ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions.

The intended use of ViewStation is to provide health care facility personnel with an efficient and effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images.

Device Description

The primary function of ViewStation is to provide a means to move image information in a therapy or treatment environment. ViewStation provides the ability to import, view, annotate, manage, and archive patient images during the course of therapy, treatment, and follow-up.

ViewStation imports existing digital images acquired or generated by other products. ViewStation retains the original image, which was acquired or generated by a third party product.

AI/ML Overview

The provided text describes a Premarket Notification (510(k)) Summary of Safety and Effectiveness for "ViewStation, Image Processing System" by IMPAC Medical Systems, Inc. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics typically seen for standalone diagnostic AI/ML devices.

Here's an analysis based on the provided text, highlighting what is present and what is absent in relation to your request:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics in the way one would expect for a diagnostic or AI/ML algorithm that generates specific output values (e.g., accuracy, sensitivity, specificity, AUC).

Instead, the "acceptance criteria" can be inferred from the document's claims about equivalency and safety:

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Safety: No increase in health or safety risk to patients, users, or third parties.	System Hazard Analysis performed, reviewed, and implemented (SHA2101). Design Review Team determined no increase in risk.
Effectiveness: Algorithms function exactly as intended.	Engineering testing performed and demonstrated successful implementation of algorithms and functionality.
Intended Use: Remains the same as the predicate device.	IMPAC determined and certified that "The intended use of ViewStation remains the same."
Substantial Equivalence: Equivalent in intended use, safety, and effectiveness to the predicate device.	ViewStation is "substantially equivalent to the original ViewStation product" and "the new ViewStation and previous ViewStation products are equivalent in intended use and safety and effectiveness."
Quality System Compliance: Developed under established quality standards.	Developed according to IMPAC Software Design Control Procedure (SDCP) and in compliance with 21 CFR 820, ISO 9001:1994, ISO 13485:1996, 93/42/EEC, EN 46001:1997, EN 601-1-4:1996.

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

Test Set Sample Size: Not specified. The document states "Engineering testing was also performed to ensure that the algorithms and all other technical changes function exactly as intended." This implies internal testing, but no details on the size or characteristics of the test data are provided.
Data Provenance: Not specified.

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

Not applicable as this is not a diagnostic device undergoing a typical clinical validation study with ground truth established by experts. The "effectiveness" is primarily about the algorithms functioning as intended, not about diagnostic accuracy against expert consensus.

4. Adjudication method for the test set

Not specified.

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 or comparative effectiveness study is mentioned. The device's purpose is to automate a previously manual process (identifying a treatment field edge and ordering images), not to provide a diagnostic AI/ML assistant to human readers. The document explicitly states: "No additional or changed diagnostic or therapeutic claims arise as the result of the ViewStation product. Therefore, demonstration of clinical efficacy is not a required element of this Premarket Notification. Further, clinical performance data is not required for determination of substantial equivalence for this type and class of device."

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

Yes, in a sense. The algorithms perform automated functions without human intervention in the specific tasks they are designed for (determining treatment field images, identifying edges, ordering images). The document focuses on the standalone functioning of these algorithms as part of the overall ViewStation system. "Engineering testing was also performed to ensure that the algorithms and all other technical changes function exactly as intended."

7. The type of ground truth used

The concept of "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. The "ground truth" for the engineering testing would relate to whether the algorithms correctly identify the treatment field image, correctly identify the field edge (based on pre-defined criteria or reference images), and correctly order the images. This would be a technical ground truth related to the algorithm's intended function, not clinical ground truth for diagnosis.

8. The sample size for the training set

Not specified.

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

Not specified.

Summary of Device and its Purpose:

The ViewStation is an image processing system primarily for radiation therapy, designed to import, view, annotate, manipulate, enhance, manage, and archive patient images during therapy. The reported changes involve new automated image processing algorithms to:
* Determine which of two portal images is the treatment field portal image.
* Employ an edge detection algorithm to identify the treatment field edge in a portal image.
* Modify an existing histogram optimization algorithm to accept dynamic inputs from the new edge detection algorithm.
* Superimpose a polygon of the field edge onto an open field image and automatically order images.

Crucially, the document states, "ViewStation is not intended for use in diagnosis." and explicitly notes that "No additional or changed diagnostic or therapeutic claims arise as the result of the ViewStation product." This means it is a tool to enhance workflow and image management in a therapy setting, not a device that provides diagnostic outputs requiring traditional clinical performance metrics. The "study" referenced is the internal verification and validation testing to ensure the algorithms function as intended and that the changes do not introduce new safety concerns or alter the intended use, maintaining substantial equivalence to its predicate device.

Summary

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Image /page/0/Picture/1 description: The image shows the word "IMPAC" in a bold, sans-serif font. Above the word is a logo that appears to be a square divided into smaller sections with a curved line running through it. The logo is simple and geometric, contrasting with the bold, straightforward text below. The overall impression is clean and professional.

AUG 2 9 2001

IMPAC Medical Systems, Inc. www.imnac.com

Corporate Office: 100 West Evelyn Avenue Mountain View, CA 94041-1464 T 650-254 4700 F 650—428 0721

Eastern Region: 43 Thorndike Street Cambridge, MA 02141-176 T 617-621 2557 F 617-494 6109

Tuesday, May 29, 2001

ViewStation, Image Processing System Premarket Notification (510(k)) Summary of Safety and Effectiveness

Introduction

This document provides a summary of the safety and effectiveness information contained in the ViewStation Premarket I his document provides a sammary of Safety and Effectiveness contains no confidential or trade secret information and Notitied for full public disclosure and distribution. For additional information, feel free to contact the submitter's Management Representative listed below.

Premarket Notification Information

Previous Notification Information: 1.
- Previous Premarket Notification ત.
- Previous Submission Date b.
- Product Name c.
Product Information: 2.
- Product Name a.
- Release Version Number b.
Classification Information: 3.
- Classification Name a.
- Common/Usual Name b.
- Product Classification C.
- Product Code d.
- Reference e.
- f. Review Panel

Establishment Information: র্বা

Submitter a.
Submitter Address b.
Establishment Number C.
Contact d.
Contact Phone e.
Contact Fax f.

K942346 12/28/94 IMAGE RT (renamed ViewStation)

ViewStation Version 5.2

Picture Archiving and Communications System Image Processing System Class II 90 LLZ 21 CFR 892.2050 Radiology

IMPAC Medical Systems, Inc. 100 West Evelyn Ave., Mountain View, CA 94041 2950347 Thomas H. Faris, Director RA/QA 650-623-8807 650-428-0721

Predicate Device

ViewStation is substantially equivalent to the original ViewStation product, which is currently marketed by IMPAC Medical Systems, Inc., and was the subject of Premarket Notification K942346. The new ViewStation and previous ViewStation products are equivalent in intended use and safety and effectiveness.

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ViewStation Intended Use

ViewStation Indications for Use

ViewStation supports image and information flow among healthcare facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions.

Description of the Product

The primary function of ViewStation is to provide a means to more image information in a therapy or treatment environment. ViewStation provides the ability to import, view, annotate, manage, and archive patient images during the course of therapy, treatment, and follow-up.

ViewStation imports existing digital images acquired or generated by other products. ViewStation retains the original image, which was acquired or generated by a third party product. With these facts in mind, the goal of ViewStation is to make electronic patient image information more accessible throughout the department. IMPAC is providing a tool to increase department productivity since digital images, unlike films, do not have to be physically transferred from one station to another.

Description of the Change

New automated image processing algorithms have been implemented to perform previously manual processes. The new algorithms:

determine which of two portal images is the treatment field portal image; and .
employ an edge detection algorithm to identify the treatment field edge in a portal image. .

An existing histogram optimization algorithm has been modified to accept new, dynamic inputs derived from the new edge detection algorithm. ViewStation superimposes a polygon representing the field edge from the treatment image onto the oven field image of a double exposure portal image series and automatically orders the images so that the open field image is followed by the treatment image when displayed.

Clinical Demonstration of Efficacy

No additional or changed diagnostic or therapeutic claims arise as the result of the ViewStation product. Therefore, demonstration of clinical efficacy is not a required element of this Premarket Notification. Further, clinical performance data is not required for determination of substantial equivalence for this type and class of device.

Device Safety

ViewStation is a medical device that is to be used in a treatment or therapy setting under the use of appropriately trained health care professionals who are responsible for ensuring the correct and accurate use of medical images.

The ViewStation System Hazard Analysis was performed to determine and evaluate all areas that represent potential safety or health hazards during ViewStation system operation. For all system hazards, effects, and mitigations have all been documented (SHA2101), reviewed, and implemented. This System Hazard Analysis is reviewed with every change and release of the product, including the above-mentioned changes. Validation and verification activities trace the hazard identification through evaluation, design, specification,

Image /page/1/Picture/17 description: The image shows the logo for IMPAC. The logo consists of the word "IMPAC" in a bold, serif typeface. Above the word is a geometric symbol that resembles a globe or sphere intersected by lines. The lines create a grid-like pattern within the circular shape.

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implementation, and testing. The Design Review Team has reviewed the product change and System Hazard Analysis and has determined that the product change does not increase health or safety risk to patients, users, or other third parties.

Substantial Equivalence Determination

Improvements have been implemented in the form of an enhancement of ViewStation's existing feature. New algorithms, based upon a well-known field edge detection algorithm, were designed and implemented to automate a previously manual function.

IMPAC has determined and certified that:

The intended use of ViewStation remains the same. A.
ViewStation technology has changed by the introduction of a new algorithm to enhance an existing function. B.
C. The enhanced functionality does not raise any new issue of safety or effectiveness, nor are novel verification or validation methods required to assure safety and effectiveness.
D. The enhanced functionality does not result in a loss of safety or effectiveness of ViewStation.

ViewStation is substantially equivalent to the previously cleared ViewStation product.

Quality System

The fundamental goal of IMPAC's quality program is to provide value to customers and internal operations by producing better and safer products that are less expensive to build and maintain, simpler to use, and easier to support. IMPAC has implemented the IMPAC Quality System to operate in a manner that has proven to be the most efficient and effective. Organizational expertise is built into the management system to ensure that each process consistently meets defined specifications and continuously seeks improvement. All employees receive extensive Quality System training and take pride in the value that they contribute to IMPAC products and to the final customer and their patients.

ViewStation was developed according to the IMPAC Software Design Control Procedure (SDCP). This procedure governs the process by which system and software development are to be planned, dested, and released.

DOC. ID	TITLE
21 CFR 820	Quality System Regulation
ISO 9001:1994	Quality Systems-Model for Quality Assurance in Design, Development,Production, Installation, and Servicing
ISO 13485:1996	Quality Systems-Medical Devices-Particular Requirements for the Application ofISO 9001
93/42/EEC	Medical Device Directive
EN 46001: 1997	Application of EN ISO 9001 to the Manufacture of Medical Devices
EN 601-1-4: 1996	General Requirements for Safety

The IMPAC Quality System was developed in compliance with all of the following standards and regulations:

Image /page/2/Picture/14 description: The image shows the word "IMPAC" in a bold, sans-serif font. Above the word is a logo that appears to be a square divided into sections with a partial circle inside. The logo is simple and geometric, contrasting with the bold, blocky letters of the word below.

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Verification and Validation Testing

A Traceability Matrix has been created, based upon the project plan, to ensure the completion of the specification, implementation, and testing of all requirements of the feature enhancement, including performance of full system hazard mitigation and basic operational testing. The System Test Plan defines the overall plan for completing full application, integration, and system testing of ViewStation, while the Test Procedures capture the desting parameters, results, and certification. The included Test Certification Statement certifies that the planned testing requirements were completed successfully. Design Reviews have been performed at the conclusion of each software design and development phase to review and validate the fulfillment of all of the phase requirements and deliverables. All of the above have been completed for ViewStation and representative documents have been included in the Premarket Notification.

Summary of Test Conclusions

IMPAC's Quality Engineering department has completed all product operation and hazard mitigation testing and has certified passing test results. Engineering testing was also performed to ensure that the algorithms and all other technical changes function exactly as intended. The testing demonstrated that the algorithms and all other functionality of ViewStation were successfully implemented.

Image /page/3/Picture/5 description: The image shows the logo for IMPAC. The logo consists of the word "IMPAC" in large, bold, sans-serif font. Above the word is a geometric design that includes a circle divided into sections by lines. The overall impression is clean and professional.

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Image /page/4/Picture/18 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, ribbon-like appearance. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2001

Mr. Thomas H. Faris Regulatory Affairs & Quality Assurance Impac Medical Systems, Inc. 100 West Evelyn Ave. MOUNTAIN VIEW CA 94041

Re: K011694 Viewstation (Radiation therapy workstation) Dated: May 29, 2001 Received: May 31, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Faris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed in interstate commerce prior to May 28, 1976, the enactnent date of the Medical Device that have been reclassified in eccordate 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 this 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, 4,xxx, 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" (21 CFR 807.97). 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

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2-1

ViewStation Indications for Use and Intended Use Statement

510(k) Number (if known): Ko ( 1/2 94

Device Name: ViewStation, Image Processing System

Indications for Use:

ViewStation supports image and information flow among health care facility personnel. ViewStation supports may only interest digital images and associated data are the means for ViewStation can be assa when the station is not intended for use in diagnosis.

The intended use of ViewStation is to provide health care facility personnel with an The intended use of Tionbated is e patient images during the course of therapy or enticlent and encerve means to import, view, annotate, manipulate, enhance, treatinent. - Viewstation anows accres to the images and associated information are stored in manage, and archive pattent mages. " and a many to perform their functions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Prescription Use ✓

Nancy C. Promo

(Division Sign-Off)
Division of Reproduction,
and Radiological Daten K011694
610(ld 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).