(146 days)
This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. The display is not intended for mammography.
The 21HK512D is a 21.3" LCD display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc.
The provided text describes a 510(k) premarket notification for a medical monitor (21HK512D) by LG Electronics Inc. It focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce RX350). The key takeaway regarding this device's performance validation is: No clinical studies were considered necessary and performed.
Therefore, the requested information regarding acceptance criteria, proven device performance through a study, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from this document, as a clinical performance study was not conducted for this device.
The document primarily relies on non-clinical testing for electrical safety, electromagnetic compatibility, usability, and software validation. It asserts substantial equivalence based on comparable intended use and technological characteristics with the predicate device.
Here's a breakdown of what can be extracted and why other points cannot:
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A table of acceptance criteria and the reported device performance
- Not applicable for clinical performance. The document states "No clinical studies were considered necessary and performed."
- For non-clinical tests, it states compliance with standards:
- Acceptance Criteria (Implied): Compliance with IEC 60601-1:2005/AMD1:2012 (Electrical Basic Safety and Essential Performance), IEC 60601-1-2 Edition 4.0:2014 (Electromagnetic Compatibility), and IEC 60601-1-6:2010/A1:2013 (Usability).
- Reported Performance: "The test results demonstrated that the proposed device complies with the following standards." (For software: "The 21HK512D contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.")
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for clinical performance. No clinical test set was used.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No clinical test was performed with associated ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test was performed.
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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. This device is a medical monitor, not an AI-assisted diagnostic tool. No MRMC study was done.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (monitor), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical performance study was conducted.
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The sample size for the training set
- Not applicable. This device does not use a training set as it's a monitor, not an AI algorithm.
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How the ground truth for the training set was established
- Not applicable. This device does not use a training set.
In summary, the provided text details the regulatory submission for a medical monitor and explicitly states that no clinical studies were performed. The device's safety and effectiveness were demonstrated through non-clinical testing and a comparison of technological characteristics to a predicate device, as opposed to a performance study involving patient data or expert readers.
§ 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).