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510(k) Data Aggregation
(92 days)
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 2 MHz setting for the 40 cm² handpiece is indicated for temporary reduction in circumference of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
The truSculpt device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, 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. In addition, there is a separate mechanical roller that can be used as a massager.
The TruSculpt device from Cutera, Inc. (K162512) underwent a clinical study to demonstrate its safety and effectiveness for temporary circumferential reduction of the abdomen and flank regions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficacy Primary Endpoint: | |
| Statistically significant difference in circumferential measurement between Sham and Treatment groups at 12 weeks post-treatment. | Subjects in the Treatment group demonstrated a statistically significant reduction in circumference of 1.9 cm (Fisher's exact test, two-tailed, p<0.0001) of the treated flanks and abdomen, as compared to the Sham group, at 12 weeks following treatments. |
| Efficacy Secondary Endpoints: | |
| Subject assessment of improvement at 12 weeks post-treatment. | Improvement was reported by 98% of subjects in the Treatment group. |
| Subject satisfaction level at 12 weeks post-treatment. | Subjects in the Treatment group were satisfied (54%) and highly satisfied (30%) with their treatment outcome. |
| Subject discomfort and pain levels during treatment. | No treatments were discontinued due to patient discomfort. The median pain score for the Treatment group was 6 on a 0 - 10 scale, with a range of pain scores from 4 – 8. |
| Safety Endpoint: | |
| Incidence and severity of adverse device effects during the study period, including subject pain level at follow-up visits. | As expected, all Treatment group subjects experienced erythema (redness) and edema (swelling), and 9 (20%) subjects experienced palpable lumps. Additionally, soreness was observed in 40 (87%) subjects. All adverse effects resolved without intervention. No serious adverse events were noted. |
| Responder Rate (≥ 1 cm reduction) | 35 (76%) subjects in the Treatment group were considered treatment responders. The difference in responder rates between the Treatment and Sham groups was statistically significant (p < 0.0001). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 70 subjects were enrolled in the clinical study. 47 subjects were in the Treatment group and 23 subjects were in the Sham group. 69 subjects completed the study (1 subject was lost to follow-up from the treatment group).
- Data Provenance: The study was a "single-center" study. The document does not specify the country of origin of the data, but it is a
FDA submission for a US company ("Cutera, Inc. 3240 Bayshore Blvd. Brisbane, California 94005"), implying the study was likely conducted in the US. The study design was prospective and controlled.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish ground truth. The primary efficacy endpoint was based on "difference in circumferential measurement," which suggests objective measurements rather than expert consensus on images. The secondary endpoints involved "subject assessment of improvement and satisfaction," which relies on patient self-reporting.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the nature of the measurements (circumferential reduction and patient-reported outcomes), a formal adjudication process by external experts would likely not be applicable in the same way it would be for image-based diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the device's standalone clinical effectiveness compared to a sham control, not on human readers' performance with and without AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the clinical study performed was a standalone study for the device. The study evaluated the direct effect of the truSculpt RF device's application on subjects, without human-in-the-loop performance involving an AI algorithm interpreting data for a human. It assessed the outcome of the device's treatment directly.
7. The Type of Ground Truth Used
The ground truth for the primary efficacy endpoint was objective physical measurement: "circumferential measurement" taken at baseline and at follow-up visits. For secondary endpoints, the ground truth was patient-reported outcomes (subject assessment of improvement, satisfaction level, and discomfort/pain levels). Safety endpoints utilized observation of adverse events and subject pain reporting.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" in the context of an AI/algorithm. The clinical study described is for the device's performance itself and does not involve machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As no training set for an AI/algorithm is described, this question is not applicable.
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