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The Or-Light® is a non-coherent light-based device intended to carry out dermatologic and aesthetic care. It is meant to be handled by competent professionals trained in intense pulsed light technology.

Two different applicators can be used on the Or-Light® device.

The HR applicator (610-1000 nm) is indicated for:

• Hair Removal for skintype I to IV
  The SR applicator (400-1000 nm) is indicated for

• Benign pigmentary lesions for skintype I to III

• Benign vascular lesions for skintype I to III

• Inflammatory acne treatment for skintype I to III

The Or-Light® is a non-coherent light based device intended to carry out dermatologic and aesthetic care on patients by skin professional.

The system consists of a console containing a power unit controlled by electronic and software. Setting is selected by the operator through a display panel (touch screen).

Light energy for the treatment is generated by the applicators connected to the device. Two type of applicator can be connected, one at a time. The applicators are in the waveband of 400 nm - 1000 nm and 610 nm - 1000 nm.

The applicator is cooled by a closed water cooling circuit built in the device.

This 510(k) summary does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The document primarily asserts substantial equivalence to predicate devices, stating that differences in specifications "do not result in different performances or raise any new question of safety or effectiveness." It mentions "clinical data" generally but does not provide specific details about acceptance criteria, study design, sample sizes, or expert qualifications.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's what can be inferred and what is missing:

Overview of Acceptance Criteria and Device Performance

The document does not explicitly define specific "acceptance criteria" (e.g., minimum sensitivity, specificity, accuracy targets) for its performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit "acceptance criterion" is that the Or-Light® performs safely and effectively for its stated indications, similarly to the predicate devices.

Study Details (As much as can be extracted/inferred):

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

   • Not specified. The document vaguely refers to "clinical data" without providing any details on study design, sample size, or data provenance.

2. 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):

   • No information provided. Ground truth establishment, if any, for the "clinical data" is not described.

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

   • Not specified.

4. 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/Not mentioned. This device is an Intense Pulsed Light (IPL) system, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This is a hardware device for treatment, not an algorithm. Its performance is inherent to the device's physical operation.

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

   • Not specified. The "clinical data" would presumably involve patient outcomes related to the indicated treatments, but the specific nature of the data and how success was defined as ground truth is not elaborated.

7. The sample size for the training set:

   • Not applicable/Not specified. This is not an AI/machine learning device that requires a "training set" in the typical sense. Any "training" would refer to the development and testing phases of the physical device and its settings, for which specific sample sizes are not provided.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. As above, a "training set" in the AI sense is not applicable. The development of the device would involve engineering specifications and testing to meet those, but these are not described as "ground truth."

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