(120 days)
The CoolSculpting System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis of the abdomen, as well as the flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of the abdomen and the flank. Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological treatments 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 spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The ZELTIQ Gelpad facilitates thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.
The CoolSculpting System is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device includes an optional massage feature.
Here's a breakdown of the acceptance criteria and the study details for the ZELTIQ CoolSculpting device, based on the provided text:
ZELTIQ CoolSculpting Device Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance |
|---|---|
| Photographic evaluation by three independent blinded evaluators to correctly identify the baseline image at 16-week follow-up | Evaluators correctly identified the baseline image 85% of the time. (This result was statistically significant.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Sixty (60) subjects.
- Data Provenance: The study was a "prospective multicenter clinical study." The country of origin is not explicitly stated, but as the submission is to the FDA, it's highly likely to have included US sites or followed international regulatory standards acceptable to the FDA. It is prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three (3)
- Qualifications of Experts: They are described as "independent blinded evaluators." No specific professional qualifications (e.g., dermatologists, plastic surgeons, radiologists) or years of experience are provided in the document.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly detailed beyond "photographic evaluation by three independent blinded evaluators." It implies a consensus or majority agreement was used to determine the correct identification of the baseline image, but the specific rule (e.g., 2 out of 3, all 3, etc.) is not mentioned. It is not explicitly stated as 2+1, 3+1, or none.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no MRMC comparative effectiveness study described in the provided text. The study evaluates the device's performance in achieving its intended effect, not in comparing human reader performance with or without AI assistance. The evaluators are assessing the outcome of the treatment, not diagnosing or interpreting images with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the device is a physical cooling/heating device for lipolysis, not an AI or algorithm-based imaging diagnostic tool. The "performance data" refers to the effect of the physical device on patients, not an algorithm's output.
7. Type of Ground Truth Used
The primary ground truth for the primary endpoint was expert consensus (three independent blinded evaluators judging photographic images).
Additional corroborating evidence was used:
- Patient-reported outcomes (overall positive patient survey results).
- Objective measurements (statistically significant ultrasound results for fat layer reduction).
- Safety data (lipid profile and liver function tests, absence of serious adverse events).
8. Sample Size for the Training Set
The document does not mention a training set as this study is a clinical trial evaluating the therapeutic effect of a physical device, not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for an AI/machine learning algorithm.
§ 878.4340 Contact cooling system for aesthetic use.
(a)
Identification. A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.