(147 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Decrease of at least 1 in the Fitzpatrick Wrinkle Severity Score at 3 months post the last treatment, as agreed upon by 2 of 3 blinded evaluators. | 85% of subjects who completed the 3-month follow-up met this success criterion. |
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.