Search Results
Found 1 results
510(k) Data Aggregation
(302 days)
The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.
EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.
Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned by a robotic arm. The treatment head is never in contact with the skin.
During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (42°C to 50°C). The cooling system will maintain the skin at comfortable temperature (<43°C).
Here's a breakdown of the acceptance criteria and the study details for the EON device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Objectives) | Reported Device Performance and Study Success |
|---|---|
| Primary Objective: Confirm safety of the 1064-nm laser device for non-invasive subcutaneous fat reduction in the flank area. | Low incidence of adverse effects (only 1 subject developed palpable thickening, resolved by Week 12). Mean pain score during procedure was 1.95 (0-10 scale), decreasing to 0.9 at 30 minutes post-procedure. |
| Primary Efficacy Endpoint: Blinded evaluation of pre- and post-treatment photos. Study success if at least two of three independent readers correctly identify at least 9 of 11 photo sets as pre-treatment. | 27 (81.8%) of 33 image sets were correctly scored overall. Two of the three readers correctly identified pre- and post-treatment photos in at least 9 of 11 subjects, thus achieving study success. |
| Secondary Efficacy Endpoint: Mean fat reduction by ultrasound. | At Week 12 after one treatment, the mean reduction in subcutaneous adipose thickness was 6.1 mm per flank and 12.1 mm per patient (-15%; p<0.01, both measures). |
| Secondary Objective: Assess extent of subject discomfort during treatment. | Mean pain score during procedure was 1.95 (0-10 scale), decreasing to 0.9 at 30 minutes post-procedure. |
| Secondary Objective: Assess overall subject satisfaction with the results of the procedure. | Subject satisfaction was "Excellent" for all subjects (100%). |
2. Sample Size Used for the Test Set and Data Provenance
The text doesn't explicitly state the total number of subjects enrolled in the clinical study, but it implies a minimum of 11 subjects for the blinded photo evaluation ("at least 9 of the 11 photos as pre-treatment"). For the "27 (81.8%) of 33 image sets" for blinded evaluation, this implies 33 image sets were evaluated, which likely corresponds to 33 subjects or 33 treatment areas. Considering the 12.1mm reduction "per patient," it refers to patient-level data.
The data provenance is prospective clinical study. The country of origin of the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Three independent readers were used for the blinded evaluation of pre- and post-treatment photos. Their specific qualifications (e.g., radiologist, years of experience) are not specified in the provided text.
4. Adjudication Method for the Test Set
The adjudication method for the blinded photo evaluation was 2 out of 3 concensus. The study was declared successful if "at least two of the three independent readers correctly identified at least 9 of the 11 photos as pre-treatment."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly described in the provided text. The study involved a blinded evaluation by human readers, but it was for assessing the visual outcomes of the EON device itself, not to compare human reader performance with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The EON device is a laser system for lipolysis, not an AI-powered diagnostic tool. Therefore, a standalone (algorithm only) performance study in the context of diagnostic AI is not applicable and was not performed. The performance evaluation focuses on the efficacy and safety of the laser device itself.
7. The Type of Ground Truth Used
The ground truth used in the study included:
- Expert Consensus (implied): For the blinded photo evaluation, the consensus of at least two out of three independent readers served as the ground truth for identifying pre- and post-treatment images.
- Objective Measurements: Ultrasound measurements were used to objectively quantify subcutaneous fat reduction.
- Subjective Outcomes: Patient satisfaction surveys and pain scores were also collected.
8. The Sample Size for the Training Set
The provided text does not mention a training set specific to the EON device's clinical study. This is expected as the EON is a physical device (laser system) and not a software algorithm that requires a training set in the typical AI/machine learning sense.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set for the EON device in the context of the provided clinical study description, this question is not applicable.
Ask a specific question about this device
Page 1 of 1