(117 days)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ is intended to be displaying and viewing radiographs of the breast for review and analysis by trained medical practitioners.
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ is a flat panel hi-resolution LCD monitor system for displaying gray scale medical images for diagnostic and referral use. The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower The Displays use active maths liquit aryonal and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly displays - The Dioplay controller via a Digital Visual Interface (DVI) 1.0 interface. to a common graphios arepray stors (TFTs) control transmissive liquid-crystal elements and use integrated Cold Cathode Fluorescent Tube (CCFT) backlight systems The and use miegrated Cold Cathodo Flabroom 7 Section 1 Section of 2018 DOME CSI uisplays five megapixolo of cattle LCD display panel, integrated drive x 2500 o-bit pixers. The system mora an external power supply. Optional connections to electronics, megrated backlight, and an oxlority, including keyboard, mouse, and calibration technology.
The provided document is a 510(k) summary for the DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™, a flat panel hi-resolution LCD monitor system intended for displaying grayscale medical images for diagnostic and referral use, specifically for viewing radiographs of the breast for review and analysis by trained medical practitioners.
This document describes the device, its intended use, and its substantial equivalence to a predicate device, as required for FDA 510(k) clearance. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in performance studies for AI/software as a medical device (SaMD).
The 510(k) submission process for this type of device (a display monitor) focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and the same or similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The concept of "acceptance criteria" and "device performance" in this context refers to meeting the standards of display quality necessary for diagnostic imaging, rather than the clinical performance metrics (like sensitivity or specificity) that would be evaluated for an AI algorithm.
Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this specific type of device and its 510(k) submission.
However, based on the information present, I can infer the "acceptance criteria" as implied by the FDA clearance process for a display monitor and address other points where information is available or can be reasonably inferred.
1. A table of acceptance criteria and the reported device performance
For a medical display system like the DOME CX™, Model C5i™, the "acceptance criteria" are generally related to its technical specifications matching or exceeding those required for its intended diagnostic purpose (e.g., mammography), and demonstrating substantial equivalence to a predicate device. The document states "The new and predicate devices are both 5Million Pixel Medical Flat Panel Display Systems intended to be used in displaying and viewing radiographs for review and analysis by trained medical practitioners. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, and intended use."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: For displaying and viewing radiographs of the breast for review and analysis by trained medical practitioners. | Met: The device has the same intended use as the predicate device. |
| Display Resolution: Suitable for mammographic imaging. | Met: Five-megapixel (5MP) flat panel LCD display, similar to predicate. |
| Image Quality: Capable of displaying gray scale medical images for diagnostic and referral use. | Met: Hi-resolution LCD monitor system for displaying gray scale medical images. |
| Technological Characteristics: Similar to legally marketed predicate device. | Met: Same internal interface controller, DVI 1.0 interface, AMLCD panels, CCFT backlight systems as the predicate device. Differences do not affect safety or efficacy. |
| Safety Standards: Compliance with relevant voluntary and safety standards. | Met: Manufactured in accordance with voluntary and safety standards. Hazard analysis concluded potential hazards are Minor. |
| Substantial Equivalence: To a predicate device. | Met: Determined to be substantially equivalent to the DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model C5i™ (K032202). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a display monitor, not an AI algorithm evaluated for diagnostic performance on a dataset of patient images. The evaluation is focused on technical specifications and substantial equivalence, not a clinical test set of images.
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 applicable. There is no clinical "ground truth" derived from patient images in the context of this 510(k) submission for a display monitor.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process is described for this device.
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 applicable. This is a display monitor, not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display monitor, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Evaluation relies on technical specifications and substantial equivalence, not clinical ground truth derived from patient data.
8. The sample size for the training set
Not applicable. This is a display monitor, not an AI algorithm that requires a training set.
9. 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).