(76 days)
The L218TJ 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 L218TJ 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, L218TJ is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*156) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided document is a 510(k) summary for a medical display (LCD monitor), not an AI/ML device. Therefore, it does not contain information on acceptance criteria for an AI algorithm's performance, nor does it describe a study to prove such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device based on design, performance, safety, and intended use for the LCD monitor itself, not for an AI component.
Here's an breakdown of the information that can be extracted, and where the requested AI/ML specific information is not present:
Missing Information (as this is not an AI/ML device submission):
- A table of acceptance criteria and the reported device performance: This document specifies performance characteristics for an LCD monitor (e.g., resolution, grayscale), but not for an AI algorithm's diagnostic performance (e.g., sensitivity, specificity, AUC).
- Sample size used for the test set and the data provenance: Not applicable to an LCD monitor's performance evaluation in this context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information that can be extracted from the provided text, re-contextualized for a medical display:
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Acceptance Criteria and Reported Device Performance (Table – Conceptual, based on device specifications):
Acceptance Criteria (Predicate Device K063579) (Inferred) Reported Device Performance (L218TJ) 21.3" Color LCD Monitor 21.3" Color LCD Monitor 2 Mega Pixel Resolution (2048x1536 is 3MP, but predicate is 2MP) 3 Mega Pixel (2048*1536) Resolution Adjustable Gamma Grayscale (Inferred) Adjustable Gamma Grayscale Target Population: Trained practitioners in hospital Target Population: Trained physicians Intended Use: Displaying digital image diagnosis Intended Use: Displaying digital image diagnosis Design: Same (Claimed) Design: Same (Claimed) Performance: Same (Claimed) Performance: Same (Claimed) Radiation Safety (EN60601-1-2) Compliant Radiation Safety (EN60601-1-2) Compliant Mechanical Safety Compliant Mechanical Safety Compliant Electrical Safety (UL60601-1) Compliant Electrical Safety (UL60601-1) Compliant Human Factors Compliant Human Factors Compliant Compatibility with environment/other devices Compatibility with environment/other devices Exclusions: Not for life-support, not for digital mammography Exclusions: Not for life-support, not for digital mammography Note: The resolution of the predicate device is not explicitly stated in the provided text beyond "2MP". The subject device has 3MP. The claim of "same performance" could be interpreted as meeting functional display requirements rather than strict pixel count identity. -
Sample sized used for the test set and the data provenance:
- Not applicable. This is a 510(k) for an LCD monitor asserting substantial equivalence based on technical specifications and safety standards, not a clinical study involving a test set of medical data for an AI algorithm.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable.
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Adjudication method for the test set:
- Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" here is the adherence to specifications and safety standards relevant to medical displays.
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The sample size for the training set:
- Not applicable.
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How the ground truth for the training set was established:
- Not applicable.
Overall Study Described (for the medical display):
The "study" described is a comparison to a predicate device (MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd., K063579) to establish substantial equivalence. The document asserts that the new device (L218TJ) "shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors. It use similar material, and have same compatibility with environment and other device." This comparison is the basis for its clearance, not a clinical performance study with patient data.
§ 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).