The BEAMSCAN MR system is used preferably in combined MRI-radiation therapy systems with static magnetic fields of up to 1.5T and is intended to collect beam data in water under the aspect of machine QA for the following purposes:

acceptance testing and/or commissioning of a combined MRI-radiation therapy system
measurements after repair or replacement of major treatment unit components of a combined MRI-Radiation therapy system
beam data analysis according to international therapy dosimetry protocols
acquisition, formatting and transfer of basic data to treatment planning systems
periodic QA procedures, e.g. constancy check
high precision data acquisition for scientific research (not a medical device indication)

Device Description

The BEAMSCAN MR system is comprised of a PMMA tank with a moving mechanism and radiation detectors. Further main components are a carriage with built-in electrometer, control unit and control interface. The carriage includes a water reservoir. The whole system is controlled by software for data display and processing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the BEAMSCAN MR device, based on the provided FDA 510(k) summary:

The document focuses on demonstrating substantial equivalence to a predicate device (BEAMSCAN water phantom system, K161807) and adapting the system for use in combined MRI-radiation therapy systems with static magnetic fields up to 1.5T. Therefore, the "acceptance criteria" largely revolve around meeting relevant safety and performance standards for this new environment, and the "study" involves verification and validation testing to confirm these aspects.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Electrical Safety	IEC 61010-1:2010 (focus on user safety)	Certified as compliant with IEC 61010-1:2010.
EMC (Emission & Immunity)	IEC 60601-1-2:2014 (emission and immunity) according to IEC/CISPR 11:2009 (modified + A1:2010)	Certified as compliant with IEC 60601-1-2:2014 (emission and immunity) according to IEC/CISPR 11:2009 (modified + A1:2010).
MR Safety	ASTM F2052-15	MR safety testing was performed according to ASTM F2052-15, and the device is "MR conditional" in a static 1.5 Tesla magnetic field. (Implies satisfactory performance against the standard).
Software Verification	FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)	Software verification and validation testing results were conducted and submitted according to the guidance. The BEAMSCAN software contains no new functions and was previously cleared with 510(k) #K161807.
Bench/Non-clinical Performance	IEC 60731:2016 and specific properties of water phantom systems (radiotherapy dose measurements, detector positioning accuracy, reproducibility, mechanical alignment, design output vs. input)	Verification and validation testing demonstrated that BEAMSCAN MR fulfills the design specification and its intended use. Non-clinical performance testing was performed according to IEC 60731:2016 and specific properties of water phantom systems, including radiotherapy dose measurements (step-by-step), measurement accuracy (detector positioning), reproducibility, and mechanical alignment.
Clinical Workflow Validation	Not a formal standard, but demonstration of safe and effective use in intended environment.	Validation of the clinical workflow has been conducted in BEAMSCAN MR validation testing with qualified medical physicists and experienced PTW staff (in the context of pre-treatment quality assurance without a patient).
Substantial Equivalence	Equivalence in indications for use, technological characteristics, performance, safety, and effectiveness to predicate device.	The comparison showed that, when used within an MR Radiation Therapy system, the PTW BEAMSCAN MR system is as safe and effective as the predicate device within a non-MR environment.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" with a number of cases in the traditional sense of a clinical study. The performance evaluation is based on:

Bench and Non-clinical Testing: These are laboratory-based tests. The "sample size" would relate to the number of measurements taken or the number of units tested. This information is not provided beyond stating that verification and validation were performed.
Clinical Workflow Validation: This was conducted "with qualified medical physicists and experienced PTW staff." There is no specific number of "cases" or "patients" as the device is for QA and not used with patients. The provenance is internal to the manufacturer (PTW staff) and likely conducted at their facilities or collaborator sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No "ground truth" established by external experts in the way typical for AI/diagnostic devices. The "validation of the clinical workflow" was performed by:

"qualified medical physicists"
"experienced PTW staff"

The specific number of these individuals or their detailed qualifications (e.g., years of experience) are not provided. Given the nature of a QA device, the "ground truth" for its performance accuracy would be derived from physical dosimetry standards and established protocols, rather than expert interpretation of patient data.

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

No adjudication method is mentioned as there isn't a traditional "test set" requiring expert consensus on findings. The performance evaluation relies on objective measurements against engineering specifications and relevant industry standards.

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, an MRMC comparative effectiveness study was not done. This device is a quality assurance tool for radiation therapy systems, not a diagnostic imaging device that assists human readers. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

The BEAMSCAN MR is a hardware system with integrated software for data display and processing. It performs "standalone" measurements of beam characteristics. There isn't a human-in-the-loop diagnostic process for the device itself; rather, humans (medical physicists) operate the device to perform QA. The software itself contains "no new functions" and was previously cleared. The focus is on the hardware's performance in an MR environment.

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

The "ground truth" for the device's performance is based on:

Physical Dosimetry Standards: Compliance with standards like IEC 60731:2016 for radiotherapy dose measurements.
Engineering Specifications: The device's ability to accurately measure parameters like detector positioning, reproducibility, and mechanical alignment against its design inputs.
Regulatory Standards: Adherence to electrical safety (IEC 61010-1:2010), EMC (IEC 60601-1-2:2014), and MR safety (ASTM F2052-15) standards.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this device because it is a measurement tool, not a diagnostic or prognostic one.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning, as this device primarily relies on physics principles and engineering. The "software contains no new functions" and was previously cleared. Therefore, any development data for the original software would have been part of the predicate device's clearance.

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

Not applicable as there is no mention of a "training set" for machine learning purposes for this device. The software's ground truth (i.e., its correct functionality) would have been established through traditional software verification and validation, ensuring it correctly implements the algorithms for data acquisition, processing, and display as specified by physics principles and dosimetry protocols.

Summary

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February 21, 2020

PTW-Freiburg Physikalisch-Technische-Werkstaetten-Dr. Pychlau GmbH % Sandor-Csaba Ats Regulatory Affairs Manager Loerracher Strasse 7 79115 Freiburg, BW GERMANY

Re: K191646

Trade/Device Name: BEAMSCAN MR Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: January 14, 2020 Received: January 17, 2020

Dear Sandor-Csaba Ats:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

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) K191646

Device Name BEAMSCAN MR

Indications for Use (Describe)

acceptance testing and/or commissioning of a combined MRI-radiation therapy system
measurements after repair or replacement of major treatment unit components of a combined MRI-Radiation therapy system
beam data analysis according to international therapy dosimetry protocols
acquisition, formatting and transfer of basic data to treatment planning systems
periodic QA procedures, e.g. constancy check
high precision data acquisition for scientific research (not a medical device indication)

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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BEAMSCAN MR water phantom system

510(k) premarket notification

510(k) Summary		K191646
1.	Applicant:	PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr.Pychlau GmbH
2.	Address:	Loerracher Strasse 779115 FreiburgGermanywww.ptw.de
3.	Contact Person:	Dr. Sándor-Csaba ÁtsTel. +49 (0) 761 49055 896sandor.ats@ptw.de
4.	Preparation Date:	June 14, 2019
5.	Device Name:	BEAMSCAN MR
6.	Proprietary Name:	BEAMSCAN MR
7.	Common Name:	Water Phantom
8.	Classification:	Regulation number: 21 CFR 892.5050Name: Medical charged-particle radiation therapy system,Product Code: IYE
9.	Predicate Device:	K161807BEAMSCAN water phantom systemPTW Freiburg
10.	Device Description:	The BEAMSCAN MR system is comprised of a PMMA tank witha moving mechanism and radiation detectors. Further maincomponents are a carriage with built-in electrometer, controlunit and control interface. The carriage includes a water reservoir. The whole system is controlled by software for data displayand processing.
11.	Intended Use:	The PTW water phantom system BEAMSCAN MR is intendedfor dosimetry measurements in radiotherapy systems.The device is intended to determine the beam characteristics ofthe radiotherapy system (beam data acquisition) during thecommissioning and/or for periodic quality assurance proceduresaccording to the QA plan of the responsible medical physicist.The system can also be used at combined MRI-Radiation Therapy systems with static magnetic fields of up to 1.5T
12.	Indications:	The BEAMSCAN MR system is used preferably in combinedMRI-radiation therapy systems with static magnetic fields of upto 1.5T and is intended to collect beam data in water under theaspect of machine QA for the following purposes: acceptance testing and/or commissioning of a combinedMR-radiation therapy system. measurements after repair or replacement of major treat-ment unit components of a combined MRI-radiation therapy system beam data analysis according to international therapy dosimetry protocols acquisition, formatting and transfer of basic data to treatment planning systems periodic QA procedures, e.g. constancy check high precision data acquisition for scientific research (not a medical device indication)
13.	Contraindications:	The BEAMSCAN MR system is intended for QA purposes andmust not be used while a patient is present.It must not be used for Particle Beam dosimetry nor for Diagnostic Radiology.It must not be used while an MR-Linac is taking MR-imagesThe resulting measurement data must not be used to controlthe radiotherapy device.
14.	Intended User:	The BEAMSCAN MR system must be used only by qualifiedpersonnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
15.	Summary of the ProductChange:	The intended use is the same compared to the predicate devicebut will be carried out within a MR Radiation Therapy system.
	Differences to the predicate devices:	In order to use the device with a MR-linac, the PMMA tank wasmade to be removable for putting it on the linac treatment tableand the size was adapted to move it into the MRT tube. This ledto a smaller size of the entire device.Ferromagnetic components were replaced by non-ferrous material to finally be "MR conditional" in a static 1.5 Tesla magneticfield.The software contains no new functions.
16.	Performance Data:	The FDA has not published any performance standards for thisproduct.
	Biocompatibility:	The device is used for pre-treatment quality assurance while nopatient is present. Since the contact of the operator with thedevice occurs only with uninjured skin and the surface of thedevice components contains no critical material, the contactwith the operator is biologically uncritical.

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510(k) premarket notification

Electrical & mechanicalsafety and electromagneticcompatibility (EMC):	Electrical safety, EMC testing and MR safety testing were con-ducted by independent test laboratories. BEAMSCAN MR iscertified as in compliance with IEC 61010-1:2010 (with no pa-tient contact of the product the focus is directed to user safety)and IEC 60601-1-2:2014 (emission and immunity) according toIEC/CISPR 11:2009 (modified + A1:2010). MR safety testingwas performed according to ASTM F2052-15.
Software Verification andValidation Testing:	Software verification and validation testing results were con-ducted and submitted according to the Guidance for the Con-tent of Premarket Submissions for Software Contained in Medi-cal Devices (2005). The BEAMSCAN software contains no newfunctions and was previously cleared with 510(k) #K161807 andis thus not part of this submission.
Bench and Non-clinicalTesting:	Verification and validation testing demonstrated that BEAM-SCAN MR fulfils the design specification and its intended use.Non-clinical performance testing was performed according toIEC 60731:2016 and to specific properties of water phantomsystems which included radiotherapy dose measurements i.e.with step by step measurements and also measurement accu-racy with respect to detector positioning, reproducibility andmechanical alignment. The verification of the design outputagainst the design input was performed in BEAMSCAN MRsystem testing. Validation of the clinical workflow has beenconducted in BEAMSCAN MR validation testing with qualifiedmedical physicists and experienced PTW staff. Testing with apatient present was not required since BEAMSCAN MR acts asa pre-treatment quality assurance tool while no patient is pre-sent.
Conclusions:	The comparison of the indications for use, the technologicalcharacteristics, the performance, safety and effectiveness of thepredicate and the subject device has shown that, when usedwithin a MR Radiation Therapy system, the PTW BEAMSCANMR system is as safe and effective as the predicate devicewithin a non-MR environment.

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.