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510(k) Data Aggregation
(261 days)
STOP U (Packed Black USA), STOP U (Packed White USA)
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.
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(103 days)
STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)
Pollogen's STOP U is intended for use in the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
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.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Electrical Verification: Validate power control and accuracy. | "STOP U Electrical Verification was done to validate the STOP U power control and accuracy in reference to the user's input. In all instances, the STOP U system functioned as intended and observations were as expected." |
| Software Validation: Ensure software functions as required. | "The STOP U software was validated as required. In all instances, the STOP U system functioned as intended and observations were as expected." |
| Safety and Efficacy for Wrinkle Treatment: Evaluate safety and efficacy for treating mild to moderate facial wrinkles and rhytides. | "Over 80% of the subjects showed at least one grade improvement in Fitzpatrick wrinkle score at three months follow-up post treatment based on objective evaluations of the baseline and three months follow-up photographs. There were no incidences of adverse effects or complications. As expected, mild to moderate erytherna and mild edema were detected at the site of treatment immediately after treatment. All cases resolved without treatment within few hours. Treatment was well tolerated with minimal to no pain in the majority of study subjects. The data reported in this study clearly indicates that the Stop U provides a safe and effective treatment for facial wrinkles." |
| Compliance with Performance Standards: | |
| - EN/IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, Collateral Standard: Safety Requirements for Medical Electrical Systems. | "The STOP U system complies with the following performance standards..." (Implicitly, the successful operation implies compliance). |
| - EN/IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. | "The STOP U system complies with the following performance standards..." |
| - EN/IEC 60601-2-2 Safety of high frequency surgical equipment. | "The STOP U system complies with the following performance standards..." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 40 subjects were enrolled in the study.
- Data Provenance: The document does not explicitly state the country of origin. The study was a "study" which implies it was specifically conducted for this purpose. The timing of follow-up (3 months post last treatment) suggests it was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Three uninvolved physicians.
- Qualifications of Experts: Not specified beyond "uninvolved physicians." We do not know their specialty (e.g., dermatologists, plastic surgeons) or years of experience.
4. Adjudication Method for the Test Set
- Adjudication Method: The ground truth was established by the "blinded evaluation" of pre and post-treatment photos by three uninvolved physicians using the Fitzpatrick Wrinkle and Elastosis scale. It is unclear if a consensus was required or how discrepancies were handled (e.g., simple majority, all three agreeing).
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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. This study is a clinical efficacy trial of the device itself, not an evaluation of an AI component aiding human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This device is an electrosurgical system, not an AI diagnostic algorithm. The "objective evaluations" based on photographs by physicians are part of the clinical study, not a standalone algorithm evaluation.
7. The Type of Ground Truth Used
- The ground truth for the efficacy assessment was expert consensus (three uninvolved physicians) based on photographic evaluation using the Fitzpatrick Wrinkle and Elastosis scale.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical electrosurgical system, not a software algorithm that requires a training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set in the AI sense for this device.
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