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The Clarity™ OBP System is intended for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.

The Clarity™ OBP System integrates medical diagnostic ultrasound and optical position tracking to acquire and reconstruct three-dimensional ultrasound (3DUS) images of soft-tissue anatomy for use in external beam radiation therapy. During the course of radiation therapy, the Clority™ OBP System offers a non-ionizing means for daily localization of target anatomical structures.

The Clarity™ OBP System comprises the following functional components:

• The 3DUS imaging station (typically one in the CT-simulation room and one in the treatment . room}, including the 3DUS console with an integrated computer system and opticallytracked ultrasound probes, patient/couch position tracking tools, and a ceiling-mounted optical tracking system.
• . A multimodality phantom, for 3DUS image calibration to the room's coordinate system defined by the corresponding room lasers, and for daily verification of system integrity.
• . One or more dedicated workstation computer systems for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and monitoring of treatment progress.
• . A dedicated central server computer system (typically combined with a workstation), which houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol.

All networked Clarity™ OBP System stations are configured to run the same software version. The software interface is designed to 'walk' the user through a sequence of steps (or "course") to acquire 3DUS scans in the planning position, import planning CT data and fuse with 3DUS, define the structure of interest and approve a baseline positioning reference, acquire another 3DUS in the treatment position to determine target displacement relative planning-day position, and adjust patient positioning prior to treatment. The 3DUS data may be exported through DICOM to a third-party virtual simulator or treatment planning system (TPS).

Different courses are defined in the software (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g. prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC tasks. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for large target misalignments.

The Clarity™ OBP System provides the option for hand-held ultrasound scanning or automated scanning with a motorized probe. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The autoscan probe comes with a probe holder apparatus and a remote control console, specifically designed to facilitate transperineal imaging of the prostate and surrounding soft tissues.

The Clarity™ OBP System also includes an optional web-based interface for remote review of treatment session data and positioning reference images.

The provided text does not contain specific acceptance criteria or details of a study with reported device performance metrics in tabular or descriptive form. The document is a 510(k) summary for the Clarity™ OBP System, primarily focusing on its intended use, device description, comparison to predicate devices, and a general statement about verification and validation testing.

Here's what can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) are provided in the document. The text only states that "The verification test results demonstrate that this next-generation device fulfills design and risk management requirements, and performs well in accordance with established specifications for its intended use."

2. Sample Size for Test Set and Data Provenance:

The document broadly mentions "clinical settings under conditions of simulated use" for testing but does not specify any sample sizes (e.g., number of patients, number of images) for a test set. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

The document does not mention an MRMC comparative effectiveness study or any effect sizes related to human readers' improvement with or without AI assistance. The Clarity™ OBP System is described as a patient positioning system utilizing 3D ultrasound and optical tracking, not an AI-assisted diagnostic or interpretive tool in the context of human reader performance.

6. Standalone (Algorithm Only) Performance:

The document describes the Clarity™ OBP System as an integrated system involving hardware and software for acquiring and reconstructing 3D ultrasound images to guide patient positioning for radiation therapy. It does not present a standalone algorithm performance study. The system provides tools for image fusion, contouring, and defining positioning references, but the document does not detail an "algorithm only" performance separate from the overall system's function with a human in the loop (the user).

7. Type of Ground Truth Used:

The document mentions "definition of a positioning reference" and "define the structure of interest" as part of the system's function. The "ground truth" implicitly refers to the accurate localization of target anatomical structures for radiation therapy. However, the exact method for establishing this ground truth for validation purposes (e.g., expert consensus based on other imaging modalities like CT, pathology, or direct outcome data) is not explicitly stated.

8. Sample Size for the Training Set:

This information is not provided in the document. The system uses "predefined "courses" tailored for the target anatomy" and "assisted segmentation tools," which implies some form of training data or rules, but no details on size are given.

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

This information is not provided in the document.

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