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This product is to be used by radiation therapy oncologist, dosimetrist, and radiation therapy physicist, to plan the treatment with x-rays for patients undergoing radiation therapy for stationary and gantry arc beams. Support is included for field shaping with multi-leaf collimators and auxiliary blocking, and the use of wedges. Electron therapy and intensity modulated radiation therapy is not included in this product.

RtDosePlan is a radiation therapy external beam treatment planning program that supports treatment planning for x-rays only. The following functions are included:

1. Provide means to read in CT scans and form a patient model.
2. Provide means to define a skin boundary.
3. Provide means to convert CT numbers to physical density.
4. Provide means to define a plan that consists of one or more treatment beams.
5. Provide means to define a treatment beam.
6. Provide means to locate isocenter of the treatment beam within the patient model.
7. Provide means to set the gantry, collimator, and couch angles, and to specify a gantry arc rotation.
8. Provide means to specify a wedge.
9. Provide means to shape a field with a multi-leaf collimator.
10. Provide means to shape a field with auxiliary blocking (cerrobend).
11. Provide means to fit a poly-energetic pencil beam algorithm for the purpose of computing the dose.
12. Provide means to compute the dose to the patient model from the specified treatment beams.
13. Provide means to display the dose on 2d planes in the patient model and 3d room views.
14. Provide means to specify a dose prescription and calculate monitor units for each treatment beam.
15. Provide means to outline regions of interest.
16. Provide means to fuse other image sets and transfer outlines and points from the other image set.
17. Provide means to compute and display dose volume histograms.

The provided text is a 510(k) summary for a medical device called "RtDosePlan," a radiation therapy external beam treatment planning program. This type of document focuses on establishing substantial equivalence to a predicate device and outlining the device's functions and indications for use. It does not contain information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies.

Therefore, I cannot extract the requested information to populate the table and answer the specific questions about device performance against acceptance criteria and the details of a proving study. The 510(k) summary confirms the device's functions but doesn't include the empirical evidence of its performance in the way you've requested.

Here's a breakdown of why the information isn't available in the provided text:

• Acceptance Criteria and Reported Device Performance: These are typically quantitative metrics (e.g., accuracy, precision) compared against predefined thresholds. The 510(k) summary lists the functions of the device but not its performance statistics.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth type, Training Set Size/Ground Truth): These details are integral to clinical or technical validation studies. A 510(k) submission generally refers to design controls and predicate comparisons, but often doesn't include the full performance study details if they are not specifically required for substantial equivalence. For a treatment planning system, performance would likely be validated through dose calculation accuracy and comparison against established physics principles and possibly phantom studies rather than human-in-the-loop performance with patients in the initial submission.

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