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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.

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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.

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.

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