(10 days)
3MP Mcdical Monochrome Reference Display, MDM2130-3NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Medical Display, MDM2130-3NC is a 21.3" monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
The provided document is a 510(k) premarket notification for a medical display, not a study evaluating a device's performance against acceptance criteria for an AI algorithm. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for AI development and evaluation is not present in this document.
The document primarily focuses on establishing "substantial equivalence" of the Medical Display, MDM2130-3NC, to a predicate device (MDM1900-1NR) based on similar intended use and characteristics. It does not contain information about a clinical trial or performance study typical for AI/CAD devices.
Here's an analysis of the provided information, noting what is present and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document is for a medical display device, not an AI algorithm. It does not include specific performance metrics (like sensitivity, specificity, AUC) or acceptance criteria typically associated with AI device evaluation. The "performance" assessment here is a declaration of substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Provided. No test set data or provenance information is included as this is not a performance study for an AI algorithm.
3. 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 Provided. Ground truth establishment is not relevant for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Provided. Adjudication methods for test sets are not relevant for this type of device submission.
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
- Not Provided. No MRMC study was conducted or mentioned, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Provided. This is not an algorithm; it's a display monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Provided. Ground truth generation is not applicable to a medical display device.
8. The sample size for the training set
- Not Provided. No training set is mentioned or applicable.
9. How the ground truth for the training set was established
- Not Provided. No training set or ground truth establishment relevant to AI is mentioned.
Summary of what is available in the document:
- Device Name: Medical Display, MDM2130-3NC
- Intended Use: To display images for review and analysis by trained medical practitioners for diagnosis in CT, MRI, HIS, and PACS. Explicitly stated as "not suitable for a digital mammography system."
- Predicate Device: Medical Display - MDM1900-1NR (K061303)
- Conclusion: The device is substantially equivalent to the predicate device, sharing similar characteristics with minor differences that "do not raise new questions of safety and effectiveness."
- Regulatory Classification: Class II, 21 CFR 892.2050 (System, Image Processing, Radiological).
This document serves as a regulatory submission for a display device, focusing on its equivalence to an already approved device rather than clinical performance testing against specific diagnostic criteria.
§ 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).