(15 days)
The L307TD Color 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.
TheL307TD 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, L307TD is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Here's an analysis of the provided text regarding the NEC L307TD Medical Display, focusing on acceptance criteria and study details.
Based solely on the provided document (K083916 510(k) Summary), the information requested about acceptance criteria and a detailed study proving performance is not explicitly contained.
This 510(k) summary is for a medical display monitor, not an AI algorithm or a diagnostic device that performs interpretations. Therefore, the "acceptance criteria" discussed are largely related to electrical safety, mechanical safety, human factors, and display performance specifications (e.g., resolution, gamma grayscale adjustment) to ensure it's suitable for displaying medical images, rather than diagnostic accuracy metrics like sensitivity or specificity. The "study" proving performance is a substantial equivalence comparison to a predicate device, not a clinical trial involving human readers or a standalone algorithm.
Here's how to address your points based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with numerical performance data in the way one would expect for an AI diagnostic device. Instead, the basis for acceptance is a demonstration of equivalence to a legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. - K063579) across various characteristics.
| Acceptance Criteria (Implied from Equivalence Claim) | Reported Device Performance (Implied from Equivalence Claim) |
|---|---|
| Intended Use | Same target population (trained practitioners in hospital), same intended use (displaying digital image diagnosis). |
| Design | Shares the same design as the predicate. |
| Performance (General) | Same general performance as the predicate (e.g., sufficient for digital image diagnosis). Explicitly states 4 megapixel (2560x1600) resolution with adjustable gamma grayscale. |
| Radiation Safety | EN60601-1-2 compliant (same as predicate). |
| Mechanical Safety | Compliant (same as predicate). |
| Electrical Safety | UL60601-1 compliant (same as predicate). |
| Human Factors | Compliant (same as predicate). |
| Material | Uses similar material as the predicate. |
| Compatibility (Environment & Other Devices) | Same compatibility as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided: For a medical display monitor's 510(k) submission based on substantial equivalence, there isn't a "test set" of medical images or patient data in the context of diagnostic accuracy. The testing involves engineering and safety evaluations against standards and comparison to a predicate device's specifications. The document does not mention any medical image datasets being used for testing or evaluation of diagnostic performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Provided: As there is no diagnostic "test set" of patient cases for interpretation, there are no experts establishing ground truth for such a set. The "ground truth" for a display monitor relates to engineering specifications and safety compliance.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: No diagnostic test set, therefore no adjudication method for ground truth.
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
- No: This document is for a medical display monitor. MRMC studies are relevant for diagnostic algorithms or systems that assist human readers in making diagnoses. This device simply provides the visual interface.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No: This device is a display monitor, not an algorithm.
7. The type of Ground Truth Used
- Engineering Specifications and Regulatory Standards: The "ground truth" in this context refers to established technical specifications (e.g., resolution, grayscale accuracy, contrast, brightness) and compliance with electrical, mechanical, and radiation safety standards (e.g., IEC60601-1, UL60601-1, EN60601-1-2).
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: As this is a display monitor, there is no "training set" in the context of machine learning or diagnostic algorithms.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided: No training set exists for this type of device.
Summary of the Study Proving Device Meets Acceptance Criteria (as per K083916):
The "study" proving the device meets its "acceptance criteria" is a substantial equivalence demonstration to a legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. - K063579).
The manufacturer (NEC Display Solutions Ltd.) states that the L307TD Medical Display is substantially equivalent to its predicate because:
- They have the same intended use: displaying digital image diagnosis by trained physicians.
- They share the same design, performance characteristics (e.g., 4 megapixel resolution, adjustable gamma), and are the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1), and human factors.
- They use similar material.
- They have the same compatibility with environment and other devices.
- They serve the same target population of trained practitioners in a hospital setting.
This 510(k) summary (K083916) does not detail specific experiments, clinical trials, or performance metrics beyond the general statement of equivalence and the device's technical specifications relevant to its function as a display monitor. The FDA's 510(k) clearance process determined that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective as the predicate 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).