(114 days)
The Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. The Reverso Pro System utilizing the Reverso Applicator is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin. The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
The Reverso Pro System, positioned on a rolling cart, is a computerized system comprised of a console (main unit) and two Applicators: The Reverso Applicator with detachable single-use tips and the Quadro RF Applicator. The system using the Reverso Applicator delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin, or using the Quadro RF Applicator in a continuous wave manner to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Reverso Pro System provides individual adjustments of energy settings and treatment time, and, in the Reverso mode, it also enables the adjustment of tip pattern and pulse profile, to achieve appropriate efficiency and safety for each eligible patient. The system console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso Pro System Applicators are designed for use in dermatological procedures, they are hand-held and ergonomically designed for the treatment requirements. The applicators are connected to the system via a separate cable, each. When not in use, the applicators can be placed within the applicator holder, where the Reverso Applicator is positioned on the system console and the Quadro RF Applicator is positioned on the rolling cart. The Reverso Applicator is compatible with five types of fractional RF tip heads: 44, 80, 88, 160 pin tip head and 176 pin tip head. The Quadro RF Applicator is emitting continues RF energy through a set of two pairs of stainless steel, RF electrodes. The applicator is hand-held and ergonomically designed to induce heat of the skin and beneath tissues for topical heating sensation.
This document is a 510(k) summary for the Indiba S.A.U. Reverso Pro System (K243139). It details the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, the device in question is an electrosurgical cutting and coagulation device. The information provided outlines the non-clinical (bench) performance data for the device, and a qualitative assessment of its similarities to predicate devices to establish substantial equivalence. However, there is no detailed clinical study or acceptance criteria table in the format requested, nor is there information about AI/ML algorithm performance.
The document states:
- "Clinical Performance Data: Not Applicable" (Page 8)
- The "Non-Clinical (Bench) Performance Data" section primarily discusses the device's RF performance specifications and thermal effects. It does not describe a study involving human or expert evaluation for determining accuracy or clinical efficacy in the context of an AI/ML device.
- The entire submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and safety standards, rather than proving the device meets specific performance criteria through a rigorous clinical trial or AI/ML validation study.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets them, specifically for an AI/ML algorithm with human-in-the-loop performance, ground truth establishment, or sample sizes for test/training sets, because this submission is for a medical device that does not appear to involve an AI/ML component or a clinical performance study in the way typically required for AI/ML-driven devices.
The information provided relates to the physical device's electrical and mechanical safety, electromagnetic compatibility, and thermal performance.
Based on the provided text, the device is a radiofrequency aesthetic device, not an AI/ML-driven diagnostic or therapeutic device. As such, the types of studies and acceptance criteria you've asked about (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information presented in this 510(k) summary. The "study" mentioned for performance is a skin temperature test on 3 human volunteers for the Quadro RF Applicator, which is a very different type of study than an AI/ML validation.
Therefore, providing a specific table and detailed answers to your questions on AI/ML performance would be misleading as the document does not contain this information.
§ 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.