The THALES 3D MR SCANNER system is designed to measure the characteristic radiation beam for an irradiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.

Device Description

The THALES 3D MR SCANNER system consists of a water phantom with a carriage system, a manual control unit and a software program. A water basin with the corresponding pump, a control unit with an electrometer, and a motor controller are integrated in the carriage system. The software program is used to control the three axes of the water basin, perform measurements and analyse measured data.

The software program has the following properties: Acquisition of measured data, analysis, and recording of photon beams with the water phantom. Generation and export of beam data libraries for a treatment planning system (TPS) for commissioning of irradiation units. The software program is equipped with a central database and/or a file system for central storage of all recorded data for different irradiation units within a large hospital network with different sites. The software program offers the option of defining different user levels to support the typical clinical workflows.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the THALES 3D MR Scanner:

Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a comprehensive efficacy study with predefined acceptance criteria for its performance metrics as one might see in a clinical trial. The "acceptance criteria" here are more about meeting safety, electromagnetic compatibility, and dosimeter standards, and showing that its operational parameters are comparable or superior without introducing new risks. There is no information about a comparative effectiveness study (MRMC) with human readers, nor a standalone algorithm performance study as would be applicable for AI/CADe devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from predicate comparison/standards)	Reported Device Performance (THALES 3D MR Scanner)
Intended Use	QA for radiation therapy systems, commissioning, and other occasions; use with integrated MRI (up to 1.5T for predicate)	QA for radiation therapy systems, commissioning, and other occasions; use with integrated MRI with magnetic field ≤ 0.35 Tesla
Scanning Range	408mm * 355mm * 248mm (predicate)	380mm * 380mm * 242mm
Tank Shape	Square	Square
Wall Material	PMMA	PMMA
Chamber Holder Orientation	Horizontal and vertical	Horizontal and vertical
Motor Scanning Mode	Step by step	Step by step
Step Size	0.1mm	0.1mm
Maximum Speed	30mm/s (predicate)	40mm/s
Position Accuracy	+/-0.1mm (predicate)	+/- 0.25mm (at 0.35Tesla)
Reproducibility	+/-0.1mm (predicate)	+/- 0.25mm (at 0.35Tesla)
MRI Compatibility	Up to 1.5 Tesla (predicate)	Up to 0.35 Tesla
Electrometer Channels	2 entries	2 entries
Electrometer Resolution	10 fA (predicate)	1 fA
Electrical Safety	IEC 61010	IEC 61010
Dosimeter Testing	IEC 60731	IEC 60731
EMC	IEC 60601-1-2:2007 (predicate)	IEC 60601-1-2:2015
MRI Safety	N/A (implied by predicate's MRI compatibility)	Tested in accordance with applicable ASTM standards

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

The document does not describe a "test set" in the context of an AI/ML algorithm or a specific patient-data based study. Instead, it details performance characteristics of a physical measurement device (water phantom) for radiation therapy. The performance testing refers to evaluating the device's physical and electrical characteristics against standards (IEC, ASTM). Therefore, there is no information about a sample size or data provenance related to patient data. The "test set" implies physical testing of the device itself.

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

Not applicable. The ground truth for this device's performance is established by engineering and physics standards (IEC, ASTM) for safety, compatibility, and measurement accuracy, not by human expert consensus on clinical data.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical data or expert review process described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document makes no mention of an MRMC study or any study involving human readers or comparative effectiveness in a clinical workflow with or without AI assistance. This device is a measurement tool, not an AI diagnostic or assistive tool in the traditional sense.

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

No. This is not an AI algorithm but a physical device with integrated software to control movement, acquire, analyze, and export measurement data. Its "performance" refers to how accurately it physically measures radiation beams, not its ability to interpret images or suggest diagnoses.

7. The Type of Ground Truth Used

The ground truth used for validating the device's performance comes from established engineering and medical device standards:

Electrical and mechanical safety: IEC 61010
EMC: IEC 60601-1-2
Dosimeter requirements: IEC 60731
MRI safety: Applicable ASTM standards
Performance metrics (e.g., position accuracy, electrometer resolution) are likely validated against manufacturer-defined specifications derived from engineering principles and comparison to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" of data in the conventional sense. Its software controls hardware and processes raw measurement data based on established physics, not learned patterns from a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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June 3, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LAP GmbH Laser Applikationen % Mr. Martin Pfabel Director Quality Management & Regulatory Affairs Zeppelinstrasse 23 21337 Lueneburg. Lower Saxony GERMANY

Re: K200907

Trade/Device Name: Thales 3D MR Scanner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: March 31, 2020 Received: April 6, 2020

Dear Mr. Pfabel:

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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Indications for Use

510(k) Number (if known)

K200907

Device Name THALES 3D MR SCANNER

Indications for Use (Describe)

The THALES 3D MR SCANNER system is designed to measure the characteristic radiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

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510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, LAP GmbH Laser Applikationen herewith submits a Summary of Safety and Effectiveness. This 510(k) summary for the THALES 3D MR Scanner meets the requirements of 21 CFR 807.92.

Submitter information:	LAP GmbH Laser ApplikationenZeppelinstrasse 2321337 LueneburgPhone: +49 4131 951167Fax: +49 4131 951196
	Establishment Registration Number: 968113-Owner/Operator Number: 9019434
Official Correspondent:	Martin PfabelZeppelinstrasse 2321337 LueneburgGermanyPhone: +49 4131 951167Email: m.pfabel@lap-laser.com
US Agent (Contact):	Trent Van ArkelLAP of America Laser Applications, L.C.161 Commerce Rd Ste 3Boynton Beach, FL 33426Phone: 561 4169250Fax: 561 4169263Email: Tava@Lap-Laser.com
Date Prepared:	31 March 2020

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Device(s) Identification:

Device trade name: Common name:

THALES 3D MR scanner 3D water phantom

Classification of the device:

Device Classification Name: Product Code: C.F.R. Section .: Classification Panel: Device Class:

Medical charged-particle radiation therapy system IYE 892.5050 Radiology devices Class II

Device Description:

Indications for use:

Predicate device:

Device Name:	BEAMSCAN MR
510k number:	K191646
Device Classification Name:	Medical charged-particle radiation therapy system
Product Code:	IYE
C.F.R. Section .:	892.5050
Classification Panel:	Radiology devices
Device Class:	Class II

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Comparison to predicate device:

The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate device and the proposed device.

Parameter	Predicate device	Proposed device	Evaluation
	BEAMSCAN MR	THALES 3D MR
		Scanner
Intended Use	The PTW waterphantom systemBEAMSCAN MR isintended for dosimetrymeasurements inradiotherapy systems.The device isintended to determinethe beamcharacteristics of theradiotherapy system(beam dataacquisition) during thecommissioning and/orfor periodic qualityassurance proceduresaccording to the QAplan of theresponsible medicalphysicist. The systemcan also be used atcombined MRI-Radiation Therapysystems with staticmagnetic fields of upto 1.5T.	The THALES 3D MRSCANNER system isdesigned to measurethe characteristicradiation beam for anirradiation unit. Thebeam data is storedin the softwareprogram and can beexported from therefor use duringcommissioning in atreatment planningsystem (TPS) or forquality assurance.The THALES 3D MRSCANNER systemcan be used withirradiation units withintegrated magneticresonance imagingand a magnetic fieldof less than or equalto 0.35 tesla.	SimilarThe intended use ofboth systems coversthe quality assurancefor radiation therapysystems as part ofregular quality checks,commissioning orother occasions.Both systems arefurther indicated foruse with integratedmagnetic resonanceimaging of magneticfield.The predicate deviceis indicated to be usedin combined MRI-Radiation therapysystems with staticmagnetic fields up to1.5 Tesla.The proposed devicecan be used withirradiation units withintegrated magneticresonance imagingand a magnetic fieldof less than or equalto 0.35 tesla.
Scanning range	408mm * 355mm *248mm(model for ViewRay)	380mm * 380mm *242mm	SimilarThe scanning rangesare nearly identical
Parameter	Predicate deviceBEAMSCAN MR	Proposed deviceTHALES 3D MRScanner	Evaluation
Tank shape	Square	Square	Identical
Wall material	PMMA	PMMA	Identical
Chamber holderorientation	Horizontal and vertical	Horizontal andvertical	Identical
Motor scanning mode	Step by step	Step by step	Identical
Step size	0.1mm	0.1mm	Identical
Maximum speed	30mm/s	40mm/s	SimilarThe THALES systemhas a highermaximum speedwhich allows a fasterscanning process
Position accuracy	+/-0.1mm	+/- 0.25mm(at 0.35Tesla)	SimilarThe difference inaccuracy does notaffect the safety or theeffectiveness of theproposed system.The constructionrequirements onphantoms inaccordance with IEC60731 have been met.
Reproducibility	+/-0.1mm	+/- 0.25mm(at 0.35Tesla)	SimilarThe difference inreproducibility doesnot affect the safety orthe effectiveness ofthe proposed system.The constructionrequirements onphantoms inaccordance with IEC60731 have been met.
MRI compatible	Up to 1.5 Tesla	Up to 0.35 Tesla	DifferentThe LAP system isindicated for use withintegrated magneticresonance imaging ofmagnetic fields less orequal than 0.35T
Parameter	Predicate deviceBEAMSCAN MR	Proposed deviceTHALES 3D MRScanner	Evaluation
			while the predicatedevice is indicated tobe used in a staticmagnetic field up to1.5 Tesla. Thedifference in MRcompatibility does notaffect the safety oreffectiveness of thesystem while thetarget system of theproposed device(ViewRay MRidian)only provides a staticmagnetic field of 0.35Tesla or less.LAP has tested theperformance andsafety aspects withthe target system andcan confirm that theproposed device canbe used in therespective MRIenvironment.
Electrometer channels	2 entries	2 entries	Identical
Electrometerresolution	10 fA	1 fA	DifferentThe electrometerresolution for theproposed device isbetter (10x better)than the predicatedevice's.
Electrical safety	IEC 61010	IEC 61010	Identical
Dosimeter testing	IEC 60731	IEC 60731	Identical
Electromagneticcompatibility	IEC 60601-1-2:2007	IEC 60601-1-2:2015	Identical

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Summary of performance testing:

The proposed device has been tested in respect to electrical and mechanical safety in accordance with IEC 61010, EMC in accordance with IEC 60601-1-2 and dosimeter requirements in accordance with IEC 60731. MRI safety has been tested in accordance with applicable ASTM standards.

Conclusion:

LAP GmbH Laser Applikationen believes that the THALES 3D MR Scanner is substantially equivalent to currently legally marketed devices. The device does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.

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.