MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic radiological images and information about these images in a single user or network environment. Typical users of MEDImage are trained medical professionals.

Device Description

MEDImage is a software package designed to acquire analogue and digital images from any modality, store and archive these images together with patient information on hard disk and/or on long-term media such as standard optical disks; search for and retrieve these images for re-consultation, processing and/or transmission. MEDImage utilizes industry standard equipment.

AI/ML Overview

This document is a 510(k) summary for the VEPRO MEDImage Picture Archiving and Communications System (PACS). It primarily focuses on establishing substantial equivalence to a predicate device (Siemens PACS/I-A (K880690)) rather than providing detailed acceptance criteria and a study report with performance metrics for the MEDImage device itself.

Based on the provided text, there is no specific information describing acceptance criteria or a dedicated study proving the device meets performance criteria in the way a modern medical device submission typically would for a novel algorithm.

Here's a breakdown of why and what information is available:

There is no table of acceptance criteria and reported device performance because the submission's focus is on substantial equivalence to an existing PACS system and its functionality as a Class I device (which does not require a demonstration of clinical performance that relies on outcome or diagnostic accuracy measurements).

The document states:

"MEDimage is a software package designed to acquire analogue and digital images from any modality, store and archive these images together with patient information on hard disk and/or on long-term media such as standard optical disks; search for and retrieve these images for re-consultation, processing and/or transmission. MEDImage utilizes industry standard equipment."
"MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic radiological images and information about these images in a single user or network environment."

These descriptions define the functionality and intended use of the device, implying that its performance is measured by its ability to reliably perform these functions, which would have been demonstrated through system testing and validation, but not explicitly summarized here with specific metrics.

Here's a summary of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance:

Not provided. The submission focuses on substantial equivalence based on functionality and intended use aligning with a predicate device, rather than specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy or algorithmic performance.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. This type of information would be relevant for a device performing automated analysis or diagnosis, which MEDImage is not presented as. The document does not describe a "test set" for evaluating algorithmic performance on 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/Not provided. This information is typically relevant for studies evaluating the diagnostic accuracy or classification performance of an algorithm. MEDImage is a PACS system, and its performance is not assessed in this manner in this submission. The document states, "Evaluation of the output is performed by health care professionals and provides adequate opportunity for competent human intervention," indicating human oversight.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. As there's no mention of a test set for diagnostic performance, there's no adjudication method 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 study was not done. This document pertains to a Picture Archiving and Communications System (PACS), not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not described or relevant for this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This device is a PACS, which is fundamentally a human-in-the-loop system for image management and display, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not provided. Ground truth is not discussed in the context of diagnostic accuracy, as this is not an AI diagnostic algorithm.

8. The sample size for the training set:

Not applicable/Not provided. This device is a software package for managing images, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As there is no training set for a machine learning model, ground truth establishment is not relevant in this context.

In summary:
This 510(k) submission for VEPRO MEDImage focuses on demonstrating substantial equivalence to a predicate PACS device (Siemens PACS/I-A (K880690)) based on its intended use and functional capabilities (acquiring, displaying, processing, archiving, retrieving, and transmitting images). It does not present specific acceptance criteria or performance study results related to diagnostic accuracy, as would be expected for an AI-powered diagnostic algorithm. The device is classified as Class I, meaning it is subject to general controls and FDA believes it poses a low risk, with "adequate opportunity for competent human intervention."

Summary

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Image /page/0/Picture/0 description: The image shows the company name and address of VEPRO GmbH. The address is An der Tuchbleiche 26, 64319 Pfungstadt. The text is black and the background is white.

Document Mail Center (HFZ - 401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard

Image /page/0/Picture/2 description: The image shows a logo with a check mark and the word "VEPRO" in bold letters. Below the logo, the word "Computersysteme" is written in a smaller font. The text "K972215" is handwritten below "Computersysteme". The date "NOV 1 9 1997" is printed at the bottom of the image.

Rockville, Maryland 20850 USA

510(K) SUMMARY

This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with requirements of SMDA 1990.

The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to Siemens PACS/1-A (K880690). This data is summarized as follows:

MEDimage has been and will be manufactured in accordance with the voluntary 1. standards listed in the enclosed voluntary standard survey.
The MEDimage User's Guide contains comprehensive and extensive information on 2. how to operate the system.
This submission contains the results of a hazard analysis. 3.

Submitter:

Harald G. Roth VEPRO-Computersysteme GmbH An der Tuchbleiche 26 D -64319 Pfungstadt Germany tel. (06157) 800 600 fax.(06157) 800 666

contact person:

Ms. Cissis Cox VEPRO-Computersysteme GmbH An der Tuchbleiche 26 D - 64319 Pfungstadt Germany tel. (06157) 800 600 fax.(06157) 800 666

Summary Prepared on:	06. June 1997
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Trade name:

MEDImage

Common name:

Picture Archiving and Communications System (PACS)

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Image /page/1/Picture/0 description: The image shows the logo for VEPRO Computersysteme. The logo features a large checkmark to the left of the word "VEPRO" in bold, sans-serif font. Below the word "VEPRO" is the word "Computersysteme" in a smaller, less bold font.

Classification name:

No formal classifications have been issued for Picture Archiving, and Communications Systems (PACS) or components, under Section 513 of the Food, Drug, and Cosmetic Act. Images from the VEPRO MEDImage system may be used for primary diagnosis as do other PACS Systems; however, these systems are not represented to be used in supporting or sustaining human life, nor do they present a potential for unreasonable risk of illness or injury. Evaluation of the output is performed by health care professionals and provides adequate opportunity for competent human intervention. Therefore, we believe that all digital archives meet the requirements of a Class I Device.

VEPRO claims Substantial Equivalence to: Siemens PACS/I-A (K880690)

Device Description:

Intended Use:

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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1997

Cissie Cox . Sales Support Vepro Computersysteme GMBH An der Tuchbleiche 26 D-64319 Pfungstadt, Germany

K972215 Medimage Dated: September 26, 1997 Received: October 2, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Ms. Cox:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrf/dsmamain.html".

Sincerely yours,

W. Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT 3

510(k) Number:_

Device Name: MEDImage

Indications For Use:

MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic medical images and information about these images in a single user or network environment. The typical users are trained medical professionals.

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).