AlignRT Plus by Vision RT Ltd | FDA 510(k) Summary

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

Device Description

The AlignRT Plus system (K203387) is a combination of the devices AlignRT, GateCT and GateRT.

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals.

Real-time imaging and surface matchinq of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances.

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.

Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module".

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

This 510(k) is requested for a modifications to FDA 510(k) cleared product "AlignRT Plus" (K203387).

This 510(k) is to obtain clearance for the following changes to the cleared device:

Introduction of new software, SimRT 7.2. This is an updated version of the cleared software, GateCT, with a new user interface similar to the cleared AlignRT 6.2/6.3/6.4 software;
1. Introduction of new camera pods (hardware). These function in the same way as the currently cleared hardware but are aesthetically different and have upgraded capabilities to support future product development;
1. Improve the product's accuracy claim for Source-Surface Distancing (SSD) from <2.0mm to <0.2mm.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the AlignRT Plus system. It details modifications to an already cleared device. The key information regarding acceptance criteria and device performance is found under the "System Performance and Accuracy" section within the "Summary of the Technological Characteristics" table.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Predicate Device)	Reported Device Performance (Modified Device)	Comments
Positioning Accuracy	Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.	Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.	The system performance and accuracy have not changed.
Respiratory Tracking	Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating).	Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating).	The system performance and accuracy have not changed.
Surface Displacements	RMS errors < 0.5mm over 10 or more breathing cycles.	RMS errors < 0.5mm over 10 or more breathing cycles.	The system performance and accuracy have not changed.
Source-Surface Distancing (SSD) Accuracy	Not explicitly stated in the predicate column, but implied by the change to the modified device.	< 0.2mm (This is an improvement from a previous claim of < 2.0mm)	This is one of the key improvements being sought with this 510(k).

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

The document mentions that the changes were tested with "test method and acceptance criteria as the predicate device," but it does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective study). The study appears to be a technical verification and validation of changes to functionality and hardware.

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

The document does not mention the use of experts to establish ground truth for the test set. The performance metrics appear to be based on physical measurements using calibration phantoms and internal system testing.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set, as the testing appears to be highly technical and objective (measurements against known standards/phantoms) rather than subjective expert review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is an objective measurement system for patient positioning and monitoring, not an image interpretation or diagnostic aid that would typically involve human readers. Therefore, an effect size of human readers improving with AI assistance is not applicable in this context.

6. Standalone (Algorithm Only) Performance:

The provided information focuses on the integrated system's performance, as the system consists of hardware (cameras) and software working together to deliver the stated functionalities. The performance metrics (positioning accuracy, surface displacement, SSD accuracy) inherently describe the algorithm's capability within the system context. However, it's not explicitly presented as a separate "algorithm-only" study with distinct metrics from the integrated device.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations (positioning accuracy, surface displacements) appears to be based on physical measurements using a custom-designed calibration phantom. For respiratory tracking, it's based on the system's ability to track "user selected points" and real-time 3D surface models. For the improved SSD accuracy, it's also likely a technical measurement against a known standard.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. The nature of the device (surface imaging and tracking) suggests it may rely on established physics and geometric principles rather than a large, data-driven machine learning model that requires explicit training sets in the same manner as a diagnostic imaging AI. The "software" updates mentioned (SimRT 7.2) are described as an updated version with a new user interface, not necessarily a re-trained AI model from a new dataset.

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

As no explicit training set or AI model requiring such a set is detailed, the document does not provide information on how ground truth for a training set was established.

Summary

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Vision RT Ltd. % Jade Dunphy Regulatory Affairs Manager Dove House Arcadia Avenue London, N3 2JU United Kingdom

Re: K212583

Trade/Device Name: AlignRT Plus Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: August 13, 2021 Received: August 16, 2021

Dear Jade Dunphy:

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,

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) K212583

Device Name AlignRT Plus

Indications for Use (Describe)

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

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)

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visionrt

510(k) Premarket Notification – AlignRT Plus

510(k) Summary

The information below is provided for the modifications to AlignRT following the format of 21 CFR 807.92.

Submitter:

Vision RT Ltd. Dove House Arcadia Avenue London, N3 2JU United Kingdom Contact Name: Jade Dunphy Tel: +44 (0)20 8346 4300 Fax: +44 (0)20 8346 4634

Date Summary was prepared: 17 December 2020

PREDICATE DEVICE INFORMATION:

Name of the Device:	AlignRT Plus
Premarket Notification:	K203387
Trade/Proprietary Name:	AlignRT Plus (incorporating AlignRT, GateCT, GateRT), may bebranded as OSMS (Optical Surface Monitoring System).
Manufacturer:	Vision RT Limited
Common or Usual Name:	Surface Guided Radio Therapy System (Patient Positioning System- accessory to a linear accelerator)
Device Class:	II
Classification Name:	Accessory to Medical charged-particle radiation therapy accessories,IYE, (per 21 CFR section 892.5050)
Review Panel:	Radiology

SUBJECT (MODIFIED) DEVICE:

Name of the Device:	AlignRT Plus (incorporating AlignRT, GateCT, SimRT, GateRT), maybe branded as OSMS (Optical Surface Monitoring System)
Device Manufacturer:	Vision RT Limited
Common or Usual Name:	Surface Guided Radio Therapy System (Patient Positioning Systemaccessory to a linear accelerator)
Device Class:	II
Classification Name:	Accessory to Medical charged-particle radiation therapy accessories,IYE, (per 21 CFR section 892.5050)
Review Panel:	Radiology

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510(k) Premarket Notification - AlignRT Plus

Description of Device:

The AlignRT Plus system (K203387) is a combination of the devices AlignRT, GateCT and GateRT.

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.

Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module".

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

This 510(k) is requested for a modifications to FDA 510(k) cleared product "AlignRT Plus" (K203387).

This 510(k) is to obtain clearance for the following changes to the cleared device:

一 Introduction of new software, SimRT 7.2. This is an updated version of the cleared software, GateCT, with a new user interface similar to the cleared AlignRT 6.2/6.3/6.4 software;
1. Introduction of new camera pods (hardware). These function in the same way as the currently cleared hardware but are aesthetically different and have upgraded capabilities to support future product development;
1. Improve the product's accuracy claim for Source-Surface Distancing (SSD) from <2.0mm to <0.2mm.

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visionrt

510(k) Premarket Notification – AlignRT Plus

Addition of a new medical device software application for patient and accessory identification, SafeID.

Indications for Use:

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

No changes are made to the intended use and indications for use.

Summary of the Technological Characteristics:

The Substantial Equivalence Comparison Table shown below provides a comparison of the technological characteristics of AlignRT Plus to those of the predicate device:

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	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
Device name	AlignRT Plus (K203387)Incorporating AlignRT, GateCT, GateRT	AlignRT PlusIncorporating AlignRT, GateCT, SimRT,GateRT	Addition of SimRT v7.2 software.
Manufacturer	Vision RT Ltd	Vision RT Ltd	The manufacturer has notchanged.
Indications forUse	The AlignRT Plus system is indicated for useto position and monitor patients relative to theprescribed treatment isocenter, and towithhold the beam automatically duringradiation delivery.For cranial treatments, a manual headadjuster is included which can be used inconcert with AlignRT Plus to provide finecorrections for pitch, roll and yaw rotations.AlignRT Plus is also used to track thepatient's respiratory pattern for respiratorysynchronized image acquisition, andradiation therapy treatment. Patient contourdata can be extracted and exported from thedata acquired for the purpose of treatmentplanning.AlignRT Plus can be calibrated directly to thetreatment beam isocenter and in turn assistsin performing quality assurance on MV, kVimagers, room lasers and the treatmentcouch.	The AlignRT Plus system is indicated for useto position and monitor patients relative to theprescribed treatment isocenter, and towithhold the beam automatically duringradiation delivery.For cranial treatments, a manual headadjuster is included which can be used inconcert with AlignRT Plus to provide finecorrections for pitch, roll and yaw rotations.AlignRT Plus is also used to track thepatient's respiratory pattern for respiratorysynchronized image acquisition, andradiation therapy treatment. Patient contourdata can be extracted and exported from thedata acquired for the purpose of treatmentplanning.AlignRT Plus can be calibrated directly to thetreatment beam isocenter and in turn assistsin performing quality assurance on MV, kVimagers, room lasers and the treatmentcouch.	The indications for use are thesame as those of the previouslycleared device.

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	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
Packaging	The system is packaged in a variety of boxesand then packaged within palletised crate.	The system is packaged in a variety of boxesand then packaged within palletised crate.	The packaging of the device isthe same as that of the previouslycleared device.
Environmentalrange	AlignRT Plus is intended for use at altitudesbelow 2000m (6,561ft).The operating temperature is +16°C to +30°C(60.8° to 86° Fahrenheit).The shipping and storage conditions are -20°C to +50°C (-4° to 122° Fahrenheit).	AlignRT Plus is intended for use at altitudesbelow 3000m (9,842ft).The operating temperature is +16°C to +30°C(60.8° to 86° Fahrenheit).The shipping and storage conditions are -20°C to +50°C (-4° to 122° Fahrenheit).	The device is a solid-stateproduct and is not affected byaltitude.The modified device issubstantially equivalent to itspredicate device.
WorkstationOperatingSystem	Windows 10	Windows 10	No change to operating system.
Number ofcameras	1-3Optional InBore camera	1-3Optional InBore camera	The number of cameras used arethe same as those of thepreviously cleared device.
Powerrequirements	110-230V 50/60Hz	110-230V 50/60Hz	The power requirements of thedevice are the same as those of thepreviously cleared device.
Networkrequirements	10BaseT internet connection behind a localfirewall.	10BaseT internet connection behind a localfirewall.	The network requirements of thedevice are the same as those of thepreviously cleared device.
Serviceprovision	All service to be performed by swap-out andreturn-to-base by Vision RT engineers.Remote support provided by Vision RTengineers through secure remote internetsoftware.	All service to be performed by swap-out andreturn-to-base by Vision RT engineers.Remote support provided by Vision RTengineers through secure remote internetsoftware.	The service approach of thedevice is the same as that of thepreviously cleared device.

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510(k) Premarket Notification - AlignRT Plus

Conclusion

The proposed changes are made by the legal manufacturer and submitted by the legal manufacturer authorized to market he existing device (AlignRT Plus). The changes made in subject device were test method and acceptance criteria as the predicate device and the subject device is substantially equivalent to the prodication and/or validation demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. The conces intended use, indications for use, fundamental technological characteristics, principle of operation and performance specifications.

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.

	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	AlignRT Plus may be used during simulation,setup and stereotactic radiosurgery andprecision radiotherapy for lesions, tumorsand conditions anywhere in the body whereradiation is indicated.	AlignRT Plus may be used during simulation,setup and stereotactic radiosurgery andprecision radiotherapy for lesions, tumorsand conditions anywhere in the body whereradiation is indicated.
Principles ofoperation	Video based imaging of 3D skin surface datausing surface matching software.	Video based imaging of 3D skin surface datausing surface matching software.	The principles of operation arethe same as those of thepreviously cleared device.
TargetPopulation	Any individual (adult or child) undergoingradiotherapy.	Any individual (adult or child) undergoingradiotherapy.	The target population is the sameas that of the previously cleareddevice.
Materials	PC workstation, cables, video cameras.Block Polystyrene (calibration phantom),carbon fibre laminate material (headadjuster).	PC workstation, cables, video cameras.Block Polystyrene (calibration phantom),carbon fibre laminate material (headadjuster).	Although the Horizon camera ismanufactured to a differentdesign specification, the materialsused are the same as those ofthe previously cleared device.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
SystemPerformanceand Accuracy	Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm (0.5mm) for all couchangles.	Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm (0.5mm) for all couchangles.	The system performance andaccuracy have not changed sinceprevious clearances.
	Respiratory tracking: Tracks respiratorysignal from imaged surface data and sendsto CT (4D CT) or to Linac or imaging device(gating).	Respiratory tracking: Tracks respiratorysignal from imaged surface data and sendsto CT (4D CT) or to Linac or imaging device(gating).
	Surface displacements can be tracked withRMS errors < 0.5mm over 10 or morebreathing cycles.	Surface displacements can be tracked withRMS errors < 0.5mm over 10 or morebreathing cycles.
Biocompatibility	The AlignRT Plus product requires no directcontact with the patient.	The AlignRT Plus product requires no directcontact with the patient.	Although the Horizon camera ismanufactured to a differentdesign specification, the materials
	The only interactions between the user andthe system are with:	The only interactions between the user andthe system are with:	used are the same as those ofthe previously cleared device.
	the PC (in the control room) orremote workstation (in the vault), the Remote Control (in the vault), the Real Time Coach (RTC) (in thevault), or the Head Adjuster (in the vault). Calibration plate (in the vault) Calibration cube (in the vault) Calibration levelling plate (in thevault)	the PC (in the control room) orremote workstation (in the vault), the Remote Control (in the vault), the Real Time Coach (RTC) (in thevault), or the Head Adjuster (in the vault). Calibration plate (in the vault) Calibration cube (in the vault) Calibration levelling plate (in thevault)
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	The materials of the devices (which arecommonly used in light-industrial, commercialand home use) and that the application onlyinvolves intermittent external contact withintact skin.	The materials of the devices (which arecommonly used in light-industrial, commercialand home use) and that the application onlyinvolves intermittent external contact withintact skin.
MechanicalSafety	Cameras are ceiling mounted and do notcontact patient or user.	Cameras are ceiling mounted and do notcontact patient or user.	The mechanical safety of thedevice is the same as that of the
	The InBore camera solution is fixed to theinside of the bore-based linac.	The InBore camera solution is fixed to theinside of the bore-based linac.	previously cleared device.
	Head adjuster is clamped to the treatmentcouch through universal base plate.	Head adjuster is clamped to the treatmentcouch through universal base plate.
Anatomicaltreatment sites	Entire body surface.	Entire body surface.	The anatomical treatment sites ofthe device are the same as thoseof the previously cleared device.
Human factors	Imaging process is fully automatic as isestimation of new couch position; 3D visualdisplay provided to show any discrepancy inpatient position.For respiratory tracking, user selects regionof interest or tracking point(s) during firstsession. These are detected automaticallyduring subsequent sessions.For cranial treatments, a manual head	Imaging process is fully automatic as isestimation of new couch position; 3D visualdisplay provided to show any discrepancy inpatient position.For respiratory tracking, user selects regionof interest or tracking point(s) during firstsession. These are detected automaticallyduring subsequent sessions.For cranial treatments, a manual head	The human factors are the sameas that of the previously cleareddevice.
	adjuster may be used by turning designateddials to provide fine corrections for pitch, yawand roll rotations in concert with real timevisual feedback provided to the user byAlignRT Plus.	adjuster may be used by turning designateddials to provide fine corrections for pitch, yawand roll rotations in concert with real timevisual feedback provided to the user byAlignRT Plus.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	There is an extra non-clinical workflow for theInBore camera. A customer must remove thecamera in order to service the bore-basedlinear accelerator.	There is an extra non-clinical workflow for theInBore camera. A customer must remove thecamera in order to service the bore-basedlinear accelerator.
Optical pattern	Optical (near infra-red) pattern is projected topatient.	Optical (near infra-red) pattern is projected topatient.	The optical pattern of the deviceis the same as that of thepreviously cleared device.
Compatibilitywith theenvironment andother devices	For use in hospital and clinic environments.	For use in hospital and clinic environments.	The compatibility with theenvironment is the same as thatof the previously cleared device.
GeneralElectrical safetystandards	IEC 60601-1 compliant.	IEC 60601-1 compliant.	The modified device has beentested and continues to comply toIEC 60601-1.
EMC standards	IEC 60601-1-2 compliant.	IEC 60601-1-2 compliant.	The modified device has beentested and continues to comply toIEC 60601-1-2: 2014 (4th Ed.).
Size	The camera (key part of the system) has thefollowing dimensions:Cameras (each) – 470 x 220 x 70 – 4.5kgInBore optional camera accessory - Ring499mm diameter (plus 1mm protrusions) x177mm wide (max) – 3.2kg	The camera (key part of the system) has thefollowing dimensions:HD Cameras (each) – 470 x 220 x 70 – 4.5kgHorizon cameras (each) – 480 x 140 x 127 –2.75kgInBore optional camera accessory - Ring499mm diameter (plus 1mm protrusions) x177mm wide (max) - 3.2kg	The new Horizon camera isslightly different in size, but lighterin weight to that of the previouslycleared cameras.