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 (K193431) is a combination of the devices AlignRT, GateCT and GateRT. A special 510(K) K193431 was submitted by Vision RT Ltd. in December 2019 and this was cleared by FDA in January 2020 for the changes and improvements made in AlignRT.

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 matching 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 new optional InBore camera and a change in memory size for an existing FDA 510(k) cleared product "AlignRT Plus" (K193431).

The InBore camera is optional hardware for use with bore-based linear accelerators.

The increase in memory size from 32 to 64bit increases the system's processing speed, enabling a frame rate improvement.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the AlignRT Plus device K203387, which describes modifications to an existing cleared device K193431. The document does not contain a detailed study that proves the device meets specific acceptance criteria with supporting data, an approach often seen for substantial equivalence claims where modifications are minor and performance remains unchanged from a previously cleared predicate. Instead, it relies on demonstrating that the modified device's performance and characteristics are the same as its predicate device.

Therefore, the following information is based on what is stated and what can be inferred from the provided text, primarily focusing on the comparison to the predicate device.

Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" for this submission are fundamentally defined by the performance of the predicate device (K193431). The "Reported Device Performance" for the modified device (K203387) is stated to be unchanged from that of the predicate.

Acceptance Criteria (Based on Predicate Device Performance)	Reported Device Performance (Modified Device K203387)
Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.	Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles. (Stated as "not changed")
Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating). Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles.	Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating). Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles. (Stated as "not changed")

Study Details (Based on provided text)

Since the document asserts that the system performance and accuracy have not changed since previous clearances, a new comprehensive performance study against acceptance criteria is not explicitly provided. The submission focuses on demonstrating substantial equivalence through a comparison of the modified device to its predicate, stating that 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 predication and/or validation demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device."

Sample size used for the test set and the data provenance: Not explicitly detailed in this document. The document states that "The system performance and accuracy have not changed since previous clearances, including with the additional optional hardware (InBore camera)." This implies that the performance characteristics were established in previous submissions (e.g., K193431) and are considered to apply to the current modified device. No new test set or data provenance is detailed for K203387 for these performance metrics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly detailed. The ground truth for the performance metrics (positioning accuracy, respiratory tracking RMS errors) would likely have been established using physical phantoms and measurement references rather than human expert consensus for the quantitative metrics stated.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring human adjudication for diagnostic outcomes is described for this submission. The performance metrics are technical measurements against a known reference.
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: Not applicable. This device is a surface-guided radiation therapy system that primarily assists in patient positioning and monitoring, not in diagnostic interpretation by human readers. It does not involve AI in the context of improving human reader diagnostic performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "System Performance and Accuracy" section indirectly refers to standalone performance:
- "Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles." This is a measurement of the system's inherent accuracy using a physical phantom, which is a standalone assessment.
- "Respiratory tracking: Tracks respiratory signal from imaged surface data... Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles." This also describes the device's intrinsic capability to track surface displacements, tested against a measurable reference.
  The document states these performances "have not changed since previous clearances."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance characteristics mentioned, the ground truth is based on physical reference measurements using a calibration phantom. For instance, "Target registration errors (as measured using calibration phantom)" is directly specified.
The sample size for the training set: Not applicable based on the information provided. This device is a surface imaging and tracking system where performance is validated through precision measurements, not a machine learning model that requires a "training set" in the conventional sense for image classification or prediction tasks. The software changes mentioned are minor and related to functionality improvements (e.g., frame rate due to memory increase, new camera for bore-based linacs, user interface features), not a re-training of a core algorithmic performance.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for machine learning.

Summary

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March 4, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Vision RT Ltd % Jade Dunphy Regulatory Affairs Manager Dove House, Arcadia Avenue London, N3 2JU UNITED KINGDOM

Re: K203387

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: December 28, 2020 Received: December 28, 2020

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203387

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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visienrt

510(k) Premarket Notification – AlignRT v.6.4

510(k) Summary

K203387

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:	K193431
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
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 v.6.4

Description of Device:

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 new optional InBore camera and a change in memory size for an existing FDA 510(k) cleared product "AlignRT Plus" (K193431).

The InBore camera is optional hardware for use with bore-based linear accelerators.

The increase in memory size from 32 to 64bit increases the system's processing speed, enabling a frame rate improvement.

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510(k) Premarket Notification – AlignRT v.6.4

In line with the FDA's guidance on full disclosure, there are also minor software changes which we have evaluated as not meeting the threshold for clearance under the 510(k) programme, but which are nonetheless described in this application:

Thermal check .
ROI Metrics feature ●
Hitachi, IBA and C-Series interfaces
OPASCA lighting control system ●
Protocol Navigator ●
Treatment report improvement
Surface Deformation
QA Workflows ●

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 provides a comparison of the technological characteristics of AlignRT Plus to those of the predicate device:

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visionrt

510(k) Premarket Notification - AlignRT v.6.4

	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
Number ofcameras	1-3	1-3Optional InBore camera	An additional camera has beenincluded in this submission, whichis exclusively for bore-based linacaccelerators, which uses thesame technology as the other 1-3cameras.
Powerrequirements	110-230V 50/60Hz	110-230V 50/60Hz	The power requirements of thedevice are the same as those ofthe previously 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 ofthe previously 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.

Conclusion

The proposed changes are made by the legal manufacturer and submitted to market the 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 predication and/or validation demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. The condusion is devices intended use, indications for use, fundamental technological characteristiss, 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
Device name	AlignRT Plus (K193431)Incorporating AlignRT, GateCT, GateRT	AlignRT PlusIncorporating AlignRT, GateCT, GateRT	The device name is the same.The AlignRT software applicationhas been up issued from v.6.2 tov.6.4.
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.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	AlignRT Plus may be used during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.	AlignRT Plus may be used during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Principles of operation	Video based imaging of 3D skin surface data using surface matching software.	Video based imaging of 3D skin surface data using surface matching software.	The principles of operation are the same as those of the previously cleared device.
Target Population	Any individual (adult or child) undergoing radiotherapy.	Any individual (adult or child) undergoing radiotherapy.	The target population is the same as that of the previously cleared device.
Materials	PC workstation, cables, video cameras.Block Polystyrene (calibration phantom), carbon fibre laminate material (head adjuster).	PC workstation, cables, video cameras.Block Polystyrene (calibration phantom), carbon fibre laminate material (head adjuster).	The materials used are the same as those of the previously cleared device.
System Performance and Accuracy	Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating).Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles.	Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating).Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles.	The system performance and accuracy have not changed since previous clearances, including with the additional optional hardware (InBore camera).
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
Biocompatibility	The AlignRT Plus product requires no directcontact with the patient.The only interactions between the user andthe system are with:the PC (in the control room) or remote workstation (in the vault), the Remote Control (in the vault), the Real Time Coach (RTC) (in the vault), or the Head Adjuster (in the vault). Calibration plate (in the vault) Calibration cube (in the vault) Calibration levelling plate (in the vault)	The AlignRT Plus product requires no directcontact with the patient.The only interactions between the user andthe system are with:the PC (in the control room) or remote workstation (in the vault), the Remote Control (in the vault), the Real Time Coach (RTC) (in the vault), or the Head Adjuster (in the vault). Calibration plate (in the vault) Calibration cube (in the vault) Calibration levelling plate (in the vault)	The materials used tomanufacture the device are thesame as those of the previouslycleared device.
	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.Head adjuster is clamped to the treatmentcouch through universal base plate.	Cameras are ceiling mounted and do notcontact patient or user.The InBore camera solution is fixed to theinside of the bore-based linac.Head adjuster is clamped to the treatmentcouch through universal base plate.	The location of the InBore camerais inside of the bore-based linac;as with the ceiling-mountedcameras the mechanical safetyhas been verified through riskmanagement processes to ISO14971:2019.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
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	lmaging 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 headadjuster 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.	There is an extra non-clinical workflow for theInBore camera. A customer must remove thecamera in order to service the bore-basedlinear accelerator.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 headadjuster 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.	The modified device continues tomeet FDA guidance on "ApplyingHuman Factors and UsabilityEngineering to Medical Devices"and IEC 62366-1: 2015 MedicalDevices-Part 1: Application ofUsability Engineering to MedicalDevices.
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.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
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 – 4.5kg	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 thesystem) has not changed in size.The InBore camera is new to thisapplication.
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.