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510(k) Data Aggregation
(71 days)
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
| Acceptance Criterion (As indicated by regulatory standards and testing) | Reported Device Performance |
|---|---|
| Temperature Control Accuracy | Steady state accuracy within +/- 0.5°C of the target value. |
| Feedback and Control of Cooling Mechanism | Active during treatment. |
| Safe Cooling/Vacuum Limit Mechanism | Mechanism incorporated to ensure device does not exceed safe cooling/vacuum limit. |
| Electrical Safety | Complies with IEC 60601-1 AMD.1.ED.3.0B(2012). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 (Fourth Edition, 2014). |
| Software Verification and Validation (V&V) | 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 level of concern: "moderate") |
| Cybersecurity Risk Management | Performed as part of overall risk management process, following FDA guidance. Design measures implemented to secure the device. |
| Biocompatibility | No material changes to patient contacting components, thus no additional testing indicated. |
| Applicator Performance | Bench testing reports demonstrate that applicators perform as intended within pre-set parameters of each treatment profile. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document as it pertains to clinical study data or a test set for an AI model. The document describes engineering and software verification/validation, not a clinical trial with a "test set" in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as it relates to expert review for clinical ground truth, typically for AI model validation. The ground truth for this device's performance is established through technical specifications and industry standards for electrical, mechanical, and software performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it pertains to expert adjudication in clinical studies or for AI model ground truth establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC comparative effectiveness study was done, or that AI assistance is part of this device's functionality. The CoolSculpting Elite System is described as a medical device for physical treatment (cold-assisted lipolysis), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication of an algorithm-only standalone performance evaluation as the device is a physical therapeutic system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance of the CoolSculpting Elite System, the "ground truth" is based on:
- Engineering Specifications and Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and device-specific performance requirements (e.g., temperature accuracy).
- Bench Testing: Verification that the applicators perform as intended within pre-set parameters.
- Software Verification and Validation: Adherence to FDA guidance for medical device software.
8. The sample size for the training set
This information is not applicable/provided as the document describes a physical medical device and its predicate, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided as the document describes a physical medical device and its predicate, not an AI model requiring ground truth for a training set.
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(29 days)
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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(85 days)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.
The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
The provided document is a 510(k) premarket notification for the Cynosure SculpSure device, specifically seeking clearance for the treatment of the submental area. It contains information about the device's
description, indications for use, and a summary of clinical and non-clinical tests conducted to demonstrate safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal table of pre-defined acceptance criteria with corresponding performance metrics. Instead, it describes performance outcomes that were achieved. However, based on the narrative, we can infer the implied acceptance criteria from the reported results.
| Metric/Criteria (Inferred) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy: Blind Evaluation of Photos | High percentage of post-treatment photos identifiable by blind evaluators (indicating visible change). | 93% (51/55) of post-treatment photographs were identifiable by blind evaluators. |
| Efficacy: Fat Reduction (Ultrasound) | Demonstrable and statistically significant reduction in adipose tissue thickness via ultrasound. | 15.2% (1.785mm) normalized fat reduction at 12 weeks post-final treatment was shown by ultrasound imaging. |
| Efficacy: Patient Satisfaction | High patient satisfaction rate with the treatment. | 100% (55/55 subjects) satisfaction rate reported at 12 weeks post-final treatment follow-up visit using a 6-point Likert scale. |
| Safety: Adverse Events | Side effects should be transient, and the majority should be mild or moderate in nature, with no significant difference across BMI groups. | All reported adverse events (swelling, pain, nodules, redness, hardness, numbness, hair loss, itching, bruising, and blisters), except for one, were transient, and the majority were mild or moderate in nature. No significant difference in safety (or efficacy) between BMI = 30 groups. |
| Software Verification & Validation | Software performs as intended. | Software verification and validation was performed, and it was demonstrated that the software performs as intended. |
| Power Output Consistency | Power output meets specification. | Testing confirmed that the power output meets specification. |
| Electromagnetic Compatibility (EMC) & Electrical Safety | Device meets relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1). | Results confirmed the device meets the standards. |
| Biocompatibility | Patient-contacting materials are biocompatible per ISO 10993-1. | All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible. |
| Submental Mask Beam Uniformity | Submental mask provides beam uniformity within +/- 15% specification. | Additional bench testing was performed to demonstrate that the submental mask provides beam uniformity to the treatment area within +/- 15% specification. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 57 subjects were enrolled in the study for the submental area.
- 23 subjects had a BMI = 30.
- 5 patients received 1 treatment, the rest received 2 treatments.
- Efficacy analysis performed on 55 subjects (implied that 2 subjects were lost to follow-up or excluded from efficacy analysis, as 51/55 and 55/55 are reported).
- Safety analysis performed on all 57 subjects.
- Data Provenance: The study was a "prospective, controlled study" conducted at "3 study centers." The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it is highly likely the study was conducted in the United States, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document states "On an average, blind evaluators were able to identify 93% (51/55) of the post treatment photographs." The exact number of individual blind evaluators is not specified.
- Qualifications of Experts: The qualifications of these "blind evaluators" are not provided in the document.
4. Adjudication Method for the Test Set
- For the blind evaluation of photographs, the document only states "blind evaluation of pre- and post- final treatment (12 week) photographs." No specific adjudication method (e.g., 2+1, 3+1) is mentioned. It's unclear if multiple evaluators independently rated and then their results were averaged or if consensus was reached, or if there was a primary and secondary read.
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
- This document describes a clinical study for a medical device (laser system) for fat reduction, not a diagnostic AI system that assists human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not conducted for this device. The efficacy endpoints were direct measurements (fat reduction, patient satisfaction) and blind photo evaluation, not diagnostic accuracy requiring human reader interaction with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to the SculpSure device as it is a physical medical device (a laser system), not an algorithm or AI software for diagnostic purposes. Its performance is measured directly by its physical effect on the body, not as a standalone software output.
7. The Type of Ground Truth Used
The ground truth for the efficacy endpoints in this study was established using a combination of:
- Expert Consensus/Blind Evaluation: Implicitly, the ability of "blind evaluators" (human experts) to correctly identify post-treatment photographs served as a form of ground truth for visible changes.
- Objective Measurement: Percentage change in adipose tissue thickness from baseline, measured through ultrasound imaging, provided an objective, quantifiable ground truth for fat reduction.
- Patient-Reported Outcomes: Patient satisfaction measured via a 6-point Likert scale represents a subjective but crucial ground truth from the patient's perspective.
- Observed Clinical Outcomes: For safety, the reporting and assessment of adverse events observed during visits forms the ground truth for safety.
8. The Sample Size for the Training Set
- The document describes a clinical study to evaluate the device's performance, not to train an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The 57 subjects were part of the clinical test set (or study cohort) to assess the device's efficacy and safety.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there was no AI training set involved in this device submission.
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(60 days)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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 abdomen, flanks, back, and thighs.
The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
Acceptance Criteria and Study Details for SculpSure Device
The SculpSure device is intended for non-invasive lipolysis to reduce fat in specific body areas. The following information details the acceptance criteria and the study that demonstrated the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness - Photographic Assessment | Blind evaluators able to identify 86% of post-treatment photographs (Back: 91%, Outer Thigh: 87%, Inner Thigh: 83%). |
| Effectiveness - Fat Reduction (Ultrasound) | At 12-week post-follow-up, average 8.6% normalized fat reduction (Back: 10.6%, Outer Thigh: 7.2%, Inner Thigh: 8.0%). All treatments had a *p-value of X% fat reduction"). Instead, it reports the observed performance and concludes that the results demonstrate safety and effectiveness for substantial equivalence. The reported performance values in the table are the actual results from the study.) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: A total of 168 subjects, making up 214 treatment areas, were enrolled in the study.
- Back: 55 subjects / 55 treatment areas
- Outer Thigh: 52 subjects / 52 treatment areas
- Inner Thigh: 61 subjects / 107 treatment areas
- Data Provenance: The study was a prospective, controlled study conducted at 3 study centers. The specific country of origin is not explicitly stated, but it can be inferred to be within the US given the submission to the FDA.
3. Number of Experts and Qualifications for Ground Truth
The document mentions "blind evaluation of pre and post treatment (12-week) photographs," and "blind evaluators were able to identify 86% of the post treatment photographs." However, the number of experts used to establish the ground truth for the test set and their specific qualifications are not provided in the provided text.
4. Adjudication Method
The document states "blind evaluation of pre and post treatment (12-week) photographs." This indicates a degree of blinding. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly stated for establishing ground truth or for resolving discrepancies in photographic evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The study evaluated the device's efficacy in non-invasive fat reduction.
6. Standalone (Algorithm Only) Performance
This device is a laser system (SculpSure), not an AI algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" does not apply to this medical device. The study evaluates the performance of the physical device as used by a human operator.
7. Type of Ground Truth Used
The efficacy of the treatment was assessed using a combination of:
- Photographic assessment: Blind evaluation of pre and post-treatment photographs.
- Ultrasound imaging: Measurement of percentage change in adipose tissue thickness from baseline to 12-week follow-up.
8. Sample Size for the Training Set
The document describes a clinical study to evaluate the device's safety and efficacy for specific body areas. This study serves as the primary evidence for the device's performance. The concept of a "training set" typically applies to machine learning models. For a physical device like SculpSure, the provided documentation does not refer to a separate "training set" in the context of clinical studies.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the concept of a "training set" as it applies to software or AI algorithms is not directly relevant here. The "ground truth" for the clinical study's effectiveness was established through the objective measurements of ultrasound imaging for fat reduction and the subjective yet blinded assessment of photographic changes.
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