IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.

Device Description

IMSure is a software program designed to provide a second, independent verification of IMRT plans created on primary radiation therapy treatment planning systems. After independently calculating the imported plan and fluence maps, IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan. IMSure also may be used to compute primary monitor unit calculations for single and multiple beams with open, blocked, and wedged fields.

AI/ML Overview

The provided 510(k) notification for the IMSure device (K031975) does not contain explicit acceptance criteria or detailed study results demonstrating performance against such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (RadCalc V4.0, K010464) by comparing technological characteristics and intended use. While it states that "The New Device has the same intended use and safety characteristics as the predicate device," it does not present a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document. However, I can still provide what little is available:

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

Acceptance Criteria: Not explicitly stated in the document.
Reported Device Performance: Not reported in terms of specific metrics against acceptance criteria. The document claims "IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan," but no quantitative performance data is given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. No formal test set or study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided as no formal test set and ground truth establishment process are described.

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

This information is not provided as no formal test set and adjudication process are described.

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

This information is not provided. The device is a software program for IMRT plan verification and monitor unit calculation, not an AI-assisted diagnostic tool that would typically involve human readers.

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

The document implies a standalone performance comparison by stating "IMSure compares results with the imported plan and maps, and calculates the differences." However, no specific standalone performance metrics or studies are detailed. The comparison is against the primary radiation therapy treatment planning system, but the agreement or difference thresholds are not quantified.

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

This information is not explicitly stated as no formal ground truth for a performance study is described. For a QA tool verifying IMRT plans, the "ground truth" would implicitly be the correct physical dose distribution and monitor units as determined by established physics principles and measurements, which the device aims to verify.

8. The sample size for the training set

This information is not provided. The document describes the algorithms used (Single Source model, Three Source model, Clarkson scatter algorithm, Khan (classical)), which are based on established physics models rather than machine learning algorithms that typically require a "training set" in the conventional sense.

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

Not applicable in the context of this device, as it employs physics-based algorithms rather than machine learning requiring a training set with established ground truth. The algorithms are based on "measured physical data" and "measured and modeled" scatter tables, implying established physical properties and calibrations as their basis.

Summary

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KO31975

AUG 2 9 2003

Premarket Notification [510(k)] Summary Tab 4

Date Prepared:

April 24, 2003

IMSure Trade Name:

IMRT QA Device and Monitor Unit Calculator Common Name:

Classification Name: Medical Linear Accelerator

Manufacturer's Name: Address:

Prodiam. Inc. 585 Manzanita Ave. Chico, CA 95926

Suzanne Wild

Corresponding Official: Title: Telephone: Fax:

Director of Quality Assurance/ Regulatory Affairs 530-897-0937 530-897-0934

Predicate:

K010464 RadCalc V4.0

Device Description:

IMSure also may be used to compute primary monitor unit calculations for single and multiple beams with open, blocked, and wedged fields.

Intended Use:

IMSure is intended for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics for plans of known geometry.

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Technological Characteristics: The New Device has the same intended use and safety characteristics as the predicate device.

SystemComponent	Device
	LifeLine Software, Inc.RadCalc, Model V.4.0	Prodigm, Inc.IMSure
K number	K010464	This filing.
Application (Use)	Utilized for determination ofmonitor units or dose. Servesto validate those monitor unitscomputed by the primaryradiation therapy planningsystem. Primary means ofcalculating monitor units insituations where the physiciandoes not order the user of aradiation therapy treatmentplan.	Independent dose andfluence map verificationsoftware for IntensityModulated Radiation Therapybased on Linear acceleratorplans containing multi-leafcollimator leaf sequence dataand fluence maps fromprimary IMRT treatmentplanning systems.Independent dosecomputation software forstandard, simple geometryradiation therapy treatmentplanning and verification ofmonitor units based on LinearAccelerator parameters andphysician prescribed doseinformation.
Platform	Minimum Pentium II processor,MFS network enabled	Minimum Pentium IIIprocessor, MFS networkenabled
Operating system	Any MS Windows	Windows 2000 and XP
Algorithm - mapverification	Single Source model	Single source model
Algorithm - IMRTdose Calculation	Single Source model, Clarksonscatter algorithm based onUniversity of Chicago method	Three Source model,Clarkson scatter algorithmbased on Stanford Universitymethod
MU CalculationDose Algorithm	Khan (classical)	Khan (classical)
Patient GeometrySpecifications	Two dimensional, graphicaluser interface based, based	Two dimensional, graphicaluser interface based
Machinessupported	Commercially available LinearAccelerators with multi-modalityenergies and both photon andelectron particles, includingfield blocking and linear wedgeapplicators for photon fluencemodulation, and with 52,80 and120 leaf Multi-leaf collimators	Commercially availableLinear Accelerators withmulti-modality energies andphoton and electron particles,including field blocking andlinear wedge applicators forphoton fluence modulation,and with 52,80 and 120 leafMulti-leaf collimators
SystemComponent	Device
	LifeLine Software, Inc.RadCalc, Model V.4.0	Prodigm, Inc.IMSure
Calculation pointfor IMRT QA	Fixed, iso-centric	Off-Axis calculation pointsincorporating modeled headscatter information andmeasured fluenceperturbations
Calculation pointfor MUCalculations	Off-Axis and depth specifiedcalculation points usingmeasured physical data	Off-Axis and depth specifiedcalculation points usingmeasured physical data
Physics Data	Measured, tabular databasestored, multiple linearaccelerators allowed	Measured, tabular, flat filestorage, multiple linearaccelerators allowed
Scatter table	Measured	Measured and modeled (3-source model, Yang, et. al )
Import data	RTP link, Dicom RT for IMRTQA and MU Calculations	RTP link for IMRT QAGraphical User Interface forMU Calculations
Calibrationmethod(s)	Iso-centric or fixed CalibrationDistance	Iso-centric or fixed CalibrationDistance
Export data	RTP link, Dicom RT, Paperdocumentation	Paper or Worddocumentation
User security	Two levels of user, passwordenabled	Three levels of user,password enabled

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Page 3 of 3

and the control control control of the control of

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Image /page/3/Picture/1 description: The image shows a logo with a stylized bird in flight, composed of three parallel lines that curve upwards and to the right. The bird is enclosed within a circle, and the words "U.S. Department of Health & Human Services" are arranged around the circumference of the circle. The logo is rendered in black and white, with a simple and clean design.

Food and Drug Administration 0 Corporate Boulevard kville MD 20850

AUG 2 9 2003

Prodigm, Inc. % Mr. Juergen Welte Program Manager TUV Rheinland of North America 1279 Quarry Lane, Suite A Pleasanton, CA 94566

Re: K031975

Trade/Device Name: IMSure (IMRT QA Device and Monitor Unit Calculator) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: August 15, 2003 Received: August 18, 2003

Dear Mr. Welte:

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 enactnient 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 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/dsmaldsmamain.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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Tab 3

Indications For Use

510(k) Number (if known): Ko31975

Device Name: IMSure

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031975

Prescription Use Y (per 21 CFR 801.109)

Over-The-Counter Use

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.