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510(k) Data Aggregation
(258 days)
The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners.
The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0
These devices must not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
The DELL UltraSharp U3011 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 4 mega pixel (2560x1600) resolution with a adjustable Look Up Table and a 10 bit Panel.
It is combined with QUBYX PerfectLum 3.0 and PerfectLum remote QA, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows to set the display function to DICOM, display testpattern and perform acceptance and constancy tests.
The provided text is a 510(k) summary for the DELL UltraSharp U3011 with QUBYX PerfectLum bundle. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed results.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies cannot be extracted directly from this document. The document describes a comparison, not an independent performance study against set criteria as would typically be seen for a new diagnostic algorithm or device requiring such validation.
The primary method used to "prove" the device meets acceptance criteria in this context is through substantial equivalence to an existing legally marketed device (the predicate device). The acceptance criteria, in this case, are implicitly that the new device performs at least as well as, or is sufficiently similar to, the predicate device in its intended use and technical specifications.
Here's a breakdown of what can be extracted and explanations for what cannot:
1. Table of acceptance criteria and the reported device performance:
As explained above, explicit acceptance criteria in the sense of performance metrics (sensitivity, specificity, accuracy, etc.) are not provided. The "performance" is a comparison to a predicate device.
| Characteristic | DELL U3011 with PerfectLum version 3 (New Device) | Predicate device NEC LCD3090WQXI (K083916) | Implicit Acceptance/Comparison |
|---|---|---|---|
| Panel Type | IPS | IPS | Equivalent |
| Panel size | 30" viewable | 29.8" viewable | Similar |
| Native Resolution | 2560 x 1600 | 2560 x 1600 | Equivalent |
| Pixel Pitch | 0.25 mm | 0.25 mm | Equivalent |
| Brightness (typical) | 370 cd/m2 | 350 cd/m2 | New device is slightly better |
| Contrast Ratio (typical) | 1000:1 | 1000:1 | Equivalent |
| Viewing Angle (typical) | 178° Vert., 178° Hor. | 178° Vert., 178° Hor. | Equivalent |
| Displayable Colors | 1.07 billion colors | 16.7 million | New device is significantly better |
| DICOM calibration software and AAPM verification software | bundled | optional | New device offers as standard, old as option |
| Panel bit depth | 10 bit | 8 bit | New device is better |
| Color Gamut | 117% | 102% | New device is better |
The "acceptance criteria" here are that the new device should not be worse than the predicate in critical areas and can be better. The conclusion states: "The new and predicate device are substantially equivalent in the areas of technical characteristics, general function, application and indented use."
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This document describes a technical comparison of display specifications and software features, not a diagnostic performance study using a test set of medical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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/Not provided. This is a medical display, not an AI-assisted diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is a medical display, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The "ground truth" for this submission would be the published specifications and performance of the predicate device and the measured specifications of the new device.
8. The sample size for the training set:
- Not applicable/Not provided. This is a hardware/software bundle, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
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