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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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