(67 days)
The VivAer® 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, including cartilage in the internal nasal valve area.
The VivAer® Stylus is a disposable, handheld device capable of delivering bipolar radiofrequency energy to tissue. The stylus consists of an array of bipolar electrodes positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature during treatment. The product's intended users are physicians including otolaryngologists, maxillofacial surgeons and other physicians specialized in nasal procedures.
The VivAer® Stylus improves nasal breathing by modifying the soft tissues of the nasal airway through the use of low doses of radiofrequency energy. The low-power radiofrequency generates heat within the submucosal tissue, creating a coagulation lesion. As the lesion heals, the tissue retracts and stiffens. This decreases the nasal airflow resistance thereby improving inflow of air through the nose.
Here's a breakdown of the acceptance criteria and study information for the VivAer Stylus based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Packaging Validation | ||
| Sterilization (Ethylene Oxide) | Sterility Assurance Level (SAL) of 10-6 | Demonstrated ability to achieve SAL of 10-6 |
| Shelf-life (Accelerated Aging) | Pass all testing acceptance criteria | Passed all accelerated aging and transit testing |
| Usability | No use-related errors that may result in serious harms | No use-related errors identified |
| Biocompatibility | Not applicable (no new patient-contacting materials) | Not repeated |
| Device Performance Testing | ||
| Thermocouple Accuracy & Response Time | Met all requirements | Met all requirements |
| Treatment Parameter Verification | Confirmed correct programming of parameters | Confirmed correct programming of parameters |
| Reuse Prevention Verification | Met all requirements | Met all requirements |
| Force Load Testing (Shaft Strength) | Met all requirements | Met all requirements |
| Tissue Heating & Conductive Gel Compatibility | Confirmed energy delivery to tissue samples at variety of treatment parameters | Confirmed energy delivery to tissue samples at variety of treatment parameters |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of an AI/algorithm-based device. The testing described is primarily non-clinical performance testing of a physical medical device (VivAer Stylus) and its packaging.
- Sample Size: Not specified in terms of numerical units for each test, but implied to be sufficient for demonstrating compliance with acceptance criteria.
- Data Provenance: The studies were conducted internally by Aerin Medical Inc. in Sunnyvale, California, as part of their 510(k) submission. These are prospective tests performed on the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the described testing is for a surgical device focused on its physical and functional performance, not for an AI/algorithm that requires expert-established ground truth for image interpretation or diagnosis. The ground truth for these tests is based on engineering specifications, regulatory standards, and objective measurements (e.g., temperature readings, force measurements, sterility verification).
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of a human-in-the-loop diagnostic or interpretive task that would require adjudication. The testing involves engineering and performance validations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic or screening devices to assess the impact of AI on human reader performance. The VivAer Stylus is a surgical device, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical electrosurgical tool and does not employ an AI algorithm in the manner described. The "algorithm" here refers to the pre-programmed treatment parameters of the device (power, temperature, time), which were verified for correct programming.
7. The Type of Ground Truth Used
The ground truth used for the described non-clinical tests is based on:
- Engineering Specifications: E.g., for thermocouple accuracy, shaft strength, power output.
- Regulatory Standards: E.g., for sterilization (SAL of 10-6), biocompatibility.
- Objective Measurements: E.g., confirmed energy delivery to tissue samples, verification of programmed parameters.
8. The Sample Size for the Training Set
This is not applicable. The device is a surgical instrument, not an AI/machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as #8.
§ 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.