(14 days)
2MP Medical Color Reference Display, MDC2130-2HC 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, MDC2130-2HC is a 21.3" color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600 x 1200) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
The provided text describes a 510(k) premarket notification for a medical display device (MDC2130-2HC). However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to AI performance, ground truth, or sample sizes for a study.
The document is a regulatory submission for a display monitor, which does not typically involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that AI/CAD devices require. The core of this submission is to demonstrate substantial equivalence to a predicate device based on its intended use and general characteristics, not on a clinical performance study.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance criteria but inferred from the "sameness" claim to the predicate device. The primary acceptance criterion for a display is likely its ability to accurately and reliably display medical images. This would include resolution, color/grayscale accuracy (e.g., DICOM GSDF adherence), brightness, contrast, and stability over time.
- Inferred Technical Acceptance Criteria:
- Resolution: 2 mega pixel (1600 x 1200)
- Gamma settings: DICOM GSDF Gamma settings (1.8, 2.0, 2.2)
- Inferred Technical Acceptance Criteria:
- Reported Device Performance:
- Resolution: 2 mega pixel (1600 x 1200)
- Gamma settings: Supports DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2.
- Intended Use: Displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS.
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a medical display, not a diagnostic AI device that would undergo a test set evaluation for diagnostic performance. The substantial equivalence argument relies on comparing technical specifications and intended use, not clinical performance data from a patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. See point 2.
4. Adjudication method for the test set:
- Not applicable. See point 2.
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:
- No. This is a medical display, not an AI device. An MRMC study would not be conducted for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device (display), not an algorithm.
7. The type of ground truth used:
- Not applicable. The "ground truth" for a medical display typically relates to objective display characteristics (e.g., a calibrated photometer verifying luminance levels and DICOM GSDF curve adherence) rather than diagnostic outcomes. These tests are typically performed in a lab setting rather than using patient data with expert-established ground truth.
8. The sample size for the training set:
- Not applicable. This is a hardware device and does not involve AI model training.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Study Proving Acceptance Criteria:
The document states: "Medical Display, MDC2130-2HC has the same intended use as the predicate device MDC1900-1LG, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness."
This statement implies that the "study" proving the device meets acceptance criteria is primarily a comparison to a legally marketed predicate device (MDC1900-1LG), demonstrating "substantial equivalence." The acceptance criteria are essentially met by demonstrating that the new device's technical specifications and performance are comparable to the predicate, and that any differences do not introduce new safety or effectiveness concerns. There is no detailed study methodology or results provided within this summary for either device. Regulatory submissions for display monitors typically include technical specifications and adherence to relevant industry standards (e.g., DICOM Part 14 for grayscale display, resolution standards) rather than clinical performance studies.
§ 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).