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UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.

The Momentum is a self-contained compact laser light source that operates on standard AC supply power requiring no special power or cooling considerations. A protective interlocked housing encloses the laser source, electronics, and gas storage and distribution system. The XTRAC Momentum Model AL10000 comes in two spatial configurations: a horizontal (Velocity)configuration and a vertical (upright / Momentum) configuration.

A core element of both the Momentum excimer laser and the Velocity is a sealed chamber containing a mixture of pressurized Neon, Xenon, and HCl gases. High-voltage electrical discharges into the gas mixture create unstable XeCl molecules, which dissociate rapidly, creating monochromatic ultraviolet light at a wavelength of 308 nm. The electrical discharges are repeated in a fast sequence, producing a train of light pulses of a nominal duration of 30ns each. The timing of electrical discharges and energy of the produced light are constantly monitored by an on-board microprocessor to ensure safety.

Using a set of optical devices such as mirrors, shutters, lenses, and optic fibers, the produced light is focused and directed by the user to skin areas affected by disease. Each dose delivered by the system is composed of multiple laser pulses delivered at a preset repetition rate for a duration that is managed by the system processor.

The provided text does not describe acceptance criteria or a study proving that a device meets such criteria.

Instead, the document is an FDA 510(k) clearance letter for the XTRAC Momentum Excimer Laser System, Model AL10000. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (XTRAC Velocity Excimer Laser System, Model AL10000), rather than proving performance against specific acceptance criteria through a clinical study.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• "No mechanical, animal or clinical testing was performed."
• "The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent."

Therefore, it is not possible to extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, etc.) from this document, as the clearance was not based on a clinical study designed to prove the device met specific performance acceptance criteria. The clearance was based on demonstrating the new device is as safe and effective as an already cleared device through comparison of technological characteristics and non-clinical performance testing (biocompatibility, electrical safety, EMC, software verification/validation).

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The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate the maximum non-blistering dose for a particular patient.

The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.

The subject device is the Multi-Micro Dose ("MMD") Tip.

The Multi-Micro Dose ("MMD") tip provides another method, separate of the MED mode, for determining the Optimal Therapeutic Dose ("OTD") for each patient. The OTD is the power setting on the XTRAC Phototherapy system customized for each patient that enables the user to provide patient specific treatment doses. As an alternative to the trial and error method of the MED mode, using the MMD Tip can often determine the optimal XTRAC power setting with a single test application.

The MMD Tip filters and reduces the laser output, providing four different dose levels in a single application. The reaction of the target area to the different dose levels assists in determining the patient specific Optimal Therapeutic Dose ("OTD").

The MMD Tip design places four (5mm x 5mm) square filters in the laser aperture.

The MMD Tip design is constructed of similar materials and components as the predicate tip. It connects to the XTRAC hand-piece in the same manner as the standard Tips of the XTRAC system.

This document describes the MMD Tip, an accessory for the XTRAC laser system. The document is a 510(k) premarket notification and focuses on establishing substantial equivalence to a legally marketed predicate device (K073659 - Strata Skin Sciences - XTRAC).

Here's an analysis of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance:

The document primarily states that "The performance was within pre-defined acceptance criteria" for the bench tests. It does not provide specific numerical acceptance criteria or the exact reported performance values. It only lists the tests performed and a general statement of compliance.

2. Sample size used for the test set and the data provenance:

• Bench Testing: The document does not specify the sample size for any of the bench tests (Tip Dose Accuracy and Uniformity, Tip Transmission, Tip Shelf Life, Tip Shipping). It merely states that "We performed testing to support the filtration performance of the MMD Tip" and "We have performed bench tests and found that the MMD Tip... met all requirements specifications."
• Biocompatibility Testing: The document does not specify the sample size used for the biocompatibility tests.
• Data Provenance: Not specified, but given the nature of the tests (bench and biocompatibility), the data would originate from laboratory or manufacturing testing. There is no mention of human subject data for proving the device's functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this submission. The MMD Tip is an accessory to a laser system used to calculate the Optimal Therapeutic Dose (OTD) for patients. The studies described are bench and biocompatibility tests, not clinical studies involving expert interpretation of results to establish ground truth about medical conditions.

4. Adjudication method for the test set:

This information is not applicable. There is no mention of a human test set requiring adjudication in this submission.

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:

This information is not applicable. The MMD Tip is a physical accessory for a laser system. It is not an AI-powered diagnostic or assistive device, and therefore no MRMC study or AI-related effectiveness study was conducted or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The MMD Tip is a physical device, not an algorithm.

7. The type of ground truth used:

• Bench Testing: The ground truth would be established by physical measurements and engineering specifications, e.g., using calibrated measuring equipment to verify dose accuracy and transmission, or environmental chambers for shelf-life testing.
• Biocompatibility Testing: The ground truth is established by adherence to recognized international standards, specifically ISO 10993-1 tests, which have defined endpoints for toxicity, sensitization, etc.

8. The sample size for the training set:

This information is not applicable. The MMD Tip is a physical accessory and does not involve AI or machine learning that would require a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the same reasons as above.

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