In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As part of the planning process monitor unit settings and dose to a volume or specific anatomical points will be generated.

The MuCheck - Monitor Unit/Dose validation Software verifies the monitor unit or dose calculated by the primary treatment planning system. MuCheck can also be used to calculate the monitor or dose for simple plans that do not require the use of the primary treatment planning system.

The intended use of the MuCheck software has been extended by the addition of an optional module called BrachyCheck. Brachycheck is used to verify brachytherapy procedures(implants using radioactive sources) performed by a brachytherapy treatment planning system. As part of the planning process, dwell positions will be generated and dose contributions from these dwell positions to specified anatomical points will be calculated.

The BrachyCheck module (device under review) verifies the dose calculated to the specified points by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

Device Description

The BrachyCheck Dose Validation module is an optional software module that is part of the MuCheck software. MuCheck is designed to operate on a personal computer in a Windows environment. It has been designed to operate either in a stand alone mode independent of any brachytherapy treatment planning system or to import plans from a brachytherapy treatment planning system. It does not connect to or control any radiation hardware device. BrachyCheck performs dose calculations to verify the dose calculated by the primary radiation brachytherapy treatment planning system.

AI/ML Overview

The provided text describes the MuCheck - Monitor Unit/Dose Validation Program, with a specific focus on the BrachyCheck Dose Validation module. The information provided outlines the regulatory submission for premarket notification (510(k)) and details about its intended use and a summary of safety and effectiveness.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Aspect	Acceptance Criteria (Explicitly Stated or Inferred)	Reported Device Performance
Primary Function	Verify dose calculated by primary brachytherapy treatment planning system.	BrachyCheck performs dose calculations to verify the dose calculated by the primary radiation brachytherapy treatment planning system. The non-clinical tests were conducted using a brachytherapy treatment planning system or hand calculations and BrachyCheck. The test results all matched very closely.
Quality Assurance Tool	Provide a secondary check for primary dose calculation.	Intended use as a quality assurance tool only, not as a treatment planning device. Provides secondary check for primary dose calculation, which is part of good treatment protocol and a recommendation by AAPM Task Group 43.
Accuracy (Inferred)	Match closely with primary treatment planning system or hand calculations.	"The test results all matched very closely." (This is the primary metric reported, implying accuracy relative to established methods).
Compliance with Regulations	Conformance to GMP regulations.	"Conformance to the GMP regulations helped to insure that the finished product is safe and effective to use."
Hazard Resolution	Hazards resolved as appropriate.	"A Hazard Analysis was completed and hazards were resolved as appropriate."
System Specifications	All system specifications met.	"All system specifications were met and testing performed to demonstrate substantial equivalence."
Substantial Equivalence (Overall)	Demonstrate substantial equivalence to predicate devices.	The FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The document explicitly states: "Based upon the technological characteristics, intended use, and non-clinical tests, BrachyCheck is substantially equivalent to the predicate device. The documentation submitted for review supports this claim."

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

The document does not explicitly state a specific sample size for a "test set" in the context of typical clinical study reporting. The evaluation appears to be based on non-clinical tests comparing BrachyCheck's calculations to those of a brachytherapy treatment planning system or hand calculations.

Test Set Size: Not explicitly stated as a number of cases or plans. It refers to "tests" that were "conducted using a brachytherapy treatment planning system or hand calculations and BrachyCheck."
Data Provenance: The data used for these non-clinical tests would be internally generated or from established brachytherapy treatment planning systems and hand calculations. The origin is not specified as a country, and it is inherently retrospective in the sense that it evaluates the device against existing calculation methods rather than collecting new patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the non-clinical tests appears to have been established by:

"A brachytherapy treatment planning system": These are established systems used in clinical practice, which serve as a de facto "expert" in terms of established calculation methods.
"Hand calculations": These would be performed by qualified medical physicists or dosimetrists. The document mentions "The staff at Oncology Data Systems includes a certified medical dosimetrist with over 34 years of clinical experience." While not explicitly stated that this individual established the ground truth for every test case, their expertise underpins the company's capabilities and the validity of hand calculations.
Number of Experts: Not explicitly stated for specific test cases. It implies reliance on output from existing validated systems and potentially multiple dosimetrists/physicists for hand calculations.
Qualifications: For hand calculations, the internal expertise includes a "certified medical dosimetrist with over 34 years of clinical experience."

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "tests results all matched very closely" implies a direct comparison rather than an adjudicated consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Testing: Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness." The evaluation was based on non-clinical tests. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported.

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

Yes, a standalone (algorithm only) performance evaluation was done. The BrachyCheck module is a software tool that performs calculations and verifies doses. The non-clinical tests directly compare its computational output to existing systems or hand calculations. It functions as a "standalone mode independent of any brachytherapy treatment planning system" for its verification task. The results reported ("test results all matched very closely") refer to the algorithm's performance in this standalone capacity.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests was based on:

Established gold standard calculations: Output from a "primary radiation brachytherapy treatment planning system."
Expert hand calculations: Performed by qualified personnel (e.g., certified medical dosimetrist).

This implicitly represents a form of expert consensus or established methodologies rather than pathology or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set or machine learning components. BrachyCheck appears to be a deterministic software system that performs dose calculations based on established physics algorithms, not a machine learning model that requires training data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned (as the device is not described as involving machine learning), this question is not applicable to the provided information.

Summary

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VAY 10 1 0 1 1

	K061152
Submitter:	Oncology Data Systems, Inc.1601 S.W 89th, Ste. E-100Oklahoma City, Ok. 73159tel. (405) 680-5222fax (405) 680-5444
Contact:	Gregory G. Miller
Date:	March 24, 2006
Trade Name:	MuCheck - Monitor Unit/Dose Validation Program
Common Name:	MuCheck
Classification Panel:	Radiology
Classification Name:	Medical Charged Particle Radiation TherapySystem(Accessory)21 CFR 892.5050 (class II)
Performance Standards:	none established under section 514

510(k) Safety and Effectiveness Summary

Substantial Equivalence:

Device Name	510(k) #
Plato Brachytherapy (BPS v14.0)	K983343
MuCheck - Monitor Unit Validation Program	K980904
MuCheck - Monitor Unit/Dose Validation Program	K012227

Description:

Substantial Equivalence Summary:

Intended Use:

The intended use for the BrachyCheck module is to calculate dose and dwell times for the purpose of validating a dose previously calculated by a primary brachytherapy treatment

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planning system . The intended use is as a quality assurance tool only and not as a treatment planning device.

In a radiation therapy department quality assurance is an important part of patient care. The ability to provide a secondary check for the primary dose calculation is part of good treatment protocol as well being a recommendation by AAPM Task Group 43. BrachyCheck provides this very important quality assurance function.

Safety and Effectiveness:

The staff at Oncology Data Systems includes a certified medical dosimetrist with over 34 years of clinical experience. The computer programming and design has been provided by a programming staff with combined experience of over 48 years in the design and development of systems. The combined expertise as well as conformance to the GMP regulations helped to insure that the finished product is safe and effective to use.

A comprehensive users manual provides extensive documentation for the user. Optional system startup and training is provided as part of the service provided by Oncology Data Systems.

Technological Characteristics:

The technological characteristics are the same as for the predicate devices. BrachyCheck was designed to operate in a windows environment using both mouse and keyboard.

Non-clinical tests:

Verification and validation test plans were completed in accordance with Oncology Data Systems procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate. All system specifications were met and testing performed to demonstrate substantial equivalence. The non-clinical tests were conducted using a brachytherapy treatment planning system or hand calculations and BrachyCheck. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.

Summary of Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness.

Conclusions:

Based upon the technological characteristics, intended use, and non-clinical tests, BrachyCheck is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Oncology Data Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K061152

Trade/Device Name: MuCheck - Monitor Unit/Dose Validation Software Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: LHN, JAO, and KXK Dated: April 21, 2006 Received: April 26, 2006

MAY 1 0 2006

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/9 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration (FDA). The text is all in black and the background is white.

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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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toH-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Indications for Use

510(k) Number (if known): _ Қобыл >2

Device Name: MuCheck - Monitor Unit/Dose Validation Software

Indications for Use:

Prescription Use 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

d Radiological Devices

10(k) Number

page 1 of 1

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

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.