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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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