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510(k) Data Aggregation
(41 days)
MEDICIS TECHNOLOGIES CORPORATION
The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.
The LipoSonix system is specifically indicated for non-invasive waist circumference reduction
The LipoSonix system is a cart-based medical device intended for non-invasive disruption of subcutaneous adipose tissue (SAT) by employing ultrasound energy. The system consists of a cart, a detachable handpiece and a user interface display in one unit.
The provided text describes the LipoSonix® system Model 2, a focused ultrasound stimulator for aesthetic use, and its performance evaluation in a clinical study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Primary Efficacy Endpoint: Superiority to sham control in reducing waist circumference. | The 59 J/cm² treatment group demonstrated a 1.01 cm greater waist circumference reduction as compared to sham. The least square (LS) mean change from baseline to 12 weeks in the 59 J/cm² group was -2.44 cm. On average, the mean change in waist circumference was approximately 2.55 cm (1 inch) compared to baseline, which "could equal one dress or pant size." This met the pre-specified primary endpoint. |
| Safety Endpoint: Acceptable safety profile with mostly mild, short-lived, and resolvable adverse events. | The AEs (Adverse Events) resulting from treatment were mostly mild, short-lived in duration, and resolved without incident, assessed through 24 weeks post-treatment. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to the treatment. This indicates an acceptable safety profile. |
| Non-clinical safety and performance (Thermal, electrical, electromagnetic, mechanical safety, etc.) | The system was found to conform to "essential specifications, thermal, electrical, electromagnetic and mechanical safety" and "FDA consensus, medical device safety standards and international harmonized standards." Specific risks from the FDA special control guidance document were addressed, including: Thermal Injury, Mechanical Injury, Ocular Injury, Electrical Shock, Inflammation/Foreign Body Response, and Use Error. (While no specific metrics are given for these, the statement confirms they were addressed and conformed to standards.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only refers to a "multicenter, randomized study." It does not explicitly state the total number of participants in the study or specifically the test set (which in this context is the entire study population used for evaluation). It only mentions the performance of the "59 J/cm² treatment group."
- Data Provenance: The document states it was a "multicenter, randomized study." While the specific countries are not mentioned, the context of a 510(k) submission to the FDA for a US company suggests it likely involved studies conducted in the USA or under internationally recognized clinical trial guidelines. It is a prospective study, given that it's a "randomized study" evaluating treatment effects over time (baseline to 12 weeks, safety assessed through 24 weeks).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study measures objective outcomes (waist circumference reduction) and reports adverse events, which are typically assessed by clinical investigators and not
ground-truthed by independent experts in the same way an image interpretation study might be. Expert interpretation for efficacy assessment beyond the direct measurements is not applicable here.
4. Adjudication Method for the Test Set
This information is not provided in the document. For objective measurements like waist circumference, inter-observer variability would ideally be addressed by standardized measurement protocols rather than an adjudication process typically seen in subjective assessments. Adverse events are usually reported and classified by the treating physician/investigator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
An MRMC study is not applicable here as this is a device for physical intervention (waist circumference reduction) and not an imaging-based diagnostic or screening tool requiring human reader interpretation. The study was a "multicenter, randomized study" comparing the device to a sham control, focusing on objective physical measurements and safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to this device. The LipoSonix system is a physical treatment device, not an AI algorithm. Its performance is the direct outcome of the device application.
7. The Type of Ground Truth Used
The ground truth for efficacy was direct physical measurement: "waist circumference reduction." This is an objective, quantifiable anatomical change.
For safety, the ground truth was clinical observation and recording of adverse events by medical professionals.
8. The Sample Size for the Training Set
This information is not applicable as the LipoSonix system is a medical device for physical intervention, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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(507 days)
MEDICIS TECHNOLOGIES CORPORATION
The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The LipoSonix system is specifically indicated for non-invasive waist circumference reduction.
The LipoSonix system is a cart-based system intended for non-invasive waist circumference reduction. The LipoSonix system uses ultrasound energy to disrupt subcutaneous adipose tissue (soft tissue). The system consists of a base, a treatment head (which contains the transducer) and a treatment arm in one unit.
Here's a breakdown of the acceptance criteria and study information for the LipoSonix® system Model 1, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Objective) | Reported Device Performance |
|---|---|
| Primary Endpoint: Superiority to sham control in reducing waist circumference. | The 59 J/cm² treatment group demonstrated a 1.01 cm greater waist circumference reduction as compared to sham. The least square (LS) mean change from baseline to 12 weeks of the waist circumference in the same 59 J/cm² group was -2.44 cm. On average, a mean change of approximately 2.55 cm (1 inch) compared to baseline was demonstrated in the 59 J/cm² treatment group. |
| Safety: Low incidence of serious adverse events (SAEs) or unanticipated adverse device effects (UADEs), with adverse events being mostly mild, short-lived, and resolving without incident. | AEs were mostly mild, short-lived in duration, and resolved without incident. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the investigational device through 24 weeks post-treatment. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the "test set" in the traditional sense of a split dataset for algorithm evaluation. However, it indicates that the device was evaluated in a "multicenter, randomized study." The specific number of participants in this study is not provided, nor is the country of origin. Given the context of a 510(k) submission, it's a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document. For a device like this, waist circumference measurements are typically taken by trained clinical staff using standardized protocols, rather than requiring expert consensus in the same way an imaging diagnostic might.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the study results. Measurements like waist circumference are generally objective, and while there might be quality control checks on the measurement process, an adjudication panel for "ground truth" isn't typically used in this context.
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, an MRMC comparative effectiveness study was not done. The LipoSonix system is a treatment device, not a diagnostic imaging device that involves human readers interpreting results. Therefore, the concept of "human readers improve with AI" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented is for the LipoSonix system as a standalone treatment device. The study evaluates the device's ability to reduce waist circumference compared to a sham control, without human-in-the-loop intervention in the treatment application itself (though a human operates the device).
7. The Type of Ground Truth Used
The ground truth used was objective measurement data: "waist circumference reduction" measured from baseline to 12 weeks, as well as adverse events monitored throughout the study.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm. The LipoSonix system is a physical device that delivers ultrasound energy, not an AI/algorithm-based diagnostic or predictive tool that requires a training set in the machine learning sense. The clinical study described evaluates the device itself, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the machine learning sense) is mentioned or relevant for this type of device, the method for establishing ground truth for a training set is not applicable.
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