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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 I-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 FDA 510(k) summary describes the Pollogen STOP U Model UXV Device, which is intended for the non-invasive treatment of mild to moderate facial wrinkles. The document details the device's technical specifications, performance tests, and comparison to a predicate device to demonstrate substantial equivalence for clearance.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. Instead, compliance is reported against various performance standards and general functional expectations.

• IEC/EN 60601-1 Ed 3.1 & A1:2012 (Medical Electrical Equipment: General safety)
• IEC 60601-1-6 (Usability)
• IEC 60601-1-11:2015 (Home healthcare environment)
• IEC/EN 60601-2-2 (High frequency surgical equipment)
• IEC 62304 (Software life cycle processes)
• IEC 60601-1-2 (Electromagnetic disturbances)
• ISO 15223-1:2016 (Symbols on labels)
• ISO 14971:2007 (Risk management) | The STOP U Model UXV device complies with all listed performance standards. (Implicitly, the device met the requirements of these standards). |
  | Biocompatibility (Cytotoxicity, Sensitization) | The body contact materials are biocompatible per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization). |

2. Sample Size Used for the Test Set and Data Provenance

• Self-Selection Study:
  • Sample Size: Not explicitly stated for the "test set" demonstrating the correct self-selection rate, but the study "produced a correct self-selection rate that met Pollogen's goal."
  • Data Provenance: Not specified (e.g., country of origin). The study was likely prospective, conducted by Pollogen Ltd.
• Human Factors Validation:
  • Sample Size: 61 subjects.
  • Data Provenance: Not specified (e.g., country of origin). The study was prospective, conducted by Pollogen Ltd.
• Clinical Study (for TriPollar Technology):
  • Sample Size: Not specified.
  • Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective, though "a clinical study was conducted" generally implies a prospective study. It refers to a previously cleared device (K140255), suggesting this data predates the current submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Self-Selection Study & Human Factors Validation: The document does not describe the use of experts to establish a "ground truth" in the traditional sense. These studies evaluated user interaction and self-selection by users, not by expert interpretation of clinical outcomes.
• Clinical Study (for TriPollar Technology): The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study that demonstrated the effect on wrinkles. It only states that the study "demonstrating the effect... for mild to moderate facial wrinkles and rhytides."

4. Adjudication Method for the Test Set

• Self-Selection Study & Human Factors Validation: Adjudication methods are not described as these studies focused on user performance with the device/packaging, not expert consensus on specific findings.
• Clinical Study (for TriPollar Technology): The adjudication method for assessing wrinkle reduction in the clinical study is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device in question is a medical aesthetic device, not an AI diagnostic or assistance tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical electrosurgical device for aesthetic use, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant.

7. The Type of Ground Truth Used

• Self-Selection Study & Human Factors Validation: The ground truth was based on the outcome of user tasks (e.g., correct self-selection, successful setup and treatment delivery). There wasn't a "ground truth" in terms of a clinical diagnosis or objective measurement adjudicated by experts.
• Clinical Study (for TriPollar Technology): The ground truth for this study was the effect on mild to moderate facial wrinkles and rhytides. The specific methodology for measuring and verifying this effect (e.g., blinded assessments, imaging, standardized scales) is not detailed.

8. The Sample Size for the Training Set

Not applicable. The document describes a physical medical device, not an AI algorithm that requires a training set. The clinical study mentioned would be considered for validation/performance, not for training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI algorithm.

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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.

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.

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