiveness | Modifications (Indications for Use, performance specifications, materials, labeling) are not substantial changes or modifications, and do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a numerical sample size for the "Performance Testing - Bench" or "Performance Testing - Animal" studies. For the animal study, it refers to "Pre-Clinical study" without specifying the number of animals or trials.
- Data Provenance:
- Bench Testing: Performed internally by ArthroCare Corporation.
- Animal Testing: A "Pre-Clinical study" was conducted, implying prospective data collection. The country of origin is not specified, but it's presumed to be the USA, given the submitting company's location and the FDA submission.
- Clinical Testing: "No clinical data are included in this submission."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The provided document does not describe any studies involving human experts to establish ground truth for a test set in the context of diagnostic or interpretive performance. The performance evaluations are against engineering specifications and comparisons to a predicate device's functional characteristics.
4. Adjudication Method for the Test Set
Not applicable, as no studies involving human interpretation or subjective assessment of a test set are reported in the document. The performance evaluations were objective measurements and comparisons.
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. This device is an electrosurgical wand, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical electrosurgical tool and not a standalone algorithm or AI. Performance is evaluated on its physical and functional characteristics.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The type of "ground truth" for this device can be inferred from the performance testing:
- Bench Testing: The ground truth would be defined by the design and performance specifications for the wand (e.g., power output, temperature, tissue ablation characteristics).
- Animal Testing: The ground truth for tissue effects would be based on histopathological examination of the treated tissue in comparison to tissue treated with the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a physical electrosurgical tool, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used for this type of medical device.
§ 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.