(261 days)
The STOP U device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.
The STOP U device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U device (applicator unit), the STOP U Power Supply and the STOP Preparation Gel.
The provided text describes the acceptance criteria and a clinical study conducted for the Pollogen Ltd. STOP U device (K182774), intended for non-invasive treatment of mild to moderate facial wrinkles.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (Clinical Study Findings) |
|---|---|
| Safety | No incidences of adverse effects or complications. Mild to moderate erythema and mild edema detected immediately after treatment, resolving within a few hours without treatment. Treatment was well tolerated with minimal to no pain. |
| Effectiveness (Improvement in facial wrinkles) | Over 80% of subjects showed at least one grade improvement in Fitzpatrick wrinkle score at three months follow-up post-treatment. |
| Usability/Self-Selection | Correct self-selection rate met Pollogen's goal (study with final packaging design). The packaging adequately explains user eligibility. |
| Human Factors Validation | 100% success rate in human factors validation (design and instructional materials facilitated safe use). |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Clinical Efficacy and Safety): 40 subjects (37 female, 3 male)
- Sample Size (Usability/Self-Selection Study): Not explicitly stated, but the text mentions "using the final STOP U packaging design produced a correct self-selection rate that met Pollogen's goal."
- Sample Size (Human Factors Validation): 61 subjects (39 female, 22 male)
- Data Provenance: The clinical trial "was conducted to support the clearance of the prescription version of the STOP U device (K140255)." This implies it was a prospective clinical study. The country of origin for the clinical study is not explicitly stated in the provided text.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three uninvolved physicians.
- Qualifications of Experts: Not explicitly stated beyond "uninvolved physicians." It is implied they are qualified to evaluate facial wrinkles and elastosis using the Fitzpatrick scale.
4. Adjudication Method for the Test Set
The adjudication method for evaluating treatment efficacy was blinded evaluation by three uninvolved physicians based on the Fitzpatrick Wrinkle and Elastosis scale using pre and post-treatment photos. A specific method like "2+1" or "3+1" is not detailed, but the use of three independent evaluators suggests a consensus-based approach would likely have been employed if there were disagreements.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a direct-to-consumer medical device, not an AI-powered diagnostic or assistive tool for clinicians.
6. Standalone Performance Study
The clinical trial described (40 subjects) assessed the standalone performance of the STOP U device regarding its safety and effectiveness in treating facial wrinkles. It measured the device's effect directly on subjects without human-in-the-loop assistance for the core treatment, though a human user operates the device. The evaluation of results, however, involved human experts (physicians) reviewing images.
7. Type of Ground Truth Used
The ground truth for effectiveness was established by expert consensus/evaluation using the Fitzpatrick Wrinkle and Elastosis scale based on pre and post-treatment photographs. Safety was assessed by monitoring adverse events.
8. Sample Size for the Training Set
The provided document describes performance testing and clinical trials for validation. It does not mention a "training set" as would be relevant for machine learning models. The studies described are for verifying the device's physical and clinical performance.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for a machine learning model, this question is not applicable based on the provided text. The studies validate the device itself, not an algorithm that would require a training set.
§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.
(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.