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Centricity PACS-IW with Universal viewer is a software only product that is part of a Picture Archiving and Communication System (PACS) medical device. Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, 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 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Centricity PACS-IW with Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS-IW with Universal Viewer includes features to access and manage medical imaging studies from Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear medicine (NM). Computerized radiography (CR). Diaital mammography (MG),Digital x-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic x-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN) and other DICOM imaging modalities. Centricity PACS-IW with Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in in most healthcare organizations and utilizes commercially available computer platforms and operating systems. The system does not produce any origing| medical images. All images located on the Centricity PACS, PACS-IW, and Enterprise Archive systems have been received from DICOM compliant modalities and/or image acquisition systems. The Universal Viewer Zero Foot Print (ZFP) clinical viewer is an optional viewer which allows trained professionals to display and manipulate images stored in Centricity Enterprise Archive or other DICOM archive devices. These trained professionals include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants. The Universal Viewer Zero Foot Print option is not intended for primary diagnosis.

Here's a breakdown of the acceptance criteria and study information for the Centricity PACS-IW with Universal Viewer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table of acceptance criteria or quantified device performance metrics. Instead, it states that the device did not require clinical studies. The "acceptance" in this context refers to demonstrating substantial equivalence to a predicate device through non-clinical means.

The "performance" is implicitly deemed acceptable because the device leverages the same fundamental scientific technology as its predicate and the modifications are primarily related to user interface, integration, and minor enhancements, which were validated through non-clinical testing.

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

• Sample Size for Test Set: Not applicable. The document explicitly states: "The subject of this premarket notification submission, Centricity PACS-IW with Universal Viewer, did not require clinical studies to support substantial equivalence."
• Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing data provenance is not specified (e.g., country of origin).

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

Not applicable, as no clinical studies were performed and no separate "test set" with expert-established ground truth for performance evaluation is mentioned beyond internal verification and validation.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies or a separate "test set" requiring adjudication for ground truth were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states that clinical studies were not required.

6. Standalone Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study was not done or at least not described as a separate study for the purpose of demonstrating device performance in this submission. The device is a Picture Archiving and Communication System (PACS) component, intended to be used by human professionals (physicians, radiologists, etc.). Its performance is primarily assessed through its functionality, integration, and display capabilities as part of a human workflow, rather than as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

Not applicable in the context of clinical performance evaluation. For non-clinical verification and validation testing, the "ground truth" would have been defined by the device's functional requirements and design specifications.

8. Sample Size for the Training Set

Not applicable. The Centricity PACS-IW with Universal Viewer is a software product for image DISPLAY and MANAGEMENT, not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable, as there is no "training set" for this type of software device.

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