(107 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. 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 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, geltraps, gaskets, 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
| Acceptance Criteria (Effectiveness) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint (from original IDE study for submental area - K151179): Independent panel review to correctly identify baseline photographs of the treatment area. | Correct baseline photograph identification rate by the independent panel reviewers was 91.4% (for the per protocol population). |
| Secondary Effectiveness Endpoint (from original IDE study for submental area - K151179): Subject satisfaction regarding the treatment making their chin look more toned. | 75% of subjects reported that they agree or strongly agree that the treatment made their chin look more toned. |
| New Effectiveness Endpoint (for lax tissue appearance in submental area - based on retrospective photo analysis): ≥ 20 mm² decrease in area as measured on both the right lateral and left lateral views of the submental region. | 77.2% (44/57) of subjects exhibited a ≥ 20 mm² area reduction in the submental area and neck. |
| Concordance with physician panel review (for lax tissue appearance): For subjects showing ≥ 20 mm² area reduction, physician panel should correctly identify a visible response. | Of the 44 subjects showing ≥ 20 mm² area reduction, 42 (95.5%) were correctly identified by the physician panel as having a visible response. |
| Primary Safety Endpoint (from original IDE study for submental area - K151179): (Not explicitly defined in terms of a specific metric but implied to be met and remain unchanged). | The primary safety endpoint of the original IDE approved study was met and remains unchanged since the close of the study. All device- and/or procedure-related adverse events have resolved spontaneously. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Effectiveness Analysis: 57 subjects (per-protocol population of an original IDE study, with one exclusion due to excessive hair).
- Data Provenance: The study was a retrospective photo analysis of data from an original IDE approved study. While the country of origin isn't explicitly stated, the context of FDA submission suggests a US-based study or one adhering to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the "original IDE study" (K151179): An "independent panel reviewers" performed photographic identification. The number and specific qualifications of these reviewers are not explicitly stated in this document.
- For the "retrospective photo analysis" of lax tissue: The photographic analysis involved:
- One board-certified plastic surgeon who identified anatomical points and performed measurements.
- A "physician panel" (presumably the same "independent panel reviewers" from the original IDE study, but not explicitly confirmed) who reviewed photographs for a visible response. The number and specific qualifications of this panel are not explicitly stated in this document beyond being "physician."
4. Adjudication Method for the Test Set
- For the original IDE study's primary effectiveness endpoint (photographic identification): It was a review by an "independent panel reviewers." No specific adjudication method (e.g., 2+1) is mentioned, only that a "correct baseline photograph identification rate" was reported.
- For the retrospective photo analysis (lax tissue appearance):
- A single board-certified plastic surgeon performed the quantitative measurements (≥ 20 mm² decrease). This wasn't an adjudication but a direct measurement by an expert.
- A "physician panel" retrospectively evaluated visible response, and their agreement (or lack thereof) with the quantitative findings was noted. The exact adjudication method used by this panel is not specified.
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, an MRMC comparative effectiveness study involving AI assistance was not performed. This submission describes the performance of a physical medical device (CoolSculpting System) based on human expert review of photographic evidence, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. This document describes a physical medical device, not an algorithm or AI system. The "performance data" section mentions "Software Verification and Validation Testing" but states it's the same as a previously cleared predicate device and does not involve AI for diagnostic purposes.
7. The Type of Ground Truth Used
- Expert Consensus/Measurement:
- For the original IDE study's primary effectiveness endpoint, the ground truth was based on the "correct baseline photograph identification" by independent panel reviewers.
- For the retrospective study on lax tissue, the primary measure of effectiveness (>20 mm² reduction) was derived from measurements performed by a board-certified plastic surgeon on anatomical points. This was then corroborated by an "independent physician review panel" confirming a "visible response."
- Subject Reported Outcomes: For the secondary effectiveness endpoint in the original IDE study, subject satisfaction (agreement that the treatment made their chin look more toned) served as a ground truth measure.
8. The Sample Size for the Training Set
- Not applicable / Not specified. This submission is for an updated indication for a physical medical device. There is no mention of a "training set" in the context of an AI algorithm learning from data. The effectiveness study relies on an independent panel review and expert measurement on a test set, not on a machine learning model trained on a separate dataset. The "original IDE approved study" involved 60 enrolled subjects, but this served as the source for the test set for the retrospective analysis, not a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm mentioned in this document, the method for establishing its ground truth is not relevant. The ground truth for the test set was established as described 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.