(296 days)
The CoolSculpting Elite System is a skin cooling or heating device. It can be used in cooling or heating mode.
Cooling Mode
• 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.
• Intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2.
· 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.
- · Can be used to minimize pain and thermal injury during laser and dermatological treatments.
- · Can be used as a local anesthetic for procedures that induce minor local discomfort.
Heating or Cooling Mode
- · Can be used to minimize pain post-trauma and post-surgery.
- · Can be used to provide temporary relief of minor aches, pains, and muscle spasms.
• The ZELTIQ Pretreatment Skin Wipe and gel pad 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 device that applies controlled cooling to a treatment site. The CoolSculpting Elite System comprises of a control unit, detachable applicators, and accessories such as cycle cards, CoolAdhesive gelpads, gel traps, pretreatment skin wipes, liners, foam borders, and comfort straps. The device treats 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
While the provided text describes the CoolSculpting Elite System, its indications for use, and a 510(k) summary, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria, particularly not for AI/ML-based performance parameters.
The document outlines a traditional 510(k) submission for a software update (including Wi-Fi functionality) and a new S180 applicator for the CoolSculpting Elite System. The primary focus of the performance testing mentioned is to demonstrate equivalence to the predicate device and confirm that the modified system functions as intended, without raising new safety or effectiveness concerns.
The 510(k) summary explicitly states: "The modified CoolSculpting Elite System is identical to the predicate device in terms of principle of operation, mechanical features, performance specifications, software, hardware, algorithm, and treatment workflow." This indicates that there isn't a new AI/ML algorithm being introduced with this submission that would require detailed performance metrics against specific acceptance criteria for AI-driven diagnostic or treatment recommendations. The Wi-Fi functionality is for data transfer (logs, errors, diagnostics) and not for achieving the device's intended use.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving the device meets them, as it pertains to AI/ML performance, because this information is not present in the provided document. The document concerns a hardware and minor software update to an existing device, not the validation of a new AI/ML component.
§ 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.