(188 days)
The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) massage device is intended to provide a temporary reduction in the appearance of cellulite.
The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) is a medical electrical equipment for the development of localized heat that can heat the subcutaneous tissue with radio frequency. Its particular emission frequency of 470 kHz ± 10%, the ability to regulate and control the increase of the desired temperature allows to operate with a maximum temperature of 45 ° C, and never exceed 47 °C (for safety). The electrodes dimensions included, allow to obtain a controlled heating.
The provided document is a 510(k) Premarket Notification for a Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250). It focuses on demonstrating substantial equivalence to predicate devices for its intended uses. The document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the typical clinical performance sense that would be described for an AI/ML device.
However, based on the information provided, I can extract what is available regarding performance testing and what might be considered "acceptance criteria" in this context.
Here's a breakdown of the requested information, with the understanding that not all points are directly addressed for a "device performance" in the way one might expect for an AI/ML diagnostic:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (radiofrequency system for heating tissue), the "acceptance criteria" discussed are primarily related to electrical safety, electromagnetic compatibility, and temperature control, rather than performance metrics like sensitivity or specificity for an AI-powered diagnostic.
| Acceptance Criterion (Implicit/Explicit) | Reported Device Performance |
|---|---|
| Compliance with EN 60601-1 (Medical electrical equipment: General requirements for basic safety and essential performance) | Device "has been tested and is in compliance with EN 60601-1, Medical electrical equipment. Part 1: General requirements for basic safety and essential performance 2006/A11:2010/A1:2013." |
| Compliance with EN 60601-1-2 (Medical electrical equipment: Electromagnetic Compatibility - Requirements and tests) | Device "has been tested and is in compliance with ... EN60601-1-2 Medical electrical equipment. Part1: General requirements for safety - Collateral standard: Electromagnetic Compatibility -Requirements and tests. 2007." |
| Compliance with EN 60601-2-2 (Medical electrical equipment: Particular requirements for the safety of high frequency surgical equipment) | Device "has been tested and is in compliance with ... EN 60601-2-2 Medical electrical equipment. Part 2-2: Particular requirements for the safety of high frequency surgical equipment. 2009." |
| Software Verification (compliance with FDA regulations, standards, guidance) | "software verification was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements." |
| Design Verification (compliance with internal design control procedures) | "Design verification was also performed on the Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) in compliance with internal design control procedures. The results of this testing concludes the Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) is determined to be safe and effective and is substantially equivalent to the predicate devices." |
| Ability to heat skin to 40-45 degrees C and maintain temperature for 10 minutes (Clinical Performance Protocol) | "Clinical Performance Protocol was performed to support use of the medical device, in particular the tests demonstrate that the device can heat the skin to 40-45 degrees C and can maintain the skin temperature inside that interval for 10 minutes similar to a heating lamp." The device itself states it operates with a maximum temperature of 45°C and never exceeds 47°C (for safety). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical images or patient data for an AI/ML device. The "Clinical Performance Protocol" mentioned focuses on the device's ability to heat tissue.
- Sample Size: Not explicitly stated for the clinical performance protocol.
- Data Provenance: Not specified, but the device manufacturer is located in Italy (Vimodrone, Milan). "Similar to a heating lamp" suggests a basic physiological response, not complex disease assessment in a specific patient population.
- Retrospective/Prospective: Not specified, but the limited description suggests a controlled, prospective technical test rather than a large-scale clinical study on patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for this device appears to be the physical heating capabilities and temperature control, verifiable through instrumentation, rather than expert interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
Not applicable. The clinical performance testing described is objective measurement of temperature and heating, not subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically performed for diagnostic devices where human readers interpret medical data (e.g., images) with and without AI assistance. This document is for a therapeutic/electrosurgical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. While software verification was done, the entire device (ThermiSmooth 250) is a physical radiofrequency system, not a standalone algorithm. Its performance is tied to its physical operation and interaction with tissue.
7. Type of Ground Truth Used
- Clinical Performance Protocol: Objective measurement of tissue temperature, and duration of temperature maintenance.
- Safety and EMC: Compliance with international standards (EN 60601 series), which is verified through specific test methods outlined in those standards.
- Software Verification: Compliance with FDA regulations, standards, and guidance for software quality.
- Design Verification: Compliance with internal design control procedures.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The device's operation is based on established radiofrequency physics and engineering, not pattern recognition learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.