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The InvisaRED™ Technology ELITE is indicated for use as a non-invasive dermatological aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation, affecting adipocyte cells within the adipose layer for the release of lipids from these cells.

Device console:

• Electrical Power: 110v
• Cooling: Air Cooled
• Operation: LCD touch screen
• Allows Control of Individual Patient Session Protocol (Time, Energy, Pulse, Delay)
• Integrated Device Power-On Self Test
• Emergency Safety cut off switch
• Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12
• Paddle Cooling: Air cooled
• . Dual Coherent Frequencies: Thirteen (13) 680nm and thirteen (13) 980nm laser diodes on each paddle
• Concurrent Laser Diode Mode of Operation: pulsed or continuous output
• . Power output: Variable up to 200mw per diode for both 680nm and 980mm wavelengths

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the InvisaRED™ Technology ELITE, as inferred from the clinical study, is the demonstration of superiority over a sham device in temporarily reducing the circumference of the waist, hips, and thighs.

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size: 40 subjects (35 female, 5 male).
• Data Provenance: The document does not explicitly state the country of origin. It specifies that IR Technology LLC conducted the randomized double-blind study. It is a prospective study, as indicated by "conducted a randomized double blind study."

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 in the document. The ground truth appears to be objective measurements of body circumference rather than expert-derived assessments.

4. Adjudication method for the test set:

• This information is not explicitly stated. Given that the primary endpoint is a direct measurement ("Change in Measured Body Circumference"), formal adjudication by experts may not have been deemed necessary in the same way it would be for subjective clinical assessments. The study was randomized and double-blind, which helps mitigate bias in data collection.

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, this was not an MRMC comparative effectiveness study. This study evaluated a medical device (laser system) for aesthetic treatment, not an AI system assisting human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, in a sense, a standalone study was done. The "device" in question (Invisa-RED Elite) operates autonomously as a treatment device. The clinical study directly measured its effect on subjects compared to a sham device, without explicit human-in-the-loop interaction in the delivery of the treatment itself once initiated. The performance described is of the device on its own.

7. The type of ground truth used:

• The ground truth used was objective outcomes data, specifically "Change in Measured Body Circumference" of the waist, hips, and thighs.

8. The sample size for the training set:

• This information is not applicable/not provided. The Invisa-RED Elite is a physical device (a laser system), not an AI algorithm that requires a separate training set. The clinical study described is a validation study for the device's efficacy and safety.

9. How the ground truth for the training set was established:

• This information is not applicable. As mentioned above, the device is not an AI algorithm requiring a training set with established ground truth.

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