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

UltraSlim DIGITAL is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

UltraSmooth DIGITAL 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.

UltraSlim® Digital and UltraSmooth® Digital are LED light therapy devices. The UltraSlim Digital uses 625nm red light (UltraSlim Digital), and the UltraSmooth Digital uses 532nm green light (UltraSmooth Digitial). The devices are generally described as pole-mounted and free-standing on a rolling base as shown in the figures below.

Both devices, UltraSlim® Digital and UltraSmooth® Digital, continue to share the same design platform, and only differ in the color of the LED light array. The associated branding/names, warning labels, and differences due to their respective indications for use will remain the same as previously cleared, and do not change as a result of this proposed controller change.

All design and manufacturing parameters are very similar in both devices including the power supply, drivers, internal components, physical form, and control. The devices consist of a main control unit, LED panel, and cable connections. The main control unit contains the main input, fuses, power supply, control circuits, and Minutes selector switch. The power switch has a failsafe system that ensures the voltage from a wall socket can never come in contact with the user. A hospital-approved isolation transformer is mounted on the base of the medical pole cart whose low center of gravity also supports the main control unit and the light fixture from tipping. The console is mounted to the pole with an articulated arm. Treatment time is selected from pre-determined options programmed into the digital timer relay that do not allow the user to vary treatment times. System operation is preset. Both units operate at a frequency of 50Hz – 60Hz and a total power output of 300 W.

A design change was implemented, in an identical way, in the control of both devices that changes the unit from manual control to WiFi control. In general terms, the design change effectively replaces the electronic relay from the old design with a WiFi relay switch that is activated via WiFi from a mobile, desktop, tablet, or laptop device.

The new control design centers around replacing the manual time interval select and start button with a 4-Channel WiFi Relay Switch. Initiating a start sequence of the unit will be performed via internet control using a Relay Switch that receives its instructions from the user through WiFi control. Users continue to be restricted to the treatment time options of 8 and 20 minutes in the web app, and are able to start the device from the WiFi control.

The push button momentary start switch is removed in the new design. Users only have the ability to start the device by way of WiFi control.

The devices with the new design change do not contain any software. However, a web app accessible through the internet allows users to log in, select treatment time options of 8 minutes or 20 minutes, and to initiate treatment. The built-in timer control via the 4-Channel WiFi Relay Switch automatically stops the treatment at the end of the approved treatment time based upon the input received from the user.

Each device has a unique local IP address that is associated with its assigned router. Each router has its own unique client's ISP-assigned Static IP and may be controlled by WiFi from any phone, tablet, or computer with Internet access.

I am sorry, but the provided text does not contain information regarding a study that proves the device meets specific acceptance criteria in the way you've outlined for clinical performance. The document explicitly states:

• "No new Clinical Testing was conducted." (page 8)
• "The submission does not contain clinical performance data." (page 8)

The document is a 510(k) summary for a premarket notification for device modifications (changing from manual control to WiFi control) for existing devices (UltraSlim® Digital and UltraSmooth® Digital). The focus is on demonstrating substantial equivalence to predicate devices and compliance with non-clinical performance standards and safety evaluations for the design change, rather than providing new clinical data for acceptance criteria directly related to the treatment efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance for clinical efficacy, as this information is not present in the provided text.

The information I can extract that is somewhat related to your request, but not directly for clinical acceptance criteria, pertains to non-clinical testing for the design change:

• Non-Clinical Performance Data: The device was tested for compliance with applicable standards given in the "Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use." This includes IEC 60601-2-57 (Medical electrical equipment for basic safety and essential performance of non-laser light source equipment).
• Electromagnetic Disturbances and Wireless Compliance: Testing was conducted by SGS in Suwannee, Georgia, to ensure compliance with IEC 60601-1-2:2014 (Electromagnetic disturbances) and ANSI C63.10: 2013 (FCC Part 15 Subpart C, § 15.247) for RF emissions due to the addition of a 4-Channel WiFi Relay Switch. All test results were compliant.
• Software Validation: The web app control for logging in and initiating treatments was validated.
• Cybersecurity: A risk-based cybersecurity safety evaluation was performed, and the device was classified as Tier 2 "Standard Cybersecurity Risk."

These points demonstrate compliance with certain safety and performance standards for the device's design and control system, but they are not clinical acceptance criteria for the device's intended aesthetic treatment efficacy (e.g., reduction of circumference).

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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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Photonica Professional is indicated for use as a non-invasive dermatological aesthetic treatment of circumference of hips, waist, and thighs. Photonica Professional is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

The Photonica Professional ("Photonica") is a non-invasive red light system with a power output of 105mW/cm2, consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 635nm ± 2nm (visible red light spectrum) and a spectral bandwidth of 10nm. Photonica Professional is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. Photonica Professional is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

Photonica Professional was previously cleared (K150336), as a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX).

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 hospitalgrade 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. Treatment time is preset to 8 minutes for non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs, (or 20 minutes for treatment of superficial, benign vascular and pigmented lesions, prior clearance K150336) 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/cm²and standard energy dose of 126 J/cm². Photonica does not use any software.

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

Device Name: Photonica Professional

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a clinical study aimed at demonstrating the device's effectiveness. The acceptance criteria can be inferred from the objective of the study and the comparison made to the predicate device.

The document asserts that the Photonica Professional results are "substantially equivalent" to the Zerona, achieving similar inch loss in a significantly shorter total treatment time (32 minutes total exposure vs. 240 minutes and 3 weeks for Zerona) and without the need for dieting, exercise, or proprietary pills.

Minimum observed loss: All patients lost a minimum of 1 5/8 inches and 716.6 ml.
Maximum observed loss: 10 inches and 4,608.2 ml.

Clinically significant results: 100% of patients had clinically significant results at one visit. |
| No device-related adverse events. | Adverse Events: There were no device-related adverse events. |

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

• Sample Size: 58 patients
  • 46 female (79%)
  • 12 male (21%)
• Data Provenance: Retrospective analysis of existing treatment records from multiple private practice locations in the United States of America.

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

The document does not mention the use of experts to establish ground truth for the test set. The measurements were taken using specific protocols, implying that the data collectors were trained on these protocols, but their expert qualifications or number are not specified. The measurement process itself (using self-tensioning measuring tapes) suggests a direct factual measurement rather than an expert interpretation requiring consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the measurements. Measurements were taken "immediately before and after the 32-minutes treatment using a self-tensioning measuring tape, measurement forms, and instructions (Measurements Guides) exactly as used in the clinical trials for the predicate Zerona." This suggests a direct measurement rather than a review or adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study compares the device's performance to a predicate device's published results, but not human readers with and without AI assistance. This device is a low-level laser system, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The Photonica Professional is a physical medical device (low-level laser system), not an algorithm or AI software. There is no "standalone" algorithm performance to evaluate. The device itself performs the treatment, and its efficacy is measured.

7. The Type of Ground Truth Used

The ground truth used was direct physical measurement data (circumferential measurements of hips, waist, and thighs) taken immediately before and after treatment using a standardized protocol and self-tensioning measuring tapes. This is objective, quantitative data.

8. The Sample Size for the Training Set

This question is not applicable. The Photonica Professional is a physical medical device that applies light therapy; it does not utilize machine learning or algorithms that require a "training set" in the conventional sense of AI/software development.

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

This question is not applicable, as there is no training set for this device.

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Photonica Professional is indicated for use in dermatology for the treatment of superticial, benign vascular, and pigmented lesions.

The Photonica Professional ("Photonica") is a non-invasive red light system with a power output of 105mW/cm , consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 635nm ± 2nm (visible red light spectrum) and a spectral bandwidth of 10nm, for treatment of superficial, benign vascular and pigmented lesions. The components include a mobile pole cart, controller console which plugs into a hospitalgrade 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), 20 minute timer, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. Treatment time is preset to 20 minutes 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 126 J/cm . Photonica does not use any software.

The provided document is a 510(k) Summary for the Photonica Professional device. It asserts substantial equivalence to a predicate device (Omnilux revive™) based on similarities in intended use and technological characteristics, and compliance with non-clinical performance standards. However, it explicitly states that no clinical testing was required or performed.

Therefore, based on the provided document, the Photonica Professional device does not have a study that proves it meets acceptance criteria in the way typically associated with clinical performance or effectiveness studies. The acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, relying on the predicate's established safety and effectiveness.

Here's a breakdown of the requested information based only on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Since no clinical studies were performed for the Photonica Professional itself, there are no specific clinical "acceptance criteria" or "reported device performance" related to its efficacy in treating superficial, benign vascular, and pigmented lesions. The "acceptance criteria" for its market clearance are based on its substantial equivalence to the predicate device and compliance with non-clinical safety and performance standards.

The table below summarizes the comparison of characteristics to the predicate device, which forms the basis of the substantial equivalence claim, rather than a direct acceptance criteria for clinical performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set was used for the Photonica Professional device. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth was created or used for the Photonica Professional device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This device is a light therapy system, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This device does not have an "algorithm" in the sense of AI. It is a light therapy device. The document explicitly states: "Photonica does not use any software." Therefore, no standalone performance study of an algorithm was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No direct clinical ground truth for efficacy was established for the Photonica Professional, as no clinical studies were conducted for it. Its efficacy is inferred from the substantial equivalence to the predicate device, which presumably had its efficacy established through clinical data or historical use.

8. The sample size for the training set

Not applicable. This device does not use software or AI/ML, so there is no "training set."

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

Not applicable. As there is no training set for software/AI, no ground truth for a training set was established.

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