ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Device Description

The ClearCalc device (model RADCA) is software intended to assist users in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation. The treatment plans are obtained from supported Treatment Planning System and Application Programming interfaces. It is designed to run on the Windows Operating System. ClearCalc performs calculations on the treatment plan data obtained from supported Treatment Planning System and Application Programming interfaces. A Treatment Planning System is software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.

AI/ML Overview

The provided document describes the Radformation ClearCalc device (K193640), a software intended to assist radiation treatment planners in determining the accuracy of their treatment planning calculations.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct comparison of ClearCalc's performance against such criteria in a tabular format. Instead, it focuses on demonstrating substantial equivalence to a predicate device, RadCalc (K090531), through a comparison of technological characteristics and functionalities.

The "Performance Data" section (5.7) states:
"As with the Predicate Device, no clinical trials were performed for ClearCalc. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements."

This indicates that internal verification tests were conducted, likely against pre-defined pass/fail criteria for the software's functionality and accuracy in calculating Monitor Units (MU) and dose. However, the specific metrics, thresholds, and numerical results of these tests are not provided in this document.

The "Substantial Equivalence ClearCalc vs. RadCalc" table (Table 3) highlights functional similarities and minor differences, which implicitly form the basis of the performance evaluation for regulatory submission.

Parameter	Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (ClearCalc)
Photon MU and Dose Calculation	- Utilize an independent calculation algorithm to recalculate MU/Dose on a per-field basis.- Provide accurate MU/Dose calculations for external beam radiation therapy.- Account for patient geometry and heterogeneity corrections.	- Utilizes a Finite-Size Pencil Beam (FSPB) algorithm to calculate MU/Dose on a per-field basis.- Utilizes the full 3D geometry of the patient for heterogeneity corrections and simulating scatter conditions.- Calculates dose from fields in a plan and displays results for per-field MU and provides a difference metric for evaluation in tabular format.- Allows evaluation of global point doses, as well as per-field doses.(No specific accuracy numbers or pass/fail thresholds are provided in this document, but implied to be sufficient based on "works as intended" and comparison to predicate.)
Electron MU and Dose Calculation	- Utilize an independent calculation algorithm to recalculate MU/Dose on a per-field basis.- Provide accurate MU/Dose calculations for electron external beam radiation therapy.- Account for custom cutouts and compute cutout factors.	- Utilizes a library of custom cutouts and computes cutout factors using a sector integration method.- Calculates dose based on electron field parameters and cutout geometry, and displays results for per-field MU and dose and provides a difference metric for evaluation in tabular format.(No specific accuracy numbers or pass/fail thresholds are provided, implied to be sufficient.)
Brachytherapy Dose Calculation	- Utilize an independent calculation algorithm to recalculate dose from radioactive sources.- Adhere to a recognized protocol (e.g., AAPM TG-43) for brachytherapy dose calculations.- Provide dose calculations to arbitrary points and difference metrics.	- Utilizes the AAPM TG-43 protocol for its brachytherapy dose calculations.- Calculates dose to arbitrary calculation point locations and presents difference metrics comparing the TPS dose vs. ClearCalc dose in a tabular format.(No specific accuracy numbers or pass/fail thresholds are provided, implied to be sufficient.)
Overall Functionality	- Software works as intended without errors.- Provides reliable independent verification of treatment planning calculations.	- "Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements." (No specific details on test outcomes or criteria provided).- "Verification and Validation testing and Hazard Analysis demonstrate that ClearCalc is as safe and effective as the Predicate Device."(Implied successful performance under internal testing).

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Verification tests were performed to ensure that the software works as intended".

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention using experts to establish ground truth for a test set. The performance evaluation seems to be based on internal verification against expected computational outcomes, rather than expert-derived ground truth from patient cases.

4. Adjudication Method

The document does not mention any adjudication method, as no expert review or consensus process for ground truth establishment is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or described in the document. The device is a "standalone" software tool for verifying treatment plans, and its primary function is independent calculation, not assisting human readers in interpreting images or making diagnostic/treatment decisions that would typically be evaluated with MRMC studies.

6. Standalone Performance Study

A standalone performance study of the algorithm (i.e., algorithm only without human-in-the-loop performance) was performed implicitly through "Verification tests." The document states, "Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements." However, concrete details, metrics, and quantitative results of this standalone performance are not provided. The entire submission focuses on demonstrating substantial equivalence, implying that its standalone performance would be comparable to the predicate device's independently calculated MU/dose values.

7. Type of Ground Truth Used

The type of ground truth used appears to be calculated ground truth or computationally derived truth. The ClearCalc software performs calculations based on established physics principles (Finite-Size Pencil Beam algorithm, AAPM TG-43 protocol) to verify the output of a primary Treatment Planning System (TPS). The "ground truth" for the verification tests would logically be the expected accurate MU/dose values as determined by these internal algorithms and validated against known calculation methodologies, rather than pathology, outcomes data, or expert consensus from clinical cases.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This suggests that the ClearCalc software likely relies on deterministic algorithms (e.g., Finite-Size Pencil Beam, AAPM TG-43) which are coded based on physical models and parameters, rather than being "trained" on a dataset in the manner of machine learning algorithms.

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

Since a training set is not mentioned, the method for establishing its ground truth is not applicable/not provided. The device's functionality is based on direct implementation of physics models and calculations.

Summary

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Radformation, Inc. % Mr. Kurt Sysock Co-founder/CEO 335 Madison Avenue, 16th Floor NEW YORK NY 10017

April 9, 2020

Re: K193640

Trade/Device Name: ClearCalc Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: March 9, 2020 Received: March 9, 2020

Dear Mr. 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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)

K193640

Device Name

ClearCalc

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Residential (Per §1-277-021, Subject to Planning Board Review) On-Site Composting (Per §1-277-021, Subject to Planning Board Review)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5. 510(k) Summary K193640

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This 510(k) Sumary 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	12/20/2019

5.2. Device Information

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

5.3. Predicate Device Information

RadCalc: 510(k) Number K090531; Regulation number 892.5050; Product code: MUJ

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5.4. Device Description

It is designed to run on the Windows Operating System. ClearCalc performs calculations on the treatment plan data obtained from supported Treatment Planning System and Application Programming interfaces. A Treatment Planning System is software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.

5.5. Indications for Use

5.6. Technological Characteristics

ClearCalc (Subject Device) makes use of a Predicate Device, RadCalc (K090531) for substantial equivalence comparison.

5.6.1. ClearCalc vs. RadCalc (K090531)

Lifeline Software, Inc.'s RadCalc Software "is a stand-alone program or operating from a server that provides determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. RadCalc is designed to work on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. The program makes the task of performing independent Monitor Unit validations much faster, easier, and more accurate. RadCalc determines the monitor units or dose through the process of looking data up from previously input tables or data curves."

(https://www.accessdata.fda.gov/cdrh docs/pdf9/K090531.pdf accessed 12/17/2019)

ClearCalc likewise utilizes an independent calculation algorithm to recalculate the incoming treatment plan's MU and dose for external beam plans as well as dose from radioactive sources for brachytherapy plans. The software is very similar in design and function to the RadCalc software.

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Table 3: Substantial Equivalence ClearCalc vs. RadCalc
Parameters	Subject Device: ClearCalcRadformation	Predicate Device: RadCalc(K090531)	Equivalence
Indications foruse	Used to assist radiationtreatment planners indetermining if their treatmentplanning calculations areaccurate using an independentMonitor Unit (MU) and dosecalculation algorithm.	The intended use of the RadCalcSoftware is a means of validatingthe monitors units or radiationdose to points that have beencalculated by the primaryradiation therapy planningsystem for external beamradiation therapy and/orbrachytherapy treatments. Inaddition to this, RadCalcSoftware can also be used as theprimary means of calculatingmonitor units for external beamradiation treatments in situationswhere the physician does notorder the use of a radiationtherapy plan.	SubstantiallyEquivalent
Pure software	Yes	Yes	Equivalent
Intended users	Trained radiation oncologypersonnel	Trained radiation oncologypersonnel	Equivalent
OTC/Rx	Rx	Rx	Equivalent
	ClearCalc vs. RadCalc Photon MU and Dose Calculation
Input	Files/Treatment PlanningSystem API-provided datacontaining CT, Structure Set,and Treatment Plan (includingtreatment field parameters) data	Files containing Structure Set,and Treatment Plan (includingtreatment field parameters) data	Minordifferences
Functionality	Utilizes a Finite-Size PencilBeam (FSPB) algorithm tocalculate MU/Dose on aper-field basis.ClearCalc utilizes the full 3Dgeometry of the patient forheterogeneity corrections andsimulating the scatter conditionsof the actual patient.	Utilizes a Clarkson summationalgorithm to calculate MU/Doseon a per-field basis.RadCalc utilizes a consistent flatphantom geometry usingradiological equivalent depth forheterogeneity corrections andincludes modules that allow theuser to indicate changes inscatter conditions (e.g. for breasttreatments).	Minordifferences
Output	ClearCalc calculates the dosefrom fields in a plan anddisplays results for per-field MU	RadCalc calculates the dosefrom fields in a plan and displaysresults for per-field MU and	Equivalent
	and provides a difference metricfor evaluation in tabular format.Users can also evaluate globalpoint doses, as well as per-fielddoses.	provides a difference metric forevaluation in tabular format.Users can also evaluate globalpoint doses, as well as per-fielddoses.
	ClearCalc vs. RadCalc Electron MU and Dose Calculation
Input	Files/Treatment PlanningSystem API-provided datacontaining CT, Structure Set,and Treatment Plan (includingtreatment field parameters) data	Files containing Treatment Plan(including treatment fieldparameters) data	Minordifferences
Functionality	Utilize a library of customcutouts and compute cutoutfactors using a sectorintegration method.	Utilize a library of custom cutoutsand compute cutout factors usinga sector integration or squareroot method.	Minordifferences
Output	ClearCalc calculates dosebased on electron fieldparameters and cutoutgeometry, and displays resultsfor per-field MU and dose andprovides a difference metric forevaluation in tabular format.	RadCalc calculates dose basedon electron field parameters andcutout geometry, and displays resultsfor per-field MU and dose andprovides a difference metric forevaluation in tabular format.	Equivalent
	ClearCalc vs. RadCalc Brachytherapy Dose Calculation
Input	Files or Treatment PlanningSystem API-provided datacontaining Treatment Plan(including source positions anddwell times) data	Files containing Treatment Plan(including source positions anddwell times) data	Minordifferences
Functionality	Utilizes the AAPM TG-43protocol for its brachytherapydose calculations	Utilizes the AAPM TG-43protocol for its brachytherapydose calculations	Equivalent
Output	ClearCalc calculates dose toarbitrary calculation pointlocations and presentsdifference metrics comparingthe TPS dose vs. ClearCalcdose in a tabular format	RadCalc calculates dose toarbitrary calculation pointlocations and presents differencemetrics comparing the TPS dosevs. RadCalc dose in a tabularformat	Equivalent

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5.7. Performance Data

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

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5.8. Conclusion

ClearCalc is deemed substantially equivalent to the Predicate Device, RadCalc (K090531). Verification and Validation testing and Hazard Analysis demonstrate that ClearCalc is as safe and effective as the Predicate Device. The minor technological differences between ClearCalc and the Predicate Device with regard to the independent MU and dose calculation 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.