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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.

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.

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:

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.

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