RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc Software not only performs this secondary function but can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.

RadCalc Software imports treatment planning parameters from the primary treatment planning system or a verify and record system; parameters can also be entered manually. The dosimetric calculations are then performed for photon or electron external beam radiation plans or LDR, HDR, and Permanent Implant brachytherapy treatment plans. The brachytherapy treatment module is only used to validate the dose to points of interest and not for brachytherapy treatment planning.

RadCalc Software allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system (system actually controlling the radiation beam) to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data.

Device Description

The 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.

RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.

RadCalc allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data. The software does not control any radiation hardware device, but does interface with the primary radiation therapy planning software and the Verify and Record software.

AI/ML Overview

The provided 510(k) summary for RadCalc Software (K090531) indicates that no formal acceptance criteria or a traditional clinical study were conducted to prove the device meets specific performance criteria in the way a diagnostic or image analysis AI would.

Instead, the submission focuses on substantial equivalence to predicate devices and non-clinical software verification and validation. The device is a "Medical Charged Particle Radiation Therapy System - Accessory" and primarily functions as a quality assurance tool for validating Monitor Units (MUs) or radiation doses calculated by primary radiation therapy planning systems.

Here's a breakdown based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

No specific, quantified acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are provided in the document for the RadCalc Software. The "performance" is implicitly tied to successfully passing software verification and validation tests as per FDA guidelines, demonstrating that it calculates MUs and doses in alignment with its design specifications and existing clinical practice.

Acceptance Criteria (Implied)	Reported Device Performance
Software development, verification, and validation per FDA guidelines.	Carried out in accordance with FDA guidelines.
Software met established Software Design Specifications.	Passed all testing against established Software Design Specifications for each test plan and module.
Risk control implemented to mitigate identified hazards.	Device Hazard analysis completed and risk control implemented.
Accurate calculation of monitor units/dose for external beam, LDR, HDR, and Permanent Implant brachytherapy.	Software passed all testing and supports claims of substantial equivalence. Used a brachytherapy treatment planning system for verification.
Smooth transfer of treatment planning data.	Verified to allow transfer of data and reduce errors, supporting claims of substantial equivalence.

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 data or patient cases with ground truth labels. The testing appears to be software-centric functional testing rather than clinical performance evaluation.

Sample Size: Not applicable in the traditional sense of patient data. The testing was against "established Software Design Specifications" and involved functional tests of the software's calculation capabilities and data transfer.
Data Provenance: Not applicable. No patient data or clinical imagery was used for performance evaluation as described. The testing involved "a brachytherapy treatment planning system" for verification, implying simulated or synthetic data reflective of typical treatment planning scenarios.

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

Not applicable. The "ground truth" for this software hinges on the correctness of its calculations against known physics principles and established radiation dosimetry standards, not expert interpretation of clinical data. The process involves comparing the software's calculated Monitor Units/doses against expected values derived from physics equations or existing, validated systems.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring expert adjudication.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is not an AI/CAD system designed to assist human readers in interpreting clinical data or images. It is a calculation validation tool. Therefore, an MRMC study comparing human performance with and without AI assistance is not applicable.

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

Yes, in a way. The "testing" described is essentially the standalone performance of the software. The software's function is to perform calculations independently. Its "performance" is measured by its ability to accurately output these calculations according to its design specifications. This is inherent to the type of device (a calculation validation software), where the algorithm is the primary component being evaluated for correctness.

7. The Type of Ground Truth Used

The ground truth used for this software's validation would be:

Physics-based calculations / Dosimetry principles: The expectation that the software correctly applies established radiation physics formulae to calculate monitor units and doses.
Reference data/tables: The software relies on looking up data from "previously input tables or data curves," suggesting that these reference data themselves serve as part of the ground truth for its internal look-up functions.
Comparison to existing, validated systems: The fact that it validates calculations from a "primary radiation therapy planning system" implies that the accuracy of those primary systems (or accepted gold standards in dosimetry) would form the basis for comparison.
Software Design Specifications: The software being tested against its own design specifications implies these specifications serve as the "ground truth" for its intended functional behavior.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the contemporary sense that requires a "training set" of data. It is a deterministic software program that performs calculations based on explicit rules and stored data (tables/curves), not by learning from examples.

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

Not applicable, as there is no training set.

Summary

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K090531

510(k) Summary

MAY 27 2009

For

RadCalc Software

1. Sponsor Information

LifeLine Software, Inc. 311 Hines Crossing Bullard, TX 75757 Phone: (903) 207.4298 x13 Fax: (903) 207.4298 Contact: Craig Laughton, CEO

2. Applicant Information

Emergo Group 1705 S. Capital of Texas Highway Suite 500 Austin, TX 78746 Phone: (512) 326.9997 Fax: (512) 326.9998 Contact: Richard Vincins, Senior Consultant OA/RA

3. Date Prepared

February 20, 2009

4. Device Name

Trade/Proprietary Name: RadCalc Software Common/Usual Name: RadCalc Classification Name: Medical Charged Particle Radiation Therapy System - Accessory Classification Regulation: 892.5050

5. Predicate Devices

MuCheck - Monitor Unit/Dose Program K061152 RadCalc, Model V4.0 K010464

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6. Device Description

7. Intended Use

The intended use of the RadCalc Software is a means of validating the monitors units or radiation dose to points that have been calculated by the primary radiation therapy planning system for external beam radiation therapy and/or brachytherapy treatments. In addition to this, RadCalc Software can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy plan.

8. Technological Characteristics and Substantial Equivalence

The RadCalc Software is similar in design and function to the RadCalc Model v4.0 and muCheck Monitor Unit/Dose Program. These devices all have the same intended use and indications for use as the RadCalc Software. This submission is adding LDR, HDR, and Permanent Implant brachytherapy treatment plans to the indications for use. These are two recent predicate devices cleared for market by the FDA.

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The RadCalc Software and the predicate devices are used on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. Their function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. The RadCalc, Model v4.0 and RadCalc Software can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.

The RadCalc Software and the predicate devices are similar in technical characteristics and performance.

9. Non-Clinical Testing

The software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. Software testing was conducted using a brachytheraphy treatment planning system and RadCalc to verify nonclinical testing. The testing results supports that the software specification are met for the acceptance of each module and interaction of processes. The RadCalc Software passed all testing and supports the claims of substantial equivalence.

10. Clinical Testing

There is no clinical testing required to support the additional indication for use of the submission. The supporting information is addressed by the non-clinical testing and beta-site testing. The verification and validation testing of the software passed all the testing and supports the claims of substantial equivalence.

11. Conclusion

The RadCalc Software has the same intended use and technological characteristics as the predicate devices.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the circular emblem.

Public Health Service

MAY 2 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeLine Software, Inc. % Mr. Richard Vincins Senior Consultant QA/RA Emergo Group 1705 S. Capital of Texas Hwy., Suite 500 AUSTIN TX 78746

Re: K090531

Trade/Device Name: RadCalc Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: February 26, 2009 Received: March 3, 2009

Dear Mr. Vincins:

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 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx (240) 276-0115 (Gastroenterology/Renal/Urology) 21 CFR 884.xxx (Obstetrics/Gynecology) (240) 276-0115 21 CFR 892.xxx (Radiology) (240) 276-0120 Other (240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Not Assigned. K 0 7 0 5 3 /

K070531

Device Name: RadCalc

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ______________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
	Division of Reproductive, Abdominal and
	Radiological Devices
510(k) Number	K090531

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.