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The Vivaer ARC Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, in the internal nasal valve area.

The Vivaer ARC Stylus is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Stylus comprises a handle, shaft and treatment tip. The treatment tip consists of an array of bipolar electrodes and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The Stylus is designed for use with the Aerin Console. It includes features to allow compatibility with and authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The studies collectively support the safety and efficacy of the Vivaer ARC Stylus for its intended use and its substantial equivalence to the predicate device.

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

• Clinical Study (Test Set):

  • Sample Size: 50 subjects
  • Data Provenance: Prospective, multi-center, non-randomized, non-significant risk clinical study conducted in the United States.

• In Vivo Study (Non-Clinical Test Set):

  • Sample Size: Canines (specific number not provided, but refers to "canines" implying multiple animals).
  • Data Provenance: In vivo testing.

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

• Clinical Study: Not explicitly stated that experts established the primary ground truth for the test set by independently reviewing images or data for the NOSE score. The NOSE score is a patient-reported outcome.
  • However, for physical and endoscopic nasal assessment, the assessments would have been performed by clinicians/physicians at the 8 study sites, who are presumed to be qualified in ENT surgery, given the context of the study. Specific expert qualifications (e.g., years of experience, board certification) are not detailed in the provided text.
• In Vivo Study:
  • Expert: A veterinary pathologist was used to evaluate the treated tissue histologically.
  • Qualifications: "veterinary pathologist" is mentioned. Specific years of experience or other detailed qualifications are not provided.

4. Adjudication Method for the Test Set

• The text does not explicitly mention an adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either the clinical or in vivo studies.
• For the clinical study, the primary efficacy endpoint (NOSE score) is a patient-reported outcome, not typically subject to expert adjudication of results, though it would be collected and managed by clinical study staff. The physical/endoscopic assessments would be performed by individual clinicians, and any discrepancies across sites or with baseline would likely be managed through standard clinical trial protocols (e.g., central review if severe discrepancies arose, but not detailed here).
• For the in vivo study, the veterinary pathologist evaluated histology. This implies a single expert assessment for the histological ground truth, with no multi-reader adjudication method specified.

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

• No MRMC comparative effectiveness study was mentioned or performed. This device is a surgical tool (radiofrequency probe), not an AI-powered diagnostic or assistive tool for human readers/interpreters of medical images. Therefore, the concept of human readers improving with AI assistance does not apply to this device.

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

• This is not applicable. The Vivaer ARC Stylus is a medical device, a handheld radiofrequency probe used for surgical procedures, it is not an algorithm or AI system. Its performance is directly tied to the physical action of the device and the clinician's use of it, not independent algorithmic performance.

7. The Type of Ground Truth Used

• Clinical Study:
  • Efficacy: Patient-reported outcome (Nasal Obstruction Symptom Evaluation - NOSE score) from subjects treated in a prospective study.
  • Safety: Characterization of adverse events reported by subjects and clinicians, physical/endoscopic nasal assessments performed by clinicians, and patient satisfaction surveys.
• In Vivo Study (Non-Clinical):
  • Safety/Healing: Histological evaluation by a veterinary pathologist, endoscopic evaluation, and observation of healing and long-term effects in canines.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical surgical instrument and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense. The "training" for the device's development would be through engineering design, material science, and iterative testing, not data-driven machine learning.

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

• Not applicable. As stated above, there is no "training set" for an AI/ML algorithm associated with this device. Device development relies on established engineering principles, biocompatibility standards, electrical safety standards, and pre-clinical and clinical testing to validate its design and performance against its intended use.

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