(89 days)
The SMD 21500 / DSB-2103-D-5MP device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is especially designed for digital mammography applications.
The SMD 21500 / DSB-2103-D-5MP is a grayscale diagnostic medical display
This 510(k) pertains to a medical imaging display device, not an AI/ML powered device. Therefore, the questions related to acceptance criteria, ground truth, study design, and sample sizes for AI/ML performance evaluation are not applicable.
The submission is for the SMD 21500 / DSB-2103-D-5MP 5M Pixel Grayscale Flat Panel Display.
Here's a breakdown of the relevant information from the provided text for this display device:
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A table of acceptance criteria and the reported device performance:
The provided 510(k) summary and FDA letter do not detail specific acceptance criteria or performance metrics for the display device. For display devices, acceptance criteria would typically involve technical specifications such as resolution, luminance, contrast ratio, uniformity, viewing angle, and stability over time, often benchmarked against industry standards (e.g., DICOM Part 14 Grayscale Standard Display Function). Since this is a display device, performance is described in its technical characteristics as a "high-resolution display with electronic capabilities for evaluation of high-resolution medical images" and that it's "especially designed for digital mammography applications." A separate comparison chart to a predicate device is mentioned, which would contain the performance details.Acceptance Criteria (Typical for Display Devices) Reported Device Performance (Implied/General) Display Resolution High-resolution Grayscale Fidelity/DICOM GSDF Compliance Undisclosed Luminance (Brightness) Undisclosed Contrast Ratio Undisclosed Uniformity Undisclosed Viewing Angle Undisclosed Stability over time Undisclosed Designed for Mammography Yes, "especially designed for digital mammography applications." Note: The detailed technical specifications and performance against specific acceptance criteria would be in the "comparison chart to predicate device" referenced in the "Technological Characteristics" section, which is not included in the provided text.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a display device, not a diagnostic algorithm that processes medical data. -
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. -
Adjudication method (e.g. 2+1, 3+1, none) 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.
§ 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).