(55 days)
The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The 25mm, and 30mm 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 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 TempSure generator has been upgraded to include additional surgical modes – Cut, Bipolar, Fulgurate, and Blend, along with the existing Coag. The power of the device for Surgical applications is a maximum of 300W. There have been no changes to the Smart Handpiece treatment with temperature sensitive handpieces.
TempSure system is used with the same existing Ellman electrosurgical accessories.
The TempSure™ System includes:
• TempSure™ Generator
• Temperature Sensing Handpieces
• IEC Power Cord
• Footswitch
• Disposable/Reusable Neutral Pad
• Surgical Fingerswitch/Foot Controlled Handpieces
• Monopolar Cables
• Disposable/Reusable Electrodes, Forceps
The provided document is a 510(k) summary for the Cynosure TempSure System, an electrosurgical device. It primarily details the device's substantial equivalence to predicate devices based on non-clinical testing. It does not describe an AI/ML-driven medical device, nor does it involve the use of AI assistance for human readers, ground truth establishment by experts, or MRMC studies.
Therefore, many of the requested details, such as acceptance criteria for AI performance metrics (e.g., sensitivity, specificity), sample sizes for AI test sets, expert consensus for ground truth, adjudication methods, MRMC studies, or standalone AI performance, are not applicable to this submission.
The document focuses on demonstrating substantial equivalence through:
- Indications for Use (IFU) Comparison: Showing the TempSure System has similar IFUs to legally marketed predicate devices.
- Technological Characteristics Comparison: Highlighting similarities in energy type, modality, power output, etc.
- Performance Testing (Non-Clinical): Primarily focusing on thermal effects on tissue and electrical safety/EMC.
Below is an attempt to address the relevant points based only on the provided text, while explicitly stating when information is N/A or not present.
Acceptance Criteria and Study for Cynosure TempSure System (K182365)
This submission is for an electrosurgical device and relies on showing substantial equivalence to predicate devices through non-clinical performance data and comparison of technological characteristics. It does not involve AI/ML.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative "acceptance criteria" for performance metrics in the way one might for an AI/ML device (e.g., minimum sensitivity). Instead, the acceptance is based on demonstrating the similarity of the device's performance (specifically the thermally affected zone) and safety characteristics to the predicate devices.
Acceptance Criteria (Implied / Demonstrated through comparison):
- Thermal Effects on Tissue: The Thermally Affected Zone (TAZ) created by the TempSure system should be similar to that created by the predicate devices (Surgitron and ForceTriad).
- Electrical Safety & Electromagnetic Compatibility (EMC): The device must satisfy the requirements of relevant international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
Reported Device Performance (as summarized in the document):
| Criterion / Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Thermal Effects on Tissue | TAZ of TempSure should be similar to predicate devices. | Testing was performed on ex-vivo tissue samples (liver, kidney, and muscle) in triplicate at three power settings. The TempSure device's TAZ was compared to the ForceTriad and Surgitron devices. Conclusion: "The Thermal Effects on Tissue test showed that the thermally affected zone created by the TempSure™ device was similar to that created by the predicate devices, Surgitron and ForceTriad, in ex-vivo tissue testing. Despite their difference in maximum output power, the devices created a similar TAZ and therefore the devices can be considered substantially equivalent." |
| Electrical Safety and EMC | Device must comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 standards. | Conclusion: "In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards." (Specific test results or pass/fail rates are not provided in this summary, but the general compliance is stated). |
| General Safety and Effectiveness | Device should be safe and effective and perform as well as legally marketed predicate devices. | Overall Conclusion: "The nonclinical tests demonstrate that the TempSure™ system is safe and effective and performs as well as the legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
- Test Set (for Thermal Effects on Tissue): Measurements were taken "in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings." This implies a total of 27 measurements for the TempSure device and 27 for each predicate device (3 tissues * 3 power settings * 3 replicates).
- Data Provenance: The document does not specify the country of origin for the ex-vivo tissue samples or if the testing was prospective or retrospective. Given it's ex-vivo tissue, the notion of retrospective/prospective typically applies to patient data, which is not what was used here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This applies to AI/ML systems where human experts establish ground truth. For this electrosurgical device, "ground truth" for performance was based on physical measurements (Thermally Affected Zone, electrical parameters) rather than expert interpretation of medical images or patient outcomes data.
4. Adjudication method for the test set
- N/A. Adjudication methods (e.g., 2+1, 3+1) are relevant for establishing ground truth from multiple human readers/experts, which is not applicable to the performance testing described for this electrosurgical device.
5. 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
- N/A. No clinical tests were submitted; therefore, no MRMC study, human reader improvement analysis, or AI assistance was performed or assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. No AI algorithm is involved with this device. The device itself (radiofrequency generator) is the "standalone" entity tested for its physical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Physical Measurements / Bench Testing Standards. The "ground truth" for evaluating the device's performance was based on:
- Direct measurement of the Thermally Affected Zone (TAZ) in ex-vivo tissue.
- Compliance with established electrical safety and electromagnetic compatibility standards (IEC 60601 series). This is akin to meeting engineering specifications rather than clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
- N/A. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for an AI/ML model.
§ 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.