acceptance testing and/or commissioning of a radiation therapy system.
measurements after repair or replacement of major treatment unit components.
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 checks.

Device Description

The BEAMSCAN system is comprised of a PMMA tank with a moving mechanism and a radiation detector. Further main components are a lifting carriage with built-in electrometer and control unit with separate control pendant. The lifting carriage either includes a water reservoir or a separate reservoir is used. A positioning device can be mounted on top of the lifting carriage and allows the water phantom to be aligned manually. The whole system is controlled with software for data display and processing.

AI/ML Overview

This document describes the BEAMSCAN system, a water phantom for dosimetry measurements in radiation therapy. It is intended for machine quality assurance (QA), including acceptance testing, commissioning, measurements after repair, beam data analysis, data transfer to treatment planning systems, and periodic QA procedures. Its use is restricted to qualified medical physicists and must not be used while a patient is present.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list a table of acceptance criteria with corresponding performance metrics in a pass/fail format. However, it states that "Verification and validation testing demonstrated that BEAMSCAN fulfils the design specification and its intended use." It also mentions non-clinical performance testing was conducted according to IEC 60731 A1:2016 and specific properties of water phantom systems.

Based on the "Bench and Non-clinical Testing" section, we can infer the aspects that were tested and confirmed:

Acceptance Criteria (Inferred from testing description)	Reported Device Performance (Inferred)
Fulfillment of design specification	Fulfilled
Fulfillment of intended use	Fulfilled
Compliance with IEC 60731 A1:2016	Compliant
Measurement accuracy (detector positioning)	Verified
Reproducibility of measurements	Verified
Mechanical alignment	Verified
Functionality with step-by-step measurements	Verified
Functionality with continuous measurements	Verified
Clinical workflow validation	Validated
Electrical safety (IEC 61010-1:2010)	Compliant
Electromagnetic compatibility (IEC 60601-1-2:2007 / CISPR 22:2008 / 47 CFR Part 15 Subpart B)	Compliant
Software verification and validation (according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005))	Conducted and submitted
Biocompatibility (operator contact with uninjured skin)	Biologically uncritical

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

The document does not explicitly specify a "sample size for the test set" in the context of clinical images or patient data. The BEAMSCAN system is for quality assurance of radiation therapy machines, not for patient diagnosis or treatment. The testing described focuses on the device's measurement capabilities and operational performance.

The "Bench and Non-clinical Testing" section mentions "Verification and validation testing" and "BEAMSCAN validation testing." It states that this testing was performed with "qualified medical physicists and experienced PTW staff." There is no specific number of test cases or "samples" quantified in the typical sense of a clinical study.

Data Provenance: The testing was "non-clinical" and involved "qualified medical physicists and experienced PTW staff," suggesting it was conducted internally by the manufacturer (PTW-Freiburg, Germany) or by independent test laboratories (for electrical safety and EMC), focusing on the device's physical and software performance. Therefore, the data provenance is from laboratory/bench testing and internal validation, not retrospective or prospective clinical patient data.

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

The document mentions that "Validation of the clinical workflow has been conducted in BEAMSCAN validation testing with qualified medical physicists and experienced PTW staff." It does not specify a precise number of individual experts beyond the general terms "qualified medical physicists" and "experienced PTW staff."

Qualifications of Experts:

Qualified medical physicists: This is a professional designation, implying they possess the necessary education, training, and certification to work in medical physics, which includes radiation dosimetry and QA.
Experienced PTW staff: This refers to personnel employed by the manufacturer (PTW-Freiburg) who have expertise related to the device and its intended use.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the sense of resolving discrepancies among multiple expert assessments for ground truth, as would be common in a clinical imaging study. Since the testing involved device performance against established standards (e.g., IEC 60731 A1:2016) and design specifications, the "ground truth" would be determined by these objective criteria and the observed measurements. Workflow validation would likely involve confirmation by the "qualified medical physicists" that the system operates as expected for its intended QA purposes.

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

No, an MRMC comparative effectiveness study was not done. The BEAMSCAN is a measurement device for machine QA, not a diagnostic or treatment planning tool that would involve human readers interpreting cases with and without AI assistance. The study focuses on the device's inherent measurement accuracy and performance.

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

The BEAMSCAN system is a physical device that performs measurements through mechanical movement and detector readings, controlled by software. The "performance data" section details "Software Verification and Validation Testing" and "Bench and Non-clinical Testing." These tests evaluate the device's performance, including the software's role in controlling measurements and data processing. While the human user is "in the loop" for setting up the QA procedure and interpreting the results, the core measurement functionality of the system itself, including its embedded algorithms for positioning and data acquisition, is tested in a standalone manner to ensure it meets specifications. The "automated levelling by calculating ideal coordinate axes with respect to the measured water surface" is an example of an algorithmic function that would be tested for standalone performance.

7. The Type of Ground Truth Used

The ground truth used for testing the BEAMSCAN system is based on:

Design Specifications: The device's performance was verified against its design inputs.
International Standards: Compliance with standards such as IEC 60731 A1:2016 for dosimetry and IEC electrical safety and EMC standards.
Objective Physical Quantities: Measurement accuracy, reproducibility, and mechanical alignment are compared to known or expected physical values and acceptable tolerances for radiation therapy QA.
Clinical Workflow Expectations: Validation by qualified medical physicists ensures the system functions correctly within a radiotherapy QA workflow.

This is a form of objective performance ground truth, not a subjective ground truth like expert consensus on medical images or pathology reports.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI model development. The BEAMSCAN is a physics-based measurement system, not a device that employs machine learning for its core functionality of beam data acquisition. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. Its performance is based on its physical design, calibration, and deterministic algorithms.

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

As there is no mention of a "training set" or machine learning algorithms in the context of the BEAMSCAN system's primary function, this question is not applicable based on the provided information.

Summary

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May 19, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K161807

Trade/Device Name: BEAMSCAN Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 10, 2017 Received: May 15, 2017

Dear Dr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

For Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161807

Device Name BEAMSCAN

Indications for Use (Describe)

The BEAMSCAN system 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 radiation therapy system.
measurements after repair or replacement of major treatment unit components.
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 checks.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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BEAMSCAN System

510(k) premarket notification

Image /page/3/Picture/2 description: The image shows a logo with the letters PTW in a stylized font. A red triangle is positioned above the letter T, pointing downwards. The letters are black and the background is white. The logo is enclosed in a black border.

510(k) Summary

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:	May 10, 2017
5.	Device Name:	BEAMSCAN
6.	Proprietary Name:	BEAMSCAN
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:	K954165PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOMPTW Freiburg
10.	Device Description:	The BEAMSCAN system is comprised of a PMMA tank with amoving mechanism and a radiation detector. Further main com-ponents are a lifting carriage with built-in electrometer and con-trol unit with separate control pendant. The lifting carriage eitherincludes a water reservoir or a separate reservoir is used. Apositioning device can be mounted on top of the lifting carriageand allows the water phantom to be aligned manually. Thewhole system is controlled with software for data display andprocessing.
11.	Intended Use:	The PTW water phantom system (BEAMSCAN) is intended fordosimetry measurements in the context of a radiotherapy sys-tem. The device is intended to determine the beam characteris-tics of the radiotherapy system (beam data acquisition) duringthe commissioning and/or for periodic quality assurance proce-dures according to the QA plan of the responsible medicalphysicist.
12.	Indications:	The BEAMSCAN system is intended to collect beam data inwater under the aspect of machine QA for the following purpos-es:– acceptance testing and/or commissioning of a radiationtherapy system.– measurements after repair or replacement of major treat-ment unit components.– beam data analysis according to international therapy do-simetry protocols.– acquisition, formatting and transfer of basic data to treat-ment planning systems.– periodic QA procedures, e.g. constancy checks.
13.	Contraindications:	The BEAMSCAN system is for QA purposes and must not beused while a patient is present.It must not be used for Particle Beam dosimetry, for DiagnosticRadiology, and in an MR environment.The resulting measurement data must not be used to controlthe radiotherapy device
14.	Intended User:	The BEAMSCAN system must be used only by qualified per-sonnel as medical physicists.
15.	Substantial equivalence	While the wording is not identical, the intended use, the indica-tions for use and the characteristics of this device are substan-tively the same as of the predicate devices identified on thecomparison chart, which is provided with the premarket notifica-tion submission. It is our opinion that BEAMSACAN does nothave functions and technological characteristics that raise addi-tional types of questions related to terms of safety and effec-tiveness.
	Differences to the predi-cate devices:	Aggregation of all formerly discrete components, e.g. waterphantom tank, electrometer, several control units, all cables andwater reservoir, to one physical unit and replacing cable bywireless connection.Automated levelling by calculating ideal coordinate axes withrespect to the measured water surface.Continuous measuring alternatively to repeatedly positioning ofthe detector and subsequent measuring at discrete measuringpoints.Improved dosimetry detector with respect to 3D characteristics.No additional type of safety issue is raised by these changes.
	16.	Performance Data:
	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.
Electrical & mechanicalsafety and electromagneticcompatibility (EMC):	Electrical safety and EMC testing were conducted by independ-ent test laboratories. BEAMSCAN is certified as in compliancewith IEC 61010-1:2010 (with no patient contact of the productthe focus is directed to user safety) and IEC 60601-1-2:2007(emission and immunity) / CISPR 22:2008 (RF technology) and47 CFR Part 15 Subpart B.
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).
Bench and Non-clinicalTesting:	Verification and validation testing demonstrated that BEAM-SCAN fulfils the design specification and its intended use. Non-clinical performance testing was performed according to IEC60731 A1:2016 and to specific properties of water phantomsystems which included radiotherapy dose measurements i.e.with step by step and continuous measurements and alsomeasurement accuracy with respect to detector positioning,reproducibility and mechanical alignment. The verification of thedesign output against the design input was performed inBEAMSCAN system testing. Validation of the clinical workflowhas been conducted in BEAMSCAN validation testing with qual-ified medical physicists and experienced PTW staff. Testingwith a patient present was not required since BEAMSCAN actsas a pre-treatment quality assurance while no patient is present.
Conclusions:	The comparison of the indications for use, the technologicalcharacteristics, the performance, safety and effectiveness of thepredicate and the subject device has shown that the PTWBEAMSCAN water tank system is as safe and effective as thepredicate device and that the application is as well or better.With respect to the use the device do not raised new questionsof safety and effectiveness.

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BEAMSCAN System

Image /page/4/Picture/1 description: The image shows the logo for PTW. The logo consists of the letters "PTW" in a simple, sans-serif font. A red triangle is positioned above the "T", pointing downwards. The letters are black, and the triangle is red.

510(k) premarket notification

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BEAMSCAN System

Image /page/5/Picture/1 description: The image shows a logo with the letters "PTGW" in a bold, sans-serif font. A red triangle is positioned above the "T", pointing downwards. The letters are black, and the triangle is red. The logo is enclosed within a thin black rectangular border.

510(k) premarket notification

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.