(51 days)
The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of 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 bra fat, back 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 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 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, foam borders and securement system.
Here's a breakdown of the acceptance criteria and study information for the Zeltiq Coolsculpting System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a typical quantitative pass/fail format for device performance. Instead, it relies on a compilation of clinical study results to demonstrate safety and efficacy, implying that these results meet an unstated threshold for acceptability.
| Metric (Implied Acceptance Standard) | Reported Device Performance (Mean) |
|---|---|
| Ultrasound fat layer reduction (Efficacy) | Ranged from 10.3% to 25.5% (average 20.6%) and 1.9 mm to 8.3 mm (average 3.9 mm) |
| Caliper fat layer reduction (Efficacy) | Ranged from 14.7% to 23.0% (average 22.3%) |
| Circumferential reduction (Efficacy) | Inner thigh: 0.9 cm; Flanks: 2.4 cm; Abdomen: 6.8 cm |
| Volumetric reduction (Efficacy) | Flanks: 39.6 cm³ |
| Independent photo review correctness (Efficacy) | 89.7% correct, on average |
| Serious Adverse Events (Safety) | 0.13% incidence rate (6 cases out of 4,792 treatments) |
| Common Procedural Side Effects (Safety) | Erythema, bruising, and numbness, typically resolve within one month of treatment (no specific rate) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document uses a compilation of previously published clinical studies as its "test set" or evidence for performance.
- Sample Size for Test Set: 4,792 cryolipolysis treatments.
- Abdomen: 1,695 treatments
- Flanks: 1,987 treatments
- Back: 501 treatments
- Inner thigh: 323 treatments
- Lateral thigh: 150 treatments
- Anterior thigh: 3 treatments
- Submental area: 119 treatments
- Banana roll region: 14 treatments
- Data Provenance: The data is compiled from "published scientific literature" and "clinical data from ZELTIQ." The country of origin is not specified, but the context of an FDA submission suggests an intent for use in the USA. The studies are retrospective as they are described as a "compilation of data from these studies" and a "literature review."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document mentions "blinded, independent review of clinical photographs" as one method of efficacy measurement.
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- For the "blinded, independent review of clinical photographs," the specific adjudication method is not detailed. It's unclear how discrepancies among reviewers (if more than one was used) were resolved. For other metrics like ultrasound and caliper measurements, the ground truth is objective measurement, so multi-expert adjudication isn't applicable in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. The Zeltiq Coolsculpting System is a physical device used for fat reduction, not a diagnostic AI algorithm that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. The Zeltiq Coolsculpting System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's efficacy and safety includes a combination of:
- Objective Measurements: Ultrasound and caliper measurements of fat layer reduction, circumferential measurements, and 3D quantification of volume reduction.
- Expert Review (Semi-Objective): Blinded, independent review of clinical photographs.
- Adverse Event Reporting: Incidence of serious adverse events and a description of common side effects, which would be based on clinical observation and reporting.
8. The Sample Size for the Training Set
- The document does not specify a separate "training set" in the context of an AI/algorithm-based device. The evidence for the device's performance is drawn from a compilation of diverse clinical studies, which collectively serve as the basis for demonstrating efficacy and safety. All 4,792 treatments discussed are presented as the data used to demonstrate performance, not a separate training set.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there's no explicitly defined "training set" for an AI algorithm, the concept of establishing ground truth for it doesn't apply directly in this document. The "ground truth" for the overall clinical performance demonstrated in the compiled studies was established through the various measurement techniques and expert assessments mentioned in point 7.
§ 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.