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Opal-RAD™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

Opal - RAD is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities, and offer an interface that users find to be quite intuitive after some initial learning. The Opal-RAD applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, and many others. These images can be viewed, manipulated, annotated, transmitted to other facilities, printed, animated and stored using the Opal-RAD suite.

The device is designed to be deployed over conventional 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.

This document is a 510(k) summary for the Opal-RAD™ Picture Archiving Communications System (PACS). It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific performance acceptance criteria or a dedicated clinical study proving device performance against those criteria.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be provided based on the input:

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

• Cannot be provided. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of device performance metrics against such criteria. It states that the device was "manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey" and that a "hazard analysis" was performed with a "Level of Concern for potential hazards has been classified as minor." However, these are not quantitative performance metrics against acceptance criteria typically found in clinical studies for diagnostic or AI-enabled devices.

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

• Cannot be provided. The document does not describe a test set, sample size, or data provenance for any performance evaluation.

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)

• Cannot be provided. No information about ground truth establishment or experts is present, as no specific performance study is detailed.

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

• Cannot be provided. No adjudication method is mentioned as there's no described test set or ground truth establishment process.

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

• Cannot be provided. This document is for a PACS system, which primarily handles the display, storage, and communication of medical images. It is not an AI-assisted diagnostic tool, and therefore, no MRMC study or AI-related effect size information would be present. The document explicitly states: "The system 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."

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

• Cannot be provided. As a PACS system, it's designed to facilitate human interpretation, not to provide standalone algorithmic diagnoses.

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

• Cannot be provided. No ground truth is mentioned in relation to specific device performance.

8. The sample size for the training set

• Cannot be provided. There is no mention of a training set, as this is a PACS system and not an AI/machine learning diagnostic device.

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

• Cannot be provided. No training set or ground truth establishment for a training set is described.

Summary of Device and 510(k) Scope:

The Opal-RAD™ is a Picture Archiving Communications System (PACS) software suite. Its primary function is to:

• Receive digital images and data from various sources (CT, MR, US, CR, DR, etc.).
• Store, communicate, process, and display these images and data within the system or across networks.

This 510(k) submission demonstrates substantial equivalence to an existing legally marketed predicate device (RATTAN IMACS K032176). The core argument for substantial equivalence for a PACS system often revolves around comparing its technical characteristics (e.g., DICOM compatibility, display capabilities, networking, security, data integrity) and its intended use with the predicate, rather than presenting a clinical study with detailed performance metrics like sensitivity or specificity.

The document highlights:

• Its capability to handle DICOM protocol.
• Web-based access from Microsoft Windows computers.
• Compatibility with common networking infrastructure and hardware (Intel Pentium-based).
• Crucially, it emphasizes that it does not produce any original medical images and that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."
• It also includes specific warnings regarding mammographic images (lossy compressed not for diagnostic review, use FDA-approved monitors, "for presentation" images for primary diagnosis).

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