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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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