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VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

VERIQA software is a tool for evaluation and data management of digital images and treatment plan information. It supports the medical imaging modalities CT, MR, PET according to the ACR/NEMA DICOM 3.0 standard and other modalities. VERIQA supports the following applications:

• a) Receiving, transmitting, storing, display, and processing of medical images and DICOM objects.
• b) Creating, displaying and printing of reports containing medical images.
• c) Image registration, fusion display, and review of medical images for treatment evaluation and treatment planning.
• d) Localization and definition of structures such as tumors and normal tissue in medical image sets.
• e) Creation, transfer, and modification of contours and dose distributions such as quantitative analysis, aiding adaptive radiation therapy, transferring contours and dose distributions to radiation treatment planning systems, and archiving contours and dose distributions for patient follow-up and management.
• f) Secondary Monte Carlo dose calculation for patient specific quality assurance.

VERIQA must not be used while a patient is present. VERIQA must not be used for treatment planning.

Software for viewing and analyzing of DICOM and DICOM RT data as well as for contouring of these data for radiation therapy. All the relevant data, including image data sets and treatment plans, can be imported into VERIQA. The software enables interactive viewing of these data in 2D/3D/4D and evaluation of the treatment plans with secondary Monte Carlo 3D dose calculation. The user can register images and process RT Dose, RT Plan, and RT Structure objects. Results can be saved in the DICOM RT format for use by other systems for radiation treatment planning purposes.

The provided text describes the VERIQA device, its intended use, and a comparison with predicate devices. However, it does not contain detailed information about specific acceptance criteria or a study that specifically proves the device meets those criteria with numerical performance data. It generally states that "Software verification and validation testing results were conducted and submitted according to appropriate bench testing methods" and "It was demonstrated that VERIQA fulfils the design specification and its intended use, and that it is equivalent to the predicate devices."

Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will fill in what can be inferred or explicitly stated.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or reported device performance metrics from a formal study. The "Device Comparison Table" on pages 5-6 lists technological characteristics and functionalities, indicating whether VERIQA and its predicates possess them ("Yes" or "No"), but not quantitative performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text only vaguely states "Software verification and validation testing results were conducted and submitted according to appropriate bench testing methods."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This information is not provided in the document. The device description does not imply AI assistance for human readers in the context of improving their performance, but rather offers secondary calculations and visualization tools for medical physicists and other professionals.

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

The document implies standalone performance for the Monte Carlo dose calculation ("Secondary Monte Carlo dose calculation and evaluation for patient specific quality assurance") and other automated features like "Automated processing of secondary checks" and "Automatic notification". However, specific details or results of such standalone performance are not provided, beyond the functional confirmation of their presence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. For radiation therapy QA software, ground truth for dose calculation is typically established against established physics models, phantom measurements, or other validated dose calculation systems. However, the specific method is not detailed here.

8. The sample size for the training set

This information is not provided in the document. The document describes VERIQA as software for display, evaluation, and digital processing, rather than a machine learning/AI model that typically undergoes explicit "training"; thus, a traditional "training set" might not be applicable in the same way.

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

As with point 8, this information is not provided and may not be applicable in a traditional sense for this type of software.

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