BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon® ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the background by applying a user selected threshold or outlining the lesion manually with a cursor.

The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the user from the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft.

When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Paticnt management decisions should not be based solely on forms generated by BRC.

The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.

Device Description

The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft.

AI/ML Overview

The provided text does not contain specific acceptance criteria or details of a study conducted to prove that the BI-RADS Companion device meets acceptance criteria. Instead, it focuses on establishing substantial equivalence to a predicate device based on functional comparisons.

Here's a breakdown of what can be extracted and what information is missing:

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

No explicit acceptance criteria or reported device performance are provided. The document focuses on a comparison of functions with a predicate device to establish substantial equivalence. The table presented compares functionalities, not performance metrics against acceptance criteria.

Function	BI-RADS Companion, Version 1.0 (K072258)	B-CAD System, Version 1.0. (K050846)
Intended as aide to radiologists' reviewing of images of masses in the human female breast	yes	yes
Windows 2000/XP based DICOM File Set Reader (FSR) compatible platform may be installed on a PC, Notebook or Workstation with HL7 compatibility	yes	yes
User interface designed to follow typical clinical workflow patterns to process, review and analyze digital images	yes	yes
User may annotate, tag, calibrate, measure and automatically record selected views	yes	yes
Automatically generates reports with user annotations during image analysis process. Allows saving custom annotations of images of confirmed cases to be used for future reference and education	yes	yes
Annotations is based on ACR ABCFL Breast Imaging Atlas	yes	yes
Report format supports compliance with ACR ABCFL	yes	yes
Outputs may be viewed and sent to standard film or paper printers or sent electronically to intranet web server or other HL7 compliant media format	yes	yes
Display multiple and full study views	yes	yes
Radiologist's BI-RADS assessment based on visual impressions of the user ABCFL	yes	yes

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

No information is provided about a test set sample size or data provenance. The submission relies on functional equivalence, not performance testing on a specific dataset.

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

Not applicable. There is no mention of a test set with established ground truth.

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

Not applicable. There is no mention of a test set or ground truth adjudication.

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 study was done, or at least, none is described in this document. The device is a viewing and reporting tool, not an AI-assisted diagnostic algorithm in the sense of providing automated interpretations that would typically be evaluated in an MRMC study for improved human reader performance.

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

No standalone performance study is mentioned. The device is intended to be used by a skilled radiologist as an aid, not as a standalone diagnostic tool. "The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation." and "Patient management decisions should not be based solely on forms generated by BRC." reinforces this.

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

Not applicable, as no performance study requiring ground truth is described.

8. The sample size for the training set

Not applicable. This device does not appear to be an AI/machine learning algorithm that requires a training set in the typical sense. It is a software tool for data entry, viewing, and report generation based on predefined BI-RADS classifications.

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

Not applicable.

Summary

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K072258

MAY 1 6 2008

510(k) Summary of Safety and Effectiveness As required by 807.92 for BI-RADS Companion Prepared on August 7, 2007 Revised October 31, 2007, January 29, 2008, April 18, 2008, May 16, 2008

Submitted by: Almen Laboratories, Inc. 1672 Gil Way Vista, CA 92084

Fax: 760-806-7577 Tel. 760-806-0040

Contact Person: Roger H. Schneider 6319 Massachusetts Avenue Bethesda, MD 20816-1139

Fax: 301-229-8485 Tel. 301-229-8442

Device Trade Name: BI-RADS Companion

Common Name: Medical Image Processing System

Classification: Class II, 21 CFR 892.2050 PACS

B-CAD System, Version 1.0 (K050846) Predicate Device:

MEDIPATTERN CORPORATION Manufactured by: 2300 Sheppard Avenue West Suite 204. Toronto, Ontario M9M 3 A4

Indications for Use

When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Paticnt management decisions should not be based solely on forms generated by BRC.

The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.

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Description of the Device:

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Substantial Equivalence to Predicate Device: BI-RADS Companion is substantially equivalent to: B-CAD System, Version 1.0. (K050846)

The following table is a comparison of the functions of the device.

	Function	BI-RADSCompanion,Version 1.0(K072258)	B-CADSystem,Version1.0.(K050846)
1	Intended as aide to radiologists' reviewing of images ofmasses in the human female breast	yes	yes
3	Windows 2000/XP based DICOM File Set Reader (FSR)compatible platform may be installed on a PC, Notebook orWorkstation with HL7 compatibility	yes	yes
4	User interface designed to follow typical clinical workflowpatterns to process, review and analyze digital images	yes	yes
5	User may annotate, tag, calibrate, measure andautomatically record selected views	yes	yes
6	Automatically generates reports with user annotationsduring image analysis process. Allows saving customannotations of images of confirmed cases to be used forfuture reference and education	yes	yes
7	Annotations is based on ACR ABCFL Breast Imaging Atlas	yes	yes
8	Report format supports compliance with ACR ABCFL	yes	yes
9	Outputs may be viewed and sent to standard film or paperprinters or sent electronically to intranet web server orother HL7 compliant media format	yes	yes
10	Display multiple and full study views	yes	yes
11	Radiologist's BI-RADS assessment based on visualimpressions of the user ABCFL	yes	yes

The intended use, design, function, and performance characteristics for BRC are substantially equivalent to the predicate device listed above. It is the opinion of Almen Laboratories, Inc., that BRC raises no new issues of safety and effectiveness compared to these predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized representation of the body and legs.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ALMEN LABORATORIES, Inc. % Mr. Roger Schneider Consultant Medical & Radiation Technology 6319 Massachusetts Avenue BETHESDA MD 20816

MAY 1 6 2008

Re: K072258

Trade/Device Name: BI-RADS Companion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 20, 2008 Received: March 21, 2008

Dear Mr. Schneider:

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. Ilsting 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 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.

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Page 2

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division 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/cdrh/industry/support/index.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

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Indications for Use

510(k) Number (if known): K072258

Device Name: BI-RADS Companion

Indications For Use:

BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon®" ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the lesion from the background by applying a user selected threshold or outlining the lesion manually with a cursor.

When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Patient management decisions should not be based solely on forms generated by BRC.

The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Nancy C Brogdon

ctive. A Radiological De 510(k) Number

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).