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The GENEO X ELITE system with the TriPollar RF Applicator 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 GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.

The GENEO X ELITE device is a non-invasive, tabletop console with a graphical user interface (GUI), which supports two applicator types: the TriPollar Radiofrequency (RF) Applicator utilizing bipolar radiofrequency technology for facial wrinkles treatments and the OxyGeneo Applicator utilizing mechanical vibration for facial massage sensation.

The GENEO X ELITE device is manufactured by Pollogen Ltd. Similar to the predicate device, the STOP U Model UXV device, the GENEO X ELITE device constitutes the same underlying TriPollar technology to employ bipolar RF energy in a non-invasive manner utilizing the TriPollar RF Applicator.

In addition to the TriPollar RF applicator the GENEO X ELITE device comprises the OxyGeneo Applicator. The OxyGeneo Applicator is an electrically powered massager utilizing mechanical vibration generated by an electrically powered motor housed in the applicator.

The provided document is a 510(k) summary for the Pollogen Ltd. GENEO X ELITE device and does not contain detailed information about specific acceptance criteria or a dedicated study setup to prove device performance against those criteria in the way typically found for AI/ML devices.

However, based on the non-clinical and clinical performance data sections, and the general context of a 510(k) submission for an electrosurgical device, we can infer some "acceptance criteria" based on compliance with recognized standards and successful completion of various tests related to safety and functionality. The study described is primarily a Human Factors (Usability) study and various bench performance tests, rather than a clinical efficacy study with quantitative performance metrics.

Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and corresponding performance from a single study are not explicitly detailed for clinical efficacy in this document.

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary focused on substantial equivalence rather than a detailed clinical trial report, specific quantitative acceptance criteria for clinical effectiveness (e.g., specific reduction in wrinkle severity) and their statistically proven performance are not explicitly stated. Instead, "acceptance criteria" are inferred from compliance with recognized safety and performance standards and successful completion of bench and human factors testing.

2. Sample Sizes Used for Test Set and Data Provenance

• Human Factors Validation Testing (Phase II):
  • Sample Size: The document does not explicitly state the number of participants (users or cases) in the Human Factors Validation Testing (Phase II). It only mentions that the study involved "use of the device by the device target users (estheticians / cosmeticians) and performing device operation and knowledge tasks."
  • Data Provenance: The document states that the GENEO X Human Factors (Usability) validation test further validated the device "in a real-world environment." Phase I (formative assessment) was performed "on the GENEO X TriPollar RF device (precursor to the GENEO X) in the EU (Belgium and Switzerland) and Canada." The Phase II validation study's specific location is not detailed beyond "real-world environment." This study is prospective, as it involves testing with target users.

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

• For the Human Factors Validation Testing, "ground truth" would relate to the assessment of usability and the effectiveness of training materials. The document implies that "target users (estheticians / cosmeticians)" performed the tasks and their performance/feedback constituted the data for assessing usability. No explicit mention of independent "experts" establishing a separate "ground truth" for usability, outside of the direct user experience and observation during the study, is made.

4. Adjudication Method for the Test Set

• The document does not describe a clinical performance study with an adjudication method (like 2+1, 3+1). The Human Factors study's assessment method is not detailed in terms of adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is described for clinical efficacy. The Human Factors study is not an MRMC study for clinical outcomes, but rather for usability. The document focuses on substantial equivalence to a predicate device based on similar technology, safety, and performance, not on demonstrating improved effectiveness over human readers or other devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This device is an electrosurgical device for aesthetic use, involving a human operator (esthetician/cosmetician). It is not an AI/ML diagnostic or predictive algorithm, so the concept of "standalone performance" for an algorithm without human-in-the-loop does not apply in the typical sense. The device's operation inherently involves a human user.

7. Type of Ground Truth Used

• For Bench Performance Data: The "ground truth" for technical specifications (e.g., RF output power, frequency, electrical safety) is established by measurements against recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• For Human Factors Validation Testing: The "ground truth" is derived from user performance, observations, and feedback from the device's target users (estheticians/cosmeticians) as they interact with the device and training materials in a simulated real-world environment.

8. Sample Size for the Training Set

• This document does not describe an AI/ML device in the context of a "training set" for an algorithm that learns from data. Therefore, the concept of a training set sample size is not applicable. The device design and safety features are based on engineering principles and compliance with standards, not machine learning training.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" in the context of an AI/ML algorithm learning.

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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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