(15 days)
2MP Medical Monochrome Reference Display, MDM2130-2NC 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.
2MP Medical Monochrome Reference Display - MDM2130-2NC.
The provided text does not contain information about acceptance criteria for a medical device or a study proving that the device meets those criteria.
Instead, the document is a 510(k) clearance letter from the FDA for a medical display (MDM2130-2NC). It states that the device has been found substantially equivalent to a predicate device and lists the standards it has met (Safety 60601-1, EMC - EN 60601-1-2, ITE Safety/EMC – EN 60950-1, CE, FCC), as well as DICOM conformance.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).