Search Results

The CoolSculpting System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis of the 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 the thigh, abdomen and the flank. 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 Gelpad facilitates 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, gelpads, cycle cards, foam borders and securement system.

The provided document is a 510(k) summary for the ZELTIQ CoolSculpting System. It describes the device, its indications for use, and a clinical study conducted to demonstrate its safety and efficacy.

Here's an analysis of the acceptance criteria and study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "minimum 70% accuracy"). Instead, it describes meeting "primary efficacy endpoint," "secondary efficacy endpoint," and "primary safety endpoint."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): 45 subjects.
• Data Provenance: The study was described as an "IRB-approved non-significant risk clinical study" but does not explicitly state the country of origin. Given the FDA submission, it's highly likely to be U.S.-based or conducted under equivalent regulatory standards. The study design (treatment followed by follow-up) indicates it was a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Three reviewers were used for the secondary efficacy endpoint concerning photo pair identification.
• Qualifications of Experts: The document does not specify the qualifications of these reviewers (e.g., dermatologists, radiologists, other medical professionals, or lay-reviewers).

4. Adjudication Method for the Test Set

For the secondary efficacy endpoint of photo identification, the adjudication method was:

• 85% of all photo pairs were correctly identified by at least two out of three reviewers. This suggests a "2 out of 3" (2+1) consensus method was used for determining a "correct" identification among the reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This study focused on the device's efficacy in reducing fat, subject satisfaction, and safety. The photo review aspect was a means to assess the visible effect of the treatment, not to evaluate AI performance or human reader improvement with AI.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone algorithm performance study was not done. The CoolSculpting System is a physical medical device (skin cooling/heating device), not an independent AI algorithm for image analysis or diagnostic assessment. The "algorithm" in this context refers to the device's operational parameters, not a software algorithm that performs diagnostic tasks.

7. The Type of Ground Truth Used

The study utilized multiple types of "ground truth" to assess the device's effects:

• Ultrasound data: Used for the primary efficacy endpoint (reduction in fat layer thickness). This is an objective measurement from a medical imaging modality.
• Expert Consensus (Photo Review): Used for a secondary efficacy endpoint, where three reviewers identified pre- and post-treatment images.
• Subjective Outcome Data: Used for another secondary efficacy endpoint, based on subject satisfaction reports.
• Clinical Observation/Reporting: Used for the primary safety endpoint, involving the documentation and resolution of adverse events.

8. The Sample Size for the Training Set

• Not Applicable. The provided document describes a clinical study for a physical device, not an AI model requiring a training set for machine learning. The "training" for this device would refer to its design, engineering, and manufacturing process, rather than data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable, as this is not an AI/machine learning device with a training set.

Ask a specific question about this device