(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.
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КОНО443
JUN 1 6 2004
400 Fifth Avenue, Waltham, MA 02451-8738, USA Phone: +1-781-895-1155 Fax: +1-781-895-1133 www.planar.com
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
January 19, 2004
Submitter's Information: 21 CFR 807.92(a)(1)
Planar Systems, Inc. 400 Fifth Ave. Waltham, MA 02451-8738 USA
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM |
|---|---|
| Model C5i™ | |
| Common Name: | Mammographic X-ray System |
| Classification: | 892.1710 |
| Name: | System, Image Processing |
Predicate Devices: 21 CFR 807. 92(a)(3)
| Device | SYSTEM, IMAGE |
|---|---|
| Classification | PROCESSING, |
| Name | RADIOLOGICAL |
| Regulation Number | 892.2050 |
| 510(k) Number | K032202 |
| Device Name | DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™,Model C5i™ |
| Applicant | Planar Systems, Inc.400 Fifth AveWaltham, MA 02451-8738 |
| Product Code | 90 LLZ |
Device Description: 21 CFR 807 92(a)(4)
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
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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.
Indications for Use: 21 CFR 807 92(a)(5)
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.
Technological Characteristics: 21 CFR 807 92(a)(6)
oglour one is an image display system consisting of computer software and components. The device is an image uisplay byotont bonoloing or control any life sustaining devices. A The device does not contact the pation, nor ides ample opportunity for competent human intervention to interpret images and information being displayed.
Conclusion: 21 CFR 807 92(b)(1)
- John 21 OF C OF C OF C ( ) DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model . C5i™ is substantially equivalent to the predicate device, DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model C5i™.
- The new and predicate devices are both 5Million Pixel Medical Flat Panel Display . The hew and predicate do need in be displaying and viewing radiographs for review and Systems intendod to be acou in title new device and predicate devices are analysis by trainou mot in the areas of technical characteristics, general function, substantially cquivalent in the arous ofference between the two devices does not affect safety or efficacy.
- The 510(k) Pre-Market Notification for the DOME CX™ DIGITAL FLAT-PANEL DISPLAY . SYSTEM™, Model C5i™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices.
- The Planar Systems, Inc., DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, . 11:01 tarar e your be manufactured by in accordance with voluntary and safety standards.
- The submission contains the results of a hazard analysis and the potential hazards have . been classified as Minor.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2004
Dome Imaging Systems, Inc. % Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K040443 18-16-11-15
Trade/Device Name: DOME™ CX Digital Flat-Panel Display System™ Model C5iTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 27, 2004 Received: June 1, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > Po(x) premainted in equivalent (for the indications referenced above and nave uctering a the actived predicate devices marketed in interstate for use stated in the encrosure, to regally manatiment date of the Medical Device Amendments, or to commerce prof 10 May 28, 1976, the enactined with the provisions of the Federal Food, Drug, devices that have been reclassined in according approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket af the and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the device, subject to include registration, listing of
general controls provisions of the Act include requirements for any and general controls provisions of the rice nellations against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined (see above) mio existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA mo may be subject to such additional controller Litter & Parts 800 to 898. In addition, FDA may be found in the Code of Poderal England Stages in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a saccession of the requirements of the Act of the Act one mate agempl that FDA has made a determination had your do to received agencies. You must comply
or any Federal statutes and regulations administered by other Federal and CEP Pat or any Federal statures and regulations administration and listing (2) CFR Patt (2) CFR Patt with all the Act STequirements, melaaning, out her man and manufacturing as set forth in the 807), labeling (21 CFR Part 001), good handler and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1000-1060 quality Systems (QS) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
In a legally This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of subsition for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the same of the same of a to a transmall on the same on the regulation If you desire specific advice for your device on our last ling ages on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotive and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please of their . Other accepted Office of Compliance at (301) 374-1057. This, pressed 377) you may obtain. Other general by reference to premarket nonmeanon - (Dr of Act may be obtained from the Division of Shall information on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, International and Ochounter one of the courted.html dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040443
Device Name: Device Name.
DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ from Planar Systems, Inc.
Indications For Use:
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5¡™ is The DOME OX - Dictirite Feing and viewing radiographs of the breast for intended to be boos by trained medical practitioners.
Prescription Use __________________ ANB/OR Over-The-Counter Use ______________________________________________________________________________________________________________ | Tooonption 01 Subpart D) (21 CFF 807 Subpart C) (Part 21 CFR 801 Subparto) (21 OF Froof Subjar 0)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concyrrence of CDRH, Office of Device Evaluation (ODE)
Luvila Segura
Page 1 of 1
(Division Sign-Cit) Division of Reproductive, Abdominal, and Radiological Device 510(k) ! Number
§ 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).