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The device has the following "Indications For Use"

• Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes . I-IV

Accessory handpiece electrode is intended for use with the Ellman Surgitron IEC120 / 4.0 Dual Radio-Frequency generator. The device is considered as an accessory to the RF generator. The generator has been cleared by the FDA under 510(k) K082834 Ellman International Non-Ablative Technique for Surgitron IEC.

The provided text describes a 510(k) submission for a "Non-Ablative Wrinkle Treatment Handpiece," specifically for a change in cleaning/disinfection methods. It does not contain information about clinical studies evaluating the device's performance in treating wrinkles or rhytides, nor does it define performance-based acceptance criteria for such a clinical application.

The sole "study" mentioned is related to the cleaning and disinfection methods of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text for the disinfection study. The text mentions "test devices" (plural) but does not give a specific number.
• Data Provenance: The study was "successfully executed test protocol as part of this submission" by "Ellman International" and reported by "SGS Protocol # 09A0908673 and demonstrated in SGS Report# 09A0908675." This suggests it was an in-house or contracted laboratory study, likely retrospective to the submission date. The country of origin of the data is not specified, but Ellman International Inc. is located in Oceanside, NY, USA.

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

• Not applicable. The study focuses on microbiological efficacy of disinfection, not clinical outcomes requiring expert interpretation. The "ground truth" here would be the measured reduction of microbial load.

4. Adjudication Method for the Test Set:

• Not applicable as this was a laboratory study of disinfection efficacy; no human subjective assessment for ground truth was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This submission is for a change in cleaning/disinfection methods for an accessory handpiece. No MRMC study was conducted or mentioned for the device's primary clinical indication (wrinkle treatment). The document explicitly states: "As there are no technological, structural, design or intended use changes for the subject device, Ellman International believes that no further data or clinical study is required to support the position that the device is safe and effective to use with the changes delineated in the instructions for use."

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

• Not applicable. This device is a physical handpiece and not an algorithm. The disinfection study assessed the physical and chemical process.

7. Type of Ground Truth Used:

• For the disinfection study: "Measured reduction of inoculated challenge organisms." This is an objective, quantitative laboratory measurement.

8. Sample Size for the Training Set:

• Not applicable. This submission is about a change to existing instructions for use for a medical device accessory, not the development of a predictive model or algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable for the reasons stated above.

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