(185 days)
The eTwo Skin Treatment System is intended for dermatological procedures.
The Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited to skin types I-IV.
The Sublime applicator is indicated for non-invasive wrinkles treatment. At higher energy levels greater than 100 J/cm², the Sublime applicator is limited to skin types I-IV.
The eTwo Skin Treatment System is a mobile system combining two existing technologies and applications for dermatological procedures.
The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface via an array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots of skin to temperatures that result in ablation and resurfacing of the skin that comes in contact with the multi-electrode pins.
The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.
The document provided is a 510(k) summary for the Syneron Medical Ltd.'s eTwo Skin Treatment System. It describes the device, its intended use, and provides evidence to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|---|
| Effectiveness (Wrinkle Reduction) | Reduction in wrinkles in treated areas at 12 weeks following last treatment session compared to baseline, based on photographic assessments by three independent blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale. Goal: 50% of subjects to show improvement. | 71% of study subjects achieved wrinkle reduction under the proposed parameters. |
| Safety | Favorable safety profile (occurrence of device-related adverse events). Low incidence of severe adverse events and no subjects discontinuing due to adverse events. | 6.9% (5/72 subjects) experienced device-related adverse events, all mild to moderate and resolved. No serious adverse events or discontinuations due to adverse events. |
| Investigator Assessment | (Implicit: Improvement in facial appearance) | 77% of subjects rated as improved from baseline (at least 1 unit improvement in Fitzpatrick Scale). 91% showed overall improvement in facial appearance. |
| Patient Satisfaction | (Implicit: High level of satisfaction) | ≥63% of subjects reported being satisfied or very satisfied with treatment throughout follow-up. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study): 72 subjects
- Data Provenance: Prospective multi-center clinical study. The document does not specify the country of origin, but Syneron Medical Ltd. is based in Israel and the FDA review is for the US market, suggesting a multinational or US-focused study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Three independent blinded evaluators.
- Qualifications: The document does not explicitly state the qualifications of these evaluators (e.g., "radiologist with 10 years of experience"). It only identifies them as "independent blinded evaluators."
4. Adjudication Method for the Test Set
- The document states that the primary endpoint was based on "photographic assessments by three independent blinded evaluators." It implies a consensus or majority read, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done. This study evaluated the performance of the device itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This is not an AI/algorithm-only device. The eTwo Skin Treatment System is a medical device (electrosurgical device) operated by a human, so a "standalone" algorithm-only performance study is not applicable in this context. The clinical study assessed the device's performance when used by clinicians.
7. Type of Ground Truth Used
- The ground truth for the primary effectiveness endpoint was established through expert consensus/assessment (three independent blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale based on photographic assessments).
- Additional assessments included investigator observations and subject self-reported satisfaction.
- Safety data was based on observed adverse events.
8. Sample Size for the Training Set
- This document describes a clinical study for the eTwo Skin Treatment System, which is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the typical sense for model development. The 72 subjects were for the clinical evaluation of the device's performance, not for training a software model.
- Software verification and validation were performed for minor software changes, but no training set for an AI algorithm is mentioned or relevant here.
9. How the Ground Truth for the Training Set Was Established
- As stated above, there is no mention of an AI algorithm or a training set in the context of this device's evaluation. Therefore, this question is not applicable based on the provided text.
§ 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.