(29 days)
The CoolSculpting System is a skin cooling or heating device. The 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, banana roll, submental and 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 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 applicators and accessories such as gelpads, cycle cards and geltraps. The device treats at a target temperature down to -11° 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 document is a 510(k) premarket notification for the ZELTIQ CoolSculpting System. It describes a medical device, its indications for use, and a comparison to a predicate device. It also details the performance data submitted to the FDA for review.
However, the document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop study, as implied by your detailed request. This 510(k) pertains to a physical medical device (CoolSculpting System) that uses controlled cooling/heating for aesthetic and therapeutic purposes. There is no mention of Artificial Intelligence (AI), machine learning models, or any form of image analysis or diagnostic aid that would require the typical acceptance criteria and study designs you've outlined (e.g., MRMC studies, standalone algorithm performance, expert ground truth establishment for a test set).
The "Performance Data" section primarily focuses on:
- Biocompatibility: Stating no material changes were made to patient-contacting components.
- Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC standards.
- Software Verification and Validation Testing: This refers to the control system software for the device's operation (e.g., controlling dual applicators), not an AI diagnostic algorithm. It notes the software was considered "moderate" level of concern.
- Cybersecurity: Risk management for the device's network connections.
- Performance Testing (Benchtop): This confirmed the device's ability to maintain target temperatures, feedback control, and safe cooling limits, as well as the functionality of dual vacuum systems. It also discusses the updated applicator design.
- "No clinical testing was conducted." This explicitly states that no human trials were performed for this 510(k) submission.
Therefore, I cannot fill in the requested table and study details as they are not present in this document. The document describes a hardware and control software modification to an existing medical device, not an AI-powered diagnostic or assistive tool.
To appropriately answer your request, the input document would need to be a technical report, clinical trial summary, or a regulatory submission (like a marketing authorization application) for an AI-enabled medical device, detailing its performance against clinical endpoints or, more commonly, against expert ground truth in a diagnostic or image analysis context.
§ 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.