The intended use for the muCheck Monitor Unit Validation Program is the same as for the predicate device: to calculate a monitor unit or timer setting for the purpose of validating a monitor unit or timer setting previously calculated by a primary radiation treatment planning system or hand calculation. The intended use is as a quality assurance tool only and not as a treatment planning device.

Device Description

The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to operate on a stand alone mode independent of any radiation treatment planning system. It does not connect to or control any radiation hardware device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state numerical acceptance criteria in a structured table. However, the core acceptance criterion is substantial equivalence to a predicate device, specifically the "K & S Associates, PC Setup Program (510(k) K 914698)".

The "reported device performance" is the claim that muCheck's calculations "matched very closely" with those of the predicate device and the manual/treatment plan calculations.

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (K & S Associates, PC Setup Program) in calculating monitor unit/timer settings.	Non-clinical tests: "The test results all matched very closely."
Functionality as a Quality Assurance Tool	Beta Clinical Testing: "The results received and summarized from the beta testing conducted in St. John Hospital support the claim of substantial equivalence."
Safety and Effectiveness	"The combined expertise [of staff] as well as conformance to the GMP regulations helped to insure that the finished product is safe and effective to use."
Accuracy of MU Calculation	"The muCheck Monitor Unit Validation Program (the device under review) makes this process much faster and more accurate."

Study Details

The document describes two types of testing to support the claim of substantial equivalence: Non-clinical tests and Beta Clinical Testing.

Sample Size Used for the Test Set and the Data Provenance:
- Non-clinical tests: The document doesn't specify a numerical sample size for the test set. It mentions "each test was further validated using a treatment plan which provide a monitor unit or hand calculation." This implies multiple test cases were used, but the exact number is not stated.
- Data Provenance: The data provenance is not explicitly stated. The tests seem to be internal comparisons of calculations, rather than using patient-derived data directly.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Non-clinical tests: The ground truth for these tests was established by comparison to the predicate device's calculations and "treatment plan which provide a monitor unit or hand calculation." The involvement of specific experts for establishing this ground truth for each test case is not detailed. However, the overall development involved:
  - A certified medical dosimetrist with over 20 years of experience.
  - A systems analyst with over 20 years of experience in design and development of systems.
  - It can be inferred that these individuals, or similar qualified personnel, would have been involved in verifying the accuracy of the manual/treatment plan calculations.
Adjudication Method for the Test Set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1). The "non-clinical tests" involved comparing muCheck's results against both the predicate device and a "treatment plan which provide a monitor unit or hand calculation." The "Beta Clinical Testing" results were "received and summarized" from St. John Hospital. This suggests a direct comparison of calculated values rather than an adjudicated consensus process.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a "Monitor Unit Validation Program" and acts as a quality assurance tool, not a diagnostic imaging device where human reader performance with or without AI assistance would typically be evaluated.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the non-clinical tests and beta clinical testing were essentially standalone performance evaluations of the muCheck algorithm's ability to calculate monitor units. The comparison was to established calculation methods (predicate device, treatment plan, hand calculation). The device is designed to "operate on a stand alone mode independent of any radiation treatment planning system."
Type of Ground Truth Used:
- For the non-clinical tests, the ground truth was established by:
  - Calculations from the predicate device (K & S Associates, PC Setup Program).
  - Calculations derived from a "treatment plan" or "hand calculation." This can be considered a form of expert-validated calculation/reference standard.
- For the beta clinical testing, the ground truth is implicitly the clinical setting's existing methods for monitor unit validation, against which muCheck's results were compared to support "substantial equivalence."
Sample Size for the Training Set:
- The document describes muCheck as a calculation program that stores "beam data factors" in a database. It doesn't mention a "training set" in the context of machine learning, as this is not an AI/machine learning model in the modern sense. Instead, the system is populated with predefined, measured "beam data factors" as part of its pre-installation.
How the Ground Truth for the Training Set Was Established:
- Given that this is not an AI/ML device, there isn't a "training set" in the conventional sense. The "ground truth" for the system's operational data (beam data factors) is established through physical measurements by a medical physicist, unique to each machine. These factors are then "entered into the system one time and stored in a database as part of the pre-installation process." The accuracy of this data entry is verified by "plotting on a graph and printed along with tables of actual values entered."

Summary

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Medical Dosimetry Services, Inc.

FAX (405) 745-3233 12401 S. Riverview Rd. Oklahoma City, Ok. 73173 Tel. (405) 745-2188

いましたが、そして、この日は、2008年には、日本

(405) 743-5233

K980904

JUN - 8 1998

510(k) Safety and Effectiveness Summary

Submitter:	Medical Dosimetry Services, Inc.12401 Riverview Rd.Oklahoma City, Ok. 73173tel. (405) 745-2188fax (405) 745-3233
Contact:	Gregory G. Miller, Vice-President
Date:	March 6, 1998
Trade Name:	muCheck - Monitor Unit Validation Program
Common Name:	Monitor Unit Validation Program
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:	K & S Associates, PC Setup Program510(k) K 914698

Description:

Substantial Equivalence Summary:

Intended Use:

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In a radiation therapy department quality assurance is an important part of patient care. The ability to provide a secondary check for the primary monitor unit calculation is part of good treatment protocol as well being a recommendation by Task Group 40. Mucheck provides this verv important quality assurance function.

Safety and Effectiveness:

The staff at Medical Dosimetry Services includes a certified medical dosimetrist with over 20 years of experience. The computer programming and design has been provided by a systems analyst with over 20 years of experience 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 available as a hard copy as well as on-line, provides extensive documentation and tutorial for the user. Initial system startup and training is provided on-site as part of the service provided by Medical Dosimetry Services.

Technological Characteristics:

The technological characteristics are mostly the same as for the predicate device with the main exception being that the predicate device was designed to operate in a DOS environment as a character based menu driven system. MuCheck was designed to operate in a windows environment using both mouse and keyboard.

Non-clinical tests:

The non-clinical tests were conducted using both the predicate device and muCheck. In addition each test was further validated using a treatment plan which provide a monitor unit or hand calculation. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.

Beta Clinical Testing:

The results received and summarized from the beta testing conducted in St. John Hospital support the claim of substantial equivalence. See Figure 6.1 in section 6 for comparison summary.

Conclusions:

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

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features an eagle with three human profiles within its body. Below the logo, the date "JUN - 8 1998" is printed.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gregorv Miller Medical Dosimetry Services, Inc. 12401 Riverview Road Oklahoma City, OK 73173

Re:

K980904

muCheck - Monitor Unit Validation Program Dated: March 6, 1998 Received: March 10, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Miller:

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 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). 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 (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 (OS) 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 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 vitro 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/dsmaldsmam.html",

Sincerely yours,

Lillian Yiu, Ph.D.

Lillian Yin. Ph.D. Director, Division of Reproductiv Abdominal, Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications For Use

In a radiation therapy department a course of patient treatment is prescribed by a written directive from the 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 beam therapy. As part of the planning process, a monitor unit setting will be calculated which determines the machine duration of beam exposure. The primary radiation treatment planning software may or may not calculate the monitor unit setting. Regardless, the dosimetrist or physicist will either perform a manual calculation or perhaps use an in-house developed spreadsheet or program to calculate the monitor unit setting.

A manual calculation will involve the dosimetrist looking up beam data factors from a booklet of measured beam data provided by the physicist. These beam data factors are unique to each machine and must be measured by the physicist. The beam data booklet can contain 50 or more pages for a typical machine consisting of 2 photon beams and 5 electron beams. These factors are plugged into a standardized worksheet and a calculator is used to compute the monitor unit setting. This can be a tedious, time consuming process as well as error prone. The dosimetrist may have to search through multiple pages of data to find the correct factors to use. They will then have to be written down on the worksheet to be used for the final monitor unit calculation. Ideally they should be double checked for accuracy.

The muCheck Monitor Unit Validation Program (the device under review) makes this process much faster and more accurate. Initially, all of the beam data factors for each beam energy are entered into the system one time and stored in a database as part of the pre-installation process. After entry these factors are then plotted on a graph and printed along with tables of actual values entered to verify accuracy of data entry. To use the program, the dosimetrist simply enters the key data parameters as prompted by the program. As the parameters are entered into the system, beam factors are looked up and are automatically used by the program to calculate the correct monitor unit setting. All of the pertinent calculation data is displayed on the screen in worksheet form. This worksheet can be printed out and stored in the patients chart for permanent documentation. There are many user imput edits incorporated into the system during the pre-installation process to insure the accuracy of the calculation. It must be stressed that this program does not provide the primary treatment calculation. It merely serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

Prescription Use
(Per 21 CFR 801.109)

Ginist G. Sejrom

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

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.