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The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area.

The device is comprised of four main components:

• A base station
• A touchscreen where the user can enter system commands
• Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece.
• A printer accessory that can print out verification of treatment parameters for hard copy records.

The document describes the acceptance criteria and study for the Enhanced AURORA™ Medical Diode system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a 'test set' in the context of clinical data or patient samples. The performance data is based on bench testing only. Therefore, there is no sample size for a test set of patient data, nor is there information about data provenance (country of origin, retrospective/prospective).

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

Not applicable. The performance data is derived from bench testing of the device's output, not from expert interpretation of medical images or patient data requiring ground truth establishment by experts.

4. Adjudication method for the test set

Not applicable, as a test set requiring adjudication by experts (e.g., for diagnostic accuracy) was not conducted. The assessment was based on physical measurements during bench testing.

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 phototherapy system, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

Not applicable. This device is a medical phototherapy system, not an algorithm. Its performance is assessed by its physical output characteristics during bench testing, not by an algorithm's standalone performance.

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

The "ground truth" for this device's performance was the user-selected power settings, against which the actual UVA and UVB energy dosage output was measured. This is a technical performance measurement, not a clinical ground truth.

8. The sample size for the training set

Not applicable. This document describes a medical device for phototherapy, not a machine learning model requiring a training set.

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

Not applicable, for the same reason as above.

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The AURORA system is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

The Psoria-Shield AURORA system delivers UVA or UVB phototherapy to target skin areas through one of two handpieces. The handpieces are connected to a base unit which uses an air cooling system to maintain system temperature, and has a built-in touchscreen to operate the device.

This document is a 510(k) summary for the Psoria-Shield AURORA system, a medical device for phototherapy. It asserts substantial equivalence to a predicate device (Psoria-Shield PS1000). The information provided focuses on the device's design, intended use, and safety compliance, rather than comprehensive performance studies with acceptance criteria in the context of clinical efficacy or diagnostic accuracy that would typically involve statistical metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of predefined thresholds for clinical or diagnostic performance metrics. Instead, it describes compliance with safety and electrical standards and consistency of energy output.

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

The document mentions "pre-production AURORA systems" and "production devices" for performance and safety testing. However, it does not specify the sample size (e.g., number of devices or test cycles) used for these tests. There is no information regarding the data provenance (e.g., country of origin, retrospective/prospective). This device is a phototherapy device, not a diagnostic one, so traditional "test sets" for diagnostic accuracy are not applicable here.

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

This information is not applicable to this submission. The device is a phototherapy system, not an AI/diagnostic device that requires expert-established ground truth for performance evaluation in the context of a 510(k) submission. Its safety and operational characteristics are evaluated against engineering and medical device standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. There is no "test set" in the diagnostic context requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

This information is not applicable. The AURORA system is a phototherapy device, not a diagnostic AI system where MRMC studies comparing human readers with and without AI assistance would be relevant. The submission focuses on device safety and operational equivalence to a predicate.

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

This information is not applicable. The AURORA is a physical phototherapy device, not an algorithm. Its operation involves a human user selecting settings and applying treatment.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) typically applies to diagnostic or prognostic AI devices. For this phototherapy device, the "truth" is established by:

• Compliance with recognized electrical and safety standards (IEC 60601 series, IEC 62471).
• Measurement of physical outputs (energy levels) against defined specifications.
• Substantial equivalence to a legally marketed predicate device, implying its safety and effectiveness have been previously established.

8. The Sample Size for the Training Set

This information is not applicable. The AURORA system is a hardware device; there is no "training set" in the context of machine learning.

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

This information is not applicable for the same reasons as #8.

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The Psoria-Light Model PS1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

Psoria-Light™ Model PS1000 delivers targeted ultraviolet (UV) light to small regions of affected skin (2.88 cm), sparring healthy skin. The system is capable of delivering either UVB light (300 to 320nm) or UVA light (350 to 395nm). Psoria-Light™ Model PS1000 generates both UVA and UVB light via LED technology, avoiding environmental concerns associated with disposal and exchange of mercury gas lamps, Xenon, and Chlorine gases commonly associated with targeted UV phototherapy devices. Psoria-Light's™ UVB LEDs emit light between 300 and 320 nm, avoiding light emissions below 300nm. Psoria-Light™ Model PS1000 incorporates a unique safety feature, a non-contact sensor located about the aperture of the handpiece that detects human skin. The trigger mechanism for UV dosage administration (located on the handpiece) is disabled until a suitable surface is detected by this sensor.

The Psoria-Light Model PS1000 is a targeted UVA/UVB phototherapy system for dermatologic disorders. The provided document is a 510(k) summary for the device, focusing on its substantial equivalence to previously cleared predicate devices rather than new clinical effectiveness studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

No clinical performance test set (i.e., patient data) was used for this 510(k) submission. The submission explicitly states that "duplicative clinical data is not required as a condition of granting market clearance" because the device does not introduce new indications for use and performs in a substantially equivalent manner to predicate devices. The "study" for acceptance criteria was based on demonstrating substantial equivalence to these previously cleared devices through non-clinical performance testing and comparison of device specifications.

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

Not applicable. No clinical test set requiring expert ground truth was employed for this 510(k) submission. The device's safety and effectiveness were argued based on substantial equivalence to predicate devices, which had presumably undergone such evaluations during their own clearance processes.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was employed.

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 phototherapy system, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.

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

Not applicable. This device is a hardware phototherapy system, not an algorithm. Its performance is evaluated based on its physical characteristics, light output, and compliance with safety and electrical standards.

7. The Type of Ground Truth Used

For the non-clinical product performance testing, the "ground truth" would be established by the specifications and requirements of the referenced international and national standards (e.g., IEC 60601, 21 CFR Part 1040.10, UL 60601-1, ISO 14971, FCC rules). The device's performance is measured against these established engineering and safety benchmarks. For the clinical indications, the "ground truth" was established by the previous 510(k) clearances of the predicate devices, which had demonstrated clinical effectiveness for the stated indications.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware phototherapy system 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

Not applicable. No training set was used.

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