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Indications for use include:

· The blue light (415nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

· The red light (633nm wavelength) indicated for treatment of superficial, benign, vascular and pigmented lesions.

• The near-infrared light (830nm wavelength) is generally indicated 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.

The Dermalux Tri-Wave MD MK II & Dermalux Compact MD is a Medical Device (MDR Class II) which emits specific wavelengths of low level, narrow band light for the treatment of certain aesthetic, dermatological and medical indications. The wavelengths used in the Tri-Wave MD MK II & Compact MD systems are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux professional use family consists of the Tri-Wave MD MKI; a floor standing unit with 4 pod treatment head, Compact MD; desk mounted unit with a 3 pod treatment head.

The system enables treatment of the body via an articulated 4 or 3 panel LED head. The panels can be easily adjusted for focused intensity treatments and application to larger body areas.

The system consists of a main body that contains the power supply (100-240Vac, 50/60Hz), power switch, touch screen control panel and a 4 or 3 panel adjustable treatment head that contains Light Emitting Diodes (LEDs).

The power supply is designed to power the internal electronics for the system and the Light Emitting Diodes. The power supply is connected to a suitable mains outlet. The device is switch located below the screen in the base unit.

The Tri-Wave MD MK II & Compact MD system is operated by a full colour capacitive touch screen which features pre-set and post treatment protocols that can be customised with three power settings. Bespoke protocols can be programmed based on delivered energy or time. The device cannot be networked or connect to the internet, software updates can be performed via a USB flash drive (thumb drive) if required.

The light is generated by Light Emitting Diodes (LED's) which a treatment head. The treatment head is connected to the main body by articulating arm mechanism. The arm allows the operator to correctly position the LED head ment area.

Protective eye wear is supplied with each Dermalux unit for patient and operator comfort.

The Dermalux systems are not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided text is a 510(k) summary for the Dermalux Tri-Wave MD MKII and Dermalux Compact MD devices. It details the device descriptions, intended use, and a comparison to a predicate device (Dermalux Tri-Wave MD, K200659).

However, this document does not contain information about acceptance criteria for device performance, nor details of specific studies that prove the device meets such criteria. It's a regulatory submission affirming substantial equivalence to a predicate device, based on similar technology and indications for use. It states that "The conclusions drawn from the noncinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section," but it does not provide the details of those non-clinical tests, their results, or any acceptance criteria.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and performance studies, including sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

The document mainly focuses on:

• Device Identification: Dermalux Tri-Wave MD MKII (1000021) and Dermalux Compact MD (1000024).
• Intended Use/Indications for Use:
  • Blue light (415nm): Treat moderate inflammatory acne vulgaris.
  • Red light (633nm): Treatment of superficial, benign, vascular and pigmented lesions.
  • Near-infrared light (830nm): Temporary relief of minor muscle and joint pain, arthritis, muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; temporarily increasing local blood circulation.
• Predicate Device: Dermalux Tri-Wave MD (K200659).
• Technological Comparison: States that the new devices have "the same technological characteristicans for use" as the predicate device.

The document does not describe any specific performance study, acceptance criteria, or statistical measures related to efficacy or performance for this specific submission. It relies on substantial equivalence to the predicate device.

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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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The Derrmalux® Tri-Wave MD 's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

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

The near-infrared light (830nm wavelength) is generally indicated 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.

The Dermalux® Tri-Wave MD is a floor standing Class II medical device which emits specific wavelengths of low level, narrow band light for the treatment of dermatological conditions. The wavelengths used in the Tri-Wave MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

The device consists of a main body that contains the power supply, power switch, touch screen control panel, and a 4 panel adjustable treatment head that contains Light Emitting Diodes enabling treatment of the face and the body. The panels can be easily adjusted for focused intensity treatments and application to larger body areas.

The provided text is a 510(k) summary for the Dermalux® Tri-Wave MD device. It outlines the administrative information, device description, indications for use, and a comparison to a predicate device. However, it explicitly states under the "VII. PERFORMANCE TESTING" section:

• Animal: No studies were performed.
• Clinical: No studies were performed.

This means that the document does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance in humans or animals. The performance testing mentioned is "Bench Testing" which refers to verification of the device against design specifications and compliance with international and FDA-recognized consensus standards (e.g., electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, usability).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance (as no performance studies are mentioned in a clinical context).
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This 510(k) summary focuses on demonstrating substantial equivalence through comparison to a predicate device and compliance with relevant safety and technical standards for a phototherapy system, rather than providing clinical efficacy or performance study data.

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