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Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.

Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images.

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 specification reviewed and accepted by FDA.

Connect Imaging PACS is intended for use by qualified physicians and radiologists and other trained personnel such as technologists and nurses.

Connect Imaging PACS is a modified version of Connect Imaging FilmLess Clinic (K031704). Both devices are picture, archiving and communication system software applications from Connect Imaging Inc.

The main difference between the modified device and the predicate device is that the modified device will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make the viewing of these images more convenient for the user.

Both systems are a complete PACS solution designed for deployment over local area networks, wide area networks, or through web access.

Connect Imaging PACS is modular and will be offered under different brand names for different modular parts of the PACS. The Connect Imaging PACS handles various images and data objects in Picture Archiving and Communications System (PACS) environment. The Connect Imaging PACS received digital images in DICOM format from DICOM compliant modalities, as well as digitized analog images using film digitizers that are 510(k) approved. These images are stored in a central archive and distributed to various locations for viewing with an imaging workstation.

The provided document is a 510(k) summary for the "Connect Imaging PACS" system. It describes a Picture Archiving Communications System (PACS) software application designed to accept, transfer, display, store, digitize, and digitally process medical images.

However, the document does not contain any information regarding specific acceptance criteria, performance metrics, or a study that proves the device meets such criteria.

The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Connect Imaging FilmLess Clinic K031704) by explaining:

• Its intended use
• Technological characteristics (software for image management and processing)
• The main difference from the predicate device (ability to display presentation-quality digital mammography images)
• Its modular nature and DICOM compliance

There is no mention of:

• Specific quantitative or qualitative acceptance criteria (e.g., accuracy, sensitivity, specificity, display quality metrics)
• A clinical or technical study conducted to evaluate the device's performance against any criteria
• Sample sizes for test or training sets
• Ground truth establishment methods or expert qualifications
• Adjudication methods
• MRMC studies or standalone algorithm performance

Therefore, I cannot provide the requested table and study details as that information is not present in the provided text. The document is a regulatory submission for substantial equivalence based on descriptive comparison and intended use, rather than a performance study report.

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Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.

Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images.

Filmless Clinic is intended for use by qualified physicians and radiologists and other personnel.

Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.

Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images.

This document is a 510(k) clearance letter from the FDA for a device named "Filmless Clinic." It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory document does not contain the detailed study information, acceptance criteria, or performance data that you've requested.

The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring new, full-scale clinical trials with specific acceptance criteria and detailed performance metrics to prove safety and effectiveness in the same way a PMA (Premarket Approval) might.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not found in a 510(k) clearance letter.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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 available. This device, being a Picture Archiving and Communication System (PACS), is not an AI-assisted diagnostic tool in the sense of image interpretation enhancement for human readers. It's a system for handling medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document confirms the device's intended use and regulatory classification but does not provide the technical performance study details you are looking for.

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