The intended use of the myQA iON product is to perform patient quality assurance activities for radiation therapy treatment delivery systems. myQA iON is a software toolbox allowing the Medical Physicist to perform quality assurance activities before and after the patient treatment fractions for all patients undergoing radiation therapy.

Device Description

The myQA iON product is a server-based software application for performing patient quality assurance for radiation therapy. In its full scope, the product delivers means for the verification of:

The patient treatment plan prior to the first treatment fraction by
- Using an independent dose algorithm to compute a dose map based on the patient treatment plan;
- Performing measurements using external measurement devices and analyzing the results;
- Performing machine log analysis during a treatment dry run session and reconstructing the delivered dose.
The patient treatment delivery by
- Performing machine log analysis and reconstructing the delivered dose for each treatment fraction.
  In its full scope, the product interfaces with the Treatment Planning System, the Oncology Information System, the treatment delivery System and the external measurement device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for the myQA iON. Instead, it describes general testing categories to assess the device's performance. The study aims to demonstrate substantial equivalence, implying that its performance should be comparable to the predicate device but doesn't quantify this in a numerical acceptance table within this document.

Acceptance Criteria Category	Reported Device Performance (as described)
Risk Analysis Testing	Verified implementation of identified hazard mitigation.
Software Testing	Verified correct software implementation.
Physics Testing	Verified correct behavior of physics algorithms.
Integration Testing	Verified correct integration of different software components.
System Testing	Verified correct implementation of the clinical workflow.
Beta Testing	Validated the usability of the software.

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

The document does not specify the sample size used for any of the described tests (Risk Analysis, Software, Physics, Integration, System, or Beta Testing). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These tests appear to be internal verification and validation activities conducted by the manufacturer.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth within the described non-clinical tests. The tests focus on software functionality, physics algorithms, and workflow, which typically rely on internal validation against established standards or expected behaviors rather than expert consensus on a "ground truth" dataset in the typical clinical AI sense.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the described non-clinical tests, such adjudication methods are typically not applicable.

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

The document explicitly states: "The subject of this premarket submission, the IBA Dosimetry myQA iON product, did not require clinical testing to support substantial equivalence to the predicate device." Therefore, no MRMC comparative effectiveness study was done, and there is no reported effect size regarding human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes "Physics Testing verifying the correct behavior of the physics algorithms" and "Software Testing verifying the correct software implementation." While these evaluate the algorithm's performance in isolation from a human user in some sense, they are part of non-clinical verification and validation activities, not a formal standalone performance study as would typically be conducted for a diagnostic AI. The device's intended use is as a "software toolbox allowing the Medical Physicist to perform quality assurance activities," implying a human-in-the-loop interaction for its full functionality. However, the core independent dose calculation and analysis features could be considered standalone algorithmic functions. The document does not present a dedicated "standalone performance study" with metrics like sensitivity, specificity, or AUC.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on:

Identified hazard mitigations: For Risk Analysis Testing.
Expected software implementation and behavior: For Software, Integration, and System Testing.
Known physical principles and expected outputs: For Physics Testing verifying the correct behavior of physics algorithms.
Usability goals: For Beta Testing.

This is not "expert consensus, pathology, or outcomes data" in the typical clinical context but rather internal validation against design specifications and established scientific/engineering principles.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The myQA iON is described as a "software toolbox" and implies deterministic physics algorithms and analysis tools rather than a machine learning model that would require a distinct training set.

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

Since the document does not indicate the use of a training set for a machine learning model, this information is not applicable and is not provided.

Summary

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July 17, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image, there is a symbol that represents the Department of Health & Human Services-USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

IBA Dosimetry GmbH % Mr. Dave Yungvirt CEO, Official Correspondent Third Party Review Group, LLC 25 Independence Blvd. WARREN NJ 07059

Re: K201798

Trade/Device Name: myQA iON Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: LHN, IYE Dated: June 28, 2020 Received: June 30, 2020

Dear Mr. Yungvirt:

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/cfpmn/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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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Indication for Use Statement

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K201798

Device Name myQA iON

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)
--	-------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

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Office of Chief Information Officer

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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PSC Publishing Services (301) 443-6740 EF

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5. 510(k) Summary of 510(k) Statement

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: K201798 Date: January 17th, 2019

1. 510(k) Holder:

Company: IBA Dosimetry GmbH Attention: Andreas Suchi, Executive Director QRS Adresse: Bahnhofstrasse 5, 90592 Schwarzenbruck – Germany Phone: +49 9128 607943 Fax : +49 9128 607-10 Email : Andreas.Suchi@iba-group.com

2. Device

Trade Name	myQA iON
Common Name	Patient Quality Assurance Software
Classification Name	Medical Charged -Particle Therapy Systems
Classification regulation	21 CFR § 892.5050
Classification Code	Main Product Code: LHN, Second Product Code: IYI

3. Predicate Device

The myQA iON product for Patient quality assurance in radiation therapy is substantially equivalent to the cleared product Mobius Medical Systems, Mobius3D (K153014). The intended uses are the same as well as the technological characteristics.

4. Device Description

The myQA iON product is a server-based software application for performing patient quality assurance for radiation therapy. In its full scope, the product delivers means for the verification of:

. The patient treatment plan prior to the first treatment fraction by
- . Using an independent dose algorithm to compute a dose map based on the patient treatment plan;

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. Performing measurements using external measurement devices and analyzing the results;
. Performing machine log analysis during a treatment dry run session and reconstructing the delivered dose.
The patient treatment delivery by
- Performing machine log analysis and reconstructing the delivered dose . for each treatment fraction.

In its full scope, the product interfaces with the Treatment Planning System, the Oncology Information System, the treatment delivery System and the external measurement device.

5. Intended Use

6. Non-Intended Use

The product is not intended to be a treatment planning system, nor is it intended to have direct or indirect contact with patients.

7. Intended User

The product is designed to be used by trained radiation oncology health professionals only.

The typical users of myQA iON are the certified Medical Physicists and technicians/dosimetrists in the radiation therapy department. The users are skilled and trained to practice patient QA activities in a clinical environment.

8. Summary of Technological Characteristics compared to the predicate device

The myQA iON and the Mobius3D (K153014 - predicate device) products are identical in terms of intended use, principles of operation and clinical performance. The difference between both systems is the type of radiation therapy they are used for.

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The following table gives a high-level overview of the technical characteristics

Characteristics	myQA iON	Mobius3D	Comment
DICOM handling-manual import-automatic import-export	Yes	Yes	The export is not needed to fulfillthe intended use of myQA iON
	Yes	Yes
	Yes	Yes
	No	Yes
Independent dose calculation	Yes	Yes
Analysis of externalmeasurements of radiationfields	Yes	Yes	myQA iON provides a wider panelof analysis tools based on thephysical measurements ofradiation fields through theanalysis of manually uploadedmachine log files and manuallyuploaded MatriXX measurementfiles (MatriXX, FDA listing NumberD032576, IBA Dosimetry GmbH).






Gamma analysis	Yes	Yes
Patient QA report generation	Yes	Yes
Server based	Yes	Yes	myQA iON can be accessed viaweb-browser from any computerconnected to the (private)network



Email notification	No	Yes	not required to fulfill myQA iONintended use

Evaluation settingsmodification	Yes	Yes

Plan approval	Yes	Yes
PDF export of patient QAreport	Yes	Yes

The differences between the products in the table above do not influence the safety and effectiveness of the myQA iON device nor does it prevent it from fulfilling its intended use.

The difference between myQA iON and the Mobius3D devices lies in the area of application. While both are designed to perform patient quality assurances tasks for radiation therapy, the Mobius3D focuses on radio-therapy whereas the myQA iON focuses on proton therapy.

We believe that in the present case, this difference is neglectable to prove substantial equivalence. Indeed, the clinical workflows are identical for both proton and radio-therapy patient quality assurance. In both cases, the treatment plan is created in DICOM format on the treatment planning system and exported to the quality assurance platform. The platform then computes an independent dose using a Monte Carlo dose engine and allows the user to complement the analysis by using machine irradiation log and ion chamber measurements at the isocenter.

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9. Environment of Use

The typical environment of use for myQA iON is the radiation therapy center. However, as myQA iON is a web application, the environment of use can vary depending on the location of the user.

10. Summary of Non-Clinical Test

IBA Dosimetry performed system and software level tests to assess the performance of the myQA iON product. The following tests have been provided in support of the substantial equivalence determination:

. Risk Analysis Testing verifying the implementation of the identified hazard mitigation;
. Software Testing verifying the correct software implementation;
. Physics Testing verifying the correct behavior of the physics algorithms;
Integration Testing verifying the correct integration of the different software components;
. System Testing verifying the correct implementation of the clinical workflow;
. Beta Testing validating the usability of the software.

11. Summary of Clinical Test

The subject of this premarket submission, the IBA Dosimetry myQA iON product, did not require clinical testing to support substantial equivalence to the predicate device.

12. Conclusion

The verification and validation activities ensure that the IBA Dosimetry myQA iON product provides substantial equivalence in terms of safety, effectiveness and performance to the predicate 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.