(14 days)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are flat panel hi-resolution LCD monitor systems for displaying gray scale medical images for diagnostic and referral use. The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower electro-magnetic emissions and heat, and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly to a common graphics display controller via a Digital Visual Interface (DVI) 1.0 interface. The Displays' Thin Film Transistors (TFTs) control transmissive liquid-crystal elements and use intedrated Cold Cathode Fluorescent Tube (CCFT) backlight systems. The DOME C2 displays two megapixels of data in a portrait or landscape orientation of 1200 x 1600 8-bit pixels. The DOME C5i displays five megapixels of data in a portrait or landscape orientation of 2048 x 2560 8-bit pixels. Both display systems include the LCD display panel, integrated drive electronics, integrated backlight, and an external power supply. Optional connections to USB can provide enhanced system functionality, including kevboard, mouse, and calibration technology.
Here's an analysis based on the provided text, outlining the acceptance criteria and the study details:
Device: DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K032202) is a 510(k) summary for a medical device. For image display systems, the acceptance criteria are generally related to demonstrating substantial equivalence to a legally marketed predicate device rather than specific performance metrics like sensitivity or specificity for disease detection. The performance is assessed against the predicate's established technical characteristics and intended use.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Intended Use | Must be for displaying and viewing medical images for review and analysis by trained medical practitioners. | The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. (Matches predicate's implied intended use). |
| Technological Characteristics | Must demonstrate similar basic technological design for displaying grayscale images (e.g., flat panel, active matrix liquid-crystal display, integrated backlight). | The DOME CX™ uses active matrix liquid-crystal display (AMLCD) panels, integrated drive electronics, integrated backlight, and an external power supply. The DOME C2 displays two megapixels (1200 x 1600 pixels) and the DOME C5i displays five megapixels (2048 x 2560 pixels). These specifications align with the 2MP and 5MP predicate devices (CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM and CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM) in terms of pixel count and general technology. The document states: "The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use." |
| Safety and Efficacy | Must not raise new questions of safety or efficacy compared to the predicate device. | The device "does not contact the patient, nor does it control any life sustaining devices." It relies on "competent human intervention to interpret images." A hazard analysis was performed, and potential hazards were classified as "Minor." The conclusion explicitly states: "Any difference between the two devices does not affect safety or efficacy." |
| Regulatory Compliance | Must comply with relevant voluntary and safety standards. | The device "will be manufactured by in accordance with voluntary and safety standards." (Specific standards are not listed in this summary but are implied to be part of the full submission). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set of medical images or data. The evaluation is focused on the device's technical specifications and how they compare to a predicate device, as this is a 510(k) for a display system, not an algorithm that interprets images. The "performance" being evaluated is the display's ability to render images according to its specifications, which are deemed equivalent to the predicate. Therefore, there's no mention of:
- Sample size for a test set
- Data provenance (country of origin, retrospective/prospective)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, there isn't a test set of images requiring expert ground truth for this type of device (a display system). The assessment is on the display's characteristics themselves.
4. Adjudication Method for the Test Set
Not applicable, as there is no test set or clinical endpoint requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
Not applicable. This is a display system, not an AI algorithm designed to assist human readers in image interpretation. Therefore, an MRMC study demonstrating human reader improvement with AI assistance would not be relevant for this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a display system, not an algorithm. Its function is to present images for human interpretation, not to provide standalone diagnostic output.
7. The Type of Ground Truth Used
Not applicable. There is no diagnostic "ground truth" established as part of this submission, as the device's function is image display, not image analysis or diagnosis. The "ground truth" in this context would implicitly be the technical specifications (e.g., pixel count, luminance, contrast) of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a display system; it does not employ machine learning or require a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).