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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
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(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.
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(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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