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INFINITT RT PACS is a software medical device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software can connect to a HIS and provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM, RT related datasets including the geometrical super imposition of 3D plan data. INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.

Infinitt RT PACS, is a radiation therapy image Management solution dedicated to the oncology department. By using Infinitt RT PACS, the treatment planning system of various vendors can be stored and managed. It also transfers DICOM RT type plan images and information to EMR through HL7or database links.

Infinitt RT PACS, provides the function to acquire and view DICOM data generated from RTP (Radiotherapy Planning) System in the form of DICOM C-Store. Supported data includes CT (Computerized Tomography) DICOM image, DICOM RT PLAN data, DRR (Digitally Reconstruct Radiography) image and DICOM RT-Structure, dose information of DICOM RT-Dose and DVH (Dose-Volume Histogram) data. In addition, it supports Axial, Coronal, Sagittal view to check the location of the corresponding Axial CT image and dose distribution to Coronal, Sagittal View through scout line.

Infinitt RT PACS, provides DICOM conformant services for both short and long-term image storage and retrieval of digital image data. The application uses DICOM as the interface to the external world and enables interoperability between different devices.

Infinitt RT PACS, accepts DICOM association requests for the purpose of storing images and for query and retrieval of images. It also initiates DICOM association requests for the purpose of sending images to an external application entity.

The provided text is a 510(k) summary for INFINITT RT PACS. It outlines the device's intended use, comparison to a predicate device, and a brief mention of non-clinical performance data. However, the document does not contain the detailed information required to answer many of your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document states:

• "The Validation Test Plan was designed to evaluate output functions, and actions performed by Infinitt RT PACS, and followed the process documented in the Validation Test Plan."
• "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

This indicates that a study was performed and acceptance criteria were met, but the specifics of what those criteria were and how the study was conducted (e.g., sample size, expert involvement, ground truth method) are not provided in this public summary.

Therefore, I can only provide limited information based on the text.

Here's a breakdown of what can be inferred and what is not present in the provided document:

Summary of Device Performance and Acceptance Criteria (Based on available information):

The INFINITT RT PACS is a Picture Archiving Communications System (PACS) specifically designed for radiation therapy environments. Its primary function is to review and assess DICOM based datasets, including RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR, and PET. It provides visualization and image manipulation tools for review, presentation, or comparison of DICOM and RT-related datasets. The device is not capable of generating new or modified RT plan data.

The document broadly states that the device was assessed and tested, and "passed all predetermined testing criteria" and "demonstrated that the predetermined acceptance criteria were met." However, the specific numerical or qualitative acceptance criteria and the corresponding reported device performance metrics are not detailed in this summary. The performance data section focuses on compliance with standards rather than specific quantitative performance metrics.

Detailed Answers to Your Questions:

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

   • Not provided in the document. The document states that "predetermined acceptance criteria were met" but does not list those criteria or specific performance results.

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

   • Not provided in the document. The document mentions "Validation Test Plan" and "nonclinical testing results" but gives no details on sample size, data origin, or whether the study was retrospective or prospective.

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):

   • Not provided in the document. The document mentions "designated individuals performed all verification and validation activities" but does not specify their number, qualifications, or their role in establishing ground truth.

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

   • 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:

   • Not applicable/Not provided. This device is a PACS for reviewing, not an AI-assisted diagnostic tool designed to improve human reader performance. The document does not indicate any AI components or MRMC studies.

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

   • Not applicable/Not provided. The device is a viewing and management system, not a standalone diagnostic algorithm. The testing described is functional validation of the PACS system itself.

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

   • Not provided in the document. The mention of "Validation Test Plan" implies a comparison against some form of expected output or "ground truth," but the nature of this ground truth is not elaborated. Given the device's function as a PACS, the "ground truth" would likely relate to accurate display, retrieval, and manipulation of DICOM data as per specifications, rather than clinical outcomes or pathology.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is a PACS, not an AI model that requires a training set.

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

   • Not applicable/Not provided. This device is a PACS, not an AI model that requires a training set.

In conclusion, the provided FDA 510(k) summary for INFINITT RT PACS confirms that non-clinical testing was performed and "predetermined acceptance criteria were met," leading to a determination of substantial equivalence. However, the details of these criteria, the study design, sample sizes, expert involvement, and ground truth methodologies are not included in this public summary document. This document primarily focuses on the device's functionality, its comparison to a predicate device, and compliance with relevant standards and regulations.

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