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INTEGRADWeb MPR/MIP™ by Dynamic Imaging, Inc. is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

INTEGRADWeb MPR/MIP ™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb MPR/MIP ™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb MPR/MIP ™ have been received from DICOM compliant modalities and/or systems.

This document is a 510(k) Summary of Safety and Effectiveness for the INTEGRADWeb MPR/MIP™ system by Dynamic Imaging, Inc., submitted to the FDA in 2004. It focuses on declaring substantial equivalence to a predicate device, rather than presenting a study for acceptance criteria.

Therefore, much of the requested information, such as acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and details on standalone or MRMC studies, is not available in the provided text. The document is primarily a regulatory submission for market clearance.

However, based on the information provided, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that the submission "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This indicates a qualitative comparison rather than a quantitative performance evaluation against pre-defined metrics within the document.

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

Not available. The document does not describe a "test set" in the context of evaluating the device's performance against specific metrics. It indicates the device handles various medical images from different modalities (CT, MR, US, NM, CR, DR, DX, XA, PT), but no details on specific image datasets used for a performance study are provided.

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

Not applicable/Not available. As no specific performance study with a "test set" is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable/Not available. No test set or adjudication method is described.

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

No. The document does not mention an MRMC study or any comparison of human readers with and without AI assistance. The focus is on the device's functionality as a Picture Archiving Communications System (PACS) and its substantial equivalence to a predicate device.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. The document describes the INTEGRADWeb MPR/MIP™ as a software system for image management, processing, and display within a PACS environment, not as an AI algorithm providing diagnostic interpretations. Therefore, a standalone algorithm performance study is not relevant to the described device. The device "does not produce any original medical images" and "a physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

7. The Type of Ground Truth Used

Not applicable/Not available. As no specific performance study that required ground truth for evaluation is described, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

Not applicable/Not available. The device is a PACS, not a machine learning model that would require a dedicated training set in the typical sense. Its functionality revolves around accepting, transferring, displaying, storing, and digitally processing existing medical images.

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

Not applicable/Not available. As there's no mention of a training set for a machine learning model, this information is not provided.

In summary, the provided document is a regulatory submission for a PACS device, attesting to its safety and substantial equivalence based on its functionalities and adherence to standards, rather than a detailed report of a clinical performance study with acceptance criteria.

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