(12 days)
The Planar DOME DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model E4c™ is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
This device must not be used in primary image diagnosis in mammography.
The Planar DOME EX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models E4c Color™ is a flat panel hi-resolution LCD monitor systems for displaying medical images. The system consists of a LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images. Cxtra is user-friendly software that purpose is to optimize the display for DICOM-compliant viewing.
The provided text describes a 510(k) summary for the Planar DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model E4c Color™. This document is a pre-market notification for a medical device seeking clearance from the FDA, asserting that the new device is substantially equivalent to existing legally marketed predicate devices.
The information provided focuses on the regulatory aspects and comparison to predicate devices, rather than a detailed study design proving performance against specific acceptance criteria for an AI model. This device is a display system, not an AI diagnostic algorithm. Therefore, many of the requested items related to AI study design (like sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this type of medical device submission.
Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not present or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for an AI algorithm's performance. Instead, it asserts substantial equivalence based on similarities to predicate devices in terms of:
| Acceptance Criteria (Implied from Substantial Equivalence Claim) | Reported Device Performance (Implied from Substantial Equivalence Claim) |
|---|---|
| Similar device components (Display Monitor, Graphic controller card, Software) | System consists of LCD monitor and high-resolution graphic control board. Cxtra software for optimizing DICOM-compliant viewing. |
| Same intended use | The device is for displaying and viewing medical images for review and analysis by trained medical practitioners (with a caveat against mammography primary diagnosis). |
| Similar performance attributes | Performance attributes are similar to predicate devices. |
| Follows DICOM PS3.14 "Grayscale Standard Display Function" | Follows DICOM PS3.14 "Grayscale Standard Display Function". |
| Validated for intended use | Has been tested to various Standards and was validated for its intended use. |
| Manufactured in accordance with voluntary and safety standards | Will be manufactured in accordance with voluntary and safety standards. |
| Hazard analysis classifies potential hazards as Minor | Hazard analysis classifies potential hazards as Minor. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not applicable and not mentioned. This is a display system, not an AI algorithm evaluated on a dataset of cases.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable and not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable and not mentioned. The device is a display, and there is no mention of a ground truth established by experts for performance evaluation in the context of diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable and not mentioned.
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 study is not relevant to an MRMC comparative effectiveness study, as the device is a display system and not an AI assistant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm, so a standalone performance evaluation of an algorithm is not applicable.
7. The type of ground truth used
- Not applicable. The "ground truth" for this device would be its technical specifications (e.g., luminance, resolution, color accuracy) meeting industry standards (like DICOM PS3.14) and functional requirements for displaying medical images, not diagnostic outcomes or pathology reports. The document states it "has been tested to various Standards and was validated for its intended use."
8. The sample size for the training set
- Not applicable and not mentioned. There is no AI model or training set involved.
9. How the ground truth for the training set was established
- Not applicable and not mentioned. There is no AI model or training set involved.
§ 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).