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The DoseView 3D system is a 3 axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear acceleratedbased radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. This data is then often used in support of a radiation treatment planning system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist. The general uses of the DoseView 3D include the following:

• Acceptance testing and/or commissioning of a radiation therapy or radiotherapy system.
• Quality assurance measurements to identify and minimize the sources of uncertainty and error in the radiation therapy system, radiotherapy system or radiation treatment planning system.
• Collection of dose depth data for radiation treatment planning system use.
• Completion of clinical dosimetry protocols and calibrations.

The DoseView 3D system is a 3-axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear accelerated based radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. This data is then often used in support of a radiation treatment plasot system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist.

The DoseView 3D is a system designed for measuring and analyzing radiation from linear accelerators and radioactive sources, primarily used in radiation therapy for acceptance testing, quality assurance, dose data collection, and calibration.

Here's an analysis of the provided text regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail a table of acceptance criteria with specific numerical targets. Instead, it states that:

It implies that the device successfully met the intended design, risk, and validation objectives.

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

The text does not specify a numerical "sample size" in the traditional statistical sense for a test set. Instead, it mentions that the DoseView 3D was "successfully evaluated by the following clinical beta sites":

• Turville Bay MRI & Radiation Oncology Center, Madison, WI
• UW Hospitals & Clinics, Madison, WI
• ATC/Tokyo Metropolitan University, Tokyo, Japan

This indicates a prospective evaluation across three clinical sites located in the United States (Wisconsin) and Japan. The "test set" in this context would likely refer to the data collected and performance observed during its use at these sites.

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

The document states that the device "is intended to be used by a trained medical physicist." Therefore, it can be inferred that medical physicists at the clinical beta sites were the users and implicitly, the experts involved in establishing or validating the "ground truth" of the device's performance.

The number of experts or their specific qualifications (e.g., years of experience) is not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The text does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The evaluation seems to be based on the successful performance observed at the clinical beta sites.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The focus is on the DoseView 3D's standalone performance and its compliance with standards and predeteremined specifications.

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

Yes, a standalone evaluation was performed. The text indicates that the device was "verified and validated at Standard Imaging" and "successfully evaluated by the following clinical beta sites." This implies that the device's performance was assessed directly, without necessarily comparing it to human performance in a comparative study format. The primary function of the DoseView 3D is to make measurements, so its "standalone" performance refers to its accuracy and reliability in those measurements.

7. The Type of Ground Truth Used

The ground truth used for evaluating the DoseView 3D would likely be based on physical dosimetry standards and established clinical dosimetry protocols and calibrations. The device itself is designed to collect dose depth data and assist in calibration. Therefore, the "ground truth" would be the known and expected dose distributions and measurements based on established physics principles and measurement techniques, against which the DoseView 3D's readings were compared. The text explicitly mentions "Completion of clinical dosimetry protocols and calibrations" as one of its general uses, suggesting that its accuracy against these known standards would be the basis of "ground truth."

8. The Sample Size for the Training Set

The provided text does not mention a training set or its sample size. The DoseView 3D is a measurement system, not a machine learning algorithm that typically requires a training set. Its development and validation would involve engineering verification and calibration rather than machine learning training.

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

As there is no mention of a training set, there is no information on how its ground truth was established.

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