CADstream is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections).

When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. CADstream can also be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues. Patient management decisions should not be made based solely on the results of CADstream analysis.

Device Description

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification.

The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an CADstream display station.

AI/ML Overview

The provided document is a 510(k) summary for the CADstream Version 2.0 MRI Image Processing Software. It does not contain detailed information about specific acceptance criteria or an explicit study proving performance against such criteria. The document focuses on the device's intended use, description, software development processes, and regulatory substantiation.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Them

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Performance testing of the features described in the user manual has been successfully completed utilizing clinical datasets" and "Software beta testing also has been completed, validating that the requirements for these features have been met." However, it does not explicitly list the acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, precision of measurements) or the quantitative results of these tests.

The document describes the device's functions:

Automatically registers serial patient image acquisitions to minimize motion impact.
Segments and labels tissue types based on enhancement characteristics (parametric image maps).
Performs user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections).
Provides accurate and reproducible measurements of the longest diameters and volume of segmented tissues.

Without explicit acceptance criteria and corresponding performance metrics, a table cannot be constructed.

2. Sample Size Used for the Test Set and Data Provenance:

The document states "Performance testing... has been successfully completed utilizing clinical datasets." However, it does not specify the sample size (number of cases or patients) used for this testing. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not provide details about the number of experts, their qualifications, or how ground truth was established for the clinical datasets used in performance testing.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance, nor does it specify any effect size or improvement. The "Intended Use Statement" notes that "When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis" and "Patient management decisions should not be made based solely on the results of CADstream analysis," implying human oversight but not a formal comparative study of reader performance.

6. Standalone (Algorithm Only) Performance Study:

The document describes the device's features and states "CADstream automatically registers... segments and labels... and performs other user-defined post-processing functions... CADstream can also be used to provide accurate and reproducible measurements..." This implies standalone algorithmic capabilities. However, it does not present a dedicated standalone performance study with quantitative metrics (e.g., sensitivity, specificity, F1-score) in isolation from human interpretation. The primary use case described involves interpretation by a skilled physician.

7. Type of Ground Truth Used:

The document refers to "clinical datasets" but does not specify the type of ground truth used (e.g., expert consensus, pathology reports, follow-up outcomes data) for evaluating the device's performance.

8. Sample Size for the Training Set:

The document does not specify the sample size of the training set used for developing the multivariate pattern recognition methods.

9. How the Ground Truth for the Training Set Was Established:

The document states that "CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification." However, it does not describe how the ground truth for training these methods was established.

In summary, the provided document is a high-level regulatory submission that attests to developmental processes and general performance testing but lacks the specific quantitative details typically found in a clinical study report regarding acceptance criteria, sample sizes, expert involvement, and explicit performance metrics.

Summary

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Summary of Safety and Effectiveness 1

Confirma, Inc. Submitter: 821 Kirkland Avenue Kirkland, WA 98033-6318 Phone: (425) 576-1226 FAX: (425) 576-9295 www.confirma.com

July 11, 2003 Date Prepared:

Patricia A. Milbank Contact Person: Regulatory Consultant Phone: (425) 497-1700 x116 pmilbank@spirationinc.com

Device Trade Name: CADstream Version 2.0

Device Common Name: MRI Image Processing Software

Classification Name: 90 LLZ

Substantially Equivalent To:

Vitrea 2: K002519 Vital Images 3300 Fembrook Lane North Suite 200 Plymouth, MN 55447-5341

AccuImage Image Display Software: K961023 AccuImage, Inc. 16303 Panormaic Way San Leandro, CA 94578-1116

Siemens BOLD MRI: K984221 Siemens Corp 186 Wood Avenue, South Iselin, NJ 08830

Voxar Plug n' View 3D: K992654 Voxar Limited Bonnington Bond, 2 Anderson Place Edinburgh, UK EH6 5 NP

Fusion 7D: K020546 Mirada Solutions Ltd Mill Street Oxford, UK OX2 OJX

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K031779

Intended Use Statement:

Device Description

The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an CADstream display station.

Software Development

The CADstream device has been designed, developed, tested and validated according to written procedures. These procedures identify functions within the organization responsible for developing and approving product specifications, coding and testing, verification and validation testing, and technical support.

Performance

The product has successfully completed the required integration and verification testing. Assessment of the product has been performed throughout the design development process in accordance with internal procedures and IEC 601-1-4.

Clinical Evaluation

Performance testing of the features described in the user manual has been successfully completed utilizing clinical datasets. Software beta testing also has been completed, validating that the requirements for these features have been met.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in flight, enclosed within a circle. The bird is depicted with three curved lines representing its wings and body. The circle surrounding the bird is not a solid line but appears to be made up of small, indistinct shapes, possibly dots or short lines. The logo is presented in black and white, with the bird and the circle standing out against a white background.

Public Health Service

AUG - 6 2003

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Patricia A. Milbank Regulatory Consultant Confirma, Inc. 821 Kirkland Avenue, Suite 100 KIRKLAND WA 98033

Re: K031779

Trade/Device Name: CADstream™ Version 2.0 MRI Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: July 11 2003 Received: July 15, 2003

Dear Ms. Milbank:

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 (PMA). it may be subject to 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 (OS) 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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Page 2

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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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FDA Indication for Use Form

Confirma, Inc. Applicant:

510(k) Number (if known): K031779

Device Name: CADstream™ Version 2.0

Indication for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Prescription Use

David A. Holzman

510(k) Numbe July 30, 2003

K031779 Confirma, Inc.

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).