IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.

This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient.

Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.

Device Description

IMSure Brachy QA Software independently computes a modeled dose that would be delivered by a high dosc rate (HDR) or low dose (LDR) brachytherapy system to a patient and compares it to the dose predicted by a primary treatment planning system. IMSure Brachy QA Software imports a file produced by a primary HDR or LDR treatment planning system (TPS), in the format of an industry standard Dicom-RT™ or vendor specific file, which contains information about a treatment. The files contain information about applicators or catheters and the associated source information in each catheter, such as source type, source strength, source location and source duration. The files may also contain information about specific calculation points and the dose predicted by the primary planning system, as well as patient specific information. The dose computation algorithm used is a superposition of point or line sources, incorporating 3-D geometrical features of the source construction, as well as radiological features of the source composition. Dosc modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results.

After importing a TPS plan, a user may edit the information, adding or modifying source positions, durations (or dwell times), type, or activity strength. Calculation point information may be edited as well. A 3-D view of the applicators, source positions, and calculation point positions is provided. A paper or electronic record can be stored including the final dose computation for each calculation point compared to the dose computed by the TPS, as well as relevant patient information for long term documentation. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.

IMSure Brachy QA Software is provided to the customer on a CD. It requires the Microsoft Windows Operating System 2000 with service pack 2 or better, or XP. Computer system requirements include Pentium III or equivalent, a minimum of 256 MB RAM and 100 MB available hard drive space. Display requirements include 1024 x 768 minimum resolution and an OpenGL compatible video card meeting OpenGL 1.1 specifications.

AI/ML Overview

The provided document does not contain explicit acceptance criteria in the form of a table or specific quantitative metrics with corresponding device performance values, nor does it detail a study designed to prove the device meets such criteria.

The document is a 510(k) summary for the Standard Imaging IMSure Brachy QA Software, primarily focusing on its purpose, intended use, and substantial equivalence to predicate devices. It describes functional areas addressed during verification and validation and lists beta sites for evaluation but does not provide details of a formal study with quantified performance data.

Therefore, most of the requested information cannot be extracted from this document.

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

1. Table of acceptance criteria and reported device performance:

Not available. The document states that "The Standard Imaging IMSure Brachy QA Software has met its predetermined design specifications, risk analysis and validation objectives." However, it does not specify what those design specifications, risk analysis objectives, or validation objectives are in a measurable way, nor does it present device performance data against them.

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

Not available. The document mentions that the software was "successfully evaluated by the following beta sites:" and lists five hospitals. This suggests some form of testing, but it does not specify what constituted the "test set" (e.g., number of patient cases, treatment plans), its size, or the provenance of the data (e.g., country of origin, retrospective or prospective).

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

Not available. While the software is intended for use by "trained medical physicians, or dosimetrists," and beta sites are listed, there is no information about experts establishing ground truth for a test set. The software's function is to independently calculate and compare doses, with the primary treatment planning system's output serving as a reference. The "ground truth" for the software itself relies on the AAPM TG-43 formalism and user adjustments to match measured or published results.

4. Adjudication method for the test set:

Not available. No details about a formal test set, expert adjudication, or adjudication method (e.g., 2+1, 3+1, none) are provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable / Not available. The IMSure Brachy QA Software is a "Dose Validation Software" intended as a quality assurance tool to verify brachytherapy treatment plans. It is not an AI-assisted diagnostic or decision-making tool for human readers in the context of image interpretation or treatment delivery. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not relevant to this type of device and is not mentioned.

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

Yes, implicitly. The device itself is described as a "stand alone software application product" that "independently computes a modeled dose." The validation and verification efforts described ("Installation", "Import Tool Module", "QA Module", "Source Library Module", "User Management Module", and various source types/settings) imply testing of the algorithm's performance in isolation, comparing its calculations to expected or reference values (e.g., based on AAPM TG-43 formalism, measured, or published results). However, no specific performance metrics like accuracy, precision, or deviation values are provided from these standalone tests.

7. The type of ground truth used:

AAPM TG-43 formalism, measured or published results. The document states: "Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results." This indicates that the "ground truth" or reference standard for the software's dose calculations is derived from established physics formalisms and potentially empirical data.

8. The sample size for the training set:

Not applicable / Not available. The IMSure Brachy QA Software is described as a software application that performs dose calculations based on specific formalisms (AAPM TG-43) and not as a machine learning or AI model that requires a "training set" in the conventional sense of data-driven learning. Its development likely involved engineering, physics modeling, and traditional software testing, rather than a supervised learning paradigm.

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

Not applicable / Not available. As the software does not appear to be an AI learning model that uses a "training set," this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Standard Imaging. The logo consists of the word "STANDARDIMAGING" in a stylized font. To the right of the text is a circular graphic with a jagged, abstract design, possibly representing a burst or explosion. The overall design is simple and modern.

September 17, 2008

Ko82773

NOV 1 9 2008

Subject:	510(k) Summary of Safety and Effectiveness Information for theStandard Imaging IMSure Brachy QA Software
Proprietary Name:	Standard Imaging IMSure Brachy QA Software
Common Name:	Dose Validation Software
Classification Name:	Primary:	Medical Charged-Particle Radiation Therapy System(accessory to)
	Secondary:	Remote Controlled Radionuclide Applicator System(accessory to)Radionuclide Brachytherapy Source(accessory to)
Classification:	Primary:	Class II - 21CFR892.5050 - LHN, IYE
	Secondary:	Class II - 21CFR892.5700 - JAQClass II - 21CFR892.5730 - KXK
Panel:	Radiology
Predicate Devices:	Primary:	Standard Imaging (Prodigm), IMSure QA Software510(k) Number K031975
	Secondary:	Oncology Data Systems, MU Check v7.0 (Brachy Check-510(k) Number K061152
Contact Person:	Raymond Riddle, PE, RACChief Regulatory Officer

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Standard Imaging IMSure Brachy QA Software was designed to comply with the applicable portions of the following voluntary standard:

IEC 60601-1-4 (Edition 1.1 2000-04) Collateral standard for programmable medical . systems
/3

STANDARDING, INC. 3120 Deming Way, Middleton, W 53562-1461 800-261-0446 608-31-025 PH 608-831-202 FAX www.standardimaging.com

Assurance is confidence™

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Image /page/1/Picture/0 description: The image shows the logo for Standard Imaging. The text "STANDARD IMAGING" is displayed in a stylized font, with the word "STANDARD" in a thinner font than "IMAGING". To the right of the text is a circular graphic with a burst-like design.

The Standard Imaging IMSure Brachy QA Software has been verified and validated at Standard Imaging, and addressed the following functional areas:

Installation .
. Import Tool Module
. User Preferences Module
. QA Module
Source Library Module .
User Management Module .
. Simple 1 strand +xyz to -xyz.
. Dual IR-192 dwl
24 channels .
. Xoft
. 4 I125 point
Line 1D aniso .
Line scalar aniso �

Additionally, the IMSure Brachy QA Software was successfully cvaluated by the following beta sites:

. UCSD Hospital, San Diego, CA
. Grant Methodist Hospital, Columbus OH
Memorial Hospital, South Bend, IN .
Edward Hospital, Naperville, IL .
. Texas Oncology Hospital, Klabzuba, TX

The Standard Imaging IMSure Brachy QA Software has met its predetermined design specifications, risk analysis and validation objectives.

STANDARDIMAGING, INC. 3120 Deming Way, Middleton, WI 53562-1461 800-261-4466 608-831-0025 PH 608-831-2202 FAX www.standardimaging.com

Assurance is confidence™

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General Information

Device Name - Proprietary:	IMSure Brachy QA Software - During development, the name has evolved, resulting inmany of the documents in this 510(k) having slightly different names. Upon 510(k)clearance, all documents, including manuals, advertisements, labeling and softwaresupplied to the marketplace and/or users will use the name IMSure Brachy QA Software.
Device Name - Common:	Dose Validation Software
Device Name - Classification(s):
Primary:	Medical Charged-Particle Radiation Therapy System (accessory to)
Secondary:	Remote Controlled Radionuclide Applicator System (accessory to)Radionuclide Brachytherapy Source (accessory to)
Device Panel:	Radiology
Device Classification(s):
Primary:	Class II - 21CFR892.5050 -- LHN, IYE
Secondary:	Class II - 21CFR892.5700 - JAQ, Class II - 21CFR892.5730 - KXK
Predicate Devices:
Primary:	Standard Imaging (Prodigm), IMSure QA Software510(k) Number K031975
Secondary:	Oncology Data Systems, MU Check v7.0 (Brachy Check)510(k) Number K061152
Performance Standards:	To the best of Standard Imaging's knowledge, performance standards have not beenpromulgated by FDA for this device.
Establishment Registration Number:	2184007
Owner/Operator Number:	9003193
Facility Information:	Standard Imaging, Inc.3120 Deming WayMiddleton, WI 53562Telephone: (608) 831-0025Fax: (608) 831-2202Webpage: www.standardimaging.com

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Device Background

Standard Imaging acquired the IMSure QA Software from Prodigm, Inc. in 2005. Since that time the company has made minor incremental improvements to the product. Since Standard Imaging had a strong market presence with brachytherapy quality assurance products, a simple standalone software product in the IMSure mold was an obvious development choice.

Device Description

IMSurc Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Raymond T. Riddle, PE, RAC Chief Regulatory Officer Standard Imaging, Inc. 3120 Deming Way MIDDLETON WI 53562-1461

NOV 1 9 2008

Re: K082773

. Trade/Device Name: IMSure Brachy QA Software Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 18, 2008 Received: September 22, 2008

Dear Mr. Riddle:

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. Iisting 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(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 Biometrics' (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,

Arque In Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Usc

K08z773

510(k) Number (if known):

Device Name:

IMSure Brachy QA Software

Indications For Use:

This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimctric accuracy is adequate for a particular patient.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-the-Counter-Use (Part 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)

Helene

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

Page 1 of 1

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.