iViewDose is a standalone software tool, available as an optional accessory of the linear accelerator. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery, or impact the clinical workflow.

The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal Imaging Device at the time of treatment) and subsequently processes it. The processed data is compared with data calculated by the treatment planning system. The comparison is derived from the application of dose conversion and reconstruction algorithms to the EPID data, which is back-projected to a plane normal to a beam (2D) or multiple planes (3D) inside the patient (in vivo) or phantom (pretreatment).

iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient.

iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed.

iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.

Device Description

This Traditional 510(k) describes a new standalone software to be used with the Elekta range of medical linear accelerators, to further enhance the existing functionality.

The iViewDose program uses iViewGT™ images to reconstruct the dose in 3D in the volume (patient or phantom). The program then uses a gamma analysis to compare the reconstructed dose with the TPS dose in 3D. iViewDose uses a dose reconstruction algorithm to calculate the dose in the patient from the dose delivered to the MV detector panel. The algorithm corrects for scattered radiation from the patient and the MV detector panel. You can use iViewDose in vivo to make an estimate of the delivered dose to a patient. You can also use iViewDose for pre-treatment checks to make an estimate of the delivered dose to a phantom.

AI/ML Overview

The provided text is a 510(k) summary for the Elekta iViewDose R1.0 device. While it describes the device's functionality and its comparison to predicate devices, it does not contain a detailed study report with specific acceptance criteria or an analysis of its performance against those criteria in a formal study.

The document states: "Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specification have been met and safety & effectiveness have been achieved." However, it does not provide the specifics of these tests.

It also mentions: "Although no clinical testing has been performed as part of the development, it can be shown that the algorithm at the core of the iViewDose product has been used extensively for a number of years. The data reviewed as part of this evaluation has been obtained from clinical sites. The data is presented in section 11 of this submission." This indicates that while there's no new clinical study specifically for this device, existing clinical data related to the underlying algorithm was reviewed. The specifics of "section 11 of this submission" are not included in the provided text.

Therefore, I cannot provide the requested information in a table format with specific metrics because the detailed acceptance criteria and performance study results are not present in the given document.

Here's what I can extract from the text regarding the nature of the evaluation, even without specific numbers:

Device Overview:

Device Name: iViewDose R1.0
Intended Use: A standalone software tool to assist in reducing clinical risk in radiotherapy treatments by detecting gross errors during delivery. It acquires data from the iViewGT Electronic Portal Imaging Device (EPID), processes it, and compares it with data calculated by the treatment planning system. It provides an independent means of checking delivered dose (in vivo or pre-treatment) and offers an added level of treatment assurance.
Functionality: Reconstructs 2D or 3D dose from EPID images, uses gamma analysis to compare reconstructed dose with TPS dose, generates reports, shows % difference, volume analysis, total dose assessment, dose profiles, and EPID images. It's compatible initially with Monaco and Pinnacle TPS and Elekta linear accelerators.

Evaluation Information (based on general statements, not specific study data):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "conformance to applicable technical design specification have been met and safety & effectiveness have been achieved."
- Reported Device Performance: Not numerically reported in the provided text. The document states "This testing has shown that iViewDose is safe in use... Also, the use of iViewDose has been shown to have equivalent clinical efficacy when compared to the predicate devices..."
Sample sized used for the test set and the data provenance: Not specified in the provided text. It mentions "data reviewed as part of this evaluation has been obtained from clinical sites," but details about the size or nature (retrospective/prospective, country of origin) of this data are absent.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. However, it indicates "Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel."
Adjudication method for the test set: Not specified in the provided text.
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 mentioned as performed. The device is described as a "standalone software tool" for checking dose, not primarily as an AI assistant for human reading.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device is explicitly described as a "standalone software tool" and its function is to objectively compare reconstructed dose with planned dose. The performance claims ("conformance to applicable technical design specification have been met") likely refer to this standalone performance.
The type of ground truth used:
- The primary comparison is between the dose calculated by the device (reconstructed from EPID data) and the data calculated by the treatment planning system (TPS dose).
- The TPS dose serves as the reference or "ground truth" for the comparison within the iViewDose system's operation.
The sample size for the training set: Not specified in the provided text. The document refers to the algorithm having "been used extensively for a number of years" and data being "obtained from clinical sites," but does not provide details on training set size.
How the ground truth for the training set was established: Not specified in the provided text. Given the device's function, it's likely that the "training" (or calibration/validation) of the dose reconstruction algorithm would involve comparisons to established dosimetry measurements (e.g., ionization chambers, film, TPS calculations on phantoms), but this is not detailed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

December 11, 2015

Elekta Limited % Mr. Maurice Paine Quality & Regulatory Affairs Engineer Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM

Re: K153011

Trade/Device Name: iVIEWDose R1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 9, 2015 Received: October 14, 2015

Dear Mr. Paine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

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

Sincerely yours.

Michael D'Hara

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K153011

Device Name

iViewDose R1.0

Indications for Use (Describe)

iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient.

iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed.

iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.

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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Image /page/3/Picture/0 description: The image shows the Elekta company logo. The logo consists of a circle with a gap in the upper right quadrant. There are five dots of decreasing size along the gap in the circle. To the right of the circle is the company name, ELEKTA, in all caps.

510(k) SUMMARY

Date of preparation of summary: Submitted by:

October 09, 2015 Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Telephone: +44 (0) 1293 654284 Fax: +44 (0) 1293 658445

Establishment Registration No.: Contact Name: Trade Name: Common Name: Classification Name:

Product Code: Predicate Devices: 9617016 Mr. Maurice Paine iViewDose R1.0 EPID Dosimetry Medical charged-particle radiation therapy system, 21 CFR 892.5050 IYE DOSIsoft SA, EPIgray (K112723) Math Resolutions LLC, Dosimetry Check Version 4 Release 1 (K132605) Math Resolutions LLC, Dosimetry Check with Exit Dose (K101503)

Product Description:

This Traditional 510(k) describes a new standalone software to be used with the Elekta range of medical linear accelerators, to further enhance the existing functionality.

Indications for Use and Intended Use statement:

The Intended Use for the iViewDose product is as follows:

The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal Imaging

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Device at the time of treatment (or prior to treatment) and subsequently processes it. The processed data is compared with data calculated by the treatment planning system. The comparison is derived from the application of dose conversion and reconstruction algorithms to the EPID data, which is back-projected to a plane normal to a beam (2D) or multiple planes (3D) inside the patient (in vivo) or phantom (pre-treatment).

iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient.

iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed.

iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.

This software does not alter the existing Indications for Use of the Elekta series of medical linear accelerators, and therefore the existing indications for use statement remains valid:

The Elekta medical linear accelerator system is indicated to be used for image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Summary of Technological Characteristics:

The software utilises MV images taken through the iViewGT™ hardware platform, and calculates the dose delivered at a user specified reference plane in 2D, or multiple planes in 3D. The calculated dose is then compared to the planned treatment dose and provides the clinical user with an indication of whether the dose delivered is in accordance with the planning dose. The software uses a back projection algorithm to product the calculated dose.

There has been no change made to the underlying technological characteristics of the linear accelerator device.

The iViewDose accessory consists of software only, and encompasses several third party software components. These third party components have been treated as SOUP in accordance with IEC62304.

The iViewDose product is subject to compliance testing as defined in internationally recognised safety standards. Details of the standards employed in the design are specified in the Standard Data Report in section 9, whilst the verification activities are captured in section 16-11 of this submission.

Substantial Equivalence:

The release of iViewDose R1.0 provides the ability to use EPID images acquired from the iViewGT imaging system mounted to a linear accelerator to reconstruct the dose delivered to the patient or phantom. The software compares the reconstructed dose with the planned dose (from a compatible treatment planning system).

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Image /page/5/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circle with a break in the upper right quadrant, and a series of dots that decrease in size along the break in the circle. To the right of the circle is the word "ELEKTA" in a sans-serif font.

The following products are identified as Predicate Devices

0 Dosimetry Check with exit Dose from Math Resolutions, LLC (K101503)
0 Dosimetry Check Version 4 Release 1 from Math Resolutions, LLC (K132605)
o EPIgray from DOSIsoft SA, (K112723)

Math Resolutions, LLC creates software for use in the radiological sciences. Dosimetry Check has been on the market since 2001.

DOSIsoft was founded in 2002, from a partnership between Gustave Roussy and Institut Curie – two major cancer treatment centres in Europe. EPIgray was launched in 2011 for EPID-based in vivo dosimetry.

The differences in technological characteristics between iViewDose and the predicate devices do not raise questions of safety and effectiveness.

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Functionality	iViewDoseR1.0	EPIgray(DOSIsoft SA)	DosimetryCheckVersion 4Release 1(MathResolutions,LLC)	DosimetryCheck withExit Dose(MathResolutions,LLC)
Control Number	K - - - - - - - - -	K112723	K132605	K101503
Independent software	Yes	Yes	Yes	Yes
Option for use with ElektaRadiation Therapy Systems	Yes	Yes	Yes	Yes
Pre-treatment images	Yes	Yes	Yes	Yes
Treatment images	Yes	Yes	Yes	Yes
Algorithm for calculatingreconstructed dose	Yes	Yes	Yes	Yes
Compares reconstructeddose to planning systemdose	Yes	Yes	Yes	Yes
Generates a report for thereviewer to export to file	Yes	Yes	Yes	Yes
Results include a %difference at the dosereference point	Yes	Yes	Yes	Yes
Volume Analysis perFraction	Yes	Yes	Yes	Yes
Volume Analysis per Beam	Yes	Yes	Yes	Yes
Total Dose assessment perfraction	Yes	Yes	Yes	Yes
Total Dose assessment pertreatment	Yes	Yes	Yes	Yes
Ability to view a Dose profile	Yes	Yes	Yes	Yes
Ability to view EPID images	Yes	Yes	Yes	Unknown
Ability to view analysis inmultiple anatomical planes	Yes	Yes	Yes	Yes
Analysis points can be singleor multiple (2D or 3D)	Yes	Yes	Yes	Yes
Filters by date, by fractionand by field	Yes	Yes	Yes	Yes
User defined Alert Criteriafor out of tolerance analysis	Yes	Yes	Yes	Yes
Import Approved Plan datafrom Treatment PlanningSystem	Yes	Yes	Yes	Yes
Import portal imagesacquired during treatment	Yes	Yes	Yes	Yes
Import portal imagesacquired during pre-treatment	Yes	Yes	Yes	Yes
Analysis performedautomatically offline	Yes	Yes	Yes	Yes
Results statistics available inthe report	Yes	Yes	Yes	Yes
Results presented as aGamma Analysis	Yes	Yes	Yes	Yes
Report may be stored withinPatient Record in MOSAIQ	Yes	Requiresconverting topdf	Requiresconverting topdf	Yes
Multiple TreatmentPlanning Systems
(initially iViewDose is onlyvalidated as beingcompatible with Monacoand Pinnacle)	Yes	Yes	Yes	Yes
MOSAIQ Record & VerifySystem	Yes	Yes	Yes	Yes
Multiple Treatmenttechniques(IMRT and VMAT)	Yes	Yes	Yes	Yes
Multiple EPID's	No	Yes	Yes	Yes
MV Panel Calibrationrequired for commissioning	Yes	Yes	Yes	Yes
Pre-treatment Check	Yes	Yes	Yes	Yes

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Image /page/7/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circle with a gap in the upper right quadrant, and a series of dots of decreasing size leading up to the gap. To the right of the circle is the word "ELEKTA" in a sans-serif font.

Elekta Limited, Linac House, Fleming Way, Crawley, West Sussex RH10 9RR UK Tel:+44 (0)1293 544422 Fax:+44 (0)1293 654321 www.elekta.com Registered in England No. 3244454

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Summary of Non-Clinical Performance Testing:

Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new features against the requirement specification.

Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specification have been met and safety & effectiveness have been achieved.

This testing has shown that iViewDose is safe in use, as it does not provide any direct clinical functionality. Also, the use of iViewDose has been shown to have equivalent clinical efficacy when compared to the predicate devices for which this submission is claiming.

The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in the Standard Data Report in section 9 which includes but not limited to IEC 62304, IEC 62366, ISO 14971, and IEC61217.

Although no clinical testing has been performed as part of the development, it can be shown that the algorithm at the core of the iViewDose product has been used extensively for a number of years. The data reviewed as part of this evaluation has been obtained from clinical sites. The data is presented in section 11 of this submission.

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.