(58 days)
The truSculpt iD device is intended to generate heat within body tissues for the treatment of selected medical conditions, such as the relief of minor aches, pain, and muscle spasms; an increase in local circulation; a reduction in circumference of the abdomen; and non-invasive lipolysis (breakdown of fat) of the abdomen. The truGlide roller is intended to provide temporary reduction in the appearance of cellulite.
The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation.
Additionally, the 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. The truGlide is a separate mechanical roller that can be used as a massager.
The provided text describes the regulatory clearance of the Cutera truSculpt iD device, focusing on its substantial equivalence to predicate devices, rather than a clinical study establishing specific acceptance criteria for a new AI/performance claim.
Based on the available information, the truSculpt iD device is an electrosurgical cutting and coagulation device intended for:
- Topical heating to elevate tissue temperature for relief of pain and muscle spasms and increase in local circulation.
- Specifically, the 2MHz setting for the 40cm² handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.
- The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
The "acceptance criteria" discussed in the document are primarily related to safety and technological equivalence compared to its predicate devices, rather than performance metrics of a novel clinical claim. The study mentioned is a technical performance study, not a clinical trial with specific performance endpoints for new indications.
Here's an breakdown based on the information provided, acknowledging its limitations regarding specific AI performance acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an equivalence submission for a traditional medical device, there aren't explicit clinical performance acceptance criteria in the typical sense of metrics like sensitivity, specificity, AUC as would be seen for an AI diagnostic algorithm. Instead, the acceptance is based on demonstrating substantially equivalent safety and effectiveness through technical characteristics and a limited performance study.
| Acceptance Criterion Type (Implied) | Description / Reported Performance |
|---|---|
| Safety - Electrical & Mechanical | Criterion: Adheres to international standards for medical electrical equipment safety. |
| Reported Performance: Compliance with IEC 60601-1/A1:2012, IEC 60601-2-2:2009, IEC 60601-1-6:2010/A1:2013, and IEC 60601-1-2:2014 demonstrated. This confirms the device meets general safety, specific safety for high-frequency surgical equipment, usability, and electromagnetic compatibility standards. | |
| Safety - Biocompatibility | Criterion: Patient-contact materials are biocompatible. |
| Reported Performance: Biocompatibility testing of patient-contact materials (Polyvinylidene fluoride (PVDF), liquid resin adhesive, silicone, hydrogel, stainless steel) according to ISO-10993-1:2018 demonstrated. | |
| Safety - Skin Temperature Control | Criterion: Skin temperatures do not exceed a safe threshold (e.g., 45°C) during treatment, while maintaining therapeutic temperatures (40°-45°C). |
| Reported Performance: Skin temperature testing on 3 human subjects demonstrated that skin temperatures do not exceed 45°C during treatment and that the device can maintain therapeutic temperatures of 40°-45°C on the surface of the human skin. | |
| Software Verification & Validation | Criterion: Software functions correctly and safely. |
| Reported Performance: Software Verification and Validation Testing completed. (No specific metrics provided, but implies successful completion.) | |
| Technological Equivalence | Criterion: Device has equivalent technological characteristics and principles of operation to predicate devices, and any differences do not raise new safety or effectiveness questions. |
| Reported Performance: Detailed comparison tables (provided in the source text) show equivalence in energy type, RF frequency, RF type, max RF power, temperature sensing, active control, and massage function. Differences were identified in patient contact materials and attachment methods for hands-free handpieces, but these were deemed not to raise new safety/effectiveness questions, supported by biocompatibility and skin temperature testing. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 3 human subjects for skin temperature testing.
- Data Provenance: Not explicitly stated, but typically such performance/safety testing might be done in a single-center setting, likely in the country of manufacture or where the regulatory submission is made (USA, given the FDA context). It is a prospective performance/safety study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. For a technical performance study like skin temperature monitoring, the "ground truth" is measured by the device itself and validated against a calibrated external measurement system (e.g., a thermometer). Clinical "ground truth" from experts is not applicable here as it's not a diagnostic or treatment outcome study with expert interpretation.
4. Adjudication method for the test set
- Not applicable as this was a technical performance/safety study (skin temperature measurement), not a clinical trial requiring adjudication of outcomes or expert review of images/diagnoses.
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
- No MRMC study was done. This device is a therapeutic energy-based device, not an AI-powered diagnostic or interpretative system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a traditional medical device, not an AI algorithm. The device has software for control, but its "performance" is its ability to deliver RF energy and monitor temperature, not to perform a diagnostic or interpretive task standalone or with human-in-the-loop.
7. The type of ground truth used
- For the skin temperature testing, the ground truth would be direct physical measurement of skin temperature using a calibrated reference thermometer, compared against the device's internal temperature sensing and control.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set in that context. The device's software is developed and validated through traditional software engineering processes.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.