(189 days)
The Small 10mm, 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The Small 10mm, 18mm, 25mm, 30mm, and 60mm handpieces and the FlexSure Applicators 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 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The following surgical modes are applicable to the generator:
Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed.
Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors. verrucae, hemostasis.
Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any, field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.
The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and surgical 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.
An additional Small 10mm Smart Handpiece is now included for the purpose of tissue heating for selected medical conditions and the treatment of mild to moderate facial wrinkles and rhytids. The handpiece is capable of operating at maximum energy setting of 30 (28W) in the Smart Handpiece Mode. There have been no additional changes to the previous existing handpieces (10, 15, 18, 20, 25, 30 or 60mm), FlexSure Applicators, or Surgical modes (COAG, Cut, Blend, Bipolar, Fulgurate) of the system. The TempSure system is still used with the same existing electrosurgical accessories.
The TempSure™ System includes:
TempSure™ Generator
Temperature Sensing Handpieces (Small 10, 10, 15, 18, 20, 25, 30, and 60mm)
Massage Heads (25, 30, and 60mm)
FlexSure™ Applicators (Large and Medium)
IEC Power Cord
Footswitch
Disposable/Reusable Neutral Pads
Surgical Fingerswitch/Foot Controlled Handpieces
Monopolar Cables
Disposable/Reusable Electrodes, Forceps
The TempSure System is an electrosurgical cutting and coagulation device. The acceptance criteria and the study that proves the device meets them are summarized below.
1. Table of Acceptance Criteria & Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical Tests: | |
| Tissue Heating with Small 10mm Handpiece | |
| Able to heat and maintain temperature of treatment area in simulated clinical conditions | Demonstrated that the device is able to maintain a temperature for at least the 10-minute treatment time when used as intended under clinical conditions at various treatment areas and settings. |
| Electromagnetic Compatibility and Electrical Safety | |
| Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) | Test reports provided in accordance with FDA Guidance demonstrate compliance. |
| Compliance with IEC 60601-1-2 (Electromagnetic disturbances requirements and tests) | Test reports provided in accordance with FDA Guidance demonstrate compliance. |
| Compliance with IEC 60601-2-2 (Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | Test reports provided in accordance with FDA Guidance demonstrate compliance. |
2. Sample Size for the Test Set and Data Provenance:
The document states that bench testing was conducted for the tissue heating evaluation. However, it does not specify a numerical sample size (e.g., number of handpieces tested, number of simulated treatment areas). The provenance is explicitly a "simulated clinical condition," indicating a laboratory-based, prospective evaluation rather than real-world patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The reported studies are non-clinical bench tests. There is no mention of expert involvement for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. The reported studies are non-clinical bench tests, which do not typically involve adjudication methods like those used for expert consensus on clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "N/A - No clinical tests submitted." Therefore, no MRMC comparative effectiveness study was done.
6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) was done, but in the context of a medical device rather than an algorithm. The non-clinical tests evaluated the device's technical performance (tissue heating capabilities, electrical safety) directly, without human interpretation of results in a diagnostic or treatment decision-making cycle.
7. Type of Ground Truth Used:
For the tissue heating test, the ground truth was based on the ability of the device to heat and maintain a specific temperature in "simulated clinical conditions." This would likely involve quantitative measurements of temperature. For the electrical safety and electromagnetic compatibility tests, the ground truth was regulatory compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2), which are objectively measurable criteria.
8. Sample Size for the Training Set:
Not applicable. The device is a radiofrequency generator with handpieces, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used 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.