The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup during the treatment planning process of external beam radiotherapy treatment. This information may then be exported to a treatment planning system for dose calculation.

Device Description

The QwikSIM Virtual Simulation System provides fast and accurate visualization, contouring and beam definition to streamline the radiation therapy planning process. QwikSIM imports image data, and provides an array of tools to straining and adjusting images. Manual and automatic contouring tools allow for anatomical and tumor contour definition. Beam placement and visualization tools facilitate treatment port definition, isocenter placement and laser center placement. The resulting plan data can then be used with laser positioning systems for patient marking and exported to therapy planning systems for dose calculation.

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for the QwikSIM Virtual Simulation System (Version 2.00). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria. As such, the document does not contain specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical trial for novel devices would.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. Here's what can be extracted and what is not present based on your request:

Acceptance Criteria and Reported Device Performance

The document states that "Clinical performance data is not required for determination of substantial equivalence for this type and class of device." Therefore, there are no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics in the submission summary. The acceptance criteria for this submission are based on demonstrating that the intended use and technological characteristics are substantially equivalent to predicate devices, and that any differences do not raise new safety or effectiveness concerns.

The closest analogue to "reported device performance" is the statement "The testing demonstrated that the functionality of QwikSIM was successfully implemented." This is a qualitative statement about successful implementation rather than a quantitative performance metric.

Remaining Information Based on Document's Content:

Due to the nature of a 510(k) submission for a virtual simulation system, many of the requested details about clinical studies, expert-established ground truth, and training data are not included or applicable.

Information Requested	Presence in Document	Details from Document (if available)
1. Table of Acceptance Criteria & Reported Device Performance	No	As stated above, clinical performance data with specific acceptance criteria (e.g., sensitivity, specificity) and corresponding reported performance metrics are not required or provided for this type of 510(k) submission focused on substantial equivalence. The document asserts that "The testing demonstrated that the functionality of QwikSIM was successfully implemented."
2. Sample size for the test set and data provenance (country, retrospective/prospective)	Not Applicable	No clinical test set data (e.g., patient cases) is mentioned or used for performance evaluation in this 510(k) summary. The "test set" refers to internal engineering verification and validation.
3. Number of experts used to establish ground truth for the test set and their qualifications	Not Applicable	Not applicable as no clinical test set requiring expert ground truth is described. The "ground truth" for internal testing was based on design specifications and expected functionality.
4. Adjudication method for the test set	Not Applicable	Not applicable as no clinical test set requiring adjudication is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, and effect size.	No	No MRMC study was conducted or reported. The submission does not claim human improvement with AI assistance, as it's a virtual simulation system for treatment planning, not an AI diagnostic tool.
6. Standalone (algorithm only) performance study.	No, but internal	"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 QwikSIM product functions as intended and specified, according to design specifications and customer labeling." This describes internal functional testing, not a standalone clinical performance study. The device is a "Virtual Simulation System," which is by its nature a standalone software application.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.)	System Specifications	For the internal verification and validation, the "ground truth" was established by the device's own design specifications, requirements, and expected operational functionality.
8. Sample size for the training set.	Not Applicable	No "training set" in the context of machine learning or AI algorithm training is mentioned or relevant for this type of device. The QwikSIM System was developed using a standard software development lifecycle (SDLC) governed by the IMPAC Software Design Control Procedure (SDCP).
9. How the ground truth for the training set was established.	Not Applicable	Not applicable as there is no mention of a training set for machine learning/AI. The "ground truth" for the overall development and testing process was adherence to established quality systems, design specifications, and regulatory standards (21 CFR 820, ISO 9001:1994, ISO 13485:1996, 93/42/EEC, EN 46001:1997, EN 601-1-4:1996). "A Traceability Matrix has been created... to ensure the completion of the specification, implementation, and testing of all requirements."

Summary

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Image /page/0/Picture/0 description: The image shows the logo for IMPAC. The logo consists of the word "IMPAC" in a bold, serif font. Above the word is a geometric design that appears to be a square with a circle inside, divided into sections by lines. The overall design is simple and professional.

NOV 0 7 2001

IMPAC Medical Systems, Inc. www.impac.com

Corporate Office: 100 West Evelyn Avenue Mountain View, CA 94041-146. T 650-254 4700 F 650-428 0721

Eastern Region: 43 Thorndike Street Cambridge, MA 02141-1764 T 617-621 2557 F 617-494 6109

Friday, July 13, 2001

K013531/

OwikSIM, Virtual Simulation System Premarket Notification (510(k)) Summary of Safety and Effectiveness

Introduction

This document summarizes the safety and effectiveness information within the QwikSIM Premarket Notification (510(k)). The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution. For additional information, feel free to contact the submitter's Management Representative listed below.

Premarket Notification Information

1. Product Information:
- Product Name a.
- Release Version Number b.

Classification Information: 2.

Classification Name a.
b. Common/Usual Name
Product Classification C.
d. Product Code
Reference e.
f. Review Panel
Establishment Information: ని.
- Submitter a.
- b. Submitter Address
- Establishment Number c.
- Contact d.
- Contact Phone e.
- f. Contact Fax

QwikSIM Virtual Simulation System Version 2.00

Radiation Therapy Simulation System

Virtual Simulation System

Class II

9 0 - KPQ 21 CFR 892.5840

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 Information

QwikSIM is substantially equivalent to the following devices that the Food and Drug Administration (FDA) has cleared for distribution and are currently being actively marketed in the United States. QwikSIM is substantially equivalent to these products in intended use and safety and effectiveness.

Advantage Sim 1.

Manufacturer	General Electric Co.
Previous Premarket Notification #	K951830
Previous Submission Date	04/20/95

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3-2
K013531

ACQSIM Simulator/Localizer 2..

	Manufacturer	Marconi Medical Systems
	Previous Premarket Notification #	K923851
	Previous Submission Date	07/31/92
3.	Somavision
	Manufacturer	Varian Assoc., Inc.
	Previous Premarket Notification #	K992751
	Previous Submission Date	08/16/99

OwikSIM Intended Use

QwikSIM is a radiation therapy virtual simulation system for patient image review, target and critical structure delineation, and geometric treatment planning.

QwikSIM Indications for Use

The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicsting and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup to support the radiother py treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.

Description of the Product

The QwikSIM Virtual Simulation System provides fast and accurate visualization, contouring and beam definition I to streamline the radiation therapy planning process. QwikSIM imports image data, and provides an array of tools to straining and adjusting images. Manual and automatic contouring tools allow for anatomical and tumor contour definition. Beam placement and visualization tools facilitate treatment port definition, isocenter placement and laser center placement. The resulting plan data can then be used with laser positioning systems for patient marking and exported to therapy planning systems for dose calculation.

Clinical Demonstration of Efficacy

No additional or changed diagnostic or therapeutic claims arise as the result of the differences between QwikSIM and the predicate devices. Clinical performance data is not required for determination of substantial equivalence for this type and class of device.

Device Safety

The QwikSIM System Hazard Analysis was performed to determine and evaluate all areas that represent potential I fo wholen by hazards during QwikSIM system operation. For all system hazards, the hazards, effects, and suitigations have all been documented (SHA4901), reviewed, and implemented. This System Hazard Analysis is reviewed with every change and release of the product. Validation and verification activities trace the hazard identification and mitigation through evaluation, design, specification, implementation, and testing. The QwikSIM Tesign Review Team has reviewed the QwikSIM System Hazard Analysis and has determined that the QwikSIM product does not pose a greater health or safety risk to patients, users, or other third parties than predicate devices listed above.

Image /page/1/Picture/13 description: The image shows the logo for IMPAC. The logo consists of a square with a stylized globe inside it, above the word "IMPAC" in a bold, serif typeface. The globe is represented by lines dividing it into sections, suggesting a network or interconnectedness.

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Substantial Equivalence Determination

IMPAC has determined and certified that:

A. The intended use of QwikSIM is the same as that of the predicate devices.
QwikSIM has the same technological characteristics as the predicate devices. B.
C. Any differences in the functionality of QwikSIM compared to the predicate devices do not raise any new issues of safety or effectiveness, nor are novel verification or validation methods required to assure safety and effectiveness.

QwikSIM is substantially equivalent to the previously cleared predicate devices listed above. Although functionality is not identical, the use and operation of the QwikSIM product is substantially equivalent to the predicate devices, as demonstrated by the Feature Comparison Matrix included in the Premarket Notification.

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 producing obtact and sales proved the IMPAC Quality System to operate in a manner that has proven to be the most efficient and effective. Organizational experience and 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 processes and to the final customer and their patients.

QwikSIM 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, defined, implemented, tested, 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:

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 QwikSIM, while the Test Procedures capture the detailed testing 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 QwikSIM and representative documents have been included in the Premarket Notification.

Image /page/2/Picture/13 description: The image shows the logo for IMPAC. The logo consists of a square with a circle inside, divided into sections by lines. Below the square is the word "IMPAC" in large, bold, sans-serif font.

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. 1

: 上

Summary of Test Conclusions

100 million in the states

11.00

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 QwikSIM product functions as intended and specified, according to design specifications and customer labeling. The testing demonstrated that the functionality of QwikSIM was successfully implemented.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 7 2001

IMPAC Medical Systems, Inc. c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K013531

Trade/Device Name: OwikSIM Virtual Simulation System, V2.00 Regulation Number: 21 CFR §892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPQ Dated: October 22, 2001 Received: October 23, 2001

Dear Mr. Job:

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 (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.

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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, 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" (21 CFR Part 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

Enclosure

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NOV 0 7 2001

QwikSIM Indications for Use Statement

510(k) Number (if known): 10 (3531

Device Name: QwikSIM Virtual Simulation System

Indications for Use:

(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)

Nancy C. borgdon

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013531

Prescription Use

10/5/01

file://G:\DOCS\QSM49\Reg\010713\21 indicate.htm

10/5/01

Regulation Number and Section

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.