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510(k) Data Aggregation
(28 days)
TempSure System
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, 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, epithelioma, 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.
There have been no changes to the TempSure Device or handpieces (Small 10, 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 provided document (K223292) is a 510(k) premarket notification for the Cynosure TempSure System. This type of submission asserts substantial equivalence to a legally marketed predicate device, rather than providing new clinical data to establish safety and effectiveness from scratch. As such, the document explicitly states:
- "807.92(b)(1) Non-clinical tests submitted– N/A – No non-clinical tests submitted"
- "807.92(b)(2) Clinical tests submitted – N/A – No clinical tests submitted"
- "807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted– N/A"
Therefore, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, because no new non-clinical or clinical studies were submitted for this 510(k) notification.
The submission establishes substantial equivalence by demonstrating that the device has the same intended use and similar technological characteristics as its predicate device (Cynosure TempSure System, K212891), with no changes to the device or handpieces, only an update to labeling with an additional contraindication.
Because no studies were submitted, the following requested information cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Ask a specific question about this device
(189 days)
TempSure System
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.
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(54 days)
TempSure System
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.
-
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.
-
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.
-
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.
-
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."
-
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.
-
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.
-
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."
-
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.
Ask a specific question about this device
(128 days)
TempSure
The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The 18mm. 25mm. 30mm. and 60mm 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: 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.
An additional 60mm Smart Handpiece is now included for the purpose of tissue heating for selected medical conditions. The 60mm handpiece can also be used with a new massage head for the temporary reduction in the appearance of cellulite. The handpiece has the same maximum output power of 300W in the Smart Handpiece Mode. In addition, a new larger disposable neutral pad is provided for these body treatments. There have been no additional changes to the previous existing handpieces (10, 15, 18, 20, 25, or 30mm) 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) 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:
60mm Smart Handpiece (ASY-12745) 60mm Massage Head (ASY-12746) Large Neutral Pad (MEL-01197)
Here's a breakdown of the acceptance criteria and study information for the Cynosure TempSure System (K190678) based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Tissue Heating (60mm Handpiece) | Ability to heat and maintain temperature of the treatment area for 10 minutes in a simulated clinical condition. | Bench testing demonstrated the device effectively heated and maintained temperature for at least the 10-minute treatment time when used as intended under clinical conditions at various treatment areas and settings. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 standards. | Testing completed as per these standards, proving safe use of the device. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Testing completed as per this standard, demonstrating the device's electromagnetic compatibility. |
| Overall Safety and Effectiveness | Device is safe and effective and performs as well or better than the legally marketed predicate device. | Non-clinical tests conclude that the TempSure generator with the 60mm handpiece is safe and effective, meets design specifications, and performs required functions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, as the study described is a bench test rather than a clinical study with human subjects. For "Tissue Heating," it refers to "various treatment areas and settings," but does not quantify these.
- Data Provenance: The studies were non-clinical bench tests. The country of origin of the data is not specified but would typically be the location of the manufacturing or testing facility, which for Cynosure, Inc. is Westford, Massachusetts, USA. The data is prospective in the sense that the tests were specifically conducted to demonstrate compliance for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for bench tests is based on objective measurements against established engineering and safety standards, rather than expert interpretation of a clinical outcome.
- Qualifications of Experts: Not applicable for this type of non-clinical study.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are objective measurements against defined performance and safety standards, not subjective interpretations requiring adjudication.
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
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (RF generator and handpieces) that performs physical treatments, not an AI-driven diagnostic or interpretative tool that would involve human "readers" or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The TempSure System is an electrosurgical cutting and coagulation device. Its performance is evaluated based on its physical operation (e.g., heating capability, electrical safety), not as an algorithm operating independently.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for these non-clinical tests is based on:
- Objective measurements and physical parameters: For tissue heating, the "ground truth" is the actual temperature achieved and maintained on a simulated tissue model.
- Compliance with established engineering and safety standards: For electrical safety and EMC, the "ground truth" is adherence to the specifications outlined in IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This submission describes a physical medical device, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(55 days)
TempSure System
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.
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(144 days)
TempSure
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.
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