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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 Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q- Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.

The Resonic™ Rapid Acoustic Pulse (RAP) device is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of cellulite. Resonic uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in accelerated tattoo fading and fewer office visits to achieve sufficient tattoo fading. When used for improving the appearance of cellulite, the acoustic waves induce physical effects in the fibrous structures and improve the appearance of skin laxity.

The Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Handpiece and the replaceable Cartridge. The Console supplies saline to the Handpiece to enable formation of the shock wave within the acoustic pulse chamber. The Handpiece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent window of the Cartridge and acoustic ultrasound gel or similar hydrogel pad, which is placed against the surface of the skin to be treated.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The independent, blinded photo assessment study comprised 56 participants. For the primary effectiveness endpoint on skin laxity, 5 participants were excluded as they were not considered to have skin laxity, resulting in an effective sample size of 51 participants.
• Data Provenance: The images for the aesthetic study were "collected from the pivotal study that evaluated the Resonic device for improvement in the appearance of cellulite." The document does not explicitly state the country of origin or if the data was retrospective or prospective for the original pivotal study. However, the skin laxity assessment itself was a retrospective analysis of existing images.

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

• Number of Experts: Three independent, blinded physicians.
• Qualifications of Experts: The document states they were "independent, blinded physicians." Specific details regarding their specializations (e.g., dermatologists, plastic surgeons) or years of experience are not provided.

4. Adjudication Method for the Test Set

• The adjudication method was a 2 out of 3 consensus. The primary effectiveness endpoint was defined as "correct identification by at least 2 of 3 blinded reviewers of 12-week post-treatment images with respect to skin laxity from randomized groups of pre- and post-treatment images."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or conducted. This study focused on assessing the device's direct effect on skin laxity through expert review of treated vs. untreated images.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not conducted or mentioned. The study described relies on human expert assessment of photographic images, not an AI algorithm's performance.

7. Type of Ground Truth Used

• The ground truth used was expert consensus (specifically, a 2 out of 3 consensus among independent, blinded physicians) based on the visual assessment of photographic images.

8. Sample Size for the Training Set

• The document does not mention a training set as this study does not involve an AI algorithm that would require training. The assessment was based on human expert review of clinical images.

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

• As there was no AI algorithm and therefore no training set, this information is not applicable.

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The Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation.

The Resonic™ Rapid Acoustic Pulse (RAP) device is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of cellulite. Resonic uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in accelerated tattoo fading and fewer office visits to achieve sufficient tattoo fading. When used for improving the appearance of cellulite, the acoustic waves induce physical effects in the fibrous structures, such as the fibrous septa in the subcutaneous tissue.

The Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Hand Piece and the Cable connecting the Hand Piece to the Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent window and acoustic ultrasound gel or similar hydrogel pad, which is placed against the surface of the skin to be treated.

The provided text describes the regulatory clearance of the Resonic Rapid Acoustic Pulse device, specifically focusing on a software modification to change the pulse repetition rate for cellulite treatment from 50Hz to 100Hz. The information primarily relates to demonstrating substantial equivalence to a predicate device rather than a comprehensive study for initial device approval.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the clinical study. Instead, it describes a "primary effectiveness endpoint" and the results of a comparison study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: 15 female participants.
• Data Provenance: The document does not explicitly state the country of origin. It indicates a "bridging study was performed," implying a prospective study. Participants were treated with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: The document refers to a "blinded independent physician assessment (IPA) panel." The specific number of physicians on this panel is not provided.
• Qualifications of Experts: Only "physician" is mentioned; no specific qualifications (e.g., specialization, years of experience) are detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The adjudication method is described as "Correct ID (2 of 3)" in Table 6-2 for the Cellulite Dose Study. This suggests that a decision was considered "correct" if at least two out of three adjudicators agreed.

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

• No MRMC comparative effectiveness study was done. This study compared two treatment settings (50Hz vs. 100Hz) of the same device on patients, with physicians assessing the outcomes after treatment, not with AI assistance. Therefore, there is no information on human reader improvement with/without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable as the device is a physical medical device (acoustic pulse device) and not an AI algorithm. The "performance data" section focuses on hardware safety, software verification, and clinical study outcomes, not an AI algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Ground Truth Type: Expert consensus based on "blinded independent physician assessment (IPA)" of before and after photographs of patients. Outcomes data (long-term improvement in cellulite appearance) from previous studies also informed the context.

8. The sample size for the training set

• The document describes a clinical study to compare two treatment settings (50Hz vs. 100Hz) of the device. It does not mention a "training set" in the context of machine learning. The device itself is not described as an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no mention of a machine learning training set for this device.

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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.

Ask a specific question about this device

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.

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The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, back 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, 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 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 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 vacuum applicators and accessories such as gelpads, cycle cards, geltraps, and gaskets.

The provided document describes the ZELTIQ CoolSculpting System, a skin cooling or heating device used for cold-assisted lipolysis. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document specifies that no clinical testing was conducted for this particular submission (K183514). The testing performed was primarily benchtop and verification/validation testing for hardware and software changes. Therefore, there is no "test set" in the context of patient data or clinical imagery. The provenance of any data used for bench testing is not specified beyond being internal company testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical testing was conducted, there were no experts establishing ground truth for a clinical test set. The performance criteria are based on regulatory guidance and engineering specifications.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used.

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

Not applicable. This device is a direct treatment device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical system for cold/heat therapy, not an algorithm.

7. The type of ground truth used

For the performance testing, the "ground truth" was established by engineering specifications, regulatory guidance (e.g., "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use"), and validated design control processes for components like applicators. For example, steady-state accuracy within +/- 0.5°C is an engineering specification, and the presence of a safe cooling limit is a regulatory requirement.

8. The sample size for the training set

Not applicable. The device is not an AI/machine learning model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The CoolSculpting 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 dermatoms 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 spassne. 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 vacuum and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, gaskets, foam borders and securement system.

The ZELTIQ CoolSculpting System's acceptance criteria and the study proving it meets them are described below, focusing on the expanded indication for cold-assisted lipolysis in the submandibular area and clarification of BMI for submental and submandibular treatments.

1. Table of Acceptance Criteria and Reported Device Performance

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

The study was a review of published literature and clinical studies. The sample size for the combined "test set" (across various studies and publications) was 228 cryolipolysis treatment cycles during clinical studies of the submental and submandibular areas.

The data provenance is from clinical studies of the submental and submandibular areas and "published literature." The document doesn't specify countries of origin, but clinical publications generally encompass international research. The data appears to be retrospective as it's a review of existing studies and literature.

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

The document mentions "Blinded, independent review of clinical photographs." This implies that experts (likely dermatologists or plastic surgeons, given the nature of the procedure) were used to assess the visual changes. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text.

4. Adjudication Method for the Test Set

For the blinded, independent photo review, the specific adjudication method is not explicitly stated. Typically, for such reviews, multiple experts independently assess images, and consensus or majority vote might be used, but this detail is missing.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device (CoolSculpting System) for cosmetic and pain relief applications, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.

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 device, and its performance relies on its direct application to the patient, not on an algorithm operating independently without human intervention.

7. The Type of Ground Truth Used

The ground truth used for effectiveness was a combination of:

• Quantitative measurements: Ultrasound measurement, caliper measurement, Magnetic Resonance Imaging (MRI), and three-dimensional (3D) quantification of volume reduction.
• Expert assessment: Blinded, independent review of clinical photographs (implicitly by experts).
• Patient-reported outcomes: Patient satisfaction.
• Clinical observation/Adverse Event reporting: For safety outcomes.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI. The CoolSculpting System is a physical device. The studies reviewed were for demonstrating the device's clinical performance, not for training an algorithm. Therefore, this question is not applicable in the context of this device.

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

As there is no "training set" for an algorithm, this question is not applicable. The effectiveness and safety were established through clinical studies and literature reviews as described in section 7.

Ask a specific question about this device

The CoolSculpting 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, submental area, 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 visible fat bulges in the upper arm, bra fat, banana roll, submental area, thigh, abdomen and 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 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 vacuum and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, gaskets, foam borders and securement system.

As part of the CoolSculpting System suite of applicators, ZELTIQ has developed two new vacuum applicators known as CoolAdvantage Plus and CoolAdvantage Petite. Both applicators feature the curved aluminum cup design with interchangeable silicone contours that is identical to the previously cleared CoolAdvantage applicator (K162050). They have been modified in size to accommodate different sizes of fat bulges. All other technological characteristics, including mechanism of action, and performance remain identical for the CoolAdvantage family of applicators.

The CoolAdvantage family of applicators is also provided with a new gelpad known as CoolAdhesive Pad. The CoolAdhesive Pad is comprised of fructose and glycerin in a pad made of rayon and spandex. This material is commonly used in the garment industry. It has the identical functionality as the previously cleared gelpads and is intended to provide consistent thermal contact during treatments with the CoolAdvantage family of applicators. Fructose and glycerin are considered safe ingredients and are found in commonly used products. Fructose is generally used as a food additive and glycerin is typically found in common cosmetic products such as lotion and soap. Glycerin is generally recognized as safe (GRAS per CFR §182.1320). The CoolAdhesive Pad has been tested for biocompatibility and is considered biocompatible. The performance remains the same for CoolAdhesive Pad as for the previously cleared gelpads.

The provided text describes the 510(k) summary for the ZELTIQ CoolSculpting System, specifically focusing on the introduction of two new applicators (CoolAdvantage Plus and CoolAdvantage Petite) and a new gelpad (CoolAdhesive Pad). The document explicitly states that no clinical studies were performed in support of this specific submission. Therefore, it is impossible to provide information regarding a study that proves the device meets acceptance criteria based on the provided text alone, as such a study was not part of this submission process.

The FDA's decision of substantial equivalence (K171069) for this device relies heavily on its similarity to a previously cleared predicate device (ZELTIQ CoolSculpting System, K162050), which presumably underwent clinical testing for its initial clearance or was cleared through other pathways.

However, based on the information provided, I can construct parts of the answer regarding acceptance criteria and the types of testing performed for this specific submission, even though they do not involve clinical performance data.

Here's an analysis of the provided text in relation to your questions, highlighting where information is absent due to the lack of clinical studies in this specific submission:

1. A table of acceptance criteria and the reported device performance

The document details various tests conducted and generally states that the device "passed successfully by meeting the acceptance criteria." Specific numerical performance data or detailed acceptance criteria from these tests are not provided in this summary.

Acceptance Criteria and Reported Device Performance (Based on provided text, non-clinical):

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable for clinical performance as "no preclinical or clinical testing was performed" for this specific submission. For bench testing, sample sizes are not explicitly mentioned.
• Data Provenance: Not applicable for clinical performance. For bench testing, the data origin is from ZELTIQ Aesthetics, Inc.'s internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. As no clinical performance study was conducted for this submission, there was no ground truth established by experts in the context of clinical efficacy or safety.

4. Adjudication method for the test set

• Not applicable. No clinical test set.

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

• Not applicable. No clinical studies, let alone MRMC studies, were performed or described for this specific submission. The device is a physical system for aesthetic treatment, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is a physical system, not an algorithm. Bench testing demonstrated the device's technical performance in a standalone manner (without patient interaction) against specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable for clinical ground truth. For the non-clinical performance and safety data:
  • Biocompatibility: Ground truth is established by the specified ISO 10993 standards and their inherent scientific principles for evaluating biological compatibility.
  • Electrical Safety & EMC: Ground truth is defined by the requirements of IEC 60601-1 and IEC 60601-1-2 standards.
  • Software V&V: Ground truth is adherence to the "General Principles of Software Validation" guidance and internal software requirements.
  • Bench Performance: Ground truth is defined by the internal design specifications and defined performance parameters of the device.

8. The sample size for the training set

• Not applicable. The device is not an AI/ML model that requires a training set in the typical sense.

9. How the ground truth for the training set was established

• Not applicable.

Summary of Device Performance Assessment in this Submission:

The ZELTIQ CoolSculpting System's K171069 submission primarily focuses on demonstrating substantial equivalence to its predicate device (K162050) by highlighting that the new applicators and gelpad maintain the same indications for use, mechanism of action, and performance characteristics. The acceptance criteria for this specific submission were met through:

• Biocompatibility testing of the new gelpad.
• Electrical safety and EMC testing of the overall system.
• Software verification and validation (since the software remained unchanged from the predicate, ensuring its continued proper function).
• Bench performance testing to ensure the new applicators and gelpad performed as expected and within previously cleared parameters (e.g., maintaining the target temperature, durability, etc.).

The key takeaway is that for this 510(k) submission, the "study that proves the device meets the acceptance criteria" refers to the non-clinical performance and safety testing outlined, rather than a clinical trial with human subjects. The substantial equivalence argument negates the need for new clinical data if the technological characteristics are sufficiently similar and safety/performance are demonstrated through non-clinical means.

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The CoolSculpting 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, submental area, 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 visible fat bulges in the upper arm, bra fat, banana roll, submental area, thigh, abdomen and 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 spassms. 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 vacuum and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, foam borders and securement system.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Zeltiq CoolSculpting System (specifically the CoolAdvantage applicator for upper arms)
Indication: Cold-assisted lipolysis of the upper arm in individuals with a BMI of 30 or less.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 30 subjects, with each subject treated on both upper arms (60 treatments total).
• Data Provenance: The study was a "Prospective, multicenter, non-randomized, interventional cohort study" conducted at "two clinical sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically assumed to be the United States unless otherwise specified.

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

• Number of Experts: Three blinded, independent reviewers.
• Qualifications: Not explicitly stated, but they are referred to as "independent panel reviewers," suggesting they are qualified professionals in assessing aesthetic outcomes.

4. Adjudication Method for the Test Set

• Adjudication Method: A majority consensus approach was used for the primary efficacy endpoint. "Correct identification of pre-treatment vs 12 Week post-treatment images by at least two out of three blinded, independent reviewers." This is a 2-out-of-3 consensus method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described in this document. This study focuses on the standalone performance of the device and its treatment outcome, not on AI assistance for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This document describes a clinical study evaluating a medical device (CoolSculpting System), not an AI algorithm. Therefore, no standalone (algorithm only) performance study was conducted or reported. The efficacy endpoints directly assess the physical outcomes on patients from the device's application.

7. Type of Ground Truth Used

• Primary Efficacy: Expert consensus (2-out-of-3 blinded independent reviewers) on photographic evidence of fat reduction.
• Secondary Efficacy:
  • Objective measurements (ultrasound-measured upper arm fat reduction).
  • Subjective patient-reported outcomes (questionnaire for satisfaction).
• Safety: Clinical safety assessment by investigators and follow-up for adverse events.

8. Sample Size for the Training Set

• This document describes a clinical investigation for device clearance, not the development of an AI model. Therefore, there is no mention of a training set sample size.

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

• As this is a device clearance document and not an AI model development report, there is no discussion of a training set or how its ground truth was established.

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The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of bra fat, banana roll, submental area, 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 visible fat bulges in bra fat, back fat, banana roll, submental area, thigh, abdomen and 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 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 vacuum and surface applicators and supplies such as liners, gel/gelpads, cycle cards, foam borders and securement system.

Here's a breakdown of the acceptance criteria and study information for the Zeltiq Coolsculpting System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a typical quantitative pass/fail format for device performance. Instead, it relies on a compilation of clinical study results to demonstrate safety and efficacy, implying that these results meet an unstated threshold for acceptability.

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

The document uses a compilation of previously published clinical studies as its "test set" or evidence for performance.

• Sample Size for Test Set: 4,792 cryolipolysis treatments.
  • Abdomen: 1,695 treatments
  • Flanks: 1,987 treatments
  • Back: 501 treatments
  • Inner thigh: 323 treatments
  • Lateral thigh: 150 treatments
  • Anterior thigh: 3 treatments
  • Submental area: 119 treatments
  • Banana roll region: 14 treatments
• Data Provenance: The data is compiled from "published scientific literature" and "clinical data from ZELTIQ." The country of origin is not specified, but the context of an FDA submission suggests an intent for use in the USA. The studies are retrospective as they are described as a "compilation of data from these studies" and a "literature review."

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

• The document mentions "blinded, independent review of clinical photographs" as one method of efficacy measurement.
• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• For the "blinded, independent review of clinical photographs," the specific adjudication method is not detailed. It's unclear how discrepancies among reviewers (if more than one was used) were resolved. For other metrics like ultrasound and caliper measurements, the ground truth is objective measurement, so multi-expert adjudication isn't applicable in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. The Zeltiq Coolsculpting System is a physical device used for fat reduction, not a diagnostic AI algorithm that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• N/A. The Zeltiq Coolsculpting System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's efficacy and safety includes a combination of:

• Objective Measurements: Ultrasound and caliper measurements of fat layer reduction, circumferential measurements, and 3D quantification of volume reduction.
• Expert Review (Semi-Objective): Blinded, independent review of clinical photographs.
• Adverse Event Reporting: Incidence of serious adverse events and a description of common side effects, which would be based on clinical observation and reporting.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" in the context of an AI/algorithm-based device. The evidence for the device's performance is drawn from a compilation of diverse clinical studies, which collectively serve as the basis for demonstrating efficacy and safety. All 4,792 treatments discussed are presented as the data used to demonstrate performance, not a separate training set.

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

• N/A. As there's no explicitly defined "training set" for an AI algorithm, the concept of establishing ground truth for it doesn't apply directly in this document. The "ground truth" for the overall clinical performance demonstrated in the compiled studies was established through the various measurement techniques and expert assessments mentioned in point 7.

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