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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.

Device Description

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.

AI/ML Overview

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.

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K Number

K983815

Device Name

PACSCACHE

Manufacturer

DOME IMAGING SYSTEMS, INC.

Date Cleared

1999-01-14

(78 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K970064,K925994

Predicate For

N/A

Intended Use

PACScache is an integrated client server software system designed to allow rapid access to radiographic data (specifically high resolution images) through out the radiology department as well as the entire hospital or clinical setting. The product is intended to enable review of images through clinical information systems and allow review of images on a digital picture archiving and communication system (PACS) network using a personal computer or workstation configured for standard internet access.

Device Description

PACScache is an imaging software program used to view medical images on a personal computer. The software is designed to function with off-the-shelf hardware and software products including standard communications products. Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the scanner.

AI/ML Overview

The provided document is a 510(k) summary for the PACScache device, an imaging software program for viewing medical images. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way that would typically be expected for demonstrating the safety and effectiveness of a device using a formal study.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices (Articas Web/Intranet Server K970064 and RSTAR's Image Management System K925994). This regulatory pathway for low-risk devices often relies on comparisons to existing technology rather than requiring de novo studies with specific performance targets.

Therefore, many of the requested categories of information cannot be extracted from this document, as they were likely not part of the submission for this particular device.

Here's a breakdown of what can be inferred or directly stated, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative metrics for accuracy, sensitivity, specificity, etc. The submission focuses on substantial equivalence to predicate devices.	The document states PACScache has "Indications for Use similar to other image viewing software products such as AMICAS (510k # K970064)." It also notes it "uses the same target endusers (competent health professionals)" and "is designed to operate with off-the-shelf hardware and systems" like the predicate devices. It "employs JPEG image compression to remove redundant or unimportant information in the original data," similar to predicate devices that use JPEG and wavelet compression.

Acceptance Criteria

Reported Device Performance

Not explicitly defined in terms of quantitative metrics for accuracy, sensitivity, specificity, etc. The submission focuses on substantial equivalence to predicate devices.

The document states PACScache has "Indications for Use similar to other image viewing software products such as AMICAS (510k # K970064)." It also notes it "uses the same target endusers (competent health professionals)" and "is designed to operate with off-the-shelf hardware and systems" like the predicate devices. It "employs JPEG image compression to remove redundant or unimportant information in the original data," similar to predicate devices that use JPEG and wavelet compression.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not mentioned.
Data provenance: Not mentioned. The document states it views "files generated by a medical scanning device and acquired according to the dominant industry standard communications format (DICOM 3.0)," but doesn't detail any specific dataset used for testing. The "test set" in the context of this submission would likely refer to internal verification and validation against software requirements, rather than a clinical dataset for performance evaluation against a gold standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. It's unlikely such ground truth establishment was required or performed for this type of software's 510(k) submission, which emphasizes "viewing" and "imaging software program" functionality rather than diagnostic interpretation.