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The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.

The provided document is a 510(k) summary for the TheraLight VersaClear™ Skin Therapy System UVA (350nm) Light Module. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for a new device's efficacy or diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study design for proving those criteria, sample sizes, expert involvement, and ground truth establishment are not typically found in a 510(k) summary for a device like this. This document primarily focuses on technical specifications and comparison to an existing device.

Here's an analysis based on the information available in the provided text:

1. Table of acceptance criteria and the reported device performance:

Explanation: The document does not explicitly state "acceptance criteria" for a clinical study to prove the device's efficacy. Instead, the "Performance Data" section describes the technical specifications of the device. The implicit acceptance criteria are that these specifications should be substantially equivalent to the predicate device (Flex Controlled Phototherapy Equipment, K050695) for the purpose of treating dermatologic/skin disorders. The "Conclusion" explicitly states that the device "is substantially equivalent to legally commercialized UV phototherapy devices."

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

• Sample Size: Not applicable. The document describes a technical characterization of the device's light output, not a clinical study involving human or even in vitro test subjects to evaluate performance against a "test set" in the context of diagnostic or treatment accuracy.
• Data Provenance: The data provided pertains to the physical characteristics of the device itself (light emission properties). It is not clinical data from patients or a specific country of origin.

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

• Number of Experts: Not applicable. No clinical ground truth or expert consensus was required for the technical specifications of light output.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. There was no "test set" requiring adjudication in the context of clinical outcomes or expert review.

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 light therapy system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported.

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

• Not applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to emit light with specified characteristics, which is described directly.

7. The type of ground truth used:

• In the context of the device's performance data (light emission): The "ground truth" is the physical measurement of the device's light output (e.g., peak wavelength, bandwidth, irradiance) using appropriate radiometric equipment.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML device that requires a "training set."

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

• Not applicable. (See #8)

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The VersaClear Skin Therapy System is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.

The document provided is a 510(k) summary for the VersaClear™ Skin Therapy System. It states that the device is substantially equivalent to predicate devices based on its performance characteristics and that there are no new safety or efficacy issues. However, it does not include a detailed study or specific acceptance criteria with reported performance data for the VersaClear™ Skin Therapy System itself.

Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was already on the market before May 28, 1976 (preamendments device) or to a device that has been reclassified.

Therefore, many of the requested details about a specific study and its acceptance criteria are not present in this document.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this document for the VersaClear™ System. The implicit "acceptance criterion" is proving substantial equivalence to predicate devices, meaning the performance characteristics are similar enough not to raise new safety/efficacy concerns.
• Reported Device Performance: The document states, "The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues." No specific quantitative performance data for the VersaClear™ System is provided.

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

• Not provided. The document does not describe a new study with a test set for the VersaClear™ System. It relies on the performance of predicate devices.

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/Not provided. No new test set data is discussed.

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

• Not applicable/Not provided. No new test set data is discussed.

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 light therapy system, not an AI-driven image analysis or diagnostic tool involving human readers.

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

• Not applicable. This device is a light therapy system, not an algorithm.

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

• Not applicable/Not provided. No new study data is discussed. The "ground truth" for the substantial equivalence claim relies on the established safety and efficacy of the predicate devices for their respective indications.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/machine learning device.

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

• Not applicable/Not provided. This is not an AI/machine learning device.

Summary based on the provided text:

Conclusion from document:

The VersaClear™ Skin Therapy System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices. The submission affirms that the performance characteristics are "substantially similar" and "technological differences do not raise new types of safety or efficacy issues," thus eliminating the need for a de novo performance study with specific acceptance criteria in this submission.

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The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.

The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¾" square patch of skin without exposure to neighboring, healthy tissues.

The provided text is a 510(k) summary for the TheraLight UV120-2 UVA / UVB Phototherapy System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study against a specified ground truth.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) cannot be answered from the provided document as they are not included.

Here's a summary of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics. Instead, it states that "System performance data (UVB output spectra) is the same or very similar that for the claimed predicate devices." This implies that the acceptance criterion was likely substantial equivalence in its UVB output spectra to the predicate devices, rather than meeting specific quantifiable clinical performance thresholds.

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

Not applicable. No specific "test set" in the context of a clinical performance study is mentioned. The assessment was based on comparing device specifications, particularly UVB output spectra, with predicate devices.

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

Not applicable. Ground truth as typically understood for diagnostic or prognostic devices (e.g., expert consensus on images, pathology results) was not established. The comparison was against predicate device specifications.

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

Not applicable. No test set adjudication method is mentioned.

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. This device is a phototherapy system, not an AI-assisted diagnostic or imaging device for which MRMC studies would be relevant.

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

Not applicable. This device is a phototherapy system, not an algorithm. Its performance is based on its physical output.

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

The "ground truth" implicitly used for comparison was the UVB output spectra of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not applicable.

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The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis.

The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¼'' square patch of skin without exposure to neighboring, healthy tissues.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the TheraLight UV120-2 UVA/UVB Phototherapy System:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not mention a test set sample size in the traditional sense of a clinical or performance study with patient data. The "Performance Data" section focuses on instrumental verification of spectral output.

• Test Set Sample Size: Not applicable/Not specified in the provided document for clinical performance. The "test" here refers to device characterization.
• Data Provenance: The document does not provide details on the origin of data for spectral output measurements (e.g., country of origin, retrospective/prospective). It simply states that "Performance data were submitted."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or not provided. Since the device performance data described is related to spectral output measurements, there isn't a need for expert-established ground truth in the context of clinical outcomes or diagnostic accuracy. The ground truth for spectral output would be established by calibrated measurement instruments.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. As explained above, the "test set" in this context refers to instrumental measurements, not a set of clinical cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. The device is a phototherapy system, not an AI-assisted diagnostic or interpretative tool.

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

• Yes, in a way, a standalone performance was done for the device itself. The performance data section describes the inherent spectral output of the device (UVA and UVB bands) without human intervention in its operation or interpretation for this specific performance metric.
• However, this is not in the context of an "algorithm only" performance as would be relevant for an AI device. It's a statement of the physical characteristics of the light emitted by the device.

7. The Type of Ground Truth Used

The ground truth used for the "Performance Data" is instrumental measurement of spectral output. This involves comparing the device's emitted wavelengths against a defined range (e.g., 330-380nm for UVA, 290-330nm for UVB). This is based on established physics and measurement standards, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. The device is a physical light therapy system, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable or not provided as there is no training set for a phototherapy device of this nature.

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