(10 days)
The DELL UP3216Q with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The DELL UP3216Q can be used only in conjunction with OUBYX PerfectLum.
The device can not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
The device does not contact with the patient.
The device is intended for prescription use.
The DELL UP3216Q with QUBYX PerfectLum is a 31.5" color display for medical viewing. It provides 3840x2160 resolution with an adjustable Look Up Table and a 10 bit panel. It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Standard Value / Method | Reported Device Performance (DELL UP3216Q with QUBYX PerfectLum) | Meets Criteria? |
|---|---|---|---|
| DICOM Part 14 GSDF Conformance | Conformance to DICOM standard (target values defined by DICOM) | Successfully passed DICOM conformance test; software analyzed results against target values | Yes |
| AAPM TG18 Conformance | Conformance to AAPM TG18 standard (target values defined by AAPM) | Successfully passed AAPM TG18 acceptance test; software analyzed results against target values | Yes |
| Maximum Luminance | > 170 cd/m² (for primary displays per AAPM guidelines) | 300 cd/m² | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices. The document implies testing was performed on "the display device" (singular), referring to the DELL UP3216Q.
- Data Provenance: Not explicitly stated. The tests were performed by QUBYX using their PerfectLum software and an X-Rite i1 Display Pro measurement device. There's no indication of geographic origin or whether it was retrospective or prospective data beyond the scope of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- DICOM Conformance: No human experts were used for ground truth. The ground truth was based on pre-defined target values within the DICOM standard, which the software compared against measured display characteristics.
- AAPM TG18 Conformance: Visual steps in the AAPM test involved a "user" analyzing test patterns and the software recording their answers. However, the number and qualifications of this "user" are not specified. It's unclear if this "user" is considered an "expert" in the sense of a medical professional establishing ground truth. The primary ground truth for the measurement part of AAPM was also based on target values defined by the AAPM standard.
4. Adjudication Method for the Test Set:
- DICOM Conformance: No adjudication method described as it was an automated comparison of measured values against a standard.
- AAPM TG18 Conformance: For the visual parts, the software "recorded the user's answers." There's no mention of a formal adjudication process (e.g., 2+1, 3+1) if multiple users were involved, or if a single user's input was sufficient.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. This document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a medical display, not an AI diagnostic tool in the sense of analyzing medical images directly to produce a diagnosis.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Yes, in a way. The "tests" described are for the technical conformance of the display device and its accompanying software (PerfectLum) to established standards (DICOM and AAPM). These tests evaluate the device's ability to accurately present images and maintain quality, independent of a specific human interpretation task. The "algorithm" here refers to the PerfectLum software for calibration and verification, which performs its functions without direct human diagnostic input.
7. The Type of Ground Truth Used:
- Standards-Based Ground Truth: The ground truth for both DICOM and AAPM TG18 conformance was established by the respective industry standards themselves (DICOM Part 14 GSDF and AAPM TG18 guidelines). The software compared the device's measured performance against the target values and criteria specified in these standards.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical display device, not an AI algorithm that is "trained" on a dataset in the conventional machine learning sense. The PerfectLum software is a calibration and verification tool, not a model that learns from training data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this type of device and software.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).