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The EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.

The Newa™ is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:

• User interface
• Programmable logic controller (PLC)
• RF power module
• Power supply
• RF electrodes

Acceptance Criteria and Device Performance Study for NEWATM

1. Table of Acceptance Criteria and Reported Device Performance

1. Preparing self for treatment (3 tasks): 100% (62/62) completed correctly.
2. Preparing device for treatment (3 tasks): 100% (62/62) completed correctly.
3. Treatment performance (8 tasks): 100% (62/62) completed correctly.
   Result: All tasks performed correctly by 100% of subjects. |
   | Clinical Performance Evaluation: Demonstrate device performs as intended for aesthetic results. | Study: 69 participants (62 completers).
   Effectiveness Criterion: At least 75% of patients show a success (≥1 score reduction on Fitzpatrick Wrinkle Severity Scale agreed by ≥2 of 3 dermatologists).
   Result (at 4-week post-treatment):

• Reviewer #1: 91.93% (57/62)
• Reviewer #2: 91.93% (57/62)
• Reviewer #3: 90.32% (56/62)
• ≥2 agree: 95.16% (59/62)
  Result (at 3-month follow-up):
• Reviewer #1: 91.93% (57/62)
• Reviewer #2: 96.77% (60/62)
• Reviewer #3: 98.39% (61/62)
• ≥2 agree: 100% (62/62)
  Conclusion: Study success criterion for treatment effectiveness was met. |
  | Biocompatibility: Patient-contacting components demonstrated to be biocompatible. | Study: Electrodes and shell (b(4)) are same as Newa™ prescription device (K130793). Tested according to ISO 10993-1 and USP Class VI tests.
  Result: Met requirements for up to 30 days contact with human tissue. |
  | Instructions for Cleaning: Cleaning instructions validated. | Study: Cleaning validation protocol and report provided.
  Result: Cleaning instructions are adequate. Device is non-sterile and reusable, for single user. |
  | Electromagnetic Compatibility (EMC) and Electrical Safety: Performance data provided. | Study: Tested against IEC 60601-1:2005/EN 60601-1:2006, IEC 60601-1-2:2007, IEC 60601-1-11:2010.
  Result: Device passed all relevant testing portions, demonstrating electrical safety for home use. |
  | Software Verification, Validation & Hazard Analysis: Performed per guidelines. | Study: Software is firmware on micro-controller, same as cleared prescription device (K130793). Considered moderate LOC. All elements for moderate LOC devices provided per FDA guidance. V&V testing conducted for system initialization, power button, power down, LEDs, vibration, temperature detection.
  Result: Satisfactory results. Software development procedures provide assurance of intended performance; all software risks adequately mitigated. |
  | Labeling: Include warnings, precautions, contraindications, and clinical summary. | Content: User Manual, Quick Reference Guide, Box Labeling. Includes: When to use (indication), What is Newa, Who can benefit, Using Newa (regimen), Who cannot use (contraindications), What to do to avoid harm (warnings, precautions), Manufacturer details.

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The EndyMed Newa is a prescription home use device intended for non-invasive treatment of mild to moderate facial wrinkles and rhytides

The Newa™ is a noninvasive, non-ablative, prescription home use hand held device consisting of:

• User interface .
• Programmable Logic controller (PLC) ●
• RF power module ●
• Power Supply .
• RF Electrodes ●
  The interface allows the selection of heating level by using the Power Level Switch as follows:
• "0" mode = the device is "OFF". .
• . "1" mode = low heating level.
• . "2" mode = high heating level.
  The PLC is a specially configured computer that provides the operational and safety function of the system.
  The RF power module provides RF energy to the active tip, producing a sinusoidal signal at a 1MHz frequency.
  Based on 3DEEP® technology, the Newa™ is comprised of 3 pairs of bipolar RF electrodes. The RF is emitted into the skin creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis, dermis or hypodermis.

Acceptance Criteria and Device Performance for EndyMed Newa™

The EndyMed Newa™ device is intended for non-invasive treatment of mild to moderate facial wrinkles and rhytides as a prescription home-use device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 69 subjects were enrolled in the study. 62 of these subjects completed the required follow-up at 3 months after the last treatment.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. However, the nature of the study, involving subjects performing task scenarios and follow-up, suggests it was a prospective clinical study.

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

• Number of Experts: 3 blinded evaluators.
• Qualifications of Experts: The document does not specify the qualifications of these evaluators (e.g., radiologist with X years of experience). It only states they were "blinded evaluators."

4. Adjudication Method for the Test Set

• Adjudication Method: A 2 out of 3 consensus method was used. Specifically, "based on 2 of the 3 blinded evaluators agreeing that they observed a decrease of at least 1 in the Fitzpatrick Wrinkle Severity Score."

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study evaluated the standalone performance of the device when used by subjects in a home-use simulation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, this study essentially represents a standalone performance evaluation of the device's effectiveness when operated by users in a simulated home-use environment. The success criteria were based on objective assessments by expert evaluators using the Fitzpatrick Wrinkle Severity Score, rather than the subjects' self-reported satisfaction or an AI's autonomous assessment. The study focused on the device's ability to induce a measurable clinical outcome.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus on clinical assessment. Specifically, it was the agreement of 2 out of 3 blinded evaluators on a change in the Fitzpatrick Wrinkle Severity Score, which is a standardized clinical grading scale.

8. The Sample Size for the Training Set

• The document does not provide information regarding a "training set" or its sample size. This study appears to be a clinical performance study for device clearance, not a study involving the training of an AI algorithm. The Newa™ device itself is a radiofrequency energy device, not an AI-powered diagnostic or therapeutic algorithm.

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

• As the device is not an AI algorithm and no "training set" is mentioned, this information is not applicable to the provided document.

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