(56 days)
BenQ LCD monitor (MD310C, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
BenQ LCD monitor (MD310C, MD310G and MD210G) is for viewing medical images other than those of mammography. MD310C is a 21.3" color LCD monitor with the resolution 1,536 x 2,048 pixels (3MP) and MD310G is a 21.3" Monochrome LCD monitor with the same resolution. MD210G is a 20.1" Monochrome LCD monitor with the resolution 1,200 x 1,600 pixels (2MP).
The provided document is a 510(k) premarket notification for a medical LCD monitor (MD310C, MD310G, MD210G). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study as seen with novel high-risk devices.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for image quality parameters or a direct measure of device performance against such criteria. Instead, it states that "All test results demonstrate that LCD Monitor (MD310C, MD310G, MD210G) meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device." (Section 5.8)
The comparison tables (starting on page 5) show the specifications of the subject device (BenQ LCD Monitor) against three predicate devices. These specifications implicitly act as the "performance" for this type of device, and the "acceptance criteria" is that the differences do not adversely impact safety and effectiveness.
Here's a summary of the key performance parameters compared, with the understanding that "acceptance" for this submission means demonstrating that differences do not present new safety/effectiveness concerns:
| Performance Parameter | BenQ LCD Monitor (Subject Device) | Predicate Devices (Examples from K153354, K150821, K143076) | Acceptance Criteria (Implicit) | Reported Device Performance (Implicitly Met) |
|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images for review, analysis, and diagnosis by trained medical practitioners (excluding mammography). | Same (or very similar wording, excluding mammography). | Intended use must be substantially equivalent. | Met (Same intended use). |
| Technology | TFT color/monochrome LCD panel (IPS) | TFT color/monochrome LCD panel (IPS, Dual Domain IPS, Monochrome TFT) | Technology must be substantially equivalent or differences justified. | Met (Similar panel technologies; differences justified). |
| Backlight | LED | LED | Same. | Met (Same). |
| Panel Size | 21.3", 20.1" | 21.3", 20.8", 20.1" | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Display Size (H x V) | Varies (e.g., 433.1 x 324.8 mm for 3MP) | Varies (e.g., 433.2 mm x 324.9 mm for 3MP predicate) | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Megapixels | 3 megapixel (MD310C/G), 2 megapixel (MD210G) | 3 megapixel, 2 megapixel | Same pixel count for corresponding models. | Met (Same). |
| Native Resolutions (H x V) | 2048 x 1536 (3MP models), 1600 x 1200 (2MP models) | 2048 x 1536, 1600 x 1200 | Same resolution for corresponding models. | Met (Same). |
| Pixel Pitch (H x V) | Varies (e.g., 0.2115 x 0.2115 mm for 3MP) | Varies (e.g., 0.2115 mm x 0.2115 mm for 3MP predicate) | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Viewing Angle (H, V) | 176°/176°, 170°/170° | 178°/178°, 176°/176°, 170°/170° | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Response Time | 40 ms (Typ.) | 25 ms (Typ.), 30 ms (Typ.) | Differences not adversely impacting safety/effectiveness. | Met (Differences noted, justified as not adverse). |
| Brightness | 800 cd/m² (Typ.), 1700 cd/m² (Typ.), 1000 cd/m² (Typ.) | 1000 cd/m² (Typ.), 1200 cd/m² (Typ.), 1000 cd/m² (Typ.) | Differences not adversely impacting safety/effectiveness. | Met (Differences noted, justified as not adverse). |
| Contrast Ratio | 1400:1 (Typ.), 1400:1 (Typ.) | 1500:1 (Typ.), 1200:1 (Typ.), 1000:1 (Typ.) | Differences not adversely impacting safety/effectiveness. | Met (Differences noted, justified as not adverse). |
| Connectivity | DVI-D, DisplayPort, USB ports | DVI-D, DisplayPort, USB ports, VGA, DVI-I | Substantially equivalent. | Met (Similar or justified differences). |
| Safety Tests | Performed (Reliability, Software, EMC/Electrical, Function, Usability) | - | Device must meet safety test requirements. | Met (All tests demonstrate compliance). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (Section 5.9). Therefore, there is no clinical test set, sample size, or data provenance from patient data for this submission. The "test set" for this device consists of the physical units undergoing non-clinical engineering and performance testing. The provenance of this would be internal to BenQ's testing facilities (Taiwan, based on the submitter's address).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical test data was used, there was no ground truth based on patient images established by medical experts for this submission. The "ground truth" for non-clinical tests would be defined by engineering standards and specifications, validated by internal company experts (e.g., engineers, quality control personnel). No specific number or qualifications of these internal experts are mentioned.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission explicitly states no clinical test data was used (Section 5.9).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is an LCD monitor, not an AI algorithm. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable. The device's performance is its ability to accurately and reliably display medical images as intended. This performance was evaluated through non-clinical testing (reliability, software validation, electromagnetic compatibility, electrical safety, function test, usability test – Section 5.8).
7. The Type of Ground Truth Used
For non-clinical testing, the "ground truth" would be the engineering specifications, industry standards, and regulatory requirements (e.g., electrical safety standards, image display quality standards relevant to medical monitors). These are deterministic and measurable, without requiring expert consensus on clinical findings.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device (LCD monitor), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of Approach:
The BenQ LCD Monitor K170944 submission followed the Traditional 510(k) pathway which relies on demonstrating substantial equivalence to existing predicate devices. For a medical display monitor, this involves comparing technical specifications and proving through non-clinical laboratory tests (reliability, safety, function, usability) that any differences from the predicate devices do not adversely affect the safety or effectiveness of the device for its intended use. Clinical studies are typically not required for this type of device unless there are significant technological differences that could introduce new questions of safety or efficacy.
§ 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).