(173 days)
The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis of the thigh, abdomen, and 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 thigh, 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 and 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 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 applicators and supplies such as liners, gelpads, and cycle cards.
The ZELTIQ CoolSculpting System is a device designed for cold-assisted lipolysis of the thigh, abdomen, and flank. The provided document details the clinical investigations conducted to demonstrate its safety and efficacy, particularly regarding its application to the thigh region.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ZELTIQ CoolSculpting System primarily focused on the visible reduction of fat in target treatment areas, as assessed by blinded evaluators based on photographic evidence.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Efficacy - Visible Fat Reduction | Overall correct identification rate by three blinded evaluators of pre-treatment photographs from a series against post-treatment photographs. | Inner Thigh Study: 90.5% correct identification rate. |
| Outer Thigh Study: 83.9% correct identification rate. | ||
| At least two out of three blinded evaluators correctly identify pre-treatment photographs from a series against post-treatment photographs. | Inner Thigh Study: 90.5% identified correctly by at least two evaluators. | |
| Outer Thigh Study: 87.1% identified correctly by at least two evaluators. | ||
| Safety - Adverse Events | Resolution of adverse events by 16-week follow-up. | All adverse events (numbness, mild contour irregularity) but one resolved by the 16-week follow-up. |
| One mild case of hyperpigmentation persisted, which is noted as a rare side effect that typically resolves spontaneously. |
2. Sample Size Used for the Test Set and Data Provenance
The test set for evaluating the device's performance consisted of patient photographs.
- Sample Size:
- Inner Thigh Study: 90 treatments completed. Each treatment likely corresponds to a unique subject/area, resulting in 90 sets of pre and post-treatment photos.
- Outer Thigh Study: 40 treatments completed. Each treatment likely corresponds to a unique subject/area, resulting in 40 sets of pre and post-treatment photos.
- Data Provenance: The document does not explicitly state the country of origin. However, the FDA 510(k) submission process is for devices marketed in the United States, suggesting the studies were likely conducted in the US or in a manner compliant with US regulatory standards. The studies appear to be prospective clinical investigations conducted specifically to determine the safety and efficacy of the device for cold-assisted lipolysis in the thigh region.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three blinded evaluators.
- Qualifications of Experts: The document does not explicitly state the specific qualifications (e.g., radiologist, dermatologist, years of experience) of the "three blinded evaluators." It only identifies them as "blinded evaluators." Their role was to assess photographic evidence of fat reduction.
4. Adjudication Method for the Test Set
The adjudication method used was based on agreement among the blinded evaluators:
- Method: The evaluators were presented with series of photographs (pre- and post-treatment) and asked to identify the pre-treatment photographs for each subject.
- Reporting: The "overall correct identification rate by the three evaluators" and "At least two out of three evaluators correctly identified" rates were reported, indicating a form of majority or consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study described involves human evaluators assessing photographic outcomes directly, not evaluating an AI's output or being assisted by AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. The performance assessment relies entirely on human evaluators' interpretation of photographic evidence. This device is not an AI algorithm; it is a physical cooling device.
7. The Type of Ground Truth Used
The ground truth used was expert consensus interpretation of photographic evidence of visible fat reduction. The three blinded evaluators' assessment of "visible reduction of fat" in the treatment areas from photographs served as the primary measure of efficacy.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI. The clinical investigations described are for evaluating the actual physical device's performance on human subjects, not for training a model.
9. How the Ground Truth for the Training Set Was Established
As there was no "training set" for an algorithm, the concept of establishing ground truth for a training set is not applicable here. The clinical studies directly demonstrated the device's effect on subjects.
§ 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.