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RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.

RTapp v1.0 is a stand-alone, cloud-based software medical device with secure access via a private internet web portal. RTqpp analyzes and visualizes the day-to-day variations in a radiation therapy patient's individual anatomical structures and the effect of those changes on the treatment dose; an aid during use by radiation oncology.

The RTapp software:

• Automatically queries and retrieves treatment plan data and images from any DICOM compliant equipment.
• Automatically processes all patient's treatment fractions, flagging and presenting an advance warning of treatment plans at risk with an email notification.
• Monitors and evaluates treatment plan performance in real time by using the Plan Performance Dose Volume Histogram (DVH). The DVH projects the amount of dose to be delivered.
• Displays Deformable Image Registration contours, cross correlation metrics and flagging of large deformations.
• Projects when Organs At Risk will exceed dose constraints.
• Dose estimation
• Generates reports as PDF with images and graphs.

RTapp is intended for use by radiation oncology professionals in a hospital/clinical setting for any patient undergoing radiation therapy based on a treatment plan.

RTapp is NOT intended as a treatment planning software and cannot be used to generate radiotherapy treatment plans.

The provided text is a 510(k) summary for the RTapp™ v1.0 device and does not contain the detailed performance data, acceptance criteria, or study specifics typically found in a comprehensive clinical study report. Therefore, I cannot fully answer your request.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided document.
• Reported Device Performance: Not detailed in the provided document. The document only states, "Non-clinical data support the safety and efficacy of the device. The software verification and validation demonstrate that the RTqpp device should perform as intended in the specified use conditions." This is a general statement and does not provide specific performance metrics or their alignment with any acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not mentioned.

4. Adjudication method for the test set:

• Not mentioned.

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 study is mentioned. The device is described as "a stand-alone software that provides a means for comparison of imaging data... as an aid during use by radiation oncology," suggesting it might be an assistive tool, but no study on human reader improvement with or without AI assistance is described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The document implies standalone performance was assessed through "Software Verification and Validation Testing." It states, "The software verification and validation demonstrate that the RTqpp device should perform as intended in the specified use conditions." However, no specifics on how this standalone performance was measured or what metrics were used are provided.

7. The type of ground truth used:

• Not mentioned.

8. The sample size for the training set:

• Not mentioned.

9. How the ground truth for the training set was established:

• Not mentioned.

In summary, the provided 510(k) document indicates that "Software verification and validation testing was conducted" and that "Non-clinical data support the safety and efficacy of the device." However, it does not provide the specific details regarding the acceptance criteria, study design, sample sizes, ground truth establishment, or performance metrics that would allow for a comprehensive answer to your request.

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