The ClearCheck device (model RADCC) is a software intended to present treatment plans obtained from Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems in a user friendly way (numerical form of data) for user approval of the treatment plan. ClearCheck runs as a dynamic link library (dll) plugin to Varian Eclipse. It is designed to run on the Windows Operating System and generated reports can be viewed on Internet Explorer. ClearCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891) and Version 13.5 (K141283)) which is a software used by trained medical professionals to design and simulate radiation therapy treatments for malignant or benign diseases. ClearCheck has two components: A standalone Windows Operating System executable application that is used for 1. administrative operations to set specified default settings and user settings. 2. A plan evaluation application that is a dynamic link library (dll) file that is a plugin to the Varian Medical Systems Eclipse TPS. The plugin is designed to evaluate the quality of an Eclipse treatment plan. Plan quality is based on user specified Dose Constraints and Plan Check Parameters.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ClearCheck device, organized according to your request.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It explicitly states that "no clinical trials were performed for ClearCheck" (Section 5.7). Therefore, a substantial portion of your requested information (e.g., MRMC studies, specific performance metrics against ground truth, expert qualifications, adjudication methods, sample sizes for test/training sets with ground truth derivation methods) is not present in this type of regulatory submission. The verification tests mentioned are likely internal software validation rather than clinical performance studies.

1. Table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria for device performance based on clinical outcomes or accuracy metrics. Instead, "pass/fail criteria were used to verify requirements" during internal verification tests. These requirements are implicit in the comparison to the predicate device and the claim of substantial equivalence.

Acceptance Criteria Category	Reported Device Performance / Assessment
Intended Use	ClearCheck is intended for quality assessment of radiotherapy treatment plans, equivalent to the predicate device.
Pure Software Device	Yes, equivalent to the predicate device.
Intended Users	Medical physicists, medical dosimetrists, and radiation oncologists, equivalent to the predicate device.
OTC/Rx	Prescription use (Rx), equivalent to the predicate device.
Operating System	Runs on Windows 7, 8, 10, Server 2008, 2008 RS, 2012. Supported an additional OS (Windows 10) compared to the predicate, which does not raise new safety/effectiveness questions.
CPU	2.4+ GHz and Multi-core processors (2+ cores, 4+ threads), equivalent to the predicate device.
Hard Drive Space	Requires ~3.5MB for software (vs. 20MB for predicate), suggests 100GB for patient data (vs. 900GB for predicate). Difference acknowledged and deemed not to raise new safety/effectiveness questions because ClearCheck stores constraint templates, not large DICOM datasets like the predicate.
Display Resolution & Color Depth	1280 x 1024, 24- or 32-bit color depth (vs. 1920 x 1080 for predicate). Difference acknowledged and deemed not to raise new safety/effectiveness questions as it supports smaller monitors without affecting image quality.
Software Functionality	Performs calculations on plans from Eclipse TPS based on user-specified Dose Constraints and Plan Check Parameters. Verification tests performed to ensure the software works as intended and passed requirements.
Safety and Effectiveness	Deemed as safe and effective as the predicate device through Verification and Validation testing and Hazard Analysis.

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

The document does not specify a "test set" in the context of clinical or performance data. It mentions "Verification tests" were performed for the software. These tests would involve internal generated data or existing clinical plans to validate the software's functionality, but no details on sample size, data provenance, or specific test cases are provided for external review.

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

This information is not provided. Since no clinical trials or external performance evaluations of this nature were conducted (as stated in Section 5.7), the concept of "ground truth" as derived by experts for a test set is not applicable to the submitted performance data.

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

This information is not provided for the same reasons as above.

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 MRMC comparative effectiveness study was done. The document explicitly states "no clinical trials were performed for ClearCheck." The device is a "quality assessment" tool for radiotherapy plans, not an AI for image interpretation or diagnosis that would typically involve human reader performance studies.

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

A standalone performance assessment in the sense of the algorithm's internal calculations and functionality was performed as part of "Verification tests." However, specific quantitative metrics common for standalone AI algorithms (e.g., sensitivity, specificity, AUC against a clinical ground truth) are not provided in this regulatory summary. The device's "performance" is primarily assessed by its functional correctness and consistency with the predicate device's overall purpose of quality assessment.

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

This is not explicitly stated. For the internal "Verification tests," the "ground truth" would likely be the expected outputs or calculated values based on established physics principles and treatment planning guidelines, which the software is designed to implement and report. This is not the same as clinical "ground truth" derived from patient outcomes or expert consensus on a diagnosis.

8. The sample size for the training set

This information is not applicable and not provided. ClearCheck is described as a software tool that performs calculations and presents data based on user-specified dose constraints and plan check parameters from an existing Eclipse TPS plan. It is not an AI/ML algorithm that learns from a "training set" of data to make predictions or classifications.

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

This information is not applicable and not provided, as the device does not employ a machine learning model that requires a training set with associated ground truth.

Summary

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

December 1, 2016

Radformation % Mr. Parul Chansoria Regulatory Consultant Elexes 6494 Tralee Village Drive DR DUBLIN CA 94568

Re: K162468 Trade/Device Name: ClearCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 28, 2016 Received: October 28, 2016

Dear Mr. Chansoria:

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 O'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)

K162468

Device Name ClearCheck

Indications for Use (Describe)

ClearCheck is intended for quality assessment of radiotherapy treatment plans.

Type of Use (Select one or both, as applicable)

Radformation 510(k) Submission

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5. 510(k) Summary

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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, LLC
Address:	429 East 52nd Street, Unit 4G,New York, NY 10022
Contact Person:	Parul ChansoriaFounder, Elexes
Phone:	650-528-2445
Fax:	----------
Email:	parul@elexes.com
Date of SummaryPreparation:	August 24th, 2016

5.2 Device Information

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

5.3 Predicate Device Information

Model 1216 Quality Reports (K142142)

5.4 Device Description

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It is designed to run on the Windows Operating System and generated reports can be viewed on Internet Explorer. ClearCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891) and Version 13.5 (K141283)) which is a software used by trained medical professionals to design and simulate radiation therapy treatments for malignant or benign diseases.

ClearCheck has two components:

A standalone Windows Operating System executable application that is used for 1. administrative operations to set specified default settings and user settings.
1. A plan evaluation application that is a dynamic link library (dll) file that is a plugin to the Varian Medical Systems Eclipse TPS. The plugin is designed to evaluate the quality of an Eclipse treatment plan. Plan quality is based on user specified Dose Constraints and Plan Check Parameters.

5.5 Indications for Use

ClearCheck is intended for quality assessment of radiotherapy treatment plans

5.6 Technological Characteristics

The ClearCheck (Subject Device) makes use of a Predicate Device, the Model 1216 Quality Reports (142142).

Table 3 : Substantial Equivalence Table for ClearCheck
Parameters	Subject Device:ClearCheckRadformation	Predicate Device:Model 1216 Quality ReportsSun Nuclear Corporation(K142142)	Equivalence
Indications for use	ClearCheck is intended forquality assessment ofradiotherapy treatment plans	Model 1216 Quality Reports isintended for quality assessment ofradiotherapy treatment plans and theradiotherapy treatment planningprocess.	Equivalent
Pure SoftwareDevice	Yes	Yes	Equivalent
Intended users	Medical physicists, medicaldosimetrists, and radiationoncologists	Medical physicists, medicaldosimetrists, and radiationoncologists	Equivalent
OTC/Rx	Rx	Rx	Equivalent

5.6.1 ClearCheck vs. Model 1216 Quality Reports (K142142)

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Table 3 : Substantial Equivalence Table for ClearCheck
Parameters	Subject Device:ClearCheckRadformation	Predicate Device:Model 1216 Quality ReportsSun Nuclear Corporation(K142142)	Equivalence
	ClearCheck software runs on astandard PC running a WindowsOperating System (OS). Thesoftware holds all vital data inmemory during each analysis andreport generation session.	Model 1216 Quality Reports softwareruns on a standard PC running aWindows Operating System (OS). Thesoftware holds all vital data in memoryduring each analysis and reportgeneration session.	Equivalent
OperatingSystem	Windows 7 ( 32- or 64-bit),Windows 8 (32- or 64-bit),Windows 10 (32- or 64-bit),Windows Server 2008, 2008 RS,and 2012.	Windows 7 (32- or 64-bit), Windows 8(32- or 64- bit), and Windows Server2008, 2008 R2, and 2012.	Equivalent
CPU	2.4+ GHz and Multi-coreprocessors (2+ cores, 4+ threads)	2.4+ GHz and Multi-core processors (2+cores, 4+ threads)	Equivalent
Hard DriveSpace	Software components fullyinstalled require only ~3.5MB,but storage requirement forpatient data are much larger andvary from clinic-to-clinic. Aminimum of 100 GB hard driveis suggested for larger patienttemplate sets.	Software components fully installedrequire ~20 MB, but storage requirementsfor patient data and archives are muchlarger but will vary clinic-to-clinic. Aminimum of 900 GB hard drive issuggested with larger drives for DICOMarchives.	Differ
DisplayResolution andColor Depth	1280 x 1024, 24- or 32- bit colordepth.	1920 x 1080 screen resolution, 24- or 32-bit color depth.	Differ

5.6.2 Similarities

The intended use is same for the Subject and the Predicate Device. ●
Both the Predicate and the Subject Devices are pure software devices meant for ● prescription use
The Subject and the Predicate Devices are classified under the Product Code IYE ● and the common name "oncology information system"
The intended user of the Subject Device is the same as the Predicate Device ●
The Subject and Predicate Devices require similar processors and operating systems. However, ClearCheck is supported by an additional Operating System Windows 10 (32- Or 64-bit)
. Both Subject and Predicate Devices run on a standard PC with a Windows Operating System (OS). The software devices hold all vital data in memory during each analysis and report generation session.

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5.6.3 Differences

The install size of the Subject Device is only ~3.5MB whereas the install size of . the Predicate Device is 20 MB of storage requirement. ClearCheck recommends 100GB of storage space and Predicate Device recommends 900GB of storage space. This is because ClearCheck only saves constraint templates whereas Model 1216 Quality Reports stores DICOM datasets which are much larger when compared to constraint template files. Thus, ClearCheck requires much less storage. However, these differences don't raise any new questions for safety and effectiveness of the Subject Device w.r.t. the Predicate Device.
The color depth for both the Predicate and Subject Devices are the same. The resolution required for the Subject Device (1280x1024: D-VHS, HD DVD, Bluray, HDV (miniDV), and the Predicate Device (1920x1080: HDV (miniDV), AVCHD, HD DVD, Blu-ray, HDCAM SR) are different. The Subject Device ClearCheck can work with the small size monitors without any impact on the image quality (1280 x 1024). Hence, this difference doesn't raise any new questions for safety and effectiveness of the Subject Device w.r.t. the Predicate Device.

5.7 Performance Data

As with the Predicate Device, no clinical trials were performed for ClearCheck. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements.

5.8 Conclusion

ClearCheck is deemed substantially equivalent to the Predicate Device. Model 1216 Quality Reports (K142142) due to the similarities in intended use and function. Verification and Validation testing and Hazard Analysis demonstrate that ClearCheck is as safe and effective as the Predicate Device. The minor technological differences between ClearCheck and the Predicate Device do not raise any questions on the safety and effectiveness of the Subject Device.

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.