(198 days)
Noninvasive treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects.
MINNIE is a noninvasive radiofrequency device consisting of:
• Touch Screen User interface
• Programmable Microcontroller
• RF Power Module
• 4 Treatment Handpieces with following characteristics
o Bipolar Handpiece Ø 36mm
o Unipolar Handpieces Ø 36mm, 60mm and 80mm
MINNIE is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.
MINNIE Device Performance Study
This response outlines the acceptance criteria and study details for the MINNIE device, based on the provided 510(k) summary (K133405).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Effectiveness: At least a 2-point decrease in Fitzpatrick Wrinkle Scale (FWS) score | Immediate Post-Treatment: All 33 subjects in the active treatment group (Group C) met the success criterion. |
| 3-Month Follow-up: All subjects in Group C demonstrated an improvement from baseline. In 42% of cases, there was no change in FWS score recorded at the completion of the treatment cycle | |
| Safety: Monitoring for adverse events | Reported Adverse Events: 4 cases of moderate skin erythema, which resolved within a maximum of 3 days with antihistamines/topical corticosteroids/skin emollients. |
2. Sample Size and Data Provenance
- Test Set (Clinical Study): 52 subjects
- Group A (Control): 8 subjects
- Group B (Sham): 11 subjects
- Group C (Radiofrequency Treatment): 33 subjects
- Data Provenance: Not explicitly stated, but the applicant (Elettronica Valseriana srl) is based in Italy, suggesting the study may have been conducted there. The study appears to be prospective as subjects were randomly assigned to groups and followed up.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: 3 physicians
- Qualifications: "Blind to the randomization group," implying independence and impartiality. Specific years of experience or subspecialty (e.g., dermatologist, plastic surgeon) are not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Implicitly, consensus or strong agreement. The summary states, "There were no differences in the scoring of the evaluators," suggesting that the 3 physicians' evaluations (on clinical photographs) matched the in-vivo scores made by the investigator. If there were discrepancies, an adjudication method was not explicitly described, but their agreement eliminates the need for one.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- **No, a specific MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done.
- The study involved human readers (3 blinded physicians and the investigator) assessing wrinkles using a standardized scale. The device itself is an energy delivery system, not an AI-based diagnostic or assistive reader tool. Therefore, an MRMC study in the typical AI context is not applicable here.
6. Standalone Performance Study (Algorithm Only)
- **No, a standalone (algorithm only) performance study was not done.
- The MINNIE device is a medical device that delivers radiofrequency energy, not an algorithm that interprets data or provides diagnostic output. The clinical study assessed the effect of the device on human subjects.
7. Type of Ground Truth Used
- Ground Truth Type: Expert consensus (for evaluations from photographs by blinded physicians that confirmed the in-vivo scores by the investigator) and clinical assessment using a standardized scale (Fitzpatrick Wrinkle Scale - FWS).
8. Sample Size for the Training Set
- Training Set Sample Size: A separate training set for an algorithm is not applicable as the MINNIE device is a hardware-based radiofrequency treatment system, not an AI software. The provided document describes a clinical study to evaluate the device's safety and effectiveness in treating wrinkles, not to train a machine learning model.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable as there is no training set for an algorithm. The clinical study used the FWS as a measure to assess the device's effects on human subjects.
§ 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.