Clarity® is indicated for use in external beam radiation therapy. It provides 3D ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (Image Guided Radiation Therapy).

When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (Intrafractional Position Tracking and Monitoring).

When configured with a gating option, Clarity® may also interface with radiation delivery systems equipped with a compatible external gating control device. With this option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the tracked anatomy returns to a position within those limits (Exception gating has been shown to be compatible with radiation delivery systems equipped with Elekta's Response™ Gating Control System.

Device Description

The Clarity® system integrates medical diagnostic ultrasound, real-time optical position tracking and proprietary software to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. Clarity® offers a non-invasive, non-ionizing means for accurate and precise localization of anatomical structures and patient positioning relative to the treatment isocenter.

The Clarity® system (Model 310C00) is configured around a mobile image acquisition station with an integrated ultrasound scanner, high-resolution touch screen, and high-performance computer system running the Clarity® software. It may be used at the patient's side in the CT-Sim room (Clarity® Sim) and the treatment room (Clarity® Guide) when equipped with a ceiling-mounted optical tracking system, patient/couch position tracking tools and, optionally, remote control and treatment monitoring equipment. With the gating option, the Clarity® Guide acquisition station may interface with radiation delivery systems equipped with a compatible external gating control device.

Each acquisition station is configured with up to three optically-tracked ultrasound probes: one or two hand-held probes for manual scanning and a motorized (autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the target anatomy and the patient's clinical presentation. The autoscan probe remains in contact with the patient for continuous imaging of the prostate and surrounding anatomy using specifically designed positioning apparatus for transperineal ultrasound (TPUS); it is operated from the acquisition station's remote control and monitoring equipment interface (touch-screen identical to that on the mobile acquisition station).

A multimodality imaging phantom is used to calibrate Clarity® to the room coordinate system and to verify system integrity for sub-millimeter target localization accuracy and precision within each room (daily and monthly QC).

A dedicated high-performance server and workstation computer system running the Clarity® software is connected to Clarity® acquisition stations through the hospital's local area network. The server houses the central database and web server, and provides for interoperability with other imaging and treatment planning/simulation systems via the DICOM 3/RT protocol. The workstation is used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, setup of monitoring parameters, and review of treatment and QC data. Optionally, additional Clarity® workstations may be connected to the central Clarity® server.

The Clarity® software is designed to step the user through a radiation therapy workflow or "course" and QC procedures. Different courses are defined to help classify patients in the database and to present the user with reminders, default choices and configuration settings tailored to the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck). Such configurations include probe type, imaging (scan) presets, contouring and assisted segmentation tools, alert values for target misalignment, and prostate monitoring (tracking) parameters.

The typical use of the system for a radiation therapy course begins with the acquisition of a baseline 3D ultrasound (3DUS) scan with the patient in the planning position. The planning CT is imported, registered and fused with the 3DUS on the Clarity® workstation to verify the alignment of the target anatomy. The structures of interest are then defined and a baseline positioning reference including, if applicable, monitoring (prostate tracking) parameters are approved. Optionally, the 3DUS and related contours may be exported via DICOM to a third-party virtual simulator or treatment planning system.

To assist with patient positioning prior to each treatment session, a new 3DUS scan is acquired and used to determine target displacement relative to the baseline planning-day position. Optical tracking of couch position allows for accurate and precise patient repositioning relative to the treatment isocenter (Image Guided Radiation Therapy).

Automatic image analysis identifies a soft-tissue structure such as the prostate in successive transperineal 3DUS images, which are acquired continuously during treatment, and allows Clarity® to track its motion and assist with patient repositioning (Intrafractional Position Tracking and Monitoring). When configured with the gating option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked structure position has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the structure returns to a position within those limits (Exception Gating).

Clarity® may optionally be configured to send calculated couch shifts for patient repositioning to the operator at the couch control user interface using the MOSAIQ® Workflow Manager.

A web-based interface is available for remote review and approval of positioning references and other treatment parameters, and review of completed treatment session and QC procedure data.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative format. Instead, it generally states that the device fulfills its design and risk management requirements and localization accuracy and precision specifications were verified.

However, based on the narrative, we can infer some implied performance expectations:

Acceptance Criteria (Implied)	Reported Device Performance
Localization accuracy and precision (sub-millimeter)	"Localization accuracy and precision specifications were verified with multimodality phantoms." and "A multimodality imaging phantom is used to calibrate Clarity® to the room coordinate system and to verify system integrity for sub-millimeter target localization accuracy and precision within each room (daily and monthly QC)."
Safe and effective performance of critical tasks	"The test results from verification and validation activities demonstrate that Clarity® fulfills its design and risk management requirements, and is as safe and effective for its intended use as the predicate device." "Formative evaluations and simulated use of the modified device with representative end-users were conducted in accordance with FDA guidance on human factors and usability engineering to assure the safe and effective performance of critical tasks."
Compatibility with Elekta's Response™ Gating Control System	"Exception gating was validated with Elekta's Response™ Gating Control System under simulated treatment conditions."
Compliance with regulatory guidance and safety standards	"Clarity® has been developed and tested in compliance with regulatory guidance and recognized consensus safety standards."
Fulfillment of design and risk management requirements	"The test results from verification and validation activities demonstrate that Clarity® fulfills its design and risk management requirements..."
Functionality as specified for intended use (e.g., Image Guided RT, Intrafractional Tracking, Exception Gating)	The documentation describes the functionality and states it is "substantially equivalent" to the predicate, implying it meets the predicate's performance for these functions. Specific improvements are noted (e.g., "Improved user interface and tracking indicators" for intrafractional prostate motion management).

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

The document does not explicitly state the sample size for a "test set" in terms of patient data. The testing primarily focuses on device verification and validation using phantoms and simulated conditions.

Sample Size: Not explicitly stated for patient data. The document mentions "multimodality phantoms" for accuracy and precision verification and "simulated treatment conditions" for exception gating validation. It also mentions "representative end-users" for human factors evaluations.
Data Provenance: Not applicable in the context of patient data for performance claims, as the testing described is primarily focused on phantom studies and simulated use, not clinical performance studies with patient data.

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

This information is not provided. The ground truth for the device's accuracy and precision was established using "multimodality phantoms" and validated against their known properties. For usability, "representative end-users" were involved, but their qualifications are not detailed beyond "end-users."

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described testing (phantom studies, simulated conditions), a formal adjudication method for a test set of clinical cases is unlikely to have been employed or documented here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned. The device, Clarity®, is presented as an image-guidance system, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone performance was assessed for the core functions of the device.

Localization Accuracy and Precision: Verified using "multimodality phantoms." This implies testing the device's ability to localize targets against a known physical ground truth independent of human interpretation during the measurement phase.
Exception Gating: "Validated with Elekta's Response™ Gating Control System under simulated treatment conditions." This suggests the algorithm's ability to trigger beam-holds based on defined limits was tested in an automated, standalone manner.

7. The Type of Ground Truth Used

Localization Accuracy and Precision: Ground truth was established using multimodality phantoms with known, precise physical properties.
Exception Gating: Ground truth was established through simulated treatment conditions which would have defined parameters for when a beam-hold should be triggered.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of a machine learning or AI model that requires training data. Clarity® appears to be an image guidance system based on established ultrasound and optical tracking technologies, not a system that relies on a large dataset for machine learning training.

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

Not applicable as no "training set" is mentioned or implied for a machine learning component. The system's functionality is based on physics, engineering, and software development, with calibration and verification against known physical standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

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

October 8, 2014

Elekta Ltd. % Mr. George Papagiannis Regulatory Affairs 2050 de Bleury, Suite 200 Montreal, Quebec, H3A 2J5 CANADA

Re: K141855

Trade/Device Name: Clarity® Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, IWB, KPQ Dated: July 10, 2014 Received: July 11, 2014

Dear Mr. Papagiannis:

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. Iisting 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.

{1}------------------------------------------------

Page 2—Ms. Yusko

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/ResourcesforYou/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/Safetw/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. O'Hara

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K141855

Device Name

Clarity®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "ELEKTA" in a bold, sans-serif font. To the left of the word is a circle with a dashed line going through it. The dashed line consists of five dots, starting from the upper left of the circle and going down to the center.

510(k) Summary

October 07, 2014

Trade/Device Name:	Clarity®
Common Name (GMDN):	Patient positioning system, ultrasound
Regulation/Classification:	Medical charged-particle radiation therapy system(21 CFR 892.5050, Product Code IYE)Radionuclide radiation therapy system(21 CFR 892.5750, Product Code IWB)Radiation therapy simulation system(21 CFR 892.5840, Product Code KPQ)
Regulatory Class:	Class II
Review Panel:	Radiology
Submitter/Manufacturer:	Elekta Ltd.
Establishment Registration No:	3004747535
Address:	2050 Bleury, Suite 200Montreal, Quebec H3A 2J5, CanadaTel: (+1) 514-840-9600 Fax: (+1) 514-840-9666
Contact:	Tony Falco, PhD

Introduction

This 510(k) Summary has been prepared in accordance with 21 CFR 807.92. It summarizes device safety and effectiveness information to provide an understanding of the basis for a determination of substantial equivalence.

Predicate Device Information

Clarity® (K121663, Dec 05, 2012; Product Codes: IYE, IWB, KPQ)

Intended Use / Indications for Use

When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the motion of the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (Intrafractional Position Tracking and Monitoring).

When configured with a gating option, Clarity® may also interface with radiation delivery systems equipped with a compatible external gating control device. With this option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beamhold when the position of the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the tracked anatomy returns to a position within those limits (Exception Gating). Exception gating has been shown to be compatible with radiation delivery systems equipped with Elekta's Response™ Gating Control System.

{4}------------------------------------------------

Device Description

{5}------------------------------------------------

Clarity® may optionally be configured to send calculated couch shifts for patient repositioning to the operator at the couch control user interface using the MOSAIQ® Workflow Manager.

A web-based interface is available for remote review and approval of positioning references and other treatment parameters, and review of completed treatment session and QC procedure data.

Comparison with Predicate Device

The current release of Clarity®, which includes usability improvements and expanded indications for exception gating, is substantially equivalent to the predicate device. The differences in labeling and technological characteristics do not raise new questions of safety and effectiveness for the intended use. A side-by-side comparison of key device characteristics is presented in the following tables:

Device Characteristic	Predicate Device (K121663)	Current Device
Equipment
Medical imaging modality(acquisition station)	Mobile console with integrateddiagnostic ultrasound scanner;Broadband curved (convex), linear,and autoscan probes	No Significant Change(Upgraded computer systemspecifications and improvedmobile console aesthetics)
Optical tracking system	Passive infrared position sensorpowered from acquisition station	No Significant Change(Independent power supply)
Patient/couch localization	Rigid tools fitted with infrared lightreflecting markers	No Significant Change
System calibration andQuality Control	Proprietary multimodality phantom	No Significant Change
Remote control interface	Touch-screen duplicating mainconsole via KVM device for imageacquisition with autoscan probe	No Significant Change(Upgraded KVM devicespecifications for gating option)
Basic safety and essentialperformance standards	IEC 60601-1:2005IEC 60601-2-37:2007 (Ultrasound)IEC 60601-1-2:2007 (EMC)IEC 60601-1-6:2010 (Usability)	AAMI/ANSI ES60601-1:2012IEC 60601-2-37:2007IEC 60601-1-2:2007IEC 60601-1-6:2010

{6}------------------------------------------------

Device Characteristic	Predicate Device (K121663)	Current Device
Software / Functionality
System calibration to roomcoordinate system andQuality Control	Manual characterization of phantomfrom high-resolution CT scan;Software-assisted calibration ofoptical sensor tilt detector, room'scoordinate system and probe;Software-assisted daily QC process;Software-configurable mobileacquisition station for CT/Tx room	No Significant Change(Simplified system calibrationand daily QC process; auto-configuration of mobileacquisition station based onoptical tracking system ID)
Ultrasound imageacquisition for dailytarget localization	Ultrasound imaging (scan) presets;Image adjustment controls;Display of previous scans forconsistent image acquisition;Assisted soft-tissue segmentation;3DUS-to-3DUS comparison	No Significant Change(Added "Live Guidance" forconsistent probe positioning indaily prostate scans)
Couch localization andcontrol interface	Option to send couch shifts for patientrepositioning to MOSAIQ®	No Significant Change
Intrafractional prostatemotion management	Tracking & monitoring with autoscanprobe kit for transperineal ultrasound	No Significant Change(Improved user interface andtracking indicators)
Exception gating duringprostate monitoring	No	Optional with compatibleradiation delivery systems
Workstation & Serverfunctionality	System-wide database; Automatedmultimodality image registration andfusion; workspaces for contouring andpositioning reference definition;DICOM RT import/export, includingbeam & MLC data; positioning andmonitoring parameters definition	No Significant Change(Compatible with Windows 7)
Web-based interface	Remote review of patient data andpositioning reference approval	No Significant Change(Improved monitoring reports andadded review of QA/QC data)

Summary of Clinical & Non-Clinical Testing

Clarity® has been developed and tested in compliance with regulatory guidance and recognized consensus safety standards. Software and system verification testing was conducted under typical and reasonably foreseeable use error and boundary conditions. Localization accuracy and precision specifications were verified with multimodality phantoms. Exception gating was validated with Elekta's Response™ Gating Control System under simulated treatment conditions. Formative evaluations and simulated use of the modified device with representative end-users were conducted in accordance with FDA guidance on human factors and usability engineering to assure the safe and effective performance of critical tasks. The test results from verification and validation activities demonstrate that Clarity® fulfills its design and risk management requirements, and is as safe and effective for its intended use as the predicate device.

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.