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The YandR System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Handpiece.

The YandR System, subject of this submission as well as the cleared systems of the Legend Pro RF Family of Systems (Pollogen Legend+ system (listed as Legend Pro); see K122200, K131758, K171359 and K173503) are computer-controlled RF devices connected to a treatment Handpiece/Applicators and disposable tips. The system is comprised of:

• System Console
• . VoluDerm Handpiece/Applicator and single-use sterile removable tips (present only in the Surgen, Legend Pro and YandR Systems)
  The YandR System with its VoluDerm Handpiece is a new model of the modified Legend Pro Family of RF Systems The YandR System as the cleared Pollogen Legend+ system can generate a 1MHz sinusoidal signal applied by the VoluDerm Handpiece and the same VoluDerm Tips with bi-polar electrode pins at up to 62 Joules/per pin. The proposed system relies on the same fundamental underlying technology of the cleared systems with some hardware and software modifications to meet the marketing requirements for a more compact and simple device (tabletop console instead of a floor-mounted, rolling console) with a modern interface and the support of only the VoluDerm Handpiece (removing the TriPollar Applicators), similarly to its predecessor, the Pollogen Ltd.'s Surgen U (K131758). Also, to simplify the system, the YandR system has a hand switch, integrated into the VoluDerm Handpiece (called the Handpiece Trigger), instead of a separated Footswitch.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to efficacy or clinical performance.

The document is a 510(k) summary for the YandR System, focusing on demonstrating substantial equivalence to a predicate device (Pollogen Legend+ system). It discusses hardware and software modifications and safety and performance testing for electrical, RF, electromagnetic compatibility, and software verification/validation. However, it does not include:

• A table of acceptance criteria and reported device performance related to a clinical outcome.
• Details about sample size, data provenance, ground truth establishment, or expert involvement for clinical performance evaluation.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

The "studies" mentioned (Risk analysis, Electrical, RF, EMC safety testing, Software verification/validation, System testing) are engineering and safety verification tests, not clinical performance studies demonstrating the device meets specific efficacy acceptance criteria.

The conclusion states that "Test results indicated that the YandR System performs in accordance with its requirements and specifications similarly to its predicate Pollogen Legend+ system...", but these "requirements and specifications" refer to technical performance and safety, not clinical efficacy metrics.

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The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).

The Pollogen Legend*™system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface.

The system consists of:

• Main Unit (includes the Controller); -
• Control Panel (User Interface); -
• RF Generator: -
• -VO (VoluDerm) Treatment Applicator;
• -Treatment Applicators 1-3 (TriPollar);
• Foot Switch; -
• Patient-Controlled Manual Switch. -

The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.

The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.

This document is a 510(k) summary for the Pollogen Legend+™ System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission does not typically include detailed clinical studies or rigorous acceptance criteria as might be found for a PMA (Premarket Approval) submission for a novel device. Instead, the focus is on demonstrating equivalence through performance testing against established standards and comparison to predicate devices.

Based on the provided text, a table of acceptance criteria and reported device performance directly related to clinical effectiveness or diagnostic accuracy is not available. The document primarily details engineering performance tests to ensure safety and functionality.

Here's an analysis of the provided information, addressing your points where data is available:

1. A table of acceptance criteria and the reported device performance

As mentioned, a table of acceptance criteria and reported device performance in the context of clinical efficacy (e.g., specific wrinkle reduction percentages, ablation effectiveness metrics) is not provided in this 510(k) summary. The performance data section focuses on engineering and safety verifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the performance tests performed. These appear to be bench tests or engineering verifications, not clinical studies involving human subjects with a "test set" in the context of diagnostic performance. There is no information on data provenance concerning geographic origin or study design (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The performance tests described are engineering validations of device functionality and adherence to technical specifications, not clinical assessments requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There is no "test set" in the clinical sense, or human expert adjudication mentioned for the performance tests.

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

This is not applicable. The Pollogen Legend+™ System is an electrosurgical device for dermatological procedures, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical electrosurgical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests described, the "ground truth" would be the engineering specifications and performance standards (e.g., maximum energy per pin not higher than 62 mJ, ability to perform 800 pulses, withstand specified force, adherence to IEC/EN standards). This is a technical or engineering ground truth, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This is not applicable. The device is not an AI/machine learning system that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

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