DoseCalc is a program utilized in a radiation therapy department for the determination of monitor units. The Monitor Unit is a quantity used by a treatment machine for determining the length of time that it should remain on in order to deliver a prescribed amount of radiation to a point. Most of the time, a radiation treatment planning system is used to define the location and dose distribution of the radiation. Radiation therapy planning systems typically calculate the monitor units needed to deliver the desired amount of reduction to a point of reference and this produce the desired dose distribution within the patient. On occasion, a hand calculation will be performed in order to determine the number of monitor units needed to deliver the prescribed amount of radiation. DoseCalc is a program which allows the user to input data by hand through the use of the mouse or keyboard or electronically from the primary radiation therapy planning system. From this data, it will then determine the number of monitor units needed to be given to a patient. The process of calculating the monitor units involves DoseCalc automatically looking up the data parameters from previously inputed data and then calculating the monitor units from these values. This process greatly increases the speed at which a calculation can be performed and also eliminates many errors that occur from manually looking up the data. DoseCalc's monitor unit calculation can then be used to validate the monitor units previously determined by hand or by the primary radiation therapy planning system. It is not the intention of DoseCalc to replace the calculation performed by the primary radiation therapy planning computer but to validate its calculation as a means of quality assurance. The practice of performing a secondary check is recommended by the American Association of Physicists in Medicine (AAPM) Task Group 40 as part of good quality assurance program. This practice is an important aspect in providing quality patient care. DoseCalc is not only being submitted to perform this secondary function but to also be used as the primary means of calculating monitor units in situations where the physician does not order the use of a radiation therapy treatment plan. For this situation, it is important to accurately determine the monitor units needed for a patient's treatment. DoseCalc provides this operation. It has many built in checks that will check for many common errors that occur when calculating monitor units as well as checking that the inputted parameters are within predefined limits for the treatment machine. The use of DoseCalc in this manner provides a means for accurately determining the monitor units. A physicist can then visually examine the inputted data for accuracy and verify the computed parameters to be sure that they are correct.

DoseCalc also allows for the transfer of the treatment planning data from the primary radiation therapy planning computer to DoseCalc and then to the facility's Verify and Record system. This will reduce the number of errors that occur as a result of manually inputting this data. This feature merely transfers information from one system to another without performing any calculations.

Device Description

DoseCalc is a software program that is designed to operate on a PC in a Windows environment on either a stand alone PC or on a server. It does not control any radiation hardware device but does interface with the primary radiation therapy planning software and verify and record software. The device performs monitor unit calculations for photon beams which can be used to validate monitor units calculated by the primary radiation therapy planning system or to simply provide the monitor units needed to treat a patient when a radiation therapy plan is not prescribed by the physician. DoseCalc determines the monitor units through the process looking data up from previously inputted tables.

AI/ML Overview

The provided text describes the DoseCalc v1.02 software, a program for calculating monitor units in radiation therapy. However, it does not contain specific acceptance criteria or a detailed study report with quantitative results to fill in the table and answer all questions comprehensively. The document focuses on demonstrating substantial equivalence to a predicate device (muCheck) rather than presenting a formal efficacy study with defined acceptance criteria and performance metrics.

Here's an attempt to extract relevant information and note what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as inferred from document)
No explicit, numerical acceptance criteria are stated for accuracy, precision, or other performance metrics. The implicit criterion is "accuracy" in calculating monitor units and "elimination of errors".	DoseCalc performs "very accurately" when validating calculations from a treatment planning system.
The device performs "accurately" when used as a primary means of calculating monitor units.	Provides "a means for accurately determining the monitor units".
Built-in checks to identify "many common errors" and ensure "inputted parameters are within predefined limits".	The system "will check for many common errors" and "checking that the inputted parameters are within predefined limits".
Accurately transfer treatment planning data from primary system to DoseCalc and then to Verify and Record system.	"Allows for the accurate transfer of this data by eliminating the numerous human errors that occur in these processes."
Substantial Equivalence to predicate device (muCheck).	Found by FDA to be "substantially equivalent".

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

Test Set Sample Size: Not explicitly stated. The "Non-Clinical Tests" involved "numerous monitor unit calculations under various situations." "Beta Testing" involved "numerous copies of actual calculations."
Data Provenance:
- Non-Clinical Tests: "Hand calculations for the same situations" (presumably synthetic or simulated scenarios).
- Beta Testing: "Actual calculations" from East Texas Medical Center in Tyler, Texas. These were compared to calculations from ADAC's Pinnacle3 APEX (K951581) or "hand calculations." This implies a mix of prospective (real patient data processed during the beta test) and potentially retrospective (past patient cases replicated) data.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: The ground truth for "hand calculations" would presumably be established by qualified medical physicists. The submitter, Craig A. Laughton, is a Medical Physicist with a Master's Degrees and 4 years of clinical experience, working with a PhD Physicist with over 25 years of experience. These individuals would be considered experts in setting up and verifying such calculations. The predicate device's calculations and "primary radiation therapy planning system" (ADAC's Pinnacle3 APEX) also serve as a form of "ground truth" or reference.

4. Adjudication method for the test set

Adjudication Method: Not explicitly detailed. The comparison involved DoseCalc's calculations against "hand calculations" and/or calculations from "the primary radiation therapy planning system." The process seems to be a direct comparison, rather than an adjudicated consensus between multiple independent experts on each case.

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

MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device is a software program for calculating monitor units, primarily for validation or as a primary calculation tool, not an AI for human interpretation of images or data where "human readers improve with AI vs without AI assistance" would be a relevant metric.

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

Standalone Performance Study: Yes, the described "Non-Clinical Tests" and "Beta Testing" sections primarily evaluate the algorithm's performance in a standalone capacity (i.e., its ability to calculate monitor units accurately when given inputs), with the resulting calculations then being compared to references (hand calculations, other TPS). While a physicist "can then visually examine the inputted data for accuracy and verify the computed parameters," this is a quality control step, not part of the primary performance evaluation of the algorithm's calculation capability itself.

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

Type of Ground Truth: The ground truth was primarily established through:
- Expert Hand Calculations: Manual calculations performed by qualified physicists.
- Reference System Calculations: Output from an established "primary radiation therapy planning system" (ADAC's Pinnacle3 APEX) and the predicate device (muCheck).

8. The sample size for the training set

Training Set Sample Size: Not explicitly stated. The document mentions that DoseCalc looks up data from "previously inputted tables" and has "many built in checks that will check for many common errors that occur when calculating monitor units as well as checking that the inputted parameters are within predefined limits for the treatment machine." This implies that the system was developed and configured based on established physics principles and possibly a substantial amount of data (e.g., machine-specific data, historical error patterns), but a formal "training set" in the context of machine learning (where this question typically applies) is not described.

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

Ground Truth for Training Set: Since a formal machine learning "training set" isn't explicitly described, the concept of "ground truth for training" as typically understood in AI is not applicable here. The "training" of this system would be more akin to populating its lookup tables and programming its calculation rules based on established medical physics principles, machine calibration data, and potentially historical data on common errors. This "ground truth" would be derived from:
- Medical Physics Principles and Formulas: The underlying equations and methodologies for calculating monitor units.
- Machine-Specific Data: Data related to the specific treatment machines (e.g., beam profiles, output factors) that are "previously inputted tables."
- Expert Knowledge: The expertise of the medical physicists developing the software, incorporating their knowledge of errors and limits.

Summary

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K990833

10. PREMARKET NOTIFICATION Summary of Safety and Effectiveness

Submitted by:	Craig A. Laughton403 Mockingbird LaneTyler, Texas, 75701(903)595-0209
Contact:	Craig A. Laughton
Date:	3/08/99
Trade Name:	DoseCalc
Common Name:	DoseCalc
Classification Panel:	Radiology
Classification Name:	Medical Charged Particle Radiation TherapySystem (Accessory); 21 CFR 892.5050 (class II)
Performance Standards:	none established under section 514
Substantial Equivalence:	muCheck - Monitor Unit Validation Program510(k) K 980904

Description:

Intended Use:

The intended use of DoseCalc is the same as the predicate device with a few additions that do not affect the safety and effectiveness of the device. DoseCalc is a program utilized in a radiation therapy department for the determination of monitor units. Radiation therapy planning systems typically calculate the monitor units needed to deliver the desired amount of radiation to a point of reference within the patient. In this situation, DoseCalc will serve to validate those monitor units computed by the primary

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radiation therapy planning system. This is the same intended use as the predicate device. The practice of performing a secondary check is recommended by the American Association of Physicists in Medicine (AAPM) Task Group 40 as part of good quality assurance program. This practice is an important aspect in providing quality patient care. DoseCalc is not only being submitted to perform this secondary function but to also be used as the primary means of calculating monitor units in situations where the physician does not order the use of a radiation therapy treatment plan. DoseCalc differs from the predicate device in this area. For this situation, it is important to accurately determine the monitor units needed for a patient's treatment. DoseCalc provides this operation. It has many built in checks that will check for many common errors that occur when calculating monitor units as well as checking that the inputted parameters are within predefined limits for the treatment machine. The use of DoseCalc in this manner provides a means for accurately determining the monitor units. Using DoseCalc in this manner is not seen as a use that effects the safety of the patient. DoseCalc performs this same calculation when validating a calculation from a treatment planning system and has shown to do this very accurately (see Supporting Data). Therefore it would only seem logical to extend its use and allow for it to be used as the primary means of determining monitor units when a radiation therapy plan is not performed. A physicist can then visually examine the inputted data for accuracy and verify the computed parameters to be sure that they are correct.

DoseCalc also differs from the predicate device by allowing for the import of the treatment planning data and the export of this same data to the facility's Verify and Record system. This will reduce the number of errors that occur as a result of manually inputting this data. This feature merely transfers information from one system to another without performing any calculations and is therefore not seen to be a threat to patient safety and effectiveness. In fact, it is seen to be an enhancement because it will allow for the accurate transfer of this data by eliminating the numerous human errors that occur in these processes.

Safety and Effectiveness:

The submitter, designer, and writer of this software. Craig A. Laughton, is a Medical Physicist with a Master's Degree in Medical Physics and a Master's Degree in Nuclear Engineering. He has 4 years of clinical experience and works with a PhD Physicist who has over 25 years of experience. His, Craig A. Laughton's, experience in this field along with his conformance to the Good Manufacturing Practices Regulations has provided for the development of a product that is safe and effective for use. A User's Manual has been written for the benefit of all users of the software in order to ensure that the software is used correctly. Validation testing was performed in order to confirm that the software performs according to the Software Requirements. These documents are included in section 9.6.

Technological Characteristics:

The technological characteristics are identical to those of the predicate device. DoseCalc was designed to be operated on a PC in the Windows environment while using the mouse and keyboard for user interaction. These are the same characteristics as the predicate device.

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Non-Clinical Tests:

The non-clinical test involved using DoseCalc to perform numerous monitor unit calculations under various situations. These calculations were then compared to hand calculations for the same situations. Side by side comparisons of these calculations are shown in the Supporting Data section just following a table summarizing the results.

Beta Testing:

Beta site testing was performed at East Texas Medical Center in Tyler, Texas. Numerous copies of actual calculations are presented in the Supporting Data section just following a table that summarizes the results. These calculations were either compared to a calculation performed by the primary radiation therapy planning system (ADAC's Pinnacle3 APEX, K951581) or to a hand calculation.

Conclusions:

According to the intended use, technological characteristics, non-clinical testing, and beta site testing, DoseCalc is substantially equivalent to muCheck (the predicate device). The documentation presented in this submission supports the claim of substantial equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1399 JUN

Craig A. Laughton President Integrity Medical Software, Inc. 403 Mockingbird Lane Tyler, Texas 75701

RE:

K990833 DoseCalc v1.02 Medical Charged Particle Radiation Therapy System Dated: March 9, 1999 Received: March 12, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Laughton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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,

CART Daniel C. Schultz, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_ K990833 ?

Device Name: DoseCalc v1.02

Indications For Use:

DoseCalc is a program utilized in a radiation therapy department for the determination of monitor units. The Monitor Unit is a quantity used by a treatment machine for determining the length of time that it should remain on in order to deliver a prescribed amount of radiation to a point. Most of the time, a radiation treatment planning system is used to decine the location and dose distribution of the radiation. Radiation therapy planning systems typically calculate the monitor units needed to deliver the desired amount of reduction to a point of reference and this produce the desired dose distribution within the patient. On occasion, a hand calculation will be performed in order to determine the number of monitor wuits needed to deliver the prescribed anount of radiation. DoseCalc is a program which allows the user to input data by hand through the use of the mouse or keyboard or clectronically from the primary radiation therapy planning system. From this data, it will then determine the number of monitor units needed to be given to a patient. The process of calculating the monitor units involves DoseCalc automatically looking up the data parameters from previously inputed data and then calculating the monitor units from these values. This process greatly increases the speed at which a calculation can be performed and also eliminates many errors that occur from manually looking up the data. DoseCalc's monitor unit calculation can then be used to validate the monitor units previously determined by hand or by the primary radiation therapy planning system. It is not the intention of DoseCalc to reglace the calculation performed by the primary radiation therapy planning computer but to validate its calculation as a means of quality assurance. The practice of performing a secondary check is recommended by the American Association of Physicists in Medicine (AAPM) Task Group 40 as part of good quality assurance program. This practice is an important aspect in providing quality patient care. DoseCalc is not only being submitted to perform this secondary function but to also be used as the primary means of calculating monitor units in situations where the physician does not order the use of a radiation therapy treatment plan. For this situation, it is important to accurately determine the monitor units needed for a patient streatment. DoseCalc provides this operation. It has many built in checks that will check for many common crrors that occur when calculating monitor unlis as well as checking that the inputted parameters are within predcfined limits for the treatment machine. The use of DoseCalc in this manner provides a means for accurately determining the monitor units. A plysicist can then visually examine the inputted data for accuracy and verify the computed parameters to be sure that they are correct.

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

Concurrence of CDRH/ Office of Device Evaluation (ODE)	Richard F. Williams for Daniel Schultz MD.
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K990833

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

5-2

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.