The personal computer code OLINDA, which is an acronym standing for Organ Level INternal Dose Assessment/EXponential Modeling, calculates radiation doses to different organs of the body from radiopharmaceuticals which are administered systemically (mostly intravenously, but sometimes by oral or inhalation intake routes).

AI/ML Overview

The provided document is a 510(k) summary for the OLINDA EXM software. It describes the software's purpose, intended use, and compares it to two predicate devices (CAMIRD and CDI3). However, it does not contain acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the way typically expected for clinical performance or diagnostic accuracy studies.

Instead, the document establishes substantial equivalence by:

Comparing the functional equivalence of OLINDA EXM to existing predicate devices (CAMIRD and CDI3) that were legally marketed prior to the Medical Device Amendments of 1976 or were widely accepted for their purpose.
Highlighting improvements and additional features in OLINDA EXM over its predicates, such as a larger number of body models and improved user-friendliness, while maintaining the same core purpose and scientific basis.
Referencing peer-reviewed publications for the underlying scientific models, decay data, and dose factors used, demonstrating that the methodology is based on established best practices.

Therefore, many of the requested details, such as specific acceptance criteria performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods for a direct performance study, are not present in this type of substantial equivalence submission. This is because the submission focuses on demonstrating that OLINDA EXM is as safe and effective as its predicates, rather than proving a specific diagnostic accuracy or clinical performance metric against a defined threshold.

Here's an attempt to answer the questions based only on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there are no explicit "acceptance criteria" defined in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or a direct study demonstrating the device meets those criteria. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices, implying similar functionality and the use of accepted scientific methodologies. The table below summarizes the comparison to predicate devices, which serves as the basis for "performance" in this context.

Feature	Predicate: CAMIRD (Performance)	Predicate: CDI3 (Performance)	OLINDA/EXM (Performance)	Discussion (Equivalence/Improvements)
Indications for Use	Estimates absorbed doses to several tissues of a reference patient for a specified radiopharmaceutical dosage.	Estimates absorbed doses to various tissues of a reference patient for specified X-ray procedures. Calculates a "cancer detriment index."	Estimates absorbed doses to several tissues of a reference patient for a specified radiopharmaceutical dosage. (Does NOT calculate "cancer detriment index," but calculates equivalent dose via ICRP radiation weighting factors).	Equivalent in core dose estimation; OLINDA/EXM focuses on radiopharmaceuticals vs. X-ray for CDI3, and does not have the "cancer detriment index" of CDI3.
Target Population/Models	Models of an average individual (reference adult male).	Models of average human body "phantom."	Models of average individuals. 10 models available (e.g., adult male, female, 5-year-old, 6-month pregnant woman). Permits varying mass of individual organs for limited patient-specificity.	Equivalent, but OLINDA/EXM has a larger number of phantoms and limited patient-specificity.
Design/Algorithm	MIRD method (Loevinger et al. 1988). User specified radiopharmaceutical kinetic parameters and previous Monte Carlo calculated organ contributions.	X-ray examination input parameters combined with previous Monte Carlo calculations of dose per unit input. Algorithm given in Rosenstein (1976).	MIRD method (Loevinger et al. 1988). User specified radiopharmaceutical kinetic parameters and previous Monte Carlo calculated organ contributions.	CAMIRD and OLINDA/EXM use the same MIRD method. CDI3 used a different algorithm for X-ray dosimetry. All use Monte Carlo based calculations.
Input/Output	Input: Radionuclide, body model, radiopharmaceutical biokinetics. Output: Dose per unit input.	Input: X-ray Spectra data, Exposure parameters, Projection parameters. Output: Dose to organs in mrad.	Input: Radionuclide, body model, radiopharmaceutical biokinetics. Output: Dose to organs in mSv/MBq and rem/mCi.	OLINDA/EXM and CAMIRD have essentially equivalent input/output for internal dosimetry. CDI3 is for X-ray dosimetry.
User Experience/Human Factors	Simpler system, Fortran IV, input driven program. Descriptive paper available.	DOS-based, input driven program. User's manual published by FDA.	User friendly, event driven. Communication tools for error prevention (error messages, help files, user manual, installation tests). Open literature publication in preparation; based on MIRDOSE code (Stabin 1996).	OLINDA/EXM is described as more user-friendly and having more robust error prevention (relative to both predicates).
Anatomical Sites	Fewer organs in output (e.g., Adrenals, Fat, Blood, ovaries, Skin, Uterus, Lower Large Intestine).	Fewer organs in output (e.g., lungs, active bone marrow, ovaries, testes, thyroid, uterus, total trunk, breasts).	More tissues included (e.g., Adrenals, Brain, Gall Bladder Wall/Cont, Lower Large Intestine Wall/Cont, Small Intestine, Stomach Wall/Cont, Upper Large Intestine Wall/Cont, Heart Wall/Cont, Kidneys, Liver, Lungs, Spleen, Pancreas, Prostate, Skeleton, Active Marrow, Skin, Thyroid, Thymus, Testes, Urin.Bl. Wall/Cont, Whole Body).	OLINDA/EXM includes a significantly greater number of anatomical sites for dose calculation.
Scientific Basis	MIRD method (Loevinger et al. 1988), dose factors from Cristy and Eckerman (1987), Stabin et al. (1995).	Algorithm given in Rosenstein (1976).	MIRD system (Loevinger et al. 1988). Decay data (Stabin and da Luz 2002); Dose factors (Siegel and Stabin 2003); Phantoms (Cristy and Eckerman 1987, Stabin et al. 1995). All extensively peer-reviewed and widely accepted.	All programs are based on established scientific best practices, with OLINDA/EXM referencing more recent and comprehensive peer-reviewed data.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This is not a study testing the device's diagnostic accuracy or clinical performance against a patient dataset. The "test" is a comparison to predicate devices and the underlying scientific literature.
Data Provenance: Not applicable. The "data" referenced are scientific models, decay data, and dose factors, which are from peer-reviewed literature and established dosimetry committees.

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 "test set" in the traditional sense of patient data requiring ground truth established by experts. The "ground truth" for the dose calculations is the established scientific methodology (MIRD method) and published dose factors/decay data, which are derived from comprehensive research and peer review by the international dosimetry community.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical or diagnostic accuracy test set requiring 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. OLINDA EXM is dosimetry calculation software, not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.

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

Yes, implicitly. The entire submission describes the standalone performance of the OLINDA EXM algorithm in calculating radiation doses based on user input. Its "performance" is evaluated by its adherence to established scientific methods (MIRD) and its ability to replicate or improve upon the functionalities of predicate devices. The outputs (dose per unit input) are the direct result of the algorithm's calculations.

7. The type of ground truth used

The "ground truth" is based on expert consensus on scientific principles and established physical models within the field of medical internal radiation dosimetry. This includes:
- The MIRD (Medical Internal Radiation Dose) Pamphlets, which provide standard methodology (Loevinger et al. 1988).
- Specific absorbed fractions (SAF) for various organs, derived from Monte Carlo simulations using anatomical models (phantoms) like those established by Cristy and Eckerman (1987) and Stabin et al. (1995).
- Peer-reviewed decay data for radiopharmaceuticals (Stabin and da Luz 2002) and dose factors (Siegel and Stabin 2003).
- Recommendations from the International Commission on Radiological Protection (ICRP Publication 60, 1991) for radiation weighting factors.

8. The sample size for the training set

Not applicable. This software uses deterministic physical models and pre-calculated data; it is not a machine learning or AI model trained on a specific dataset. The underlying physics models and parameters are "derived" from extensive research rather than "trained" in the AI sense.

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

Not applicable for a training set. The "ground truth" for the underlying physical models and data integrated into the software was established through decades of scientific research, experimental measurements, Monte Carlo simulations, and peer-reviewed publications by the international dosimetry community, as referenced in the document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2004

Mr. Michael G. Stabin, Ph.D., CHP Assistant Professor of Radiology and Radiological Sciences Vanderbilt University 1161 21st Avenue South NASHVILLE TN 37232-2675

Re: K033960

Trade/Device Name: OLINDA EXM Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: 90 IYX Dated: May 19, 2004 . Received: May 20, 2004

Dear Dr. Stabin:

This letter corrects our substantially equivalent letter of June 15, 2004 regarding the typo for the incorrect regulatory class. The June 15th letter stated this device as class II instead of class I.

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 (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

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Page 2 - Dr. Stabin

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 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" (21 CFR 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/dsma/dsmamain.html.

Sincerely yours,

Vividh. Lyam

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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510(k) Number (if known):	K033960
Device Name:	Olinda EXM
Indications For Use:	The purpose of Olinda EXM is to estimate the radiation dose received by internal organs as a result of administering a radiopharmaceutical.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
------------------------------------------	--------------------------------------

Over-The-Counter Use

(Optional Format 1-2-96)

Signature

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K033960
---------------	---------

公司

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K033960

JUN 1 5 2004

510(k) Summary

Applicants name address, phone and fax: Vanderbilt University

Contact persons name and address: Michael Stabin Vanderbilt Universitv 1161 21st Avenue South Nashville, TN 37232-2675

Telephone / Fax number of contact: (615) 343-0068 / (615) 322-3764

Date Summary prepared:

Trade Name: OLINDA/EXM

Common Name: Organ Level !Nternal Dose Assessment/EXponential Modeling Classification: Not yet classified

Devices OLINDA/EXM is substantially equivalent to: CDI3, Computer Program for Tissue Doses in Diagnostic Radiology, distributed by the Food and Drug Administration. CAMIRD, distributed by the Biomedical Computing Technology Information Center, Oak Ridge National Laboratory, PO Box X, Oak Ridge TN 37830.

Description of OLINDA/EXM:

The code requires input from the user on:

1. Which radionuclide is to be used.
1. A choice of body model(s) to represent the subject(s) of interest models exist for adult males, adult females, children, and women at different stages of pregnancy, and a number of individual organ systems (not included in the body phantoms).
1. Parameters which describe the biokinetics of the radiopharmaceutical within different organs of the body with time. Specifically, a potential user needs to provide the time integral of activity in all important source organs of the body. Alternatively, the user may provide biokinetic data and the EXM portion of the code will fit these data to a model, calculate the necessary integrals, and pass them to the OLINDA portion.

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The code works in the Windows 2000 or Windows XP Professional operating environments.

Intended Use of Olinda EXM: The purpose of OLINDA/EXM is to estimate radiation doses received by internal organs as a result of administering a radiopharmaceutical.

Comparison to CAMIRD

This program was legally distributed by the Biomedical Computing Technology Information Center, Oak Ridge National Laboratory, PO Box X, Oak Ridge TN 37830 in April 1976. It was described in a paper by Feller (1976), a copy of which is attached. It has been used by others and is referred to in a paper by Bellina and Guzzardi (1980). It is a pre-amendment device. It has not been through a 510(k) process and does not have a document control number. It has not been classified. Three versions of CAMIRD were written. The comparison here is to version II.

Comparison	CAMIRD	OLINDA/EXM	Discussion
Indications foruse	Estimates theabsorbed doses toseveral tissues of areference patient for aspecifiedradiopharmaceuticaldosage	Estimates the absorbeddoses to several tissuesof a reference patientfor a specifiedradiopharmaceuticaldosage.	Equivalent.Both calculatedose per unitinput.
Targetpopulation	Specific patients andpatient groups nottargeted. Calculationsare based on models ofan average individual(reference adultmale).	Specific patients andpatient groups nottargeted. Calculationsare based on models ofaverage individuals. 10models are availablee.g. adult male, female,5 year-old, 6-monthpregnant woman.	Targetpopulationequivalent.OLINDA/EXMhas a largernumber ofphantoms.
Design	User specifiedradiopharmaceuticalkinetic parameters andprevious Monte Carlocalculated organcontributions.Algorithm: MIRD method(Loevinger et al. 1988)	User specifiedradiopharmaceuticalkinetic parameters andprevious Monte Carlocalculated organcontributions.Algorithm: MIRD method(Loevinger et al. 1988)	The programsare essentiallyequivalent ininput andoutput. Themain differenceis in the numberof body modelsavailable.
	Input:	Input:
	1. Radionuclide2. Body model3. Radiopharmaceuticalbiokinetics	1. Radionuclide2. Body model3. Radiopharmaceuticalbiokinetics
Energy usedand/or delivered	The program estimatesdoses from user-entered criteria andprecalculated data; itis not connected to anenergy-emittingdevice.	The program estimatesdoses from user-enteredcriteria andprecalculated data; it isnot connected to anenergy-emitting device.	Equivalent
Performance	Output of dose perunit input.Simpler system thanOLINDA/EXM. FortranIV, input drivenprogram. Only 1 bodyphantom, fewer organsin output.	Output of dose per unitinput.User friendly, eventdriven, more bodyphantoms, more organsin output.	OLINDA/EXM isequivalent inperformance toCAMIRD.
Human Factors	A descriptive paper isavailable in the openliterature.	Communication tools forerror prevention havebeen systematicallyimplemented. Errormessages, help files.user manual andinstallation tests haveall been developed so asto educate the user andprevent mistakes. Anopen literaturepublication is inpreparation describingthe OLINDA/EXM code.An open literaturepublication is availabledescribing the MIRDOSEcode (Stabin 1996), onwhich the OLINDA/EXMcode was based.	OLINDA/EXM ismore user-friendly.
Anatomical sites	Program Tissue dosescalculated: Adrenals,Fat, Blood, ovaries,Skin, Uterus, Lower	Tissue doses calculated:Adrenals, Brain, GallBladder Wall, GallBladder Cont, LowerLarge Intestine Wall,Lower Large Intestine	More tissuesincluded inOLINDA/EXM.

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dose factors are based have been established previously in the literature (Cristy and Eckerman 1987, Stabin et al. 1995) and have been widely accepted and and Eckennan 1707, on one one one one only . Both programs are limited in that they use average body models and thus are not representative of any chat they use areful gu new has more body models to choose from and also particular pations. Sales the mass of individual organs to provide a limited measure of patient-specificity. Both programs are intended to be used by mcasure oversicists or appropriately trained physicians or equivalent in research er hospital facilities. Both programs need trained professional personnel to operate the program, provide the appropriate input and interpret the results.

References

Bellina CR and Guzzardi R. CAMIRD/III: a revised version of the CAMIRD/II and MIRD-S packages for internal dose calculation: concise communication. Journal of Nuclear Medicine, Vol 21, Issue 4 379-383 1980.

Cristy M. and Eckerman K. Specific absorbed fractions of energy at various ages from internal photons sources. ORNL/TM-8381 V1-V7. Oak Ridge National Laboratory, Oak Ridge, TN; 1987.

Feller PA. Computer Software to Facilitate Absorbed Dose Calculations, , in Radiopharmaceutical Dosimetry Symposium -- Proceedings of a Conference Held at Oak Ridge, Tenn., April 26-29, 1976, ed. by R.J. Cloutier, J.L. Coffey, W.S. Snyder and E.E. Watson, pp.119-126, HEW Publication (FDA) 76-8044, June 1976.

International Commission on Radiological Protection. 1990 Recommendations of the International Commission on Radiological Protection. ICRP Publication 60, Pergamon Press, New York, 1991.

Loevinger R, Budinger T, Watson E: MIRD primer for absorbed dose calculations. Society of Nuclear Medicine; 1988.

Peterson LE and Rosenstein M. Computer program for tissue doses in diagnostic radiology. Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 1989.

Rosenstein, M. HEW Publication FDA 76-8030, Food and Drug Administration, Rockville. Marvland. 1976.

Stabin M. MIRDOSE - the personal computer software for use in internal dose assessment in nuclear medicine. J Nucl Med, 37:538-546; 1996.

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Stabin MG, da Luz CQPL. New decay data For internal and external dose assessment, Health Phys. 83(4):471-475, 2002.

Stabin MG and Siegel JA. Physical Models and Dose Factors for Use in Internal Dose Assessment. Health Physics, 85(3):294-310, 2003.

Comparison to CDI3

This program is distributed by the Food and Drug Administration through their web site www.fda.gov. It has been available since 1989 and is widely available in the radiation protection community. It has not been through a 510(k) process and does not have a document control number. It has not been classified.

Comparison	CDI3	OLINDA/EXM	Discussion
Indications foruse	Estimates the absorbeddoses to various tissuesof a reference patientfor a number ofspecified X-rayprocedures. Theprogram also calculatesa "cancer detrimentindex" for the aggregateof the tissue doses.	Estimates the absorbeddoses to several tissues ofa reference patient for aspecifiedradiopharmaceuticaldosage.	First indicationessentiallyequivalent.OLINDA/EXMdoes notcalculate"cancerdetrimentindex"
Targetpopulation	Specific patients andpatient groups nottargeted. Calculationsare based on model ofaverage human body"phantom".	Specific patients andpatient groups nottargeted. Calculations arebased on models ofaverage individuals. 10models are available e.g.adult male, female, 5year-old, 6-monthpregnant woman.	Targetpopulationequivalent.OLINDA/EXMhas a largernumber ofphantoms.
Design	X-ray examination inputparameters arecombined withpreviously establishedMonte Carlo calculationsof dose per unit input togive dose estimates.Algorithm given insection 4 of "Organdoses in diagnosticradiology" (Rosenstein1976).	User specifiedradiopharmaceuticalkinetic parameters andprevious Monte Carlocalculated organcontributions. Algorithm:MIRD system (Loevinger etal. 1988)Input:Radionuclide1.	Differentalgorithms,similar inputs,same output.
	Input:
	1. X-ray Spectra data	8. Body model
	2. Exposure parameters(entrance exposure, R,source/image distance,receptor size)	9. Radiopharmaceutical biokinetics
	3. Projectionparameters	Output: Dose to organs inmSv/MBq and rem/mCi.
	Out put: Dose to organsin mrad
Energy usedand/ordelivered	The program estimatesdoses from user-enteredcriteria andprecalculated data; it isnot connected to anenergy-emitting device.	The program estimatesdoses from user-enteredcriteria and precalculateddata; it is not connectedto an energy-emittingdevice.	Equivalent

Performance	Output of dose per unitinput.DOS-based, input drivenprogram. Fewer bodyphantoms.Fewer organs in output.	Output of dose per unitinput.User friendly,Event drivenMore body phantomsMore organs in output.Communication tools forerror prevention havebeen systematicallyimplemented. Errormessages, help files, usermanual and installationtests have all beendeveloped so as to	OLINDA/EXM isequivalent inperformance toCDI3.
			educate the user andprevent mistakes.
Human Factors	A user's manual waspublished by the FDA(Peterson andRosenstein 1989).Current availability isuncertain.	An openliterature publication is inpreparation describing theOLINDA/EXM code. Anopen literaturepublication is availabledescribing the MIRDOSEcode (Stabin 1996), onwhich the OLINDA/EXMcode was based.	OLINDA/EXM isequivalent toCDI3 given thecurrent state ofcomputertechnology.

Anatomicalsites	Program Tissue dosescalculated: lungs,active bone marrow,ovaries, testes, thyroid,uterus, total trunk(excluding skeletal andlung tissues), and female	Tissue doses calculated:Adrenals, Brain, GallBladder Wall, Gall BladderCont, Lower LargeIntestine Wall, LowerLarge Intestine Cont,Small Intestine, Stomach	More tissuesare included inOLINDA/EXM.

	breasts.	Wall, Stomach Cont,
		Upper Large Intestine
		Wall, Upper Large
		Intestine Cont, Heart
		Wall, Heart Cont, Kidneys,
		Liver, Lungs, Spleen,
		Pancreas, Prostate,
		Skeleton, Active Marrow,
		Skin, Thyroid, Thymus,
		Testes, Urin.Bl. Wall,
		Urin.Bl. Cont, Whole Body
Compatibilitywith otherdevices	The only device that theprogram interacts with isthe PC on which it isrun.	The only devices that theprogram interacts with isthe PC on which it is runand the printer associatedwith the PC.	Equivalent
Where used	Used by physicists toinvestigate newradiopharmaceuticals,and estimate patientdoses. Used inuniversities,pharmaceuticalmanufacturing firms,government agencies,hospitals and researchfacilities.	Used by physicists toinvestigate newradiopharmaceuticals, andestimate patient doses.Used in universities,pharmaceuticalmanufacturing firms,government agencieshospitals and researchfacilities.	Equivalent
Standards met	None	None	Equivalent

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Summary of comparison

CDI3 and OLINDA/EXM are both computer software programs that estimate the radiation dose received by tissues in average body models. OLINDA/EXM does not estimate a "cancer detriment index", as this was deemed to be outside the scope of the program's application. OLINDA/EXM does, however, calculate equivalent dose via application of radiation weighting factors currently recommended by the ICRP (ICRP 1991). These radiation weighting factors may be modified by the user if desired. Evaluation of risk is left to the user, through application of risk models. This is not treated in OLINDA/EXM in any way.

They both use Monte Carlo based calculations and require input related to the radiation delivery method. Both programs produce tables of tissue doses. The calculation undertaken is different because the radiation source is different. The utility of OLINDA/EXM is approximately equivalent to that of the CDI3 program because the calculations for both programs are based on current scientific best practice as determined by respectively the MIRD Committee (Medical Internal Radiation Dose Committee) and the FDA. The decay data and

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dose factors used in the OLINDA/EXM code have been extensively peer reviewed. The decay data were published in the Health Physics Journal in 2002 (Stabin and da Luz 2002), and currently may be viewed through the Health (Stable Society web site. The dose factors were then published in the Health Physics Journal in 2003 (Siegel and Stabin 2003). The phantoms on which the r nyales our are based have been established previously in the literature (Cristy dose ractors and base base al. 1995) and have been widely accepted and une ablishe international dosimetry community. Both programs are limited in that they use average body models and thus are not representative of any charticular patient. OLINDA/EXM has more body models to choose from and also permits the user to vary the mass of individual organs to provide a limited measure of patient-specificity. Both programs are intended to be used by medial c or speropriately trained physicians or equivalent in research or hospital facilities. Both programs need trained professional personnel to of nospitale program, provide the appropriate input and interpret the results.

References

Cristy M. and Eckerman K. Specific absorbed fractions of energy at various ages from internal photons sources. ORNL/TM-8381 V1-V7. Oak Ridge National Laboratory, Oak Ridge, TN; 1987.

International Commission on Radiological Protection. 1990 Recommendations of the International Commission on Radiological Protection. ICRP Publication 60, Pergamon Press, New York, 1991.

Loevinger R, Budinger T, Watson E: MIRD primer for absorbed dose calculations. Society of Nuclear Medicine; 1988.

Peterson LE and Rosenstein M. Computer program for tissue doses in diagnostic radiology. Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 1989.

Rosenstein, M. HEW Publication FDA 76-8030, Food and Drug Administration, Rockville, Maryland. 1976.

Stabin M. MIRDOSE - the personal computer software for use in internal dose assessment in nuclear medicine. J Nucl Med, 37:538-546; 1996.

Stabin MG, da Luz CQPL. New decay data For internal and external dose assessment, Health Phys. 83(4):471-475, 2002.

Stabin MG and Siegel JA. Physical Models and Dose Factors for Use in Internal Dose Assessment. Health Physics, 85(3):294-310, 2003.

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).