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510(k) Data Aggregation
(58 days)
The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, banana roll, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat, banana roll, submandibular areas, thigh, abdomen and flank. When used for cold-assisted lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatoms and act as a local anesthetic for procedures that induce minor local discomfort.
The CoolSculpting System is also indicated for use to provide localized thermal therapy (hot or cold) to minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle spassne. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The ZELTIQ Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.
The CoolSculpting System is a portable thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The CoolSculpting System is comprised of a control unit, detachable vacuum and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, gaskets, foam borders and securement system.
The ZELTIQ CoolSculpting System's acceptance criteria and the study proving it meets them are described below, focusing on the expanded indication for cold-assisted lipolysis in the submandibular area and clarification of BMI for submental and submandibular treatments.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Effectiveness Endpoints) | Reported Device Performance (Mean and Range) |
|---|---|
| Fat layer reduction measured by ultrasound | 2.4 mm (range: 2.0 to 2.8 mm) |
| Fat layer reduction measured by caliper | 3.17 mm (around 33%) (range: 2.3 to 4.0 mm) |
| Subcutaneous fat layer reduction measured by MRI | 17% |
| Fat volume reduction measured by 3D quantification | 8.5 mL (one study) 4.82 cm³ (another study) |
| Reduction in submental laxity measured by 3D quantification (for submental area) | 2.25 mm |
| Blinded, independent review of clinical photographs (correct identification of baseline) | 77% (range: 60% to 91%) |
| Patient satisfaction | 85% (range: 80% to 93%) |
| Safety: No procedure or device-related serious adverse events; common procedural side effects are transient and resolve. | No procedure or device-related serious adverse events reported. Common procedural side effects were transient and resolved without long-term effect. Clinical study literature indicates a low-risk safety profile. |
2. Sample Size Used for the Test Set and Data Provenance
The study was a review of published literature and clinical studies. The sample size for the combined "test set" (across various studies and publications) was 228 cryolipolysis treatment cycles during clinical studies of the submental and submandibular areas.
The data provenance is from clinical studies of the submental and submandibular areas and "published literature." The document doesn't specify countries of origin, but clinical publications generally encompass international research. The data appears to be retrospective as it's a review of existing studies and literature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "Blinded, independent review of clinical photographs." This implies that experts (likely dermatologists or plastic surgeons, given the nature of the procedure) were used to assess the visual changes. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text.
4. Adjudication Method for the Test Set
For the blinded, independent photo review, the specific adjudication method is not explicitly stated. Typically, for such reviews, multiple experts independently assess images, and consensus or majority vote might be used, but this detail is missing.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device (CoolSculpting System) for cosmetic and pain relief applications, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The CoolSculpting System is a physical device, and its performance relies on its direct application to the patient, not on an algorithm operating independently without human intervention.
7. The Type of Ground Truth Used
The ground truth used for effectiveness was a combination of:
- Quantitative measurements: Ultrasound measurement, caliper measurement, Magnetic Resonance Imaging (MRI), and three-dimensional (3D) quantification of volume reduction.
- Expert assessment: Blinded, independent review of clinical photographs (implicitly by experts).
- Patient-reported outcomes: Patient satisfaction.
- Clinical observation/Adverse Event reporting: For safety outcomes.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI. The CoolSculpting System is a physical device. The studies reviewed were for demonstrating the device's clinical performance, not for training an algorithm. Therefore, this question is not applicable in the context of this device.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an algorithm, this question is not applicable. The effectiveness and safety were established through clinical studies and literature reviews as described in section 7.
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