(15 days)
The Planar Dome® EX line Model Dome® E2c is intended to be used in displaying and viewing digital medical images for review, analysis, and diagnosis by trained medical practitioners.
This device must not be used in primary image diagnosis in mammography.
The Planar Dome® EX line Model Dome® E2c is a flat panel hi-resolution AMLCD monitor system for displaying medical images. The system consists of an AMLCD 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, the purpose of which is to optimize the display for DICOM-compliant viewing.
The provided text is a 510(k) Summary for the Planar Dome® EX line Model Dome® E2c, which is a medical image display system. The document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical performance study would.
Instead, the summary states that the device "has been tested to various Standards and was validated for its intended use" and that "Performance attributes are similar" to the predicate device. It also mentions that the device will "Follow DICOM PS3.14 'Grayscale Standard Display Function'". This implies that the acceptance criteria are related to compliance with these standards and similar performance to the predicate, rather than clinical efficacy metrics typical of AI/CAD devices.
Given the information, I will interpret "acceptance criteria" as the performance attributes and standards the device aims to meet.
Here's the breakdown of the information that can be extracted or reasonably inferred from the provided document, addressing your points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with DICOM PS3.14 "Grayscale Standard Display Function" | "Follow DICOM PS3.14 'Grayscale Standard Display Function'" |
| Performance attributes similar to predicate BARCOView, Color Coronis 2MP-21" (K052352) | "Performance attributes are similar" |
| Intended use is same as predicate device | "Intended use is same" |
| Validated for its intended use | "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 | "potential hazards have been classified as Minor" |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a clinical study with a "test set" in the context of comparing algorithm performance on medical images. The device is a display monitor. The "testing" mentioned refers to compliance with standards and validation of the display system's functionality. Therefore, information on sample size or data provenance is not applicable and not provided.
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. As a display device, there is no "ground truth" to be established by experts for image interpretation in this context. The device's performance is likely evaluated against technical specifications and display standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there is no test set for clinical interpretation.
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 MRMC study was done. This device is a display monitor and does not incorporate AI or provide assistance to human readers in the way an AI/CAD system would. Its primary function is to render images accurately.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a display device would relate to its technical specifications and adherence to display standards (e.g., DICOM grayscale display function), which are measured objectively using calibrated equipment.
8. The sample size for the training set
Not applicable. This device is a hardware display system, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This device is a hardware display system, not a machine learning model.
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Image /page/0/Picture/1 description: The image shows a close-up of a document with the word "PLANAR" at the top. Below the word "PLANAR" is a number that appears to be "2061018". The image is cropped, focusing on these elements, and the overall quality suggests it might be a scan or a photograph of a document.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Summary Date: | 2 March 2006 |
|---|---|
| 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)(503) 748-1244 (fax)craig_harshman@planar.com (Email) |
| 21 CFR 807.92(a)(2)Device Trade NameDevice common Name:Device Classification Name: | Planar Dome® EX line Model Dome® E2cSYSTEM, IMAGE PROCESSING, RADIOLOGICAL892.2050 Picture archiving and communications system |
| Classification Product Code | LLZ |
| Establishment Registration Number: | 1226517 |
| Device Class: | Class II |
| Classification Advisory Committee: | Radiology |
| 21 CFR 807.92(a)(3)Predicate Devices: | The predicate devices:510(k) Number: K052352Decision Date: 09/30/2005BARCOView, Color Coronis 2MP-21" |
| 21 CFR 807.92(a)(4)Device Description: | The Planar Dome® EX line Model Dome® E2c is a flat panel hi-resolution AMLCD monitor system for displaying medical images.The system consists of an AMLCD monitor and a high-resolutiongraphic control board that connects to a PACS workstation for imagedisplay. The controller board is installed into the PACS workstationcomputer or other computer system used to display PACS medicalimages. CXtra is user-friendly software, the purpose of which is tooptimize the display for DICOM-compliant viewing. |
| 21 CFR 807.92(a)(5)Intended Use: | The Planar Dome® EX line Model Dome® E2c is intended to be used indisplaying and viewing digital medical images for review, analysis,and diagnosis by trained medical practitioners. This device must notbe used in primary image diagnosis in mammography. |
| 21 CFR 807.92(a)(6)Substantial Equivalence: | The Planar Dome® EX line Model Dome® E2c is substantially equivalent tothe BARCOView, Color Coronis 2MP-21"(K052352) in that:The subsection of the system are similar in that they each consist of:●Display Monitor |
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- Graphic controller card installed in a PACS or PC. ୍
- o Software
- . Intended use is same
- . Performance attributes are similar
- Follow DICOM PS3.14 "Grayscale Standard Display Function" .
This 510(k) Premarket Notification for the Planar Dome® EX line Model Dome® E2c contains adequate information and data to enable FDA CDRH to determine substantial equivalence to the predicate device.
The Planar Dome® EX line Model Dome® E2c has been tested to various Standards and was validated for its intended use.
The Planar Dome® EX line Model Dome® E2c will be manufactured 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 Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 8 2006
Planar Systems, Inc. % Mr. Marc M. Mouser Senior Project Engineer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
Re: K061018
Trade/Device Name: Planar Dome® EX line Model Dome® E2c Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 5, 2006 Received: April 13, 2006
Dear Mr. Mouser:
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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The years "1906-2006" are at the top of the seal. Below the seal is the text "Protecting and Promoting Public Health" in a decorative font.
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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.
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
Sincerely yours,
Nancy C. Brogdon
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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2-5
PLANAH
Indications for Use
510(k) Number (if known): צו בי במצ
Device Name:
Planar Dome® EX line Model Dome® E2c Indications for Use:
The Planar Dome® EX line Model Dome® E2c is intended to be used in displaying and viewing digital medical images for review, analysis, and diagnosis 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)
David H. Aronson
(Division Sign-Off) Division of Reproductive, Ab 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).