(119 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, submental area, 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 visible fat bulges in the upper arm, bra fat, banana roll, submental area, thigh, abdomen and 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 spassms. 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, foam borders and securement system.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Zeltiq CoolSculpting System (specifically the CoolAdvantage applicator for upper arms)
Indication: Cold-assisted lipolysis of the upper arm in individuals with a BMI of 30 or less.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance (Result) |
|---|---|
| Primary Safety Endpoint: Incidence of unanticipated adverse device effects (UADE). | No unanticipated adverse device effects, or serious device or procedure-related adverse effects occurred. All device- and/or procedure-related adverse events resolved spontaneously. (Anticipated side-effects, such as prolonged numbness in 4 patients, were noted). |
| Primary Efficacy Endpoint: Correct identification of pre-treatment vs. 12-week post-treatment images by at least two out of three blinded, independent reviewers. | For the per-protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%] |
| Secondary Efficacy (Ultrasound): Significant reduction in fat layer as measured by ultrasound from baseline to 12 weeks post-treatment. | Significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-treatment. |
| Secondary Efficacy (Subject Satisfaction): Percentage of subjects finding the procedure comfortable and recommending it. | 72.41% of subjects found the procedure to be comfortable to very comfortable. 63.3% of subjects reported they would recommend the procedure to a friend. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 30 subjects, with each subject treated on both upper arms (60 treatments total).
- Data Provenance: The study was a "Prospective, multicenter, non-randomized, interventional cohort study" conducted at "two clinical sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically assumed to be the United States unless otherwise specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three blinded, independent reviewers.
- Qualifications: Not explicitly stated, but they are referred to as "independent panel reviewers," suggesting they are qualified professionals in assessing aesthetic outcomes.
4. Adjudication Method for the Test Set
- Adjudication Method: A majority consensus approach was used for the primary efficacy endpoint. "Correct identification of pre-treatment vs 12 Week post-treatment images by at least two out of three blinded, independent reviewers." This is a 2-out-of-3 consensus method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described in this document. This study focuses on the standalone performance of the device and its treatment outcome, not on AI assistance for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This document describes a clinical study evaluating a medical device (CoolSculpting System), not an AI algorithm. Therefore, no standalone (algorithm only) performance study was conducted or reported. The efficacy endpoints directly assess the physical outcomes on patients from the device's application.
7. Type of Ground Truth Used
- Primary Efficacy: Expert consensus (2-out-of-3 blinded independent reviewers) on photographic evidence of fat reduction.
- Secondary Efficacy:
- Objective measurements (ultrasound-measured upper arm fat reduction).
- Subjective patient-reported outcomes (questionnaire for satisfaction).
- Safety: Clinical safety assessment by investigators and follow-up for adverse events.
8. Sample Size for the Training Set
- This document describes a clinical investigation for device clearance, not the development of an AI model. Therefore, there is no mention of a training set sample size.
9. How the Ground Truth for the Training Set Was Established
- As this is a device clearance document and not an AI model development report, there is no discussion of a training set or how its ground truth was established.
§ 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.