(152 days)
The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartidge are used for percutaneous treatment of facial wrinkles, and the 75° SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months).
The Profound System is comprised of the following components: a re-usable console containing a radiofrequency (RF) generator and graphical user interface; two re-usable treatment applicators; and two disposable, single use, sterile electrode cartridges. Bipolar RF energy is delivered from the RF generator through the electrodes into the dermal layers beneath the surface of the skin. The volume of the treated area is defined by the geometry of the individual micro-electrode needle pairs, which are all electrically isolated from each other and controlled independently by separated RF channels within the console. In addition, temperature sensors provide real-time feedback of tissue temperature. The treatment dose is controlled by the physician.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance |
|---|---|
| Primary: 80% of treated thighs show at least 1 point level of improvement in the appearance of cellulite at 3 months post-treatment relative to baseline photos, as assessed by blinded review (considering improvement in dimples and/or undulation irregularities). | Met: 94% (79/84) of the treated thighs, based on observed data, demonstrated an improvement in cellulite appearance per blinded review at 3 months. |
| 88% (37/42) of the treated subjects showed improvement in both thighs in dimples and/or undulation at 3 months follow-up. | |
| (Specifically: 86% of treated thighs with dimples at baseline showed improvement in dimples; 76% of treated thighs with undulation at baseline showed improvement in undulation irregularities.) | |
| Secondary (Effectiveness): Cellulite appearance improvement by blinded evaluators at 6 months post-treatment visit. | Met: Improvement in cellulite appearance was maintained at 6 months follow-up; 93% (78/84) of the treated thighs (per-subject success of 86%) showed improvement in cellulite appearance at 6 months post-treatment compared to baseline based on blinded review. |
| Secondary (Effectiveness): Cellulite appearance improvement by study investigators and subject improvement/satisfaction assessments. | Met: Investigator cellulite reduction assessment results demonstrated progressively improved treatment effects for the large majority of thighs at 3 and 6 months. Cellulite improvement per Nurnberger-Muller scale showed increasing levels of improvement throughout the study. Investigator satisfaction increased gradually and was demonstrated for the majority of subjects at 3 and 6 months. Subject improvement results showed moderate to excellent reduction for most thighs at 3 and 6 months. Subject satisfaction was reported by a majority of subjects at 3 and 6 months. |
| Safety: No device-related serious adverse events. Anticipated treatment responses resolve without medical intervention. | Met: Of 50 subjects, only 3 reported a total of 3 adverse events, none serious, and each resolved during the study. Anticipated treatment-associated responses (e.g., erythema, edema) resolved completely without medical intervention. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 50 treated subjects (100 thighs).
- Data Provenance: The study was conducted across 4 U.S. sites. The study was prospective, single-arm, and self-controlled.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states "blinded review" but does not specify the number or qualifications of the experts who performed this blinded review for establishing the ground truth.
4. Adjudication Method for the Test Set
The document states "blinded review" for assessing improvement in cellulite. However, it does not specify a formal adjudication method like 2+1 or 3+1. It implies direct assessment by the blinded reviewers against baseline photos.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a single-arm, self-controlled study focused on the Profound System's performance rather than comparing it against human readers or other devices in a multi-reader context. Therefore, there is no effect size reported for human readers improving with AI vs without AI assistance, as AI assistance in image interpretation is not the function of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device (Profound System) is an electrocoagulation and hemostasis device used for percutaneous treatment of facial wrinkles and cellulite. It is a physical medical device that delivers energy, not an AI algorithm for diagnostic interpretation. Therefore, a standalone algorithm-only performance study is not applicable and was not performed. The performance evaluated is that of the device itself on patients, not an AI interpreting data.
7. The Type of Ground Truth Used
The ground truth for the effectiveness endpoints was established through blinded expert review of clinical photographs at various follow-up intervals compared to baseline photos. Additionally, investigator assessments and patient self-assessments contributed to the understanding of effectiveness.
8. The Sample Size for the Training Set
The document describes a single clinical study of the device for its new indication. It does not refer to a "training set" in the context of an AI model. The 50 subjects (100 thighs) are the test set for evaluating the device's clinical efficacy for its intended use. If this device had AI components, its training set would be mentioned separately. As it is a physical device, this concept does not apply in the same way.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" for an AI model is not applicable in this context. The clinical study described served as the primary evidence to demonstrate the device's performance for regulatory clearance.
§ 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.