(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.
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1195 NW Compton Drive, Beaverton, OR 97006-1992, USA Phone: +1-503-748-1100 Fax: +1-503-748-1244 www.planar.com PLANAR
JAN 3 ] 2006
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Summary Date: | 8 December 2005 |
|---|---|
| 21 CFR 807.92(a)(1)Submitter's Information: | Mr. Craig HarshmanPlanar Systems, Inc.1195 NW Compton DriveBeaverton, OR 97006-1992(503) 748-4661 (Phone)(781) 895-1133 (fax)craig_harshman@planar.com (Email) |
| 21 CFR 807.92(a)(2)Device Trade Name | PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAYSYSTEM TM , Model E4c Color TM |
| Device common Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Device Classification Name: | 892.2050 Picture archiving and communications system |
| Classification Product Code | LLZ |
| Establishment RegistrationNumber | 1226517 |
| Device Class: | Class II |
| Classification AdvisoryCommittee: | Radiology |
| 21 CFR 807.92(a)(3)Predicate Devices: | The predicate devices:510(k) Number: K013922Decision Date: 01/28/2002BARCO NV, CORONIS 3MP MEDICAL FLAT PANEL DISPLAYSYSTEM TMAnd510(k) Number: K032638Decision Date: 09/11/2003Planar DOME CX TM DIGITAL FLAT-PANEL DISPLAY SYSTEM TM ,Models C3 Color TM and C3 Gray TM . |
| 21 CFR 807.92(a)(4)Device Description: | The Planar DOME EX TM DIGITAL FLAT-PANEL DISPLAY SYSTEM TM ,Models E4c Color TM is a flat panel hi-resolution LCD monitor systemsfor displaying medical images. The system consists of a LCD monitorand a high-resolution graphic control board that connects to a PACSworkstation for image display. The controller board is installed into thePACS workstation computer or other computer system used to displayPACS medical images. Cxtra is user-friendly software that purpose isto optimize the display for DICOM-compliant viewing. |
| 21 CFR 807.92(a)(5)Intended Use: | The Planar DOME DIGITAL FLAT-PANEL DISPLAY SYSTEM TM ,Model E4c TM is intended to be used in displaying and viewing medicalimages for review and analysis by trained medical practitioners. Thisdevice must not be used in primary image diagnosis in mammography. |
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21 CFR 807.92(a)(6) Substantial Equivalence:
The Planar DOME EX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™. Models E4c Color™ is substantially equivalent to the BARCO NV, CORONIS 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM™ (K013922) and the Planar DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ (K032638) in that:
- . The subsection of the system are similar in that they each consist of:
- o Display Monitor
- Graphic controller card installed in a PACS or PC. o
- Software 0
- . Intended use is same
- Performance attributes are similar .
- Follow DICOM PS3.14 "Grayscale Standard Display Function" .
This 510(k) Pre-Market Notification for the Planar DOME EX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™. Models E4c Color™ contain adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The Planar DOME EX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models E4c Color™ has been tested to various Standards and was validated for its intended use.
The Planar DOME EX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™. Models E4c Color™ will be manufactured by in accordance with voluntary and safety standards
This submission contains the results of a hazard analysis and the potential hazards have been classified as Minor
21 CFR 807.92(b) Conclusions and Statements:
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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 representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2006
Planar Systems, Inc. % Ms. Melissa J. DeGuia Project Engineer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
Re: K060136
Trade/Device Name: DOME EX™ Digital Flat-Panel Display System™, Models E4cTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 18, 2006 Received: January 19, 2006
Dear Ms. DeGuia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours.
Nancy C. Brigdon
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): K 060 136
Device Name:
DOME EX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models E4c™ .
Indications for Use:
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.
Prescription Use _XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of -1
(Posted November 13, 2003)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 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).