Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.

Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.

This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. The product can only be used with photons (high energy x-rays) and cannot be used with electron or proton therapy. This product does not provide any quality assurance that the fields are in fact correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.

Device Description

Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the calculated dose to the patient from the measured radiation fields that is intended to be used as a quality control tool tothen be compared to the intended planned dose. This product is to be used as a quality control check for the treatment planning system and delivery system. Dosimetry Check is not a treatment planning system. It does not design or transmit instructions to a delivery device, nor does it control any other medical device. Being a software only quality control tool, Dosimetry Check never comes into contact with patients or persons. Dosimetry Check is an analysis tool meant solely for quality assurance purposes when used by trained medical professionals.

AI/ML Overview

The provided text describes information about the Dosimetry Check Version 5 Release 1 device, but it lacks the specific details required to fully address your request regarding acceptance criteria and a detailed study. The document is a 510(k) summary for FDA clearance, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics against predefined acceptance criteria.

However, based on the available information, I can extract and infer some details:

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

The document does not explicitly state quantifiable "acceptance criteria" for the device's performance in a table format, nor does it provide a direct comparison against such criteria. The "Testing" section mentions "successful testing was accomplished," implying that whatever internal criteria existed were met. The core "performance" of the device is described in relation to its function: computing dose distribution and comparing it to the plan dose, and using a new Convolution/Superposition "Collapsed Cone" Algorithm (CC).

The closest to a performance statement is from the "Conclusion": "The successful testing demonstrates the safety and effectiveness of the Dosimetry Check Version 5 Release 1 when used for the defined indications for use demonstrates that the device for which this 510(k) is submitted perform as well as or better than the legally marketed predicate devices." This is a general statement of equivalency rather than specific performance metrics.

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

The document does not specify the sample size of the test set used for the internal testing. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective nature).

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 in the document. The device is intended to be used by an "experienced radiological physicist," but there's no mention of experts involved in establishing ground truth for the testing.

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

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not explicitly mentioned or described. The device is "standalone software" for quality control and does not appear to involve human readers in an AI-assisted diagnostic capacity. Its function is to check dose distribution, not to interpret images or assist human readers in diagnosis.

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

Yes, a standalone performance assessment was done. The "Testing" section clearly states: "Testing consisted of internal testing with and without the Graphic Processing Unit for the comparison of the results obtained using the Pencil Beam (PB) algorithm in the 510(k) cleared version of Dosimetry Check to the results obtained using the Convolution/Superposition 'Collapsed Cone' Algorithm (CC) added in Dosimetry Check Version 5 Release 1 as well as regression testing." This indicates the algorithm's performance was evaluated independently.

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

The document does not explicitly state the "ground truth" used for testing. However, given the device's function of calculating and comparing dose distributions, the ground truth would likely be established through:

Physics-based calculations: Comparison against established physics models or highly accurate, independently verified dose calculation systems.
Known measured radiation fields: Using precisely measured radiation fields to simulate and verify the accuracy of the computed dose.
Comparison against predicate device results: The testing involved comparing results with the previously cleared version of Dosimetry Check (using the Pencil Beam algorithm) and the new Collapsed Cone algorithm. The predicate device's output would serve as a reference in this context.

8. The sample size for the training set

The document does not specify a training set sample size. This type of device (a dose calculation algorithm for quality control) might not involve a "training set" in the machine learning sense, but rather a set of test cases designed to validate the accuracy of its physics-based calculations.

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

Not applicable, as a training set or its associated ground truth establishment is not discussed in the provided text.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2016

Math Resolutions, LLC % Mr. Wendel Renner President 5975 Gales Lane COLUMBIA MD 21045

Re: K162577

Trade/Device Name: Dosimetry Check Version 5 Release 1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 17, 2016 Received: September 20, 2016

Dear Mr. Renner:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162577

Device Name

Dosimetry Check Version 5 Release 1

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for Dosimetry Check Version 5 Release 1

Submitter's NameAddress	Math Resolutions, LLC5975 Gales LaneColumbia, MD USA 21045
EstablishmentRegistration Number	1833314
Summary Date	16 Nov 2016
Telephone Number	(410) 997-9578
Email	WDRenner@MathResolutions.com
Contact Person	Wendel Dean Renner, President

Name of the Device	Common or Usual Name	Classification Name
Dosimetry Check version 5 release 1	Standalone Software Quality Control System	Medical Charged-particleRadiation Therapy Systems, 21 CFR 892.5050Product Code IYE

Identification of the Legally Marketed Devices (Predicate Devices)
Dosimetry Check Version 4 Release 1, K132605	Mobius3D, K140660

Indications for Use

Dosimetry Check Version 5 Release 1 (Modified Device) ●

Dosimetry Check quality control software uses the x-ray radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.

This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. The product can only be used with photons (high energy x-rays) and cannot be used with electron or proton therapy. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.

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. Dosimetry Check Version 4 Release 1. K132605 (Predicate Device)

Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.

This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.

. Mobius3D, K140660 (Predicate Device)

Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

DEVICE DESCRIPTIONS

Dosimetry Check version 5 release 1 (Modified Device) .

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Check is an analysis tool meant solely for quality assurance purposes when used by trained medical professionals.

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510(k) Summary continued

● Dosimetry Check version 4 release 1, K132605 (Predicate Device)

System 2100 for which 510(k) K993530 was cleared by the FDA on December 15, 1999 that is a medical image display system serves as a foundation that provides basic image display functionality for Dosimetry Check.

Dosimetry Check is a software program that will compute the dose and dose distribution to the patient from a measurement of the radiation fields that are applied to the patient. The dose so computed serves as a means to verify the correctness of the radiation treatment and to serve as a final sanity check. The radiation fields are measured with media such as x-ray film or electronic devices that will measure over the area of the field, such as electronic portal imaging devices (EPID), or diode or ion chamber arrays.

To extend Dosmetry Check to support the TomoTherapy machine, the device uses the data measured by the fan beam radiation detector that is part of the TomoTherapy machine. The detectors capture the radiation intensity periodically at predetermined gantry angles and couch positions, known as control points, from the treatment plan. The detector only measures the intensity across the center of the radiation beam in the transverse plane. A prior measured profile in the perpendicular longitudinal direction is then applied to complete the radiation field map. The radiation field map is then applied as a stationary beam at the center gantry angle and couch position for the integration period (between two control points), from which the dose to the patient is computed. The patient dose is then summed up from all such radiation field maps

● Mobius3D, K140660 (Predicate Device)

Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only OA tool, Mobius3D never comes into contact with patients

Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient: The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (COS) algorithm. Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.

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Device Comparison Table

Features	PredicateDosimetry CheckVersion 4 Release 1K132605	PredicateMobius3DK140660	Modified DeviceDosimetry CheckVersion 5Release 1
Pre-treatment images	Yes	No	Yes
Exit images	Yes	No	Yes
Pencil beam dose algorithm	Yes	No	Yes
Convolution/superposition "collapsed cone"algorithm (CC). Additional technical comparisoninformation regarding this added CC algorithm isprovided above.	No	Yes	Yes
Compute dose to patient	Yes	Yes	Yes
Compare to planning system dose	Yes	Yes	Yes
Used for verifying the correctness of radiationtherapy treatments	Yes	Yes	Yes
TomoTherapy: Uses a line in the transverse planethrough the radiation field measurement provided toDosimetry Check. A prior measured longitudinalprofile is applied to each detector signal to completethe radiation field.	Yes	No, useslinac logfiles	Yes
Generates a report as described in the DosimetryCheck manual using either the auto-report feature,or the user may construct their own report using theevaluate tools.	Yes	Provides areport intheirformat	Yes
Installed by downloading the software from theMath Resolutions web site athttp://www.mathresolutions.com/downlprg.htm	Yes	unknown	Yes
Photons (x-ray)	Yes	Yes	Yes
Electrons	No	unknown	No
Protons	No	unknown	No
Ability to use measured radiation field forconventional linac in a pretreatment dry run withoutthe patient and measured radiation fields takenduring treatment.	yes	No, useslinac logfiles	yes
Ability to use the TomoTherapy detector datameasured in a pretreatment dry run without thepatient and the detector data taken during treatment	Yes	No, useslinac logfiles	Yes
Features	PredicateDosimetry CheckVersion 4 Release 1K132605	PredicateMobius3DK140660	Modified DeviceDosimetry CheckVersion 5Release 1
Operating Systems	Microsoft WindowsXP, Windows Vista,Windows 7, 10,andUbuntu 14.04 LTS(Linux)	unknown	MicrosoftWindows XP,Windows Vista,Windows 7,10,and Ubuntu14.04 LTS(Linux)
Hardware	- Open GL capablegraphics card isrequired with 24true color and adepth buffer.- For addedstereoscopic threedimensionaldisplays, an NvidiaQuadro fx card thatsupports stereo isneeded with a singlemonitor capable of120 Hertz refreshrate or the PlanarMirror System withtwo monitors.	Graphicsprocessingunit	- Open GLcapable graphicscard is requiredwith 24 truecolor and a depthbuffer.- For addedstereoscopicthreedimensionaldisplays, anNvidia Quadro fxcard that supportsstereo is neededwith a singlemonitor capableof 120 Hertzrefresh rate or thePlanar MirrorSystem with twomonitors.- Graphicsprocessing unit

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510(k) Summary continued

Description and Conclusion of Testing

Testing

Testing consisted of internal testing with and without the Graphic Processing Unit for the comparison of the results obtained using the Pencil Beam (PB) algorithm in the 510(k) cleared version of Dosimetry Check to the results obtained using the Convolution/Superposition "Collapsed Cone" Algorithm (CC) added in Dosimetry Check Version 5 Release 1 as well as regression testing. Successful testing was accomplished with internal testing. No issues were identified that required external beta testing.

Conclusion:

The successful testing demonstrates the safety and effectiveness of the Dosimetry CheckVersion 5 Release 1 when used for the defined indications for use demonstrates that the device for which this 510(k) is submitted perform as well as or better than the legally marketed predicate devices.

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.