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iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.

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.

iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.

iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.

The provided 510(k) summary for K063267, Stentor Inc.'s iSite PACS, does not include detailed information regarding acceptance criteria or a specific study proving the device meets these criteria in terms of performance metrics.

The document primarily focuses on establishing substantial equivalence to predicate devices (GE Centricity PACS, Kodak PACS, and earlier iSite PACS versions) based on design and intended use, rather than presenting a performance study with specific acceptance criteria and results.

Here's what can be extracted and what is missing based on your request:

Missing Information/Cannot be determined from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present in the document. The submission focuses on functional equivalence and safety rather than quantifiable performance criteria like accuracy, sensitivity, or specificity for diagnostic tasks.
• Sample size used for the test set and the data provenance: No specific test set for performance evaluation is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance test set is described.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study is described.
• The type of ground truth used: Not applicable as no specific performance test set is described.
• The sample size for the training set: The document does not describe AI/machine learning components requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Information provided (related to the device's development and regulatory status):

• Device Name: iSite PACS v 4.x
• Intended Use: An image management system to be used by trained professionals (physicians, nurses, medical technicians) to acquire, store, distribute, process, and display images and associated data throughout a clinical environment. It supports various DICOM modalities.
• Software Development: Stentor certifies that the iSite software is designed, developed, tested, and validated according to written procedures, identifying responsible individuals for product specifications, coding, testing, validation testing, and field maintenance.
• Safety and Effectiveness Concerns: The device labeling contains instructions, cautions, and warnings. Users are responsible for display quality and environmental conditions. Hardware components are "off the shelf."
• Conclusion for Substantial Equivalence: iSite is substantially equivalent in design and intended use to diagnostic radiological workstations, PACS, and image management systems. Any differences have no significant influence on safety or effectiveness and raise no new issues.
• Specific Restrictions/Warnings:
  • 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.

In summary, this 510(k) submission establishes substantial equivalence for a PACS system based on its functional capabilities and safety profile compared to existing predicate devices. It does not contain a performance study with quantitative acceptance criteria, as such studies are typically required for devices that perform diagnostic analysis functions (e.g., AI algorithms for detection or classification), rather than solely image management and display.

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