(14 days)
The L217TG 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. The L217TG 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, L217TG is a 21.3" Color LCD monitor that displays image for medical use. I It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided text describes a 510(k) premarket notification for a medical display device, the NEC MD212 MC 21.3" Diagnostic Imaging LCD monitor (Model L217TG). The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria in a typical clinical performance study sense.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a dedicated performance study for the device's diagnostic capabilities. Instead, it relies on demonstrating substantial equivalence to a predicate device (MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd.) based on shared design, performance, and safety characteristics.
The "performance" referred to is about the characteristics of the monitor itself, not a clinical diagnostic performance.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (L217TG) |
|---|---|---|
| Resolution | 2 mega pixel (1600x1200) (from predicate: K063579 is also 2MP) | 2 mega pixel (1600x1200) |
| Display Type | Color LCD monitor | Color LCD monitor |
| Intended Use | Displaying digital image diagnosis by trained physicians (excluding mammography, not for life-support) | Displaying digital image diagnosis by trained physicians (excluding mammography, not for life-support) |
| Gamma/Grayscale | Adjustable gamma gray scale for precise diagnostic use | Adjustable gamma gray scale for more precise diagnose use |
| Safety | EN60601-1-2 (radiation safety), UL60601-1 (electrical safety), Mechanical safety, Human factors compliance | Same as predicate (EN60601-1-2, UL60601-1, mechanical safety, human factors) |
| Interconnection | IEC60601-1 certified equipment | Exclusive interconnection with IEC60601-1 certified equipment |
| Compatibility | Consistent with predicate for environment and other devices | Same compatibility with environment and other devices |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical performance evaluation with patient data. The evaluation is for an imaging display device, not an AI algorithm or a diagnostic test directly analyzing patient images. Therefore, questions regarding data provenance and retrospective/prospective studies are not applicable in this context. The "test" would involve technical specifications and safety compliance for the monitor itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. This is a technical device submission, not a study evaluating diagnostic performance against a ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No. This document pertains to a medical display device, not an AI system. Therefore, an MRMC study and AI-related effect sizes are not applicable.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No. This is a medical display device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for a medical display device would be its technical specifications and compliance with safety standards, not a diagnostic outcome.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm or a device that "learns" from a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
Summary of the Study/Evaluation Process for K083907:
The "study" in this context is a substantial equivalence determination process. The manufacturer (NEC Display Solutions Ltd.) compared their new device, the L217TG medical display, to an already legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. K063579).
The key argument for acceptance (or substantial equivalence) is presented in section 7 ("CONCLUSION"):
- Comparison Basis: The two devices have the "same target population of trained practitioner in hospital."
- Shared Characteristics: They share "the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors." They also use "similar material" and have "same compatibility with environment and other device."
- Intended Use: Both devices have the "same intended use."
- Evidence: A "Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3" (though Section 3 itself is not provided in your input, the summary implies the comparison was successful).
Therefore, the device meets its "acceptance criteria" by demonstrating that its technical specifications, safety profile, and intended use are functionally identical or very similar to a legally marketed predicate device, as required for a 510(k) clearance.
§ 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).