Search Results

Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.

Intended to emit energy in the red and infrared spectrum for the treatment of periorbital and full face wrinkles.

The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected through selecting various wavelengths. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.

The provided document is a 510(k) summary for the Dermalux Flex MD device. It describes the device, its intended use, and its comparison to predicate devices to demonstrate substantial equivalence. However, this document does NOT contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device, which is what your request is asking for.

The Dermalux Flex MD is a light therapy device, not an AI/ML-driven diagnostic or therapeutic device. The performance testing mentioned is entirely bench testing for electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, and usability of the hardware. There are no animal or clinical studies performed or referenced for the Dermalux Flex MD in this document, let alone studies involving AI/ML performance, ground truth establishment, or human reader effectiveness.

Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

To answer your request, a different type of FDA submission document, typically a De Novo application or a more extensive 510(k) for an AI/ML device, would be required. Those documents would detail the clinical validation studies, including the metrics, ground truth, and statistical analyses relevant to AI/ML performance.

Ask a specific question about this device