CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).

CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures.

When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream.

CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.

Device Description

CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.

CADstream receives DICOM magnetic resonance images from a PACS of directly from the MRI scanner. As they are received, CADstream processes and displays the results on the CADstream server or a client personal computer.

Available features support:

. Visualization (standard image viewing tools, MIPs, and reformats)
Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, apparent diffusion coefficient maps, automatic and manual segmentation and 3D volume rendering)
Reporting of user-selected findings and assessment
Interventional planning
Workflow efficiency ■
예 Communication and storage (DICOM import/export, query/retrieve, and study storage)

The CADstream system consists of proprietary software developed by Merge Healthcare installed on an off-the-shelf computer.

AI/ML Overview

The provided 510(k) summary for CADstream Version 5 (K092954) states that the device modification primarily involves adding capabilities for calculating and presenting apparent diffusion coefficient (ADC) maps and values. It emphasizes that this change is consistent with previously cleared indications for use and does not alter the fundamental scientific technology.

Therefore, the performance testing described focuses on demonstrating that the new ADC functionality meets acceptance criteria related to its implementation and the existing functionalities.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
New ADC functionality: - Correct calculation and presentation of ADC maps and values. - Integration into existing CADstream workflow. - No adverse impact on previously cleared functionalities.	The submission states: "The potential hazards of adding the ADC map functionality have been studied and controlled as part of the product development process, including risk analysis and design considerations." and "The successful completion of verification testing has demonstrated conformance to design controls, user needs, and intended use, and that the device is safe and effective."
Overall Device Safety and Effectiveness (for the modified device): - Continues to meet intended use as an image processing system for visualization, analysis, and reporting of MRI studies. - Maintains safety and effectiveness as demonstrated by the predicate devices.	The submission concludes: "Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate devices."

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

The document states "verification testing was completed" but does not provide details regarding the sample size of the test set, or the specific provenance (country of origin, retrospective/prospective nature) of the data used for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The 510(k) summary does not specify the number of experts or their qualifications used to establish ground truth for the verification testing. Given that the modification is primarily software-based for a calculation and presentation feature (ADC maps), the "ground truth" for this specific modification would likely relate to the accuracy of the algorithm's output compared to expected mathematical results or established reference methods, rather than expert interpretation of a diagnostic outcome. The general indications for use, however, mention interpretation by a "skilled physician."

4. Adjudication method for the test set

The document does not specify any adjudication method used for the test set.

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 comparative effectiveness study was done or reported in this 510(k) summary. The modification described is focused on the technical implementation of ADC calculation and presentation, not on evaluating human reader performance with or without AI assistance.

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

The provided information indicates that "verification testing was completed," but does not explicitly detail whether standalone algorithm-only performance testing was conducted for the ADC functionality. Given the nature of ADC calculation, it is highly probable that the verification testing involved evaluating the algorithm's output accuracy against known inputs or established methods, which can be considered a form of standalone performance evaluation for that specific feature. However, the document does not break down the testing in this way.

7. The type of ground truth used

For the specific modification (ADC map functionality), the ground truth would likely be mathematical accuracy and fidelity to established methods for calculating ADC values. This would involve comparing the device's calculated ADC maps and values against highly accurate reference calculations or values derived from well-defined input MRI sequences. The document does not explicitly state the type of ground truth beyond "conformance to design controls, user needs, and intended use."

8. The sample size for the training set

The 510(k) summary does not mention a training set sample size or details about any machine learning training for this specific modification. The change described (ADC map calculations) suggests a deterministic algorithmic implementation rather than a machine learning model that would require a distinct training set.

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

As no training set is mentioned, this information is not applicable and not provided in the document.

Summary

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K092954

510(k) Summary

NOV - 6 2009

This 510(k) summary is submitted as part of the PreMarket Notification in accordance with the requirements of SMDA 1990, 21 CFR 807.87(h), and 21 CFR 807.92.

1.	Date Prepared	September 22, 2009
2.	510(k) Submitter	Merge CAD Inc11040 Main Street, Suite 100Bellevue, WA 98004Phone: 425-691-1400Fax: 425-691-1599
3.	510(k) Contact Person	Brent Lewis, Director RegulatoryAffairs and Quality AssuranceEmail: brentlewis@merge.comPhone: 206-455-5398Fax: 425-691-1599
4.	Device Common Name	Image Processing System
5.	Device Trade Name	CADstream Version 5
6.	Classification Regulation	21 CFR 892.2050
7.	Class	2
8.	Panel	Radiology Panel
9.	Product Code	LLZ

10. Comparison with Legally Marketed Devices

CADstream version 5 has been modified to add capability and user interface changes for calculation and presentation of apparent diffusion coefficient (ADC) maps and values, as is common in MRI imaging systems for general MRI studies. This modification is consistent with the previously cleared indications for use and does not alter the fundamental scientific technology of the device. The primary predicate is therefore the previous clearance of CADstream 5 in K081556. Table 1 includes several additional predicate devices cleared with substantially equivalent ADC features to those being implemented for CADstream 5.

Table 1: Predicate Devices

Manufacturer	Product	Cleared 510(k)	Product Code	Classification
Merge CAD Inc	CADstream 5	K081556	LLZ	2
Cedara	I-Response	K053301	LLZ	2
Medtronic	StealthViz	K081512	LLZ	2

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11. Device Description

Available features support:

. Visualization (standard image viewing tools, MIPs, and reformats)
Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, apparent diffusion coefficient maps, automatic and manual segmentation and 3D volume rendering)
Reporting of user-selected findings and assessment
Interventional planning
Workflow efficiency ■
예 Communication and storage (DICOM import/export, query/retrieve, and study storage)

The CADstream system consists of proprietary software developed by Merge Healthcare installed on an off-the-shelf computer.

12. Indications for Use

CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally. CADstream assists users in planning MRI guided interventional procedures.

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13. Performance Testing

The subject device modification has undergone risk analysis to assess the impact of the modification on the device. Based on the risk analysis. verification testing was completed and results demonstrate that the predetermined acceptance criteria were met.

14. Conclusion

CADstream Version 5 provides features to integrate radiology department workflow by facilitating the visualization, analysis, and reporting of MR images. The potential hazards of adding the ADC map functionality have been studied and controlled as part of the product development process, including risk analysis and design considerations. The successful completion of verification testing has demonstrated conformance to design controls, user needs, and intended use, and that the device is safe and effective.

Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health and human services. The eagle is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Brent Lewis Director, Regulatory Affairs and Quality Assurance Merge CAD, Inc. (formerly Confirma, Inc.) 11040 Main Street, Suite 100 BELLEVUE WA 98004

NOV - 6 2009

Re: K092954

Trade/Device Name: CADstream® Version 5 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 20, 2009 Received: October 29, 2009

Dear Mr. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor to May 28, 1976, the enactment date of the Medical Device Amendments, or to connineroo pror to may 20, 1976, in accordance with the provisions of the Federal Food, Drug, de neces may nat (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110-) the the device, subject to the general controls provisions of the Act. The r ou may, morelore, manos 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 (PMA), it If your device is classified (boo acove) => Existing major regulations affecting your device can be may be subjoct to additions, 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 i toase of devisou has i Drivination that your device complies with other requirements of the Act that I Dri has made a determinations administered by other Federal agencies. You must or any I edelared the Act's requirements, including, but not limited to: registration and listing comply with and rice Frequirements, rt 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as sec device-related adverse events) (21 CFR Part 820); and if applicable, the electronic forth in the quality byttering (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your dontersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mup://www.lua.gov/rtbound.blogical Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radiological ground to premarket notification" (21CR Part note the regulation entined, "Misorananing of reference events under the MDR regulation (21 CFR Part 803), please go to

CHK Part 803), please go to http://www.rada.go/ Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may other general Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4

Indication(s) for Use Statement

(092954 510(k) Number:

Device Name: CADstream® Version 5

Indications for Use:

CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Halil Demur

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number_

Merge CAD Inc

CADstream 5 Special 510(k)

Page 15

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).