Search Results

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:

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.

Ask a specific question about this device