(11 days)
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
VitreaACCESS software specifically allows remote review of Vitrea® outputs.
The provided text doesn't contain a detailed study with specific acceptance criteria and performance metrics for the VitreaACCESS™ 1.0 Medical Image Processing Software. It primarily focuses on the regulatory submission (510(k) summary) for the device.
However, based on the information provided, here's what can be extracted and inferred regarding the "studies" mentioned:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria or detailed performance metrics (sensitivity, specificity, accuracy, etc.) are provided in the document. The "performance" described is in very general terms related to software development and validation processes.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Successfully complete verification testing prior to Beta validation | VitreaACCESS software will successfully complete verification testing prior to Beta validation. |
| Successfully complete Beta testing/validation prior to release | Software Beta testing/validation will be successfully completed prior to release. |
| Adherence to written procedures for development, testing, validation, and maintenance | The software utilized was developed, tested, and validated according to written procedures. |
| Control of potential hazards through a Risk Management Plan | Potential hazards have been studied and controlled by a Risk Management Plan. |
| Substantial equivalence to predicate device regarding safety and effectiveness | VitreaACCESS software is substantially equivalent to the predicate device, with minor technological differences not raising new safety or effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "verification testing" and "Beta testing/validation" but does not give any numbers for the test cases or datasets used.
- Data Provenance: Not specified. There is no mention of the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not specified. The document does not mention the use of experts to establish ground truth for any test set. The validation seems to be focused on software functionality and adherence to internal procedures rather than clinical performance evaluated by experts.
4. Adjudication Method:
Not specified. Since there is no mention of experts establishing ground truth or a clinical evaluation, an adjudication method is not discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned or described. The document does not compare human readers with or without AI assistance.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
Not specified in terms of clinical performance metrics. The document describes software "verification testing" and "Beta testing/validation" which relate to the algorithm's functionality and bug-free operation, but not a standalone clinical performance study typically associated with AI algorithms (e.g., diagnostic accuracy compared to ground truth).
7. The Type of Ground Truth Used:
Not explicitly stated. Given the context, the "ground truth" for the software's functionality and validation appears to be defined by:
- Internal product specifications and requirements.
- Successful execution of pre-defined test cases during verification and beta testing.
- Adherence to risk management plans.
It does not appear to be based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set:
Not applicable. This device is described as "Medical Image Processing Software" intended for "remote review of Vitrea2 Software outputs." It is not presented as an AI/ML algorithm that requires a training set in the conventional sense to learn patterns from data. It appears to be a software tool for viewing and processing existing outputs.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there's no mention of a training set for an AI/ML algorithm.
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Kot 2328
6.0 510(k) Summary
Submitter's Name / Contact Person
AUG 2 1 2006
Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343
General Information
| Device Trade Name | VitreaACCESS TM 1.0 - Medical Image Processing Software |
|---|---|
| Common / Usual Name | System, Image Processing, Radiological |
| Classification | 892.2050 Picture Archiving and Communications System(LLZ; Class II) |
| Identification ofPredicate Devices | VITALConnectTM System- formally The iConnection System(K040876)Vital Images, Inc.Vitrea Version 3.9 (K061624)Vital Images, Inc. |
Device Description
VitreaACCESS software specifically allows remote review of Vitrea® outputs.
Intended Use
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
Predicate Device Comparison
VitreaACCESS software and its predicate device allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices. All devices support the DICOM protocol for communication of images with other medical imaging devices.
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Summary of Studies
The software utilized was developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.
VitreaACCESS software will successfully complete verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.
Conclusion
VitreaACCESS software has a similar intended use as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness. Thus, VitreaACCESS software is substantially equivalent to the predicate device.
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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 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 Blvd. Rockville MD 20850
AUG 2 1 2006
Vital Images. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K062328
Trade/Device Name: VitreaACCESS™ 1.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 8, 2006 Received: August 10, 2006
Dear Mr. Job:
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 is a circular logo with the text "1906 - 2006" at the top. Below the text is the abbreviation "FDA" in large, bold letters. Underneath the abbreviation is the word "Centennial" in a smaller font. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
Protecting and Promoting Public Health
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri- 3 issualles of a complies with other requirements of the Act that I DA has made a concentrations administered by other Federal agencies. You must of any I coclar statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Fart 607), favoring (21 CFR Part 800), go CFR Part 820); and If applicable, the electronic forth in the quality systems (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) I ins letter with anow you'ls begin mains of substantial equivalence of your device to a legally premits thousand. The PDF mailing of basis on 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 If you desire specific actives at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, prease note the regulation other general information on your responsibilities under (21CTN I at 601.577). 10d may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely 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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3.0 Intended Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: VitreaACCESS™ 1.0 Medical Image Processing Software
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
Prescription Use __ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Daniel A. Searson
Page __ of ___________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdomina 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).