(71 days)
The STOP U Model UXV 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 Model UXV 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 Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.
This document describes a 510(k) premarket notification for the Pollogen Ltd. STOP U Model UXV device, an electrosurgical device for over-the-counter aesthetic use. The purpose of the submission is to demonstrate substantial equivalence to a predicate device (Pollogen Ltd., STOP U, K182774).
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting specific acceptance criteria for a new clinical outcome. However, it does list performance standards related to safety and functionality that the device complies with.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| Electrical Safety Standards: | Complies with: |
| IEC/EN 60601-1 Edition 3.1 (General safety) | "Electrical safety and compatibility testing was performed to validate that the STOP U Model UXV's power control and accuracy is in reference to the user's input." |
| IEC 60601-1-6 (Usability) | Complies |
| IEC 60601-1-11 (Home healthcare environment) | Complies |
| IEC/EN 60601-2-2 (High frequency surgical equipment) | Complies |
| IEC 60601-1-2 (Electromagnetic disturbances) | Complies |
| Software Standards: | Complies with: |
| IEC 62304 (Software life cycle processes) | "The STOP U Model UXV software was validated as required." |
| Risk Management Standards: | Complies with: |
| ISO 14971 (Application of risk management) | Complies |
| Usability/Labeling Standards: | |
| ISO 15223-1 (Symbols for medical device labels) | Complies |
| Technical Specifications: | "Functioned as intended" |
| Max RF power output | "Verification test demonstrating that the STOP U Model UXV meets the system's technical specification for the, max RF power output..." |
| Vibration parameters | "...vibration parameters..." |
| Buzzer functionality | "...and buzzer functionality." |
Overall Performance Conclusion: "In all instances, the STOP U Model UXV device functioned as intended and observations were as expected."
2. Sample Size for the Test Set and Data Provenance:
The document does not describe a test set with human subjects or a clinical study that would involve a sample size for evaluating clinical effectiveness. The performance tests mentioned are verification and validation activities against technical specifications and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe clinical effectiveness studies requiring expert-established ground truth. The "ground truth" here refers to compliance with established engineering and safety standards, not clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable. As there is no clinical test set requiring human interpretation, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or described. This device is an electrosurgical tool for aesthetic use and does not involve AI for interpretation or diagnosis that would typically necessitate an MRMC study.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance):
This device does not appear to involve an AI algorithm that would have standalone performance. The "performance data" refers to technical verification and compliance with safety standards rather than a diagnostic or interpretive algorithm. The software validation mentioned is likely for embedded control software, not an AI for clinical decision-making.
7. Type of Ground Truth Used:
The "ground truth" in this context is the adherence to engineering specifications and safety standards (e.g., maximum RF power output, safety limits, software functionality as designed). It is a technical ground truth, not a clinical ground truth like pathology or expert consensus on a medical condition.
8. Sample Size for the Training Set:
Not applicable. This device does not involve a machine learning model that requires a training set in the way a diagnostic AI would. The software validation refers to standard software development lifecycle processes, not AI model training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI model, there is no ground truth established for it.
§ 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.