(71 days)
The CoolSculpting Elite 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, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat, banana roll, submandibular areas, 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 treatment and act as a local anesthetic for procedures that induce minor local discomfort.
The CoolSculpting Elite 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 Elite System is a portable thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The CoolSculpting Elite System is comprised of a control unit, detachable applicators, and accessories such as gelpads, cycle cards and geltraps. The device treats at a target temperature down to -15°C with an accuracy of +/-0.5°C. The device will automatically stop the treatment if the interface temperature goes past the target temperature by more than 1°C when treating below 5°C.
The provided text describes the CoolSculpting Elite System, a skin cooling or heating device used for cold-assisted lipolysis. However, it does not include information about a study proving the device meets acceptance criteria related to a multi-reader multi-case (MRMC) comparative effectiveness study or stand-alone algorithm performance for an AI-based system. The document is a 510(k) summary for a medical device that has undergone design verification and validation testing, electrical safety, EMC, software verification, validation, and performance testing, but not AI-based performance metrics.
Therefore, the following response will focus on the information available in the provided text, while indicating where information pertinent to AI-based device acceptance criteria is not present.
Acceptance Criteria and Device Performance (CoolSculpting Elite System)
The acceptance criteria and performance data provided in the document relate to the device's physical and functional characteristics, safety, and software, rather than AI performance. The device is being cleared as substantially equivalent to a predicate device based on these engineering and safety metrics.
Here's a summary of the relevant acceptance criteria and reported performance from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (As indicated by regulatory standards and testing) | Reported Device Performance |
|---|---|
| Temperature Control Accuracy | Steady state accuracy within +/- 0.5°C of the target value. |
| Feedback and Control of Cooling Mechanism | Active during treatment. |
| Safe Cooling/Vacuum Limit Mechanism | Mechanism incorporated to ensure device does not exceed safe cooling/vacuum limit. |
| Electrical Safety | Complies with IEC 60601-1 AMD.1.ED.3.0B(2012). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 (Fourth Edition, 2014). |
| Software Verification and Validation (V&V) | Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Software level of concern: "moderate") |
| Cybersecurity Risk Management | Performed as part of overall risk management process, following FDA guidance. Design measures implemented to secure the device. |
| Biocompatibility | No material changes to patient contacting components, thus no additional testing indicated. |
| Applicator Performance | Bench testing reports demonstrate that applicators perform as intended within pre-set parameters of each treatment profile. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document as it pertains to clinical study data or a test set for an AI model. The document describes engineering and software verification/validation, not a clinical trial with a "test set" in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as it relates to expert review for clinical ground truth, typically for AI model validation. The ground truth for this device's performance is established through technical specifications and industry standards for electrical, mechanical, and software performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it pertains to expert adjudication in clinical studies or for AI model ground truth establishment.
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
There is no indication that an MRMC comparative effectiveness study was done, or that AI assistance is part of this device's functionality. The CoolSculpting Elite System is described as a medical device for physical treatment (cold-assisted lipolysis), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication of an algorithm-only standalone performance evaluation as the device is a physical therapeutic system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance of the CoolSculpting Elite System, the "ground truth" is based on:
- Engineering Specifications and Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and device-specific performance requirements (e.g., temperature accuracy).
- Bench Testing: Verification that the applicators perform as intended within pre-set parameters.
- Software Verification and Validation: Adherence to FDA guidance for medical device software.
8. The sample size for the training set
This information is not applicable/provided as the document describes a physical medical device and its predicate, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided as the document describes a physical medical device and its predicate, not an AI model requiring ground truth for a training set.
§ 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.