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FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions.

i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions.

iii. The infrared light (850 nm wavelength) is generally used for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.

FlashHeal 2 (FlashHeal 2.0 model) is an Rx Only mobile medical device that delivers LED therapies for managing dermatological conditions using various narrow-band wavelengths of blue (405 nm), red (625 nm), and infrared (850 nm) light without any direct patient contact. The LEDs light source is placed inside an End-effector mounted on a mechanical arm maneuvered by the healthcare professional. The system is operated by a touchscreen interface which allows the user to configure the treatment settings.

The FlashHeal 2 (FlashHeal 2.0) device is a mobile medical device that delivers LED therapies for managing dermatological conditions using blue, red, and infrared light. According to the provided text, the device was found to be substantially equivalent to its predicate devices through non-clinical performance testing.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test set sample size: Not explicitly mentioned in the provided text. The text refers to "bench validation testing" and "performance testing," which typically involve testing units of the device rather than a patient sample size.
• Data provenance: Not explicitly stated as retrospective or prospective, but the testing appears to be non-clinical, controlled bench testing performed by a 3rd party testing lab. The country of origin of the data is not specified beyond the compliance with international and FDA-recognized consensus standards.

3. Number of Experts and Qualifications for Ground Truth

• Number of experts: Not applicable. The ground truth for this device's performance is established through adherence to engineering and safety standards, as well as objective measurements of optical output, rather than expert interpretation of medical images or conditions.
• Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. The performance testing involves objective measurements against established engineering and safety standards, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC study done: No, a MRMC study was not done. The text explicitly states, "Clinical testing is not applicable." The evaluation focused on the device's technical specifications and safety profile, not its comparative clinical effectiveness with human readers.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

• Standalone performance: Yes, the performance testing described is a standalone evaluation of the device's technical capabilities and adherence to standards. The device itself operates semi-autonomously in delivering light therapy, though a healthcare professional maneuvers it. The testing evaluates the device's output independently.

7. Type of Ground Truth Used

• Type of ground truth: The ground truth used is based on engineering specifications, safety standards, and objective physical measurements. This includes compliance with medical electrical equipment standards (IEC 60601 series), software development standards (IEC 62304), and direct measurements of optical output parameters like irradiance, uniformity, and adherence to specified ranges.

8. Sample Size for the Training Set

• Training set sample size: Not applicable. This device is a hardware-based LED therapy system, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground truth для training set established: Not applicable, as there is no training set for this type of device.

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