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The Photo therapy unit (model: 10PL) is intended for use in surgical and aesthetic applications in dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.

10PL is IPL device of Tentech Co., Ltd. that has technical advantages which adopted the rotary filter which can change wavelength band by rotating a revolver without replacing handpieces or filters unlike the existing IPL (Intense Pulsed Light).

When the key switch is turned on for the first time [ON], the power supply to remove noise by receiving general power (AC120V) from the block diagram is applied to the SMPS to obtain the power supply and DC12V, the power used for the motor pump and cooling fan and the main control board.

POWER SUPPLY is a device that charges DC high voltage using SMPS by receiving stable power, and generates maximum DC600V±10% to charge the CAPACITOR.

When the charged DC voltage is applied to the xenon lamp of the handpiece, a desired wavelength is selected among the emitted rays, and the push button switch is pressed the rays are irradiated.

In order to use the light irradiator safely, a motor pump and a cooling fan are used to circulate the coolant to cool the xenon lamp and operate the thermoelectric module in the handpiece to keep the folter set to the desired temperature.

Set the output intensity and operation mode on the touch screen operation panel of the LCD monitor of the main control board, and select the READY button to turn on the xenon lamp, and press the push button switch to irradiate the light.

The provided document is a 510(k) premarket notification for the 10PL Photo therapy unit. It details the device's indications for use, its comparison to predicate devices, and non-clinical testing performed.

However, the document explicitly states in section 9, "Clinical Test Summary," that "No clinical studies were considered necessary and performed." Therefore, there is no information available in this document regarding a study that proves the device meets specific performance acceptance criteria based on clinical outcomes, nor details such as sample size, expert qualifications, or adjudication methods for such a study.

The acceptance criteria provided in the document primarily relate to non-clinical tests for electrical safety, electromagnetic compatibility, software validation, and biocompatibility.

Here's the information that can be extracted based on the non-clinical testing described:

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

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

• The document explicitly states "No clinical studies were considered necessary and performed." Therefore, there is no information regarding a test set of patient data, its sample size, or provenance. The non-clinical tests were performed on the device itself and its components.

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, as no clinical studies were performed.

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

• Not applicable, as no clinical studies were performed.

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, as no clinical studies were performed and the device is a standalone phototherapy unit, not an AI-assisted diagnostic tool.

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

• This refers to the performance of the device itself against non-clinical standards, as detailed in the table above. It is not an "algorithm only" performance, but rather hardware and software performance.

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

• For the non-clinical tests, the "ground truth" is defined by the requirements and specifications of the referenced international and national standards (e.g., IEC, ISO, AAMI). For software, it's defined by the software development process and validation procedures.

8. The sample size for the training set

• Not applicable, as no clinical studies were performed and the device is not described as an AI/ML device requiring a training set in the clinical sense.

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

• Not applicable, as no clinical studies were performed and no training set is described.

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