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Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Massager component is indicated for the temporary reduction in the appearance of cellulite.

The Cellulize is a non-invasive green light system with a power output of 105mW/cm2, consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 532nm ± 3nm (visible green light spectrum) and a spectral bandwidth of 10nm. Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.

The components of the device include a mobile pole cart, controller console which plugs into a hospital-grade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), digital timer pre-selected for 8-minutes or 20-minutes, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of functional positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. The timer is set to a preset value of 8 minutes for circumference reduction treatment via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm-and standard energy dose of 50 J/cm² with 8 minutes. Cellulize does not use any software.

This document describes the acceptance criteria and the study that proves the Cellulize device meets these criteria for its indication as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Cellulize device directly relates to its ability to achieve inch loss. The primary outcome measure for the clinical study was "Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment."

Note: The FDA 510(k) clearance is based on the substantial equivalence of the device, which in this case relies on meeting the inch loss criteria, even though the cellulite reduction criterion was not met. The legally marketed predicate devices support the inch loss claim.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: A total of 52 patients participated in the clinical study.
  • 25 patients were in the Active Cellulize group.
  • 27 patients were in the Placebo Control group.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, given the FDA submission, it can be inferred that the study was conducted to meet U.S. regulatory standards. The study was a prospective, double-blind, placebo-controlled randomized evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. For objective measurements like circumference reduction, the "ground truth" would typically be derived from direct, quantitative measurements rather than expert consensus on subjective interpretation. For cellulite reduction using the Nurnberger-Muller Scale (NMS), the scale itself is an industry standard and implies a structured assessment, likely by trained personnel, but their specific qualifications or number are not mentioned.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth measurements. As direct measurements were taken, an adjudication process for subjective interpretation might not have been deemed necessary or explicitly documented. The study was double-blinded, meaning neither the participants nor the measurement takers (to the extent possible) would know if the active or placebo device was being used, which inherently reduces bias.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is there information on the effect size of how much human readers improve with AI vs. without AI assistance. This type of study is more common for diagnostic AI tools where human interpretation is the primary endpoint. For a device like Cellulize, the effectiveness is measured by physical changes (circumference reduction), not by human perception of diagnostic images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Cellulize device does not use any software for its operation (as stated in Section 14, "No Software" and the comparison table, item 3). Therefore, a standalone (algorithm-only) performance study is not applicable. The device's efficacy is based on the direct application of green light, and the study evaluated the device's physical effect on the body with human subjects.

7. Type of Ground Truth Used

The ground truth used for the primary outcome measure (inch loss) was direct, quantitative measurements of cumulative circumferences of the waist, hip, and thighs. These measurements were taken "before" and "after" treatment, as well as at 7-day and 14-day follow-ups.

For the assessment of cellulite, the Nurnberger-Muller Scale (NMS), a four-stage scale, was used as an industry standard. This would be a form of clinical assessment or qualitative measurement.

8. Sample Size for the Training Set

The document describes a clinical study in support of the 510(k) submission, which is typically a validation study (test set). There is no information provided on a separate training set or its sample size. Devices like Cellulize that do not use software or AI/machine learning models typically do not have a "training set" in the computational sense. The design and parameters of the device (such as wavelength, power output, treatment time) are based on scientific principles and potentially prior research or predicate device characteristics, which serve as the "training" for the device's physical design and treatment protocol.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no explicit "training set" in the context of an AI/ML model for this device. The physical design and treatment protocol would have been established through a combination of:

• Bench Testing: As described in the document (e.g., IEC 60601-1-2 EMC Test Report, IEC 62471 Photobiological Safety, Device Life Report), these tests validate that the system meets design specifications and performance requirements.
• Scientific Principles and Prior Knowledge: The device utilizes 532nm green light, which is also used by a predicate device (Verju Laser) that causes lipolysis. This indicates that the foundational scientific understanding of how such light interacts with biological tissue to achieve the desired effect informed the device's design.
• Predicate Device Comparison: Extensive comparison to predicate devices (Verju Laser and Photonica Professional) was performed to establish substantial equivalence in design, operation, and intended use, effectively leveraging the "ground truth" demonstrated by those previously cleared devices.

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