Search Results
Found 6 results
510(k) Data Aggregation
(97 days)
SculpSure
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 Body Mass Index (BMI) of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the 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 document describes a clinical study conducted to evaluate the safety and efficacy of the Cynosure SculpSure laser system with a new petite mask for non-invasive fat reduction and improvement of lax tissue appearance in the submental area.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state the acceptance criteria as a separate table. Instead, it describes the endpoints that were evaluated and the results. I will infer the acceptance criteria from the "met all three endpoints to prove safety and efficacy" statements.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| For Non-Invasive Fat Reduction: | |
| 1. Significant change in adipose tissue thickness from baseline. | Reduction in adipose tissue measured by ultrasound imaging at 12-week post follow-up visit showed a p-value of |
Ask a specific question about this device
(85 days)
SculpSure
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.
Ask a specific question about this device
(60 days)
Sculpsure
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.
Ask a specific question about this device
(153 days)
SculpSure
Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks 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 and flanks.
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.
This document is a 510(k) summary for the Cynosure SculpSure device, which is a diode laser system intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a dedicated study with performance metrics. Therefore, many of the requested details about acceptance criteria, detailed study design, and performance metrics are not explicitly available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with numerical performance data for specific clinical outcomes. The clinical performance is described in terms of "affecting the appearance of visible fat bulges."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Non-invasive lipolysis of abdomen and flanks | Intended to affect the appearance of visible fat bulges in the abdomen and flanks. |
| Safety within specified operating parameters | Non-clinical tests (electrical safety, EMC, biocompatibility) confirm safety standards are met. |
| Functionality as intended | Software verification and validation confirm software performs as intended. Power output meets specification. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: "Not applicable, no change in indication for use." This implies that the current 510(k) submission did not include a new clinical test set to prove device efficacy for the stated indications. Instead, it relies on the previous approvals of its predicate devices.
- Data Provenance: Not applicable for a new clinical test set in this submission. The original predicate devices' approvals would have contained this information. It is not mentioned whether any retrospective or prospective data was used for this specific submission beyond the predicate device references.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable as no new clinical test set was submitted for this 510(k) for evaluating efficacy.
4. Adjudication Method for the Test Set:
- Not applicable as no new clinical test set was submitted for this 510(k).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No MRMC comparative effectiveness study is mentioned in this 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and safety, not on comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The SculpSure device is a physical laser system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The device's performance is inherently linked to its physical output and application by a user.
7. The Type of Ground Truth Used:
- For the intended use of "affecting the appearance of visible fat bulges," the ground truth in previous studies for the predicate devices (or the original SculpSure K150230) would likely have involved clinical assessment of fat reduction (e.g., circumferences, caliper measurements, imaging such as ultrasound or MRI, and potentially patient/physician satisfaction surveys). However, this specific 510(k) does not detail new efficacy studies.
- For non-clinical tests:
- Software verification and validation: Ground truth is the predefined functional requirements and specifications of the software.
- Power output testing: Ground truth is the specified power output range.
- Biocompatibility: Ground truth is ISO 10993-1 standards.
- Electrical safety and EMC: Ground truth is the specified international standards (e.g., IEC 60601-1).
8. The Sample Size for the Training Set:
- Not applicable as this 510(k) is not for an AI/algorithm-based device that requires a training set in the typical machine learning sense. The device is a physical laser system.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as point 8.
Summary of the Study that Proves Device Meets Acceptance Criteria (based on the provided document):
The provided document (K160470) is an administrative change to a previous 510(k) and refers back to the original substantial equivalence determination for SculpSure (K150724 and K150230). This specific submission does not contain new clinical studies to prove efficacy. Instead, it relies on demonstrating substantial equivalence to its own previously cleared versions and other predicate devices, citing "no change in indication for use."
The "studies" that support the device meeting acceptance criteria (in terms of safety and performance for its intended use) are:
- Non-clinical tests:
- Software verification and validation.
- Power output testing.
- Electromagnetic compatibility (EMC) and electrical safety testing (per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
- Biocompatibility assessment (per ISO 10993-1).
These non-clinical tests aimed to ensure the device's technical specifications, safety, and compatibility were met, demonstrating that the device "should perform as intended in the specified use conditions." The efficacy for "non-invasive lipolysis of the abdomen and flanks" was established in the earlier 510(k) submissions for the predicate SculpSure devices.
Ask a specific question about this device
(103 days)
SculpSure
The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
Here's a breakdown of the acceptance criteria and study information for the Cynosure SculpSure device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary Endpoint: Photographic Evaluations (Correct identification of pre-treatment vs. post-treatment images) | In 95% of total individual evaluations, blinded evaluators correctly identified before and after images. |
| Secondary Endpoint: Change from baseline in adipose layer thickness (ultrasound measurements) | An average of 11.5% fat reduction based on ultrasound measurements at 12 weeks. |
| Third Endpoint: Subject satisfaction survey | 91% of patients rated the treatment "satisfied" on the Likert Satisfaction scale. |
| Safety: Absence of serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) | No deaths, SAEs, or UADEs reported. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: 35 subjects initially enrolled. 34 subjects returned for the 12-week post-treatment photographic evaluation.
- Data Provenance: The study was a prospective clinical study conducted at two centers. The racial demographics included Caucasian, African American, and Hispanic subjects. The country of origin for the data is not explicitly stated, but given the FDA submission, it is highly likely to be the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Three blinded evaluators.
- Qualifications of Experts: Board-certified dermatologists.
4. Adjudication Method for the Test Set
- The photographic evaluations were performed individually by three blinded evaluators. The text states, "In 95% of the total individual evaluations the evaluators correctly identified the before and after images." This suggests that the performance was aggregated from individual assessments, but it does not specify a formal adjudication method like a 2+1 or 3+1 consensus. It seems each individual expert's correct identification contributed to the overall 95% figure.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This study focused on the effectiveness of the device itself, with experts evaluating photographic outcomes as a primary endpoint.
6. Standalone (Algorithm Only) Performance
- No, a standalone (algorithm only) performance study was not explicitly mentioned or performed as described. The primary endpoint involved human evaluators (dermatologists) assessing photographs. The device itself is a laser system, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- Expert Consensus/Opinion: For the primary endpoint (photographic evaluation), the ground truth was established by the agreement of board-certified dermatologists on the correct identification of before and after images, implying visual assessment of aesthetic improvement.
- Quantitative Measurement: For the secondary and tertiary endpoints, objective measurements were used:
- Ultrasound Measurements: To determine the change in adipose layer thickness.
- Subject Satisfaction Survey: To gauge patient perception of outcome.
8. Sample Size for the Training Set
- The document does not explicitly state a sample size for a "training set." The clinical study described involved 35 subjects and appears to be the primary study for demonstrating effectiveness, not a separate training set for an AI algorithm. The device is a laser, not an AI-driven diagnostic.
9. How the Ground Truth for the Training Set Was Established
- As there's no mention of an AI-specific "training set" in the context of this device and study, the method for establishing ground truth for such a set is not applicable based on the provided text. The clinical study's results are presented as evidence of the device's performance.
Ask a specific question about this device
(102 days)
SculpSure
The Cynosure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
Here's a breakdown of the acceptance criteria and the study that proves the device (Cynosure SculpSure) meets these criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Correct identification of pre-treatment vs. post-treatment images by blinded evaluators. | In 88% of total individual evaluations, blinded board-certified dermatologists correctly identified the before and after images. The study states "all endpoints were met." |
| Secondary Endpoint: Change from baseline in adipose layer thickness between device and control based on ultrasound measurements. | An average of 13% normalized fat reduction was observed based on ultrasound measurements at 12 weeks. The study states "all endpoints were met." |
| Tertiary Endpoint: Subject satisfaction survey. | 98% of patients rated the treatment as "satisfied" on the Likert Satisfaction scale. The study states "all endpoints were met." |
| Safety: No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs). | No deaths, SAEs, or UADEs were reported. Events logged (edema, bruising, pain, blistering, erythema, nodule, hardness) were typical, transient, and resolved without medical intervention. |
| Pre-clinical: Device elevates tissue temperature to 42-47°C. (Implicitly a criterion for the hyperthermic treatment's mechanism of action to cause adipocyte injury comparable to hypothermic.) | Pre-clinical testing demonstrated that the device would elevate the temperature of the tissue to 42-47 °C. This was concluded to result in comparable adipocyte injury and fat reduction to hypothermic treatment. |
Study Details
- Sample Size used for the test set and the data provenance:
- Sample Size: 49 subjects initially, with 43 subjects returning for the 12-week post-treatment photographic evaluations.
- Data Provenance: The study was a prospective clinical study conducted at two centers. The countries of origin are not specified, but the governing body (FDA) is US-based, suggesting it was likely conducted in the US.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three blinded evaluators.
- Qualifications: Board-certified dermatologists.
- Adjudication method for the test set:
- The text states that photographs "were evaluated individually by three blinded evaluators." It doesn't explicitly mention an adjudication method like 2+1 or 3+1 for discrepancies. However, the reported 88% correct identification is presented as a singular consensus or aggregate result across all individual evaluations.
- 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, an MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was not done. This study focuses on the effectiveness of the SculpSure device for lipolysis, not on software/AI interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this device is a laser system for medical treatment. The "performance" being evaluated is the physical effect of the laser on target tissue, and the subsequent aesthetic and physiological changes, not the performance of an algorithm.
- The type of ground truth used:
- For Primary Endpoint (Photographic Evaluation): Expert consensus (specifically, correct identification by blinded evaluators) implicitly serves as the ground truth for aesthetic improvement.
- For Secondary Endpoint (Adipose Layer Thickness): Objective quantitative measurement via ultrasound scans serves as the ground truth for fat reduction.
- For Tertiary Endpoint (Satisfaction): Subjective patient satisfaction surveys.
- For Pre-Clinical (Mechanism of Action): Histologic examination and quantitative measurements comparing hyperthermic and hypothermic (predicate) treatments, suggesting a pathology-based ground truth for cellular injury and fat reduction comparability.
- The sample size for the training set:
- The document describes a single clinical study that serves as the basis for performance evaluation. It does not explicitly mention a separate "training set" in the context of machine learning or AI algorithm development. The study described is a clinical validation study for the device's efficacy and safety.
- How the ground truth for the training set was established:
- As there's no explicitly mentioned training set for an AI algorithm, this question is not directly applicable. The "ground truth" for the overall device effectiveness and safety was established through a clinical trial with the methodologies described above (photographic evaluation by experts, ultrasound measurements, patient surveys, and pre-clinical histologic analysis).
Ask a specific question about this device
Page 1 of 1