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 camera system that enables live 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. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.

AI/ML Overview

The provided text is a 510(k) summary for the BeamSite™ System, V 1.5. This document focuses on demonstrating substantial equivalence to a predicate device due to minor technological changes. It does not present acceptance criteria or detailed study results for device performance in the typical sense of clinical or standalone algorithm performance.

Here's an analysis of the provided text in relation to your request:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided document describes a Special 510(k) submission where the subject device (BeamSite™ System, V 1.5) is compared to a predicate device (BeamSite System, K200940). The primary purpose of this type of submission is to demonstrate that minor changes to a previously cleared device do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" discussed are largely related to maintaining the performance and safety characteristics of the predicate device. The "study" referenced is primarily a set of non-clinical performance tests designed to confirm that the modified device performs comparably to the predicate and meets relevant safety and quality standards, rather than a study to establish novel performance metrics or clinical efficacy.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, a table like the one requested, with specific quantitative acceptance criteria and corresponding reported device performance for clinical or diagnostic metrics, cannot be fully constructed. The document focuses on confirming that the changes in the device (specifically the "always on" imaging mode) do not negatively impact its existing, established performance.

Instead, the document details performance testing repeated on the modified device to support substantial equivalence. The implication is that the performance criteria for these tests were either identical to those successfully met by the predicate device or standard regulatory requirements for device safety and functionality.

Acceptance Criteria (Implied / Regulatory Standard)	Reported Device Performance (Summary)
Functional Verification (System, Software, Firmware)	"BeamSite functional verification testing (system, software and firmware)" was repeated on the proposed device. (Implied: Passed, demonstrating continued functionality and consistency with predicate)
Accelerated Age Testing (Service Life)	"Accelerated age testing to support expected service life claim for the BeamSite Camera" was repeated. (Implied: Passed, demonstrating maintained device longevity and durability)
Electrical Safety (IEC 60601-1:2005 / (R) 2012)	"Electrical Safety Evaluation as per IEC 60601-1:2005 / (R) 2012 and A1: 2012" was conducted. (Implied: Complies with relevant electrical safety standards)
Electromagnetic Compatibility (IEC 60601-1-2: 2014)	"Electromagnetic Compatibility testing as per IEC 60601-1-2: 2014" was conducted. (Implied: Complies with relevant EMC standards)
Software Verification & Validation (IEC 62304)	"Software Verification and Validation as per IEC 62304:2006 / A1: 2016" was performed. (Implied: Software functions correctly and safely, in accordance with V&V best practices for medical device software)
Usability Testing (IEC 60601-1-6 & IEC 62366-1)	"Usability Testing as per IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1: 2015" was performed. (Implied: The device remains safe and effective for use by radiotherapy professionals, and the new feature does not introduce usability issues)
No new safety/effectiveness concerns	The submission concludes that "the differences in technological characteristics do not raise different questions of safety and efficacy." (Implied: All performance testing confirmed that the modified device maintained the safety and efficacy profile of the predicate device, thereby meeting the implicit "acceptance criteria" of substantial equivalence.)

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 lists non-clinical performance test types, such as functional verification, accelerated age testing, electrical safety, EMC, software V&V, and usability testing. These are primarily engineering and regulatory compliance tests, not data-driven clinical studies with "test sets" in the diagnostic performance sense. Therefore, information regarding:

Sample size for a "test set" (of patient data/images) is not applicable and not provided.
Data provenance (country of origin, retrospective/prospective) is not applicable and not provided for this type of non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided and is generally not required for the type of non-clinical, substantial equivalence testing described in this document. The device is a "visualization tool" to show the beam on the patient; it's not performing diagnostic or analytical measurements that would require expert-established ground truth on image interpretation.

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 non-clinical performance testing 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, an MRMC comparative effectiveness study was not done. The BeamSite system is a visualization tool, not an AI-powered diagnostic or decision-support system intended to improve human reader accuracy. The purpose of the submission is to demonstrate substantial equivalence of a modified version of a previously cleared device, not to prove clinical efficacy or reader benefit.
The document does not mention any AI components in the device.

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

No, a standalone (algorithm-only) performance study was not done. The device's function is to provide "live visualization" for "radiotherapy professionals" to "visually monitor radiation therapy." It is inherently a human-in-the-loop system. The non-clinical tests described focus on hardware, software, safety, and usability.

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

Given the non-clinical nature of the testing described (functional verification, safety, EMC, V&V, usability), the concept of "ground truth" as it applies to diagnostic or prognostic studies is not directly relevant to the information provided. The "ground truth" for these engineering tests would be established by reference standards, regulatory requirements, and engineering specifications.

8. The sample size for the training set

Not applicable and not provided. The BeamSite system, as described, does not appear to be an AI/ML device that requires a "training set" of data for algorithm development. Its function is optical imaging of Cherenkov light and patient surface anatomy.

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

Not applicable and not provided, as there is no mention of a training set or AI/ML algorithm requiring this.

In summary: The provided FDA 510(k) summary is for a Special 510(k) submission, which focuses on demonstrating that a modified device is substantially equivalent to a predicate device and that the changes do not raise new safety or effectiveness concerns. The "performance testing" described comprises standard engineering and regulatory compliance tests (e.g., electrical safety, EMC, software validation) to confirm the continued safety and functional performance of the device after minor modifications, primarily the addition of an "always on" imaging mode. It does not contain information related to diagnostic performance, clinical efficacy studies, or AI/ML algorithm performance metrics that would involve patient data, expert ground truth, or MRMC studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of 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 the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DoseOptics LLC % Farzeen Christie Consultant 16 Cavendish Ct. LEBANON NH 03766

Re: K212606

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: August 16, 2021 Received: August 17, 2021

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/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 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,

Julie Sullivan -S

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) K212606

Device Name BeamSite™ System

Indications for Use (Describe)

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 apptal and freestanding radiation therapy environments.

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, V 1.5 Special 510(k)

5. 510(k) SUMMARY

5.1. SUBMITTER

DoseOptics LLC 16 Cavendish Court Lebanon. NH 03766 Phone: (603) 643-5177

Contact Person:	Farzeen Christie
Email:	farzeen@doseoptics.com
Date Prepared:	August 16 2021

5.2. SUBJECT DEVICE

Device Trade Name: Device Common Name: Classification Name:

Requlatory Class: Product Code: Panel:

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

5.3. PREDICATE DEVICE

BeamSite System, K200940 manufactured by DoseOptics LLC.

5.4. DEVICE DESCRIPTION

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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 size and shape of the beam on the patient during treatment. The images produced will provide real-time, direct visual indication:

that the beam is on; ●
. that the beam is impacting the patient at the intended treatment surface;
of visible patient's movement relative to the beam; and ●
that surfaces of the body, that are not intended for treatment, ● remain outside the beam path.

In addition, in the modified device, the background images of the treatment area are now continuously displayed before and after treatment, providing an "always on" imaging experience preferred by the therapists. However, like with the original device, only the images acquired during the actual beam irradiation are stored for offline review.

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.

5.5. INDICATIONS FOR USE / INTENDED USE

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COMPARISON TO PREDICATE DEVICE 5.6.

Characteristic	Predicate Device:DoseOpticsBeamSite System(K200940)	Subject Device:DoseOpticsBeamSite System, V 1.5
Intended Use / Indications for Use	The BeamSiteTM System is intended to be used only withphoton external beamradiotherapy during treatmentto acquire and visualize theshape of the treatmentradiation beam relative tosurface anatomical landmarkson the patient, anywhere inthe body where radiationtreatment is indicated.BeamSite is used byradiotherapy professionals inappropriate hospital andfreestanding radiation therapyenvironments.	Same
Type of Use	Prescription Use	Same
Device Role and System Output	Serves as an accessory toLINAC	Same
Target Population	Any individual (Adult of Childundergoing radiotherapy)	Same
Energy Delivered to the Patient	No energy delivered to thepatient by the device	Same
Use Environment	Radiation image detectionsubsystem is inside thetreatment room and the PCWorkstation to view theimages is outside thetreatment room in therapistcontrol area	Same
Beam Energies Used	All therapeutic X-Rayenergies from the linacradiation beam can beimaged	Same
Viewing Method	Display of image is on acomputer monitor using	Same
Characteristic	Predicate Device:DoseOpticsBeamSite System(K200940)	Subject Device:DoseOpticsBeamSite System, V 1.5
SupportingSystemComponents	custom software applicationinstalled on a Windows PCPC Workstation and Cablesbetween treatment room andtherapist control area	Same
Field Size ofImage	40cm X 40cm	Same
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
Types ofImagesAcquired	Images of the treatment beamfield size and shapeimpinging on the patientanatomy.	Images of the treatmentbeam field size andshape impinging on thepatient anatomy duringtreatment.Additional Feature: videofeed of the treatmentarea before and aftertreatment.
Beam ImageDetection	X-rays interact with tissue onand near the surface of thepatient's anatomy andproduce visible light by theCherenkov emission process.The light is imaged by anintensified camera systemwith a Complementary MetalOxide Semiconductor(CMOS) sensor.	Same
Patient SurfaceAnatomyImaging	Patient surface anatomy isvisualized between treatmentbeam pulses utilizing ambientlight.	Same
Characteristic	Predicate Device:DoseOpticsBeamSite System(K200940)	Subject Device:DoseOpticsBeamSite System, V 1.5
ImageProcessing	Image acquisition electronicsperforms imaging in-sync andout-of-sync with the treatmentbeam pulses. Softwareperforms image processingand displays images on themonitor.	Same
Imaging Modes	User Interface (UI) displays"waiting for beam" messageuntil the treatment beamcomes online and transitionsto displaying and recordingimages of the treatment beamintersecting the patientanatomy when the treatmentbeam comes on.	UI displays ambient lightimages of the treatmentarea continuously.UI displays and recordsimages of the treatmentbeam intersecting thepatient anatomy when thetreatment beam comeson.

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Page 5-5

The Predicate Device for the BeamSite System V 1.5 is the previously cleared BeamSite (K200940), manufactured by DoseOptics LLC. The indications for use for the proposed device is identical to the indications for use of the cleared device.

the proposed device differs in few technological However. characteristics from the cleared device. The proposed device has an additional feature of continuously displaying ambient light background images of the treatment area to the user even when the beam is not on, further referred to as "always on" mode. This way, a continuous video feedback is provided to the user. This live video is not recorded. The feature of displaying Cherenkov images, recording and providing playback options is identical to the predicate device. There is no change to the main objective / intended use of the device.

In addition to the technological characteristic change of having the always on capability, a few device components have been changed in the proposed device. These changes and technological differences do not raise new or different concerns of safety and effectiveness. The performance testing conducted on the predicate device were repeated

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on the proposed modified device to show that the differences did not affect the performance and specifications of the proposed device.

5.7. PERFORMANCE TESTING SUMMARY (NON-CLINICAL)

The following performance testing was repeated on the proposed device 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: o 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 modified BeamSite and the evaluation of predicate characteristics, we claim that the modified BeamSite System (V 1.5) to be substantially equivalent to existing legally marketed device, BeamSite (K#200940), and that the differences in technological characteristics do not raise different questions of safety and efficacy.

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.