(54 days)
The 10mm, 15mm, and 20mm Smart Handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The 18mm, 25mm, 30mm, 60mm Smart Handpieces and 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: 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.
The FlexSure TM Applicators are now included for the purpose of tissue heating for selected medical conditions. The applicator comes in 2 sizes (large and medium) and has the same maximum output power of 300W in the Smart Handpiece Mode. The FlexSure applicator utilizes the larger disposable neutral pad. There have been no changes to the Smart Handpiece (10, 15, 18, 20, 25, 30 or 60mm) 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 (10, 15, 18, 20, 25, 30, and 60mm)
Temperature Sensing single use applicator (FlexSure)
Massage Heads (25, 30, and 60mm)
IEC Power Cord
Footswitch
Disposable/Reusable Neutral Pads
Surgical Fingerswitch/Foot Controlled Handpieces
Monopolar Cables
Disposable/Reusable Electrodes, Forceps
New Additions to the Tempsure System include:
• FlexSure™ Large Applicator
• FlexSure™ Medium Applicator
The provided text describes a 510(k) premarket notification for the Cynosure TempSure™ System. This submission focuses on establishing substantial equivalence to a legally marketed predicate device (Cynosure TempSure™ K190678), with new additions being the FlexSure™ Applicators. The "study" proving the device meets acceptance criteria primarily relies on non-clinical bench testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria in the way one might expect for a clinical study with specific performance metrics (e.g., sensitivity, specificity for an AI diagnostic device). Instead, the "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to the predicate device, especially regarding safety and effectiveness.
The key performance aspect tested for the new addition (FlexSure™ Applicator) is its ability to heat and maintain temperature of the treatment area for 10 minutes in a simulated clinical condition.
Table of "Acceptance Criteria" and Reported Device Performance (as inferred from the document for the newly added feature):
| Acceptance Criteria (Inferred for New Feature) | Reported Device Performance |
|---|---|
| Ability of FlexSure™ Applicator to heat and maintain temperature of the treatment area for at least 10 minutes. | "The Tissue Heating bench test demonstrated that the device is able to maintain temperature for at least the 10-minute treatment time when used as intended under clinical conditions at various treatment areas and settings." |
| Compliance with Electromagnetic Compatibility (EMC) standards (e.g., IEC 60601-1-2). | "Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards." (Specific standards listed: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) |
| Compliance with Electrical Safety standards (e.g., IEC 60601-1, IEC 60601-2-2). | "Electrical safety testing for the Cynosure TempSure was also completed to prove the safe use of the device... and meets required standards." |
Study Details:
This submission is a 510(k) Premarket Notification, which primarily relies on demonstrating substantial equivalence to a predicate device, rather than novel clinical efficacy data. The "study" in this context refers to the non-clinical testing performed to support this equivalence for the new components.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of patient data. For the Tissue Heating with FlexSure™ Applicator bench test, it involved testing the applicator with a "large neutral pad" in a "simulated clinical condition." The specifics of how many times this was tested or over how many "simulated" areas are not provided.
- Data Provenance: The data originates from bench testing conducted by Cynosure, LLC. The location of the testing is not specified, but the applicant (Cynosure) is based in Westford, Massachusetts, USA. The data is retrospective in the sense that it's reported from completed tests, not ongoing prospective patient studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The ground truth for the performance of this electrosurgical device is established through engineering and physics principles, measured physical characteristics (temperature, electrical safety parameters), and compliance with international standards (IEC). There are no human experts establishing a "ground truth" for the device's diagnostic performance, as it is a treatment and surgical device, not a diagnostic AI system.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human readers (e.g., radiologists) interpret medical images or data, and their interpretations need to be reconciled to form a ground truth. This is a non-clinical bench test of an electrosurgical device.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI diagnostic aids where human interpretation is involved. This device is an electrosurgical system. The document explicitly states: "No clinical tests submitted."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A (not applicable in the AI sense). This device is a physical electrosurgical system. Its "standalone" performance means its inherent operational characteristics (e.g., temperature output, electrical safety) independent of a human operator's actions beyond basic control. The bench tests evaluated the device itself. It does not refer to an AI algorithm functioning in isolation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the non-clinical tests was based on physical measurements and engineering standards.
- For Tissue Heating: The "ground truth" was the measured temperature achieved and maintained over time in the simulated tissue, compared against the design specification of "at least 10 minutes."
- For Electrical Safety and EMC: The "ground truth" was compliance with specified international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
- The ground truth for the non-clinical tests was based on physical measurements and engineering standards.
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The sample size for the training set:
- Not applicable. This submission is for a physical medical device, not an AI/Machine Learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, this question is irrelevant to this device submission.
§ 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.