(76 days)
The L218TL Monochrome display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.
The L218TL cannot be used for a life-support system.
This device must not be used in digital mammography.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Medical Display, L218TL is a 21.3" Monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided text is a 510(k) summary for a medical display monitor (NEC MD213 MG / L218TL). This type of document focuses on establishing substantial equivalence to a predicate device, primarily through comparing technical specifications and safety standards, rather than detailing a rigorous clinical study of acceptance criteria and device performance in the way an AI algorithm or diagnostic tool would.
Therefore, many of the requested elements (like sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable to this submission, as it relates to a hardware display device and not a diagnostic software or AI.
However, I can extract the relevant information from the document as best as possible within the context of a hardware device submission.
Acceptance Criteria and Study for NEC MD213 MG (L218TL) Medical Display
As this submission is for a medical display monitor, the "acceptance criteria" and "device performance" primarily revolve around technical specifications and regulatory compliance demonstrating substantial equivalence to a predicate device. A clinical study with specific diagnostic performance metrics (e.g., sensitivity, specificity for disease detection) and reader performance improvement is not typically performed for a display monitor.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Feature | Acceptance Standard (Implied by Predicate Equivalence) | Reported Device Performance (NEC MD213 MG / L218TL) |
|---|---|---|
| Intended Use | Displaying and viewing digital image diagnosis by trained physicians. | Same intended use as predicate. |
| Target Population | Trained practitioners in hospital environments. | Same target population as predicate. |
| Design | Equivalent to predicate device. | Same design as predicate. |
| Performance | Equivalent to predicate device. | Same performance as predicate. |
| Radiation Safety (EN60601-1-2) | Compliant with EN60601-1-2. | Same as predicate. |
| Mechanical Safety | Compliant with relevant safety standards. | Same as predicate. |
| Electrical Safety (UL60601-1) | Compliant with UL60601-1. | Same as predicate. |
| Human Factors | Equivalent to predicate device. | Same as predicate. |
| Materials | Similar to predicate device. | Similar to predicate. |
| Compatibility with Environment/Other Devices | Similar to predicate device. | Similar to predicate. |
| Screen Size | 21.3 inches (based on predicate). | 21.3 inches. |
| Resolution | 3 Mega Pixel (e.g., 2048x1536). | 3 Mega Pixel (2048x1536). |
| Adjustable Gamma Gray Scale | Included for precise diagnosis. | Included for precise diagnosis. |
| Use Cases | CT, MRI, HIS, PACS. | CT, MRI, HIS, PACS. |
| Approved Display Cards | Use with NEC approved display cards. | Required for specified display performance. |
| Life-Support System Use | Not for life-support systems. | Cannot be used for life-support systems. |
| Digital Mammography Use | Not for digital mammography. | Must not be used in digital mammography. |
| Interconnection | Designed for interconnection with IEC60601-1 certified equipment. | Designed for exclusive interconnection with IEC60601-1 certified equipment. |
Study Details:
The "study" in this context is a substantial equivalence comparison to a legally marketed predicate device, MDM2130-3NC 21.3" 3MP Monochrome LCD Monitor by CHILIN Technology Co., Ltd. (K063266). The entire submission argues that the NEC L218TL device is substantially equivalent to this predicate based on shared design, performance, safety standards, and intended use.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable (N/A). This is a hardware device submission. There is no "test set" of patient data or images in the typical sense for evaluating diagnostic performance. The evaluation is based on the device's technical specifications and compliance with established safety and performance standards relevant to medical monitors.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable (N/A). No "ground truth" was established from expert consensus on medical images for this hardware device.
4. Adjudication Method for the Test Set:
- Not Applicable (N/A). No adjudication methods for diagnostic performance were employed.
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 (N/A). This is not an AI-assisted diagnostic device. It is a display monitor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable (N/A). This is a display monitor, not an algorithm.
7. The Type of Ground Truth Used:
- Not Applicable (N/A). For a medical display monitor, the "ground truth" is typically defined by adherence to objective performance standards (e.g., DICOM Part 14 Grayscale Standard Display Function compliance, luminance, contrast, resolution, uniformity) and safety standards (e.g., IEC 60601-1, EN 60601-1-2, UL 60601-1). The document states that the device meets these safety and performance requirements through comparison to the predicate device.
8. The Sample Size for the Training Set:
- Not Applicable (N/A). There is no "training set" as this is a hardware device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable (N/A). There is no "training set" or corresponding ground truth for a hardware display 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).