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Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The blue light (417±8nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

The infrared light (830±8mm wavelength) is generally use for the temporary relief of minor muscle and joint pain, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The photon therapy apparatus (BL-10) use specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm).

The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources.

The provided document is a 510(k) summary for the Xemis Medical Technology (Shenzhen) Co., Ltd. "Photon Therapy Apparatus (BL-10)". It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria and detailed study results as would be typically found for a study proving a device meets acceptance criteria, especially in the context of an AI/ML-driven device's performance. The provided text primarily focuses on the device's technical specifications and a comparison to predicate devices, stating that "Non-clinical tests" were performed for electrical safety, EMC, performance, and software verification/validation. It explicitly states "Clinical study: Not applicable."

Therefore, based on the provided text, I cannot fulfill most of your requested information as it pertains to clinical performance studies, acceptance criteria, test set details (sample size, data provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance, and training set details for an AI/ML device.

The document describes a photon therapy apparatus, which is a physical device emitting light for dermatological conditions, not an AI/ML-driven medical device that would involve a test set, ground truth interpretation by experts, or MRMC studies.

If this was a request for information on an AI/ML device, the provided text would be a "reject" or "missing information" response. As it is not an AI/ML device, the traditional performance acceptance criteria for a medical device of this type would typically involve measurements of parameters like wavelength, power output, irradiance, and safety adherence to relevant electrical and photobiological safety standards, which are mentioned generally.

Here's what I can extract from the document regarding "acceptance criteria" in a general sense, and "study" information as provided:

1. Table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of acceptance criteria with corresponding performance results in a standalone "acceptance criteria" section. Instead, the basis for "acceptance" (or rather, substantial equivalence for FDA clearance) is demonstrated through comparison of the proposed device's specifications and performance to predicate devices. The "performance" here refers to meeting technical specifications and safety standards, rather than clinical efficacy outcome measures from a trial.

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

• Not applicable. This document describes a physical medical device (photon therapy apparatus), not an AI/ML diagnostic or prognostic algorithm that would have a "test set" of patient data. The "tests" mentioned are non-clinical (electrical safety, EMC, performance, software V&V).

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 above, no clinical "test set" and thus no ground truth established by experts is described for this type of device submission.

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

• Not applicable. No clinical "test set" and thus no adjudication method is mentioned.

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 is not an AI-assisted diagnostic device, so no MRMC study was performed. The document explicitly states "Clinical study: Not applicable."

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

• Not applicable. This is not an algorithm.

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

• Not applicable. The "ground truth" for this device's performance would be the physical measurements of its light output and adherence to electrical safety standards, not clinical ground truth from patient data.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

In summary, the provided document is a 510(k) notification for a photon therapy device, focusing on demonstrating substantial equivalence to predicate devices based on technical specifications and non-clinical safety/performance testing. It does not involve AI/ML components or clinical performance studies typically associated with the detailed criteria you've outlined.

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The EmoLED device is intended to provide photo therapeutic light to the body. The EmoLED device is generally indicated to treat dermatological conditions. The EmoLED device is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

Emol.ED is a portable, reusable medical device powered by rechargeable lithium-ion batteries that illuminate six (6) LED light sources which emit non-coherent blue light between 415 ± 5 nanometers (nm). The EmoLED device emits a uniform and constant optical power intensity of 120 mW/cm2 over an area of approx. 50.3 cm in diameter) at a distance of 4 +/- 1 cm. The EmoLED device consists of:
a polycarbonate body containing a software-controlled processor that controls the emission of light; .
a touch screen (display), placed in the front part of the device that allows the operator to control the device;
a multi-function (on/off) button, placed in the posterior part of the body of the device;
a power jack and a micro-USB plug, placed on the left side of the body of the device;
an optic part containing the LED light source, the LED's control board, an optical lens (optic head) and a distance sensor connected to the body which can be rotated by the operator up to 180° to project the light beam on the desired skin surface;
accessories, which include a visual comfort screen and 24V power supply (with an integrated connection cable).

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for the EmoLED device. The document is a 510(k) premarket notification letter from the FDA, a 510(k) summary, and an Indications for Use statement.

It primarily focuses on:

• Regulatory clearance: The FDA's determination of substantial equivalence for the EmoLED device to legally marketed predicate devices.
• Device description: Details about the EmoLED device's components, light emission, power, and treatment area.
• Indications for Use: Specifically, to treat moderate inflammatory acne vulgaris using visible blue/violet light.
• Comparison to predicate devices: Discussion of technological similarities and differences with predicate devices (Dermalux Tri-Wave MD and BLU TOTALE) regarding wavelength, power density, treatment area, dosage, and treatment time, arguing that these differences do not raise new questions of safety and effectiveness.
• Non-clinical testing: A list of standards to which the device was tested (IEC 62471, IEC 60601-2-57, IEC 62366-1, CEI EN 60601-1-6/A1:2016, ISTA 3E 2017) to verify design specifications and demonstrate safety and effectiveness.
• Absence of clinical testing: Explicitly states, "No clinical testing has been performed to support this submission."

Therefore, based only on the provided text, I cannot furnish the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or any MRMC studies. The document only mentions that the device met design specifications and complied with listed non-clinical testing standards.

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