(253 days)
The Aerin Medical Wand 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 Wand is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Wand 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 Wand 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).
All patient-contacting materials of the Aerin Medical Wand are polymers or stainless steel that have been shown to be biocompatible for short-term contact (less than 24 hours) with breached or compromised surfaces. The Wand is individually packaged and supplied radiation-sterilized for single use.
The Aerin Medical Wand is used in the treatment of patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the Aerin Medical Wand into a patient's nostril to deliver low power RF energy to the target tissue of the nasal airway. Radiofrequency treatment of tissue creates a coagulative lesion which fibroses and retracts as it heals, thereby shrinking the tissue to lessen the degree of obstruction.
Here's an analysis of the provided text regarding the Aerin Medical Wand (Model FG011) and its acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria for device performance. However, it implicitly defines successful performance by meeting the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Freedom from unanticipated serious adverse events (SAEs) | Met: No SAEs reported in the study. |
| Minimal complications (e.g., temporary bleeding, edema, crusting, mucosal tears) | Very minimal complications observed, similar to those reported with the predicate device. All adverse events were anticipated observations from thermal treatment and healing, except for one common cold. |
| No changes in outward appearance of the nose. | Met: External photographs of each treated nostril revealed no changes in outward appearance. |
| Biocompatibility | Demonstrated through testing per AAMI / ANSI / ISO 10993 series. |
| Radiation sterilization | Validated per AAMI / ANSI / ISO 11137 series. |
| Electrical safety | Demonstrated through testing to IEC 60601-1 and 60601-2-2. |
| Electromagnetic compatibility | Performed according to IEC 60601-1-2. |
| Packaging integrity | Met all acceptance criteria of ASTM D4169-09, ASTM F1980-07, ASTM F2096-11, and ASTM F88/F88M-09. |
| No significant variation or hot spots in thermal imaging | Met: Thermal imaging showed uniform heating without significant variation or hot spots. |
| Effectiveness: | |
| Technical feasibility (ability to deliver RF energy) | Evaluated and met. |
| Clinically significant improvement in NOSE score | At 90 days, a clinically significant improvement was reported in 88% of subjects, as assessed with the NOSE scale. This is comparable to the 82-88% reported for the predicate device. One subject lost to follow-up reported a 25-point improvement at 30 days. |
| Progression in healing and nasal obstruction improvement | Demonstrated during the 90-day follow-up period via endoscopic intranasal assessments, similar to literature for predicate device. |
| Create thermal lesion volumes comparable to predicate device | Bench testing showed the Aerin Medical Wand creates thermal lesion volumes comparable to volumes created with the predicate device. Histological changes were evaluated as absent, minimal, or mild for tissue treated within specified parameters during in vivo preclinical testing. |
| Meet all design requirements (usability, thermocouple response, tissue heating times) | Met all design requirements. |
2. Sample Sizes Used for the Test Set and Data Provenance
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Clinical Study (Test Set):
- Sample Size: 33 subjects were enrolled.
- Treatments: 47 nostrils were treated in the index procedures. 10 subjects had repeat treatments (12 nostrils), for a total of 59 nostril treatments.
- Data Provenance: Prospective, multi-center, non-randomized study conducted in the United States.
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Pre-Clinical Testing (Animal Study - also a form of test set):
- Sample Size: Not explicitly stated how many animals were used, but "Several combinations of energy delivery durations and target temperatures were used" in in vivo testing.
- Data Provenance: This was an in vivo animal study. Location not specified, but typically conducted in a controlled lab/research environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Clinical Study:
- The document implies that physicians performed "physician evaluation of the tissue healing progression" and assessed "endoscopic intranasal assessments." Specific number of physicians or detailed qualifications are not provided, but they would be medical professionals (likely ENT specialists) involved in the study.
- Pre-Clinical Testing:
- A veterinary pathologist evaluated the treated tissue histologically after 8 weeks of healing. The number of pathologists and their specific experience level are not stated.
4. Adjudication Method (for the test set)
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical study's outcomes. Clinical outcomes like SAE reporting and NOSE score improvements are generally direct measures or subject self-assessments complemented by physician review.
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, an MRMC comparative effectiveness study involving AI assistance was not done. This device is an electrosurgical wand, not an AI-powered diagnostic or assistive tool. The study focused on the device's safety and effectiveness in treating nasal obstruction, comparing its outcomes to medical literature on a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This report is for a physical medical device (electrosurgical wand), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
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For the Clinical Study (human subjects):
- Outcomes Data: Primarily based on the patient's subjective "Nasal Obstruction Symptom Evaluation (NOSE) score" (a validated patient-reported outcome measure).
- Physician Evaluation: Physician assessment of tissue healing progression via endoscopic intranasal assessments.
- Safety Data: Freedom from SAEs, reporting of adverse events, and external photographic assessments.
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For the Pre-Clinical Testing (animal study):
- Pathology: Histological evaluation of treated tissue by a veterinary pathologist.
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. All samples discussed (clinical subjects, animal models) are generally considered test sets for assessing the final device's performance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm.
§ 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.