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ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, retrieve and display images and data from all image modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation" and will include standard features and other tools for analyzing mammography images. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. ZED LINK™, is not intended for diagnostic image review on mobile devices. Typical users of this system are doctors and health care professionals.

ZED LINK™ has four main uses:

• Hard copy replacement: Replaces hard-copy media for managing medical images, such as film archives.
• Remote access: Expands the possibilities of conventional systems by providing capabilities of off-site viewing and reporting (distance education, tele review). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology.
• Electronic image integration platform: Provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS).
• Radiology Workflow Management: Used by radiology personnel to manage the workflow of patient exams.

The provided text describes a 510(k) premarket notification for a medical device called "ZED LINK™", which is an image management system (PACS). However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (BOX DICOM Viewer K151957) based on technological characteristics and functional comparisons. It generally states that nonclinical testing was performed and that predetermined acceptance criteria were met, but does not provide the details of these criteria or the test results.

Here's an breakdown based on the information available and not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The document only mentions that the system and configuration were assessed and tested at "ZED Technologies PTY. LTD."

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The focus is on demonstrating functional equivalence to a predicate device without reference to diagnostic performance metrics requiring such ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no study involving expert interpretation or adjudication is described.

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

No. The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any assessment of human reader improvement with or without AI assistance. The ZED LINK™ is described as an image management system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The document presents the ZED LINK™ as an image management system, not a standalone diagnostic algorithm. Therefore, a standalone performance study in the context of an algorithm's diagnostic accuracy is not relevant to the information provided.

7. Type of Ground Truth Used

Not applicable. No ground truth is described, as the evaluation focuses on functional equivalence and passing nonclinical technical tests, rather than diagnostic accuracy.

8. Sample Size for the Training Set

Not applicable. The ZED LINK™ is an image management system, and the document does not describe an AI or machine learning component that would require a "training set" in the context of diagnostic algorithm development.

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

Not applicable, as no training set or associated ground truth is mentioned.

Summary of Device Evaluation in the Document:

The provided 510(k) summary focuses on demonstrating that ZED LINK™ is substantially equivalent to its predicate device (BOX DICOM Viewer K151957) by comparing their technological characteristics and intended uses. The evaluation primarily involved nonclinical testing to ensure the system's functionality, safety, and effectiveness. The document states that "predetermined acceptance criteria were met" and that "all verification and validation activities" were performed, but it lacks the specific details of these criteria, the tests conducted, and the quantitative results that would typically be included in a study proving performance against defined acceptance criteria. The differences noted between the predicate and subject devices (e.g., supported web browsers, absence of clockwise/counter-clockwise rotate and area measurement annotation, presence of MPR) were assessed and deemed to have no impact on safety or efficacy.

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