The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.

Device Description

BeamSite™ is a system that enables real-time visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the beam on the patient. The BeamSite system consists of a camera, workstation with pre-installed BeamSite software and a monitor to be used by clinical radiotherapy teams to visually observe the treatment, as it happens, and review after the treatment, if necessary.

The BeamSite system is designed to be used as a fixed mounted camera having a field of view of the treatment area, to routinely image patient treatments with minimal impact to the clinical workflow. The video images produced are intended to provide additional information about the treatment for the clinical team by displaying the beam size and shape on the patient during treatment. The images produced will provide real-time, direct visual indication that the beam is on, that it is impacting the patient at the intended treatment surface, provides visual feedback regarding the patient's movement relative to the beam, and that surfaces of the body not intended for treatment remain outside the beam path. BeamSite is to be used as a visualization tool. Therapeutic decisions should not be made solely based on the images acquired from this device. However, the images will provide a simple and intuitive means to visually monitor radiation therapy on a routine basis.

AI/ML Overview

The provided text is a 510(k) summary for the DoseOptics BeamSite™ System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a new clinical claim or an AI algorithm's diagnostic performance. Therefore, many of the requested details regarding acceptance criteria, ground truth, expert adjudication, and MRMC studies, which are typical for AI/ML-based diagnostic devices, are not explicitly present in this document.

The BeamSite™ System is described as an optical visualization tool for radiotherapy, showing the beam shape relative to surface anatomical landmarks. It is not an AI/ML diagnostic or assistive device in the sense that it provides a specific diagnosis, classification, or modifies treatment decisions based on an AI's output. Its primary function is to provide visual feedback to human operators.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing:

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

The document does not present a table of specific performance acceptance criteria for the visualization capabilities of the BeamSite System, nor does it quantify its diagnostic performance. The performance testing summarized primarily relates to functional verification, safety (electrical, EMC), software V&V, and usability, which are general engineering and regulatory compliance tests rather than benchmarks for clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task).

The "Performance Testing Summary (Non-Clinical)" section lists the types of tests conducted:

Test Type	Description/Reported Performance
BeamSite functional verification testing	(system, software and firmware) - Implied successful completion, but no specific metrics or acceptance criteria are provided.
Accelerated age testing	(to support expected service life claim for the BeamSite Camera) - Implied successful completion, but no specific metrics or acceptance criteria are provided.
Electrical Safety Evaluation	as per IEC 60601-1:2005 / (R) 2012 and A1: 2012 - Implied compliance.
Electromagnetic Compatibility testing	as per IEC 60601-1-2: 2014 - Implied compliance.
Software Verification and Validation	as per IEC 62304:2006 / A1: 2016 - Implied compliance.
Usability Testing	as per IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1: 2015 - Implied compliance.

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

This information is not provided in the document. The performance testing described is "non-clinical," implying it was not a patient-based clinical trial. If any data was used for functional verification or usability testing, the sample size and provenance are not specified. Given the device's function as a real-time visualization tool and its substantial equivalence argument, a large test set of patient images with verified ground truth (as would be needed for an AI diagnostic device) is not described here.

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)

This information is not provided. As "ground truth" for diagnostic performance is not within the scope of this non-clinical testing summary, no experts are mentioned for this purpose.

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

This information is not provided and is not applicable given the nature of the tests described.

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 MRMC study was conducted or reported. This device is not an AI-assistive diagnostic tool that would typically undergo such a study. It provides raw visual information, and its purpose is not to improve human reader performance on a diagnostic task, but rather to give immediate feedback on beam delivery.

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

This is not explicitly stated or implied. The device is a "system consisting of a camera, workstation with pre-installed BeamSite software and a monitor to be used by clinical radiotherapy teams to visually observe the treatment." It is inherently a human-in-the-loop device, and standalone algorithm performance, separate from human interpretation, is not a relevant measure for its function.

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

As no clinical performance claims (e.g., diagnostic accuracy) are being made based on this device's output, the concept of "ground truth" for clinical images (like expert consensus or pathology) is not applicable or mentioned in this summary. The device visualizes Cherenkov light, which itself is a direct physical phenomenon related to the beam.

8. The sample size for the training set

This information is not provided. The document does not describe the use of machine learning or deep learning that would typically involve a "training set."

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

This information is not provided and is not applicable, as there is no mention of a training set or machine learning.

Summary

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December 11, 2020

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

DoseOptics LLC % Farzeen Christie Consultant 16 Cavendish Court LEBANON NH 03766

Re: K200940

Trade/Device Name: BeamSite™ System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: November 6, 2020 Received: November 9, 2020

Dear Farzeen Christie:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 medical devices and radiation-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) K200940

Device Name BeamSite™ System

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)

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DoseOptics LLC BeamSite™ System Traditional 510(k)

5. 510(k) SUMMARY

Revised 12/04/2020

5.1. SUBMITTER

DoseOptics LLC

16 Cavendish Court Lebanon, NH 03766 Phone: (603) 643-5177

Contact Person: Email: Date Prepared:

Farzeen Christie farzeen@doseoptics.com April 7, 2020

5.2. SUBJECT DEVICE

Device Trade Name: Device Common Name: Classification Name:

Regulatory Class: Product Code: Panel:

BeamSite™ System Radiotherapy Visualization System Medical Charged Particle Radiation Therapy System (21 CFR 892.5050) ll IYE Radiology

5.3. PREDICATE DEVICE

PortalVision™ Advanced Imaging Device, K091209 manufactured by Varian Medical Systems.

DEVICE DESCRIPTION 5.4.

K200940

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5.5. INDICATIONS FOR USE / INTENDED USE

The BeamSite System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals therapy in appropriate hospital and freestanding radiation environments.

5.6. COMPARISON TO PREDICATE DEVICE

The Predicate Device for the BeamSite System is PortalVision Advanced Imaging Device, K091209, manufactured by Varian Medical Systems.

The PortalVision Advanced Imaging Device is indicated to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.

Whereas, the BeamSite System is indicated for a subset of this indication, namely, it is intended to be used during treatment to acquire and visualize the shape of the treatment radiation beam relative to

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surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated.

Both devices require the ionizing radiation beam to be exposing the patient at the time they acquire their images.

The BeamSite System is not a substitute for the predicate but provides additional information to the user when compared to the PortalVision Advanced Imaging Device in that it presents a visual image of the actual shape of the irradiation field on the patient in relation to a visual image of the patient anatomical surface in and around the irradiation field.

Both devices require image analysis and presentation software to display images on a monitor to the user for further human analysis and decision making.

Characteristic	Predicate Device:PortalVision AdvancedImaging Device(K091209)	Subject Device:DoseOpticsBeamSite System
Intended Use	The PortalVision AdvancedImaging device is used toacquire images of anatomicallandmarks, fiducial markers,the shape of the treatmentbeam and dosimetric signalsto guide the delivery ofradiation anywhere in thebody where radiationtreatment is indicated.	The BeamSite Systemis intended to be usedonly with photonexternal beamradiotherapy duringtreatment to acquireand visualize the shapeof the treatmentradiation beam relativeto surface anatomicallandmarks on thepatient, anywhere in thebody where radiationtreatment is indicated.BeamSite is used byradiotherapyprofessionals inappropriate hospitaland freestandingradiation therapyenvironments.
Characteristic	Predicate Device:PortalVision AdvancedImaging Device(K091209)	Subject Device:DoseOpticsBeamSite System
Indications forUse	The PortalVision AdvancedImaging device is used toacquire images of anatomicallandmarks, fiducial markers,the shape of the treatmentbeam and dosimetric signalsto guide the delivery ofradiation anywhere in thebody where radiationtreatment is indicated.	The BeamSite Systemis intended to be usedonly with photonexternal beamradiotherapy duringtreatment to acquireand visualize the shapeof the treatmentradiation beam relativeto surface anatomicallandmarks on thepatient, anywhere in thebody where radiationtreatment is indicated.BeamSite is used byradiotherapyprofessionals inappropriate hospitaland freestandingradiation therapyenvironments.
Type of Use	Prescription Use	Same
Device Role andSystem Output	Serves as an accessory toLINAC	Same
TargetPopulation	Any individual (Adult or Childundergoing radiotherapy)	Same
EnergyDelivered to thePatient	No energy delivered to thepatient by the device	Same
UseEnvironment	Radiation image detectionsubsystem is inside thetreatment room and the PCWorkstation to view theimages is outside thetreatment room in therapistcontrol area	Same
Beam EnergiesUsed	All therapeutic X-Rayenergies from the linac	Same
Characteristic	Predicate Device:PortalVision AdvancedImaging Device(K091209)	Subject Device:DoseOpticsBeamSite System
	radiation beam can beimaged
Viewing Method	Display of image is on acomputer monitor usingcustom software applicationinstalled on a Windows PC	Same
SupportingSystemComponents	PC Work Station and Cablesbetween treatment room andtherapist control area	Same
Field Size ofImage	Radiation Beam can beviewed within the 40cm X30cm detector area of theImage Detection Unit.	40cm X 40cm
SoftwareFeatures	Image Acquisition, Review,and Storage are possible bythe computer and software.	Same
Biocompatibility	No contact with patient orclinical staff in the treatmentroom.	Same
Image Source	X-ray treatment beam	Same
ImageAcquisitionGeometry	Images of the exit treatmentbeam field size and shape.	Images of the treatmentbeam field size andshape impinging on thepatient anatomy.
Image Detection	Flat-panel Amorphous Silicondetector	X-rays interact withtissue on and near thesurface of patient'sanatomy and produceconcomitant light outputby the Cherenkovemission process. Thelight is imaged by anintensified camerasystem with aComplementary MetalOxide Semiconductor(CMOS) sensor.
Characteristic	Predicate Device:PortalVision AdvancedImaging Device(K091209)	Subject Device:DoseOpticsBeamSite System
Image patientsurfaceanatomy	Not possible	Patient surfaceanatomy is visualizedbetween treatmentbeam pulses utilizingambient light.
ImageProcessing	Proprietary software performsimage processing anddisplays images on themonitor.	Image acquisitionelectronics performsimaging in sync and outof sync with thetreatment beam pulses.Software performsimage processing anddisplays images on themonitor.

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Although PortalVision Advanced Imaging Device and the BeamSite System acquire their images using different technologies, both are accessories to a medical linear accelerator, both require an active ionizing radiation beam and both do acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated.

For both devices, the patient receives their radiation therapy whether or not either device is in use. Neither device interacts directly with the patient, but both utilize information present in the treatment beam. Since the BeamSite System is not a substitute for the PortalVision Advanced Imaging Device, but provides new visual information to the user, the technological differences do not raise new or different concerns of safety and effectiveness.

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5.7. PERFORMANCE TESTING SUMMARY (NON-CLINICAL)

The following performance data are provided in support of the substantial equivalence determination.

. BeamSite functional verification testing (system, software and firmware)
. Accelerated age testing to support expected service life claim for the BeamSite Camera
Electrical Safety Evaluation as per IEC 60601-1:2005 / (R) 2012 . and A1: 2012
Electromagnetic Compatibility testing as per IEC 60601-1-2: 2014 .
Software Verification and Validation as per IEC 62304:2006 / A1: ● 2016
Usability Testing as per IEC 60601-1-6 Edition 3.1 2013-10 and . IEC 62366-1: 2015

5.8. CONCLUSIONS

Based on performance testing of BeamSite and the evaluation of predicate characteristics, we claim the BeamSite System to be substantially equivalent to existing legally marketed device, PortalVision (K#091209).

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.