(147 days)
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 use in dermatology 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 wavelength combinations. 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 Dermalux Flex MD device does not have explicit acceptance criteria or a study proving that it meets specific clinical or performance acceptance criteria in the provided text. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than proving efficacy against acceptance criteria through clinical trials.
The "Performance Testing" section (Page 6) details bench testing to verify that the device met design specifications and complied with various international and FDA-recognized consensus standards related to electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, usability, and biological evaluation. These are related to the safety and fundamental functioning of the device, not clinical efficacy or specific performance metrics for the indicated uses.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not present clinical acceptance criteria for efficacy in terms of specific performance metrics (like percentage reduction in acne or wrinkles) for the Dermalux Flex MD. Instead, it demonstrates compliance with safety and engineering standards. The table below lists the performance testing conducted, which can be seen as meeting "design specifications" and regulatory consensus standards, rather than clinical acceptance criteria.
| Acceptance Criteria (related to Safety & Engineering Standards) | Reported Device Performance (Compliance Shown) |
|---|---|
| EN/IEC 60601-1 (General requirements for basic safety and essential performance) | Complies |
| EN/IEC 60601-1-2 (Electromagnetic disturbances) | Complies |
| EN/IEC 60601-1-11 (Home healthcare environment) | Complies |
| EN/IEC 62304 (Medical device software life cycle processes) | Complies |
| EN/IEC 62471 (Photobiological safety) | Complies |
| IEC 60601-2-57 (Non-laser light source equipment) | Complies |
| IEC 62366-1 (Usability engineering to medical devices) | Complies |
| EN/IEC 60601-1-6 (Usability) | Complies |
| Photometric Testing of LED Light Panel | Meets design specifications |
| ISO 10993-1 (Biological evaluation of medical devices) | Complies |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for clinical efficacy studies. The testing was bench-based for engineering and safety standards.
- Data Provenance: Not applicable for clinical studies as no clinical studies were performed. The "data" refers to engineering test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical ground truth was established; testing was focused on engineering and safety standards.
4. Adjudication method for the test set
- Not applicable as no clinical ground truth was established or adjudicated; testing was focused on engineering and safety standards.
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
- No MRMC comparative effectiveness study was performed as this device is a light therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this device is a light therapy device, not an algorithm.
7. The type of ground truth used
- Not applicable for clinical efficacy. The "ground truth" for the performance testing refers to the established technical specifications of the device and the requirements of the international and FDA-recognized consensus standards.
8. The sample size for the training set
- Not applicable as no clinical training set was used. The focus was on engineering and safety testing.
9. How the ground truth for the training set was established
- Not applicable as no clinical training set was used.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.