(65 days)
The Aerin Medical 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.
The Aerin Medical 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 radiofrequency energy delivery. The stylus is connected, via a flexible cable, to a commercially-available RF generator (the ORA-50 S, cleared under K993854) meeting the following requirements: RF operating frequency of 460 kHz (± 5 kHz); bipolar low power (3 watts to 5 watts) RF energy delivery; and sensitive temperature control with low overshoot (50°C to 70°C).
This document describes a 510(k) premarket notification for the Aerin Medical Stylus, a radiofrequency wand intended for use in otorhinolaryngology (ENT) surgery to coagulate soft tissue in the nasal airway to treat nasal airway obstruction. The submission asserts substantial equivalence to the predicate device, Aerin Medical Wand (K150637).
Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of specific quantitative acceptance criteria for device performance. Instead, it describes general performance testing conducted and states that the device "met all performance testing requirements." The relevant performance aspects mentioned are:
| Acceptance Criteria (General Description) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated through testing per AAMI / ANSI / ISO 10993-1. |
| Sterilization and Packaging Validation | Validated per AAMI / ANSI / ISO 11137-1 and 11137-2. Packaging met acceptance criteria per ASTM standards. |
| Electrical Safety | Demonstrated through testing to IEC 60601-1 and 60601-2-2. |
| Electromagnetic Compatibility | Performed according to IEC 60601-1-2. |
| Usability (ergonomics, visualization, orientation, force application) | Evaluated as part of a cadaver study, implying met acceptance. |
| Shaft Strength (force load testing) | Conducted, implying adequate strength and met acceptance. |
| Thermocouple Accuracy and Response Time | Tested via water bath immersion, implying met accuracy and response criteria. |
| Tissue Heating Time | Tested using representative tissues, implying met heating time criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Cadaver Study (for usability): The document mentions a "cadaver study" but does not specify the number of cadavers or individual tests performed.
- Tissue Heating Time: The number of tissue samples or tests is not specified.
- Other tests (Biocompatibility, Sterilization, Electrical Safety, EMC, Packaging): These tests typically involve a defined number of device units or samples according to the relevant standards, but specific numbers are not provided in this summary.
- Data Provenance: Not specified in the provided text. The submission is from Aerin Medical, Inc. based in Sunnyvale, CA, USA, so it is likely that the testing was conducted in the USA or by facilities adhering to relevant international standards. The document does not indicate whether data was retrospective or prospective for any of the non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this device. The testing described is primarily non-clinical engineering and performance testing. "Ground truth" in the traditional sense of expert consensus on diagnostic images or clinical outcomes is not relevant here. Decisions on usability would likely have been made by engineers or clinical specialists involved in the cadaver study, but their qualifications and numbers are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this summary focuses on non-clinical performance and safety testing, not clinical studies requiring adjudication of outcomes or diagnoses.
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. The Aerin Medical Stylus is a surgical device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical studies described:
- Biocompatibility and Sterilization were validated against established ISO/AAMI standards.
- Electrical Safety and EMC were validated against IEC standards.
- Usability was evaluated in a cadaver study (presumably by observing ease of use, visualizing the treatment, etc.).
- Thermocouple accuracy and response time were measured against known temperatures in a water bath.
- Tissue heating time was measured directly in representative tissues.
The "ground truth" for these tests are the objective measurements against predefined engineering specifications and regulatory standards.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.