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510(k) Data Aggregation
(29 days)
ZELTIQ CoolSculpting System
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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(27 days)
ZELTIQ CoolSculpting System
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
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Electrical safety and electromagnetic compatibility (EMC) | System complies with IEC 60601-1 (Third Edition, 2005) and IEC 60601-1-2 (Fourth Edition, 2014). |
| Software Verification and Validation | Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern. |
| Interface temperature steady state accuracy (as per "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use") | Within +/- 0.5°C of the target value. |
| Feedback and control of cooling mechanism (as per "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use") | Active during treatment. |
| Mechanism to ensure device does not exceed safe cooling limit (as per "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use") | Incorporated into the device. |
| Vacuum system accuracy and performance | Bench testing performed to verify accuracy and performance. |
| CoolAdvantage and CoolAdvantage Petite applicator performance | Bench testing reports demonstrate performance at treatment parameters of -11 °C for 35 minutes. Demonstrated substantial equivalence to previously-cleared versions via design verification and validation testing. |
| Overall workflow or efficacy of the CoolSculpting System | Unchanged as a result of modifications. |
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.
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(58 days)
ZELTIQ CoolSculpting System
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
| Acceptance Criteria (Effectiveness Endpoints) | Reported Device Performance (Mean and Range) |
|---|---|
| Fat layer reduction measured by ultrasound | 2.4 mm (range: 2.0 to 2.8 mm) |
| Fat layer reduction measured by caliper | 3.17 mm (around 33%) (range: 2.3 to 4.0 mm) |
| Subcutaneous fat layer reduction measured by MRI | 17% |
| Fat volume reduction measured by 3D quantification | 8.5 mL (one study) |
| 4.82 cm³ (another study) | |
| Reduction in submental laxity measured by 3D quantification (for submental area) | 2.25 mm |
| Blinded, independent review of clinical photographs (correct identification of baseline) | 77% (range: 60% to 91%) |
| Patient satisfaction | 85% (range: 80% to 93%) |
| Safety: No procedure or device-related serious adverse events; common procedural side effects are transient and resolve. | No procedure or device-related serious adverse events reported. Common procedural side effects were transient and resolved without long-term effect. Clinical study literature indicates a low-risk safety profile. |
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.
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(88 days)
ZELTIQ CoolSculpting System
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):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Passed Cytotoxicity, Sensitization, and Irritation tests consistent with ISO 10993 standards. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1 (2005+A1:2012) for safety and IEC 60601-1-2 (2007) for EMC. |
| Software Verification and Validation | Tests conducted per FDA's "General Principles of Software Validation" (2002); device software considered "moderate level of concern." |
| Bench Performance Testing | Design verification and usability tests were passed successfully by meeting acceptance criteria (e.g., thermal performance, thermal range, reuse, physical specifications, compatibility with use environment, treatment parameters, power and operational control, labeling, interface, and support requirements). |
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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(119 days)
ZELTIQ CoolSculpting System
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
| Acceptance Criteria (Endpoint) | Reported Device Performance (Result) |
|---|---|
| Primary Safety Endpoint: Incidence of unanticipated adverse device effects (UADE). | No unanticipated adverse device effects, or serious device or procedure-related adverse effects occurred. All device- and/or procedure-related adverse events resolved spontaneously. (Anticipated side-effects, such as prolonged numbness in 4 patients, were noted). |
| Primary Efficacy Endpoint: Correct identification of pre-treatment vs. 12-week post-treatment images by at least two out of three blinded, independent reviewers. | For the per-protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%] |
| Secondary Efficacy (Ultrasound): Significant reduction in fat layer as measured by ultrasound from baseline to 12 weeks post-treatment. | Significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-treatment. |
| Secondary Efficacy (Subject Satisfaction): Percentage of subjects finding the procedure comfortable and recommending it. | 72.41% of subjects found the procedure to be comfortable to very comfortable. 63.3% of subjects reported they would recommend the procedure to a friend. |
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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(51 days)
ZELTIQ CoolSculpting System
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.
| Metric (Implied Acceptance Standard) | Reported Device Performance (Mean) |
|---|---|
| Ultrasound fat layer reduction (Efficacy) | Ranged from 10.3% to 25.5% (average 20.6%) and 1.9 mm to 8.3 mm (average 3.9 mm) |
| Caliper fat layer reduction (Efficacy) | Ranged from 14.7% to 23.0% (average 22.3%) |
| Circumferential reduction (Efficacy) | Inner thigh: 0.9 cm; Flanks: 2.4 cm; Abdomen: 6.8 cm |
| Volumetric reduction (Efficacy) | Flanks: 39.6 cm³ |
| Independent photo review correctness (Efficacy) | 89.7% correct, on average |
| Serious Adverse Events (Safety) | 0.13% incidence rate (6 cases out of 4,792 treatments) |
| Common Procedural Side Effects (Safety) | Erythema, bruising, and numbness, typically resolve within one month of treatment (no specific rate) |
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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(141 days)
ZELTIQ CoolSculpting System
The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of the 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 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 ZELTIO 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 consists of a control unit, detachable vacuum and surface applicators, as well as supplies such as liners, gelpads, skin wipes, cycle cards, foam borders and securement system, and software which includes functions to collect patient data, monitor tissue during cooling and minimize the risk of damage to tissue.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance (Result) |
|---|---|
| Primary Safety Endpoint: | The primary safety endpoint was met. |
| Incidence of device- and/or procedure-related adverse events. | No device- or procedure-related adverse events were categorized as serious adverse events (SAE) or unanticipated adverse device effects (UADE). Four device- and/or procedure-related adverse events reported: 2 incidents of prolonged erythema, 1 incident of hyperpigmentation, and 1 incident of subject report of fullness sensation in back of throat due to swelling. All adverse events resolved by the final follow-up at 12 weeks post-final treatment. Anticipated and transient side-effects (erythema, edema, numbness) observed, all resolved over the course of the study. |
| Primary Efficacy Endpoint: | The primary efficacy endpoint was met. |
| Correct identification of pre-treatment vs. 12-week post-final treatment images for discernible fat layer reduction by 3 blinded independent reviewers. (Pre-established 80% criterion for success) | Overall correct identification rate by the 3 reviewers was 91% for the per-protocol population (n=58). |
| Secondary Efficacy Endpoint: | |
| Reduction in fat layer thickness as measured by ultrasound at 12 weeks post-final treatment. | Statistically significant (p |
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(173 days)
ZELTIQ COOLSCULPTING SYSTEM
The CoolSculpting System is a skin cooling or heating 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 applicators and supplies such as liners, gelpads, and cycle cards.
The ZELTIQ CoolSculpting System is a device designed for cold-assisted lipolysis of the thigh, abdomen, and flank. The provided document details the clinical investigations conducted to demonstrate its safety and efficacy, particularly regarding its application to the thigh region.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ZELTIQ CoolSculpting System primarily focused on the visible reduction of fat in target treatment areas, as assessed by blinded evaluators based on photographic evidence.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Efficacy - Visible Fat Reduction | Overall correct identification rate by three blinded evaluators of pre-treatment photographs from a series against post-treatment photographs. | Inner Thigh Study: 90.5% correct identification rate. |
| Outer Thigh Study: 83.9% correct identification rate. | ||
| At least two out of three blinded evaluators correctly identify pre-treatment photographs from a series against post-treatment photographs. | Inner Thigh Study: 90.5% identified correctly by at least two evaluators. | |
| Outer Thigh Study: 87.1% identified correctly by at least two evaluators. | ||
| Safety - Adverse Events | Resolution of adverse events by 16-week follow-up. | All adverse events (numbness, mild contour irregularity) but one resolved by the 16-week follow-up. |
| One mild case of hyperpigmentation persisted, which is noted as a rare side effect that typically resolves spontaneously. |
2. Sample Size Used for the Test Set and Data Provenance
The test set for evaluating the device's performance consisted of patient photographs.
- Sample Size:
- Inner Thigh Study: 90 treatments completed. Each treatment likely corresponds to a unique subject/area, resulting in 90 sets of pre and post-treatment photos.
- Outer Thigh Study: 40 treatments completed. Each treatment likely corresponds to a unique subject/area, resulting in 40 sets of pre and post-treatment photos.
- Data Provenance: The document does not explicitly state the country of origin. However, the FDA 510(k) submission process is for devices marketed in the United States, suggesting the studies were likely conducted in the US or in a manner compliant with US regulatory standards. The studies appear to be prospective clinical investigations conducted specifically to determine the safety and efficacy of the device for cold-assisted lipolysis in the thigh region.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three blinded evaluators.
- Qualifications of Experts: The document does not explicitly state the specific qualifications (e.g., radiologist, dermatologist, years of experience) of the "three blinded evaluators." It only identifies them as "blinded evaluators." Their role was to assess photographic evidence of fat reduction.
4. Adjudication Method for the Test Set
The adjudication method used was based on agreement among the blinded evaluators:
- Method: The evaluators were presented with series of photographs (pre- and post-treatment) and asked to identify the pre-treatment photographs for each subject.
- Reporting: The "overall correct identification rate by the three evaluators" and "At least two out of three evaluators correctly identified" rates were reported, indicating a form of majority or consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study described involves human evaluators assessing photographic outcomes directly, not evaluating an AI's output or being assisted by AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. The performance assessment relies entirely on human evaluators' interpretation of photographic evidence. This device is not an AI algorithm; it is a physical cooling device.
7. The Type of Ground Truth Used
The ground truth used was expert consensus interpretation of photographic evidence of visible fat reduction. The three blinded evaluators' assessment of "visible reduction of fat" in the treatment areas from photographs served as the primary measure of efficacy.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI. The clinical investigations described are for evaluating the actual physical device's performance on human subjects, not for training a model.
9. How the Ground Truth for the Training Set Was Established
As there was no "training set" for an algorithm, the concept of establishing ground truth for a training set is not applicable here. The clinical studies directly demonstrated the device's effect on subjects.
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