ClearCheck is intended to assist radiation therapy professionals in generating and assessing the quality of radiotherapy treatment plans. ClearCheck is also intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.

Device Description

The ClearCheck Model RADCC V2 device is software that uses treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming Interfaces to present radiotherapy treatment plans in a user-friendly way for user approval of the treatment plan. The ClearCheck device (Model RADCC V2) is also intended to assist users to identify where collisions between the treatment machine and the patient or support structures may occur in a treatment plan.

It is designed to run on Windows Operating Systems. ClearCheck Model RADCC V2 performs calculations on the incoming supported treatment data. Supported Treatment Planning Systems are used by trained medical professionals to simulate radiation therapy treatments for malignant or benign diseases.

AI/ML Overview

The provided text describes the acceptance criteria and study for the ClearCheck Model RADCC V2 device, which assists radiation therapy professionals in generating and assessing treatment plans, including predicting potential collisions.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
BED / EQD2 Functionality
Passing criteria for dose type constraints	0.5% difference when compared to hand calculations using well-known BED/EQD2 formulas.
Passing criteria for Volume type constraints	3% difference when compared to hand calculations using well-known BED/EQD2 formulas.
Deformed Dose Functionality
Qualitative DVH analysis	Good agreement for all cases compared to known dose deformations.
Quantitative Dmax and Dmin differences	+/- 3% difference for deformed dose results compared to known dose deformations.
Overall Verification & Validation Testing	All test cases for BED/EQD2 and Deformed Dose functionalities passed. Overall software verification tests were performed to ensure intended functionality, and pass/fail criteria were used to verify requirements.

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

Test Set Sample Size: The document does not explicitly state a specific numerical sample size for the test set used for the BED/EQD2 and Deformed Dose functionality validation. It mentions "all cases" for Deformed Dose and "a plan and plan sum" for BED/EQD2. This implies testing was done on an unspecified number of representative cases, but not a statistically powered cohort.
Data Provenance: Not specified in the provided text. It does not mention the country of origin or whether the data was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for the test set.
For BED/EQD2, the ground truth was established by "values calculated by hand using the well-known BED / EQD2 formulas."
For Deformed Dose, the ground truth was established by "known dose deformations."

4. Adjudication Method for the Test Set

Not applicable as there is no mention of expert review or adjudication for the test set. Ground truth was established by calculation or "known" deformations.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "no clinical trials were performed for ClearCheck Model RADCC V2." The device is intended to "assist radiation therapy professionals," but its impact on human reader performance was not evaluated through a clinical study.

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

Yes, performance evaluations for the de novo functionalities (BED/EQD2 and Deformed Dose) appear to be standalone algorithm performance assessments. The device's calculations were compared against established mathematical formulas (BED/EQD2) or known deformations (Deformed Dose) without human intervention in the evaluation process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

BED/EQD2: Ground truth was based on "values calculated by hand using the well-known BED / EQD2 formulas." This is a computational/mathematical ground truth.
Deformed Dose: Ground truth was based on "known dose deformations." This implies a physically or computationally derived ground truth where the expected deformation results were already established.

8. The Sample Size for the Training Set

The document does not specify a sample size for the training set. It primarily focuses on the validation of new features against calculated or known results, rather than reporting on a machine learning model's training data.

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

The document does not provide information on how the ground truth for any training set was established. Given the nature of the device (software for calculations and collision prediction, building on predicate devices), it's possible that analytical methods and established physics/dosimetry principles form the basis, rather than a large labeled training dataset in the typical machine learning sense for image interpretation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.

Radformation, Inc. % Kurt Sysock Co-founder/CEO 335 Madison Avenue, 4th Floor NEW YORK NY 10017

Re: K220583

Trade/Device Name: ClearCheck Model RADCC V2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 20, 2022 Received: July 22, 2022

Dear Kurt Sysock:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Julie Sullivan. Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220583

R220963

Device Name ClearCheck

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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This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.

5.1. Submitter's Information

Table 1 : Submitter's Information
Submitter's Name:	Kurt Sysock
Company:	Radformation, Inc.
Address:	335 Madison Avenue, 16th FloorNew York, NY 10017
Contact Person:	Alan NelsonChief Science Officer, Radformation
Phone:	518-888-5727
Fax:	----------
Email:	anelson@radformation.com
Date of Summary Preparation	08/23/2022

5.2. Device Information

Table 2 : Device Information
Trade Name:	ClearCheck
Common Name:	Oncology Information System
Classification Name:	Class II
Classification:	Medical charged-particle radiation therapy system
Regulation Number:	892.5050
Product Code:	IYE
Classification Panel:	Radiology

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5.3. Predicate Device Information

Primary Predicate Device

ClearCheck Model RADCC V2 (Subject Device) makes use of its prior submission -ClearCheck Model RADCC (K162468) - as the Primary Predicate Device.

Secondary Predicate Device

With the addition of the Collision Check module included in the submission, ClearCheck Model RADCC V2 also makes use of CollisionCheck Model RADCO (K171350) as a Secondary Predicate Device for the additional functionality.

5.4. Device Description

5.5. Indications for Use

5.6. Technological Characteristics

Primary Predicate Device

ClearCheck Model RADCC V2 (Subject Device) makes use of its prior submission -ClearCheck Model RADCC (K162468) - as the Primary Predicate Device.

The functionality and technical components of this prior submission remain unchanged in ClearCheck Model RADCC V2. This submission is intended to build on the functionality and technological components of the 510(k) cleared ClearCheck Model RADCC.

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The main technological characteristics of the subject device and the Primary Predicate device remain the same. Both are computer-based software devices designed to run on Windows Operating Systems. Both use treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming Interfaces to present radiotherapy treatment plans in a user-friendly way for user approval of the treatment plan. Both devices share major functionality such as Dose Constraints, Plan Checks, Plan Reporting and Plan Comparison. Both are used by trained medical professionals to assist in the treatment planning process.

The submission for ClearCheck Model RADCC V2 contains additional functionality to assist in the plan generation process. The significant changes to the previously cleared devices (Primary and Secondary Predicates) are:

1. Prescriptions may be entered and managed within the software.
1. Radiation dose may be evaluated on different image sets through the use of a deformable registration object provided by Radformation's AutoContour Model RADAC V2 (K220598) software.
1. Biologically Equivalent Dose (BED) and Equivalent Dose in 2 Gy fractions (EQD2) may be evaluated for plans and plan sums.
1. Additional Dose Constraints and Plan Checks added.
1. Addition of a Collision Check module that alerts the user to a potential collision between the treatment machine and the patient or support structures. The Secondary Predicate Device is now included in the Subject device with additional features as stated below.
1. Additional reporting features.

Secondary Predicate Device

ClearCheck Model RADCC V2 (Subject Device) also makes use of CollisionCheck Model RADCO (K171350) as a Secondary Predicate Device for the additional functionality of the Collision Check module.

The Collision Check module within ClearCheck Model RADCC V2 is an updated version of the previously cleared CollisionCheck Model RADCO device. The core functionality of the Collision Check module is the same as in the Secondary Predicate Device, however additional features have been added. Treatment device components such as gantry head, SRS cones and Electron cones are modeled in the same way as they are in the Secondary Predicate Device. Similarly, SUPPORT, BOLUS and patient EXTERNAL structures are modeled in the same way as in the Secondary Predicate device. Collision calculations between the two classes of structures remain the same as in the Secondary Predicate Device, where a collision occurs if any part of a Treatment device component is found within a SUPPORT, BOLUS, or patient EXTERNAL structure for the particular

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plan geometry. HU collisions are calculated in the same way as in the Secondary Predicate Device as well.

The added features to the Collision Check module in the Subject Device are as follows:

1. The ability to assess collisions with kV On Board Imaging arms (OBI)
1. The ability to detect collision warnings, i.e. situations where there is no collision detected but two objects are within a user defined warning distance of each other.
1. Sticky settings
1. Printing capabilities

Table 3: Substantial Equivalence ClearCheck Model RADCC V2 vs.Primary Predicate: ClearCheck Model RADCC (K162468)and Secondary Predicate: CollisionCheck Model RADCO (K171350)
Parameters	Subject Device:ClearCheck ModelRADCC V2	PrimaryPredicate:ClearCheckModel RADCC(K162468)	SecondaryPredicate:CollisionCheckModel RADCO(K171350)	Equivalence
Indications forUse	ClearCheck isintended to assistradiation therapyprofessionals ingenerating andassessing the qualityof radiotherapytreatment plans.ClearCheck is alsointended to assistradiation treatmentplanners in predictingwhen a treatmentplan might result in acollision between thetreatment machineand the patient orsupport structures.	ClearCheck isintended forqualityassessment ofradiotherapytreatment plans	CollisionCheck isintended to assistradiation treatmentplanners in predictingwhen a treatmentplan might result in acollision between thetreatment machineand the patient orsupport structures.	Equivalent toPrimary andSecondaryPredicates
Energy Usedand/or Delivered	None - software-onlyapplication. Thesoftware applicationdoes not deliver ordepend on energydelivered to or frompatients.	None -software-onlyapplication. Thesoftwareapplication doesnot deliver ordepend onenergy deliveredto or from	None - software-onlyapplication. Thesoftware applicationdoes not deliver ordepend on energydelivered to or frompatients.	Equivalent toboth Primaryand SecondaryPredicates
		patients.
Intended users	Trained clinicallyqualified radiationoncology personnel	Trained clinicallyqualifiedradiationoncologypersonnel	Trained clinicallyqualified radiationoncology personnel	Equivalent toboth Primaryand SecondaryPredicates
OTC/Rx	Rx	Rx	Rx	Equivalent toboth Primaryand SecondaryPredicates
Functionality	Performs dosimetricand plan evaluationfor RadiationTreatment Plans. Alsosimulates the planand predicts whetherthat no gantrycollisions occur withpatient or supportstructures	Performsdosimetric andplan evaluationfor RadiationTreatment Plans.	Simulates the planand predictswhether any gantrycollisions occur withpatient or supportstructures.	Equivalent toboth Primaryand SecondaryPredicates
Design:Graphical UserInterface	Contains a DataVisualization /Graphical UserInterface	Contains a DataVisualization /Graphical UserInterface	Contains a DataVisualization /Graphical UserInterface	Equivalent toboth Primaryand SecondaryPredicates
Design:Supported Files	Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(including treatmentfield parameters) data	Files/TreatmentPlanning SystemAPI-provideddata containingCT, StructureSet, andTreatment Plan(includingtreatment fieldparameters) data	Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(including treatmentfield parameters) data	Equivalent toboth Primaryand SecondaryPredicates
Design:CalculationRequirements	Uses local hardware	Uses localhardware	Uses local hardware	Equivalent toboth Primaryand SecondaryPredicates
Design:Reporting	Reporting built-in anduser has ability tocustomize	Reporting built-inand user hasability tocustomize	No reportingcapabilities	Equivalent toPrimaryPredicate
Pure software	Yes	Yes	Yes	Equivalent toboth Primary
				and SecondaryPredicates
OperatingSystem	Windows OperatingSystem	WindowsOperatingSystem	Windows OperatingSystem	Equivalent toboth Primaryand SecondaryPredicates
Input	Treatment data,image data, andstructure set dataobtained fromsupported TreatmentPlanning System andApplicationProgramminginterfaces	Treatment data,image data, andstructure set dataobtained fromsupportedTreatmentPlanning Systemand ApplicationProgramminginterfaces	Treatment data,image data, andstructure set dataobtained fromsupported TreatmentPlanning System andApplicationProgramminginterfaces	Equivalent toboth Primaryand SecondaryPredicates
ClearCheck Model RADCC V2 vs. ClearCheck Model RADCC (K162468) Functionality Comparison
DoseConstraints	Additional doseconstraints added	Initial set of doseconstraints	N/A	Minordifferenceswith PrimaryPredicate
Plan Checks	Additional planchecks added	Initial set of planchecks	N/A	Minordifferenceswith PrimaryPredicate
Create Usersand Edit UserRights	Addition of option toauthenticate withActive Directorycredentials	User rightsmanaged byAdministrationApplication	N/A	Minordifferenceswith PrimaryPredicate
Global andPatient SpecificTemplates	Addition ofPrescriptiontemplates and overallimprovements totemplate usability	Initial set of doseconstraint andplan checktemplates	N/A	New Feature /Minordifferenceswith PrimaryPredicate
Reporting	Improvements toreport usability	Initial reportingfunctionality	N/A	Minordifferenceswith PrimaryPredicate
CompareTreatment Plans	Improvements to plancomparison usability	Initial plancomparisonfunctionality	N/A	Minordifferenceswith PrimaryPredicate
Prescription	Physician prescriptions may be entered and managed in the ClearCheck software.	N/A	N/A	New Feature
Deformed Dose Evaluation	Radiation dose may be evaluated on different image sets through the use of a deformable registration object.	N/A	N/A	New Feature
BED/EQD2 dose	Ability to evaluate BED/EQD2 for plans and plan sums	N/A	N/A	New Feature
ClearCheck Model RADCC V2 vs. CollisionCheck Model RADCO (K171350) Functionality Comparison
Parameters	Subject Device:ClearCheck ModelRADCC V2	N/A	Secondary Predicate:CollisionCheck(K171350)	Equivalence
Simulation Details	Simulates the plan and predicts whether any gantry collisions occur with patient or support structures. Calculates gantry clearance by modeling the linac as a cylinder with a user-configured value for distance between isocenter and the face of the gantry. Collision Check also supports additional applicators: Stereotactic radiosurgery cones (also modeled as a cylinder) and Electron Applicators (modeled as a rectangular prism). ClearCheck also simulates the on-board imaging (OBI) arms as a rectangular prism. User can define a	N/A	Simulates the plan and predicts whether any gantry collisions occur with patient or support structures. Calculates gantry clearance by modeling the linac as a cylinder with a user-configured value for distance between isocenter and the face of the gantry. CollisionCheck also supports additional applicators: Stereotactic radiosurgery cones (also modeled as a cylinder) and Electron Applicators (modeled as a rectangular prism).	Minor differences with Secondary Predicate
	warning distance thatadds a margin to theshapes in thesimulation.
Collision CheckOutput	Collision Check teststhousands of samplepoints against CTdata and patient andcouch structures andreports the number ofsample points thatresulted in a collision.Collision Check alsodisplays thesesample point testresults with a 3Ddisplay and an axial2D image planeviewer for the user toinspect the results.If the user hasdefined warningdistances, thencollisions within thewarning margin arepresented to the userwith a different colorand label.	N/A	Collision Check teststhousands of samplepoints against CTdata and patient andcouch structures andreports the number ofsample points thatresulted in a collision.Collision Check alsodisplays thesesample point testresults with a 3Ddisplay and an axial2D image planeviewer for the user toinspect the results.	Minordifferenceswith SecondaryPredicate

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5.7. Performance Data

As with the Primary and Secondary Predicates, no clinical trials were performed for ClearCheck Model RADCC V2. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements.

Validation testing for the added BED / EQD2 functionality compared ClearCheck's results on a plan and plan sum against values calculated by hand using the well-known BED / EQD2 formulas. A passing criteria of 0.5% difference for dose type constraints and 3% for Volume type constraints was used. Validation testing for the added Deformed

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Dose functionality compared known dose deformations to the deformed dose results from ClearCheck. Qualitative dose-volume histogram (DVH) analysis showed good agreement for all cases and evaluation of Dman and Dmax differences used a quantitative +/-3% difference to achieve a passing result. The verification and validation testing passed in all test cases.

5.8. Conclusion

ClearCheck Model RADCC V2 is substantially equivalent to the Primary Predicate Device, ClearCheck Model RADCC (K162468). Additionally, the Collision Check module found within ClearCheck Model RADCC V2 is substantially equivalent to the Secondary Predicate Device, CollisionCheck Model RADCO (K171350). The minor technological differences between ClearCheck and the Primary and Secondary Predicate Devices do not raise any questions on the safety and effectiveness of the Subject Device. Verification and Validation testing and the Risk Management Report demonstrate that the ClearCheck is as safe and effective as the Primary and Secondary Predicates.

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.