(16 days)
The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners.
It is specially designed for breast tomosynthesis applications.
MDMG-5221, system name Barco Mammo Tomosynthesis, is an update of the 5MP display, specifically addressing the requirements of the emerging modality of Digital Breast Tomosynthesis (DBT) and QA software.
The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant.
The display uses LED backlight technology.
The provided text describes a 510(k) Summary for the Barco Mammo Tomosynthesis (MDMG-5221) device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets specific acceptance criteria through extensive clinical studies.
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify formal "acceptance criteria" in the sense of performance thresholds for a clinical study (e.g., a specific sensitivity or specificity target). Instead, it compares the technical specifications and performance of the new device to its predicate. The "acceptance criteria" can be inferred as demonstrating comparable or superior performance in key technical aspects and safety as the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (New MDMG-5221) | Predicate Device (MDMG-5221 cleared under K090603) |
|---|---|---|
| Similar or superior technological characteristics | ||
| Screen technology | TFT AMLCD Dual Domain IPS grayscale | TFT AMLCD Dual Domain IPS grayscale |
| Active screen size (diagonal) | 540.9 mm (21.3") | 540.9 mm (21.3") |
| Active screen size (H x V) | 422.4 x 377.9 mm (16.6 x 13.3") | 422.4 x 377.9 mm (16.6 x 13.3") |
| Aspect ratio (H:V) | 4:5 | 4:5 |
| Resolution | 2048 x 2560 | 2048 x 2560 |
| Pixel pitch | 0.165 mm (0.0065") | 0.165 mm (0.0065") |
| Color imaging | No | No |
| Gray imaging | Yes | Yes |
| Viewing angle (H, V) | 176° (at 10:1 contrast) | 176° (at 10:1 contrast) |
| Per Pixel Uniformity (PPU) | Yes | Yes |
| Ambient Light Compensation (ALC) | Yes | Yes |
| Backlight Output Stabilization (BLOS) | No | No |
| I-Guard | Yes | Yes |
| Maximum luminance | 2100 cd/m² | 2100 cd/m² |
| DICOM calibrated luminance (ULT off) | 1000 cd/m² | 1000 cd/m² |
| Contrast ratio (typical) | 950:1 | 950:1 |
| Response time (Tr + Tf) | 15 ms (typical) | 15 ms (typical) |
| Video input signals | DP, DVI | DP, DVI |
| USB ports | 1 upstream, 2 downstream | 1 upstream, 2 downstream |
| USB standard | 2.0 | 2.0 |
| Power consumption (nominal) | 125W | 125W |
| Power save mode | Yes | Yes |
| Net weight with stand | 15.4 kg | 15.4 kg |
| Net weight w/o stand | 10.9 kg | 10.9 kg |
| Safety and Effectiveness not affected by modifications | Bench tests confirmed similar or superior characteristics, no new safety/performance issues. | |
| (Specific for LED backlight and firmware update) | DICOM calibration and Luminance Uniformity tests passed. Firmware tests passed. Electrical Safety (IEC 60601-1) and EMC (IEC 60601-1-2) tests passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Animal or clinical testing have not been performed." Therefore, there is no test set of patient data, sample size, or data provenance from a clinical study to report. The "testing" referred to in the document is bench testing of the display device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no clinical test set with medical images requiring expert ground truth was used in this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
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 display monitor, not an AI-powered diagnostic tool. The submission does not involve an MRMC study or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a display monitor, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for the technical performance tests would be the established engineering specifications and measurement standards.
8. The Sample Size for the Training Set
Not applicable. As this is a display monitor submission demonstrating substantial equivalence via technical bench testing, there is no "training set" in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned or implied in this submission for this device.
§ 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).