Search Results
Found 1 results
510(k) Data Aggregation
(302 days)
Psoria-Shield AURORA
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Energy Output Consistency | Performance testing using pre-production AURORA systems demonstrated that the energy levels output from each handpiece are consistent with user-defined energy levels. |
| Electrical Safety (IEC 60601-1:2005+A1:2012) | Successfully performed on production devices. |
| Electromagnetic Disturbances (IEC 60601-1-2:2014) | Successfully performed on production devices. |
| Basic Safety and Essential Performance (IEC 60601-2-57) | Successfully performed on production devices. |
| Photobiological Safety (IEC 62471:2009) | Successfully performed. |
| Software Development & Testing (IEC 62304) | Executed in compliance. |
| Risk Management (ISO 14971) | Executed in compliance. |
| Substantial Equivalence to Predicate | The AURORA system has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate PS1000 system. Performance data demonstrates that the AURORA system is as safe and effective as the predicate PS1000 system. |
| New Questions of Safety or Effectiveness (Design Changes) | Minor differences (air cooling, operating system, separate handpieces) do not raise any new questions of safety or effectiveness. |
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.
Ask a specific question about this device
Page 1 of 1