(144 days)
The 10mm, 15mm, and 20mm Portrait handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The 18mm, 25mm, and 30mm Portrait handpieces 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 Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite
Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed
The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and electrosurgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch. The TempSure™ system is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids, heating for the purpose of elevating tissue temperature for selected medical conditions, and hemostasis/coagulation for general surgery applications. The generator is used with a temperature sensitive handpiece for aesthetic procedures that provides real-time temperature feedback. This temperature information is displayed on the user interface that shows the temperature set point and actual tissue temperature along with procedure time, system error, and warning codes. A thermistor protrudes at the end of the temperature-sensitive handpiece at the point of patient contact, which provides a constant information feedback loop as to the tissue temperature throughout a procedure.
The TempSure™ System includes:
TempSure™ Surgical RF Generator Portrait™ Temperature Sensing Handpieces IEC Power Cord Footswitch Disposable/Reusable Neutral Pad Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes
Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the TempSure device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Temperature Monitoring Accuracy | Equivalent to Fluke Infrared Thermometer (+/- 1.5°C margin for external temperature measurement tools). Ability to maintain desired temperature throughout treatment. | Average difference in temperature between the FLIR camera and the Portrait handpiece was +/- 1.5°C, demonstrating equivalence to the Fluke Infrared Thermometer. The device maintained the desired temperature throughout the treatment with no adverse events. |
| Thermal Effects on Tissue (TAZ) | Thermally Affected Zone (TAZ) should be similar to the predicate device (ForceTriad). | When comparing the TAZ of the TempSure to the ForceTriad on ex-vivo tissue, two of the three power bars showed overlapping results for each point, indicating similar TAZs. This was deemed substantially equivalent despite differences in maximum output power. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. | The device demonstrated compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | The device demonstrated compliance with IEC 60601-1-2. |
| Safety and Effectiveness | General safety and effectiveness equivalent to legally marketed predicate devices. | Nonclinical tests demonstrated the TempSure electrosurgical generator is safe and effective and performs as well as or better than the legally marketed predicate devices. The device meets design specifications and performance requirements. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Temperature Monitoring Test: "three different power settings in various treatment areas on two subjects." The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).
- Thermal Effects on Tissue Test: "performed using both devices in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings." These were ex-vivo tissue samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The validation relies on objective measurements against a reference device (FLIR Thermal Camera) or comparative measurements between devices on physical tissue samples.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation methods relied on direct measurements or comparisons rather than expert interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The studies described are technical performance tests and ex-vivo tissue comparisons, not studies involving human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This device, "TempSure," is an electrosurgical generator and not an AI or algorithm-driven diagnostic device. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The device's performance is tested directly.
7. The Type of Ground Truth Used
- Temperature Monitoring Test: The ground truth was established by direct physical measurement using a FLIR Thermal Camera, which served as the reference standard for temperature.
- Thermal Effects on Tissue Test: The ground truth for the thermally affected zone (TAZ) was established by measurements using Image-J on ex-vivo tissue samples, comparing the output of the TempSure to the predicate device (ForceTriad).
8. The Sample Size for the Training Set
The document does not describe any machine learning or AI components for which a "training set" would be applicable. The TempSure is a radiofrequency generator, and its validation relies on traditional engineering and medical device performance testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or implied, this point is not applicable.
§ 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.