(14 days)
The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as precomputed regions-of-interest or pre-computed CAD marks from medical scanning devices.
The R2 family of Image Display Units are a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows-based CPUs, a hard drive, and various sizes of off the shelf monitors. Despite the variability in physical dimensions, all monitor display units have the identical functional specifications. R2 Uniform Image Display Software (UDS) is provided with all R2 image display units. This version of display software provides an updated user interface and CAD mark display features
The provided text for K050667, a 510(k) Premarket Notification for the R2 Family of Image Display Units with Uniform Display Software (UDS), does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) summary explicitly states:
"The family of Image Display Units with UDS Software will undergo design verification tests for conformance with specifications."
This indicates that design verification tests are planned or will be conducted to ensure the device meets its specifications, but the results or details of these tests are not provided within this document. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological specifications, rather than presenting a performance study with detailed acceptance criteria.
Therefore, many of the requested sections (Table of acceptance criteria, sample size, ground truth, MRMC study, standalone performance) cannot be filled with information from the provided document.
Here's a summary of what can be extracted based on the provided text, and where information is missing:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided document.
- Reported Device Performance: Not reported in the provided document, as performance studies are not detailed.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable as a formal performance test set is not described.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as a formal performance test set with expert-established ground truth is not described.
4. Adjudication method for the test set
- Not applicable as a formal performance test set with adjudication is not described.
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, an MRMC comparative effectiveness study was not done or at least not described in this document. The device is an "Image Display Unit" intended to display images and CAD marks, not to provide AI assistance for diagnostic interpretation that would typically necessitate such a study in 2005.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done or at least not described in this document. The device's intended use is to display images and pre-computed CAD marks, implying it's a display tool, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as a formal performance test set with ground truth is not described.
8. The sample size for the training set
- Not applicable as the document does not describe the development or training of any algorithm within the "Image Display Unit" beyond its display functionality. It is a display unit for pre-computed marks.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as above.
Conclusion:
The K050667 submission primarily focuses on demonstrating "substantial equivalence" of the R2 Image Display Units with UDS to existing predicate devices based on their intended use (displaying low-resolution, non-diagnostic medical images with annotations or CAD marks) and technological specifications. It states that design verification tests will be conducted for conformance with specifications, but the results, specific acceptance criteria, or any clinical performance studies are not detailed within this 510(k) summary. This type of submission relies on the similarity to legally marketed devices rather than extensive new clinical performance data.
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R2 Technology, Inc. R2 Image Display Units with Uniform Display Software (UDS) 510(k) Premarket Notification February 7, 2005 CONFIDENTIAL Section B-I Summary
MAR 2 9 2005
510(k) Summary Prepared February 7, 2005
-
R2 Technology, Inc. Submitted by: 1195 W. Fremont Avenue Sunnyvale, CA 94087
Richard Ball, Director of Regulatory Affairs Contact Person: -
R2 Family of Image Display Units with Product Name: R2 Uniform Display Software (UDS)
Medical Imaging Workstation Common Name:
LLZ; Class II; CFR 21 892.2050 Classification:
| Predicate Devices: | K023003 | R2 CT ImageChecker for CT |
|---|---|---|
| K042697 | ICAD Second Look Viewer | |
| K031248 | MiraMedica Consultiva | |
| K800751 | RadX, Mammolux Changers |
Description of Device:
The R2 family of Image Display Units are a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows-based CPUs, a hard drive, and various sizes of off the shelf monitors. Despite the variability in physical dimensions, all monitor display units have the identical functional specifications.
R2 Uniform Image Display Software (UDS) is provided with all R2 image display units. This version of display software provides an updated user interface and CAD mark display features
Intended Use:
The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as precomputed regions-of-interest or pre-computed CAD marks from medical scanning devices.
Comparison with Predicate Devices:
The Submission device and the predicate devices have the same intended use and equivalent technological specifications. All devices support DICOM protocol for communication of images and other medical imaging devices.
Studies:
The family of Image Display Units with UDS Software will undergo design verification tests for conformance with specifications.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
R2 Technology, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169
Re: K050667
MAR 2 9 2005
Trade/Device Name: R2 Family of Image Display Units with Uniform Display Software (UDS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: LLZ Dated: March 10, 2005 Received: March 15, 2005
Dear Mr. Christensen:
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) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket notification. The FDA miding of sacsantial of a former 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 If you desire spective advice for your device 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 Also, please note tic regulation entitled, "Albertation on your responsibilities under the Act from the 807.97). You may other general mierrational 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. Hogdon
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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R2 Technology, Inc. R2 Image Display Units with Uniform Display Software (UDS) 510(k) Premarket Notification February 7, 2005 CONFIDENTIAL
Section B-II Indications For Use
Device Name: R2 Family of Image Display Units with R2 Uniform Display Software (UDS)
The family of R2 Image Display Units with UDS software is intended to display low The failiny of RD images Displaysal images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks from medical scanning devices.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- Harry C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, B-3 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).