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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.

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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

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.

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