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The UV Biotek Multi-Directional device is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).

The UV Biotek Single Panel Unit device models 100B/80B/40B are for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)

The UV Biotek Multi-Directional model is a phototherapy device, wall mounted with 3 lighting panels containing a total of 10 Philips TL100W/01 (narrowband UVB) or 10 Philips FS72T12/BL/HO/12 (wideband UVB) lamps. The center panel contains 6 lamps and the outer panels contain 2 lamps each, driven by standard electrical lighting systems at 120 Volts, producing 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500. Cabinet dimensions: 85.5" high, 9" deep, 22.5" wide – when the door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.

The UV Biotek Single Panel device is a phototherapy device, wall mounted with a single lighting panel with an array of 4, 6, 8 or 10 Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps, driven by standard electrical lighting systems at 120 Volts, producing 400 to 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500.

Cabinet dimensions: 85.5" high, 5" deep, 22" wide – when door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.

There are 4 single panel models to choose from:
. The100B model is one metal cabinet, housing (10) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
The 80B model is one metal cabinet, housing (8) Philips TL100W/01 ● (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 60B model is one metal cabinet, housing (6) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 40B model is one metal cabinet, housing (4) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.

This document is a 510(k) premarket notification for the "UV Biotek Multi-Directional and UV Biotek Single Panel (models 100B/80B/60B/40B)". It claims substantial equivalence to a predicate device, the "UV Biotek Mobile/Versa Lite (K111049)". The provided text does not contain a study with acceptance criteria or reported device performance in terms of diagnostic accuracy or clinical outcomes for the treatment of dermatologic disorders.

Instead, the document details the device's technical specifications and asserts its equivalence to a predicate device based on similar characteristics and compliance with electrical safety and EMC standards.

Therefore, the requested information about acceptance criteria for a study demonstrating efficacy and device performance cannot be extracted from this document, as such a study is not described. The performance testing mentioned specifically related to "irradiance" and "comparison to the predicate device" to "reach the recommended dose (mJ/cm2) for the treatment of psoriasis found in published scientific literature", not a clinical study proving the device meets specific efficacy acceptance criteria.

However, based on the information provided, here's what can be inferred and stated:

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

The document does not provide a table of acceptance criteria for clinical efficacy (e.g., reduction in psoriasis severity scores) or diagnostic performance, nor does it report the device's performance against such criteria. The "Performance Standards" section (page 6) mentions:

• "These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act." (general compliance)
• "All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks and are found to be in conformance with EN/IEC 60601-1 Electrical Safety and EN/IEC 60601-1-2:2007 EMC." (electrical and EMC safety)
• "Specific performance testing was done on these devices to measure irradiance and for comparison to the predicate device. These measurements were used to reach the recommended dose (mJ/cm2) for the treatment of psoriasis found in published scientific literature." (technical measurement for dosing, not clinical outcome)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical test set or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a clinical test set or ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a clinical test set.

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

Not applicable. This device is a UV phototherapy device for treatment, not an AI-assisted diagnostic device.

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

Not applicable. This device is a UV phototherapy device for treatment, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document does not describe a clinical study requiring ground truth for clinical outcomes. The "performance testing" mentioned focuses on physical measurements (irradiance) rather than clinical efficacy. The basis for efficacy relies on the predicate device and "published scientific literature" for recommended doses of UV radiation for psoriasis treatment.

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML model or a training set.

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

Not applicable. The document does not describe an AI/ML model or a training set.

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The Disposable Thyroid Collar is intended for use as a radiation shield against scatter radiation. It is intended to be placed around the neck of the user who remains outside of the primary radiation beam.

The Disposable Thyroid Collar is a radiation protective shield for the thyroid intended to be used in various medical procedures where X-ray radiation is used. It is a non-sterile device, designed for single use. The device is constructed with environmentally friendly radiation attenuating materials, which do not contain lead or heavy metals. The radiation attenuating material is encased in a medical grade polypropylene (PP) non-woven drape material. The device is available in three sizes, small, medium, and large.

The device blocks radiation in a similar manner to lead - via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation attenuating material, in a manner identical to lead.

The provided document describes the BloXR Disposable Thyroid Collar, a device intended to attenuate scatter radiation. The study focuses on demonstrating its substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting extensive clinical trials typical for software or complex medical devices.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (Inferred from the document):
The primary acceptance criterion was demonstrating that the BloXR Disposable Thyroid Collar provides similar radiation attenuation to legally marketed predicate devices and a 0.5 mm lead sheet control. Specifically, the device should achieve a radiation attenuation level equivalent to 0.5 mm of lead.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical "sample size" in terms of number of devices tested. It mentions "two laboratory studies" that evaluated "the device materials of the Disposable Thyroid Collar to the two predicate devices and to a 0.5 millimeter (mm) lead sheet, as a control." This implies a comparison of material properties rather than a large-scale clinical trial. The "sample" in this context refers to the specific materials chosen for testing (BloXR's material, predicate device materials, and a lead control).
• Data Provenance: The studies were laboratory studies, one conducted at an independent laboratory and the other in-house by BloXR. There is no information about the country of origin of the data beyond the location of the independent lab and BloXR itself. The studies are explicitly described as performance testing and are not clinical studies involving human subjects, therefore the terms "retrospective" or "prospective" do not apply.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This type of device (a physical radiation shield) does not involve "ground truth" derived from expert interpretation in the way an AI diagnostic algorithm would. The performance was measured directly using scientific instrumentation to assess radiation attenuation, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not Applicable. As the performance assessment involved direct physical measurements of radiation attenuation using a standardized methodology (ASTM F 2547-06), there was no need for an adjudication method by experts. The results were quantitative and objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This was not a MRMC comparative effectiveness study. This type of study is relevant for diagnostic devices (especially imaging AI) where human readers interpret cases. The BloXR Disposable Thyroid Collar is a physical protective device, and its performance was assessed through laboratory measurements of its material properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not Applicable. The device is a physical product, not an algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• Measured Physical Properties (Radiation Attenuation): The "ground truth" in this context was the scientifically measured radiation attenuation provided by the materials, as compared against a known standard (0.5 mm lead sheet) and the predicate devices. This is based on objective physical measurements using a standardized method (ASTM F 2547-06).

8. The Sample Size for the Training Set

• Not Applicable. There was no "training set" as this device is a physical product and not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there was no training set, this question is not relevant.

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The intended use of this device is to sheild healthy tissue from radiation. The MED-TEC, INC. MT-MX3 thermoplastic shield MATRIX operates in the same manner as other personnel protective shields. or The intended use of the MED-TEC, INC. MT-MX3 MATRIX thermoplastic shield is to shield healthy tissue from radiation.

MED-TEC, INC. has a Personnel Protective Shield System to be manufactured by MED-TEC, INC.

I am sorry, but the provided text from the FDA 510(k) letter and the indications for use document for the Med-Tec Corporation Matrix MT-MX3 device does not contain the kind of detailed information requested about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications.

The documents indicate that the Matrix MT-MX3 is a "Personnel Protective Shield System" (thermoplastic shield) intended to "shield healthy tissue from radiation." The 510(k) letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a de novo clinical study with pre-defined acceptance criteria for performance metrics in the same way a novel AI or diagnostic device might. The provided documents are administrative and regulatory approvals, not clinical study reports.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the given information.

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