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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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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 used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging device or modalities.

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 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 that is 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 text (K042292) is a 510(k) summary for the iSite PACS v3.3 software. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "Stentor certifies that the iSite software is designed, developed, tested and validated according to written procedures."
• "iSite is substantially equivalent in design and intended use to diagnostic radiological workstations. PACS and image management systems as substantiated in the feature comparison. Any differences between the iSite PACS software and the equivalent devices have no significant influence on safety or effectiveness. Therefore, iSite PACS raises no new issues of safety or effectiveness from its predicate devices."

This indicates that the device's approval was based on demonstrating substantial equivalence to existing predicate devices, rather than a specific performance study against predefined acceptance criteria for a new clinical claim. The 510(k) process often relies on this substantial equivalence demonstration for devices that are not making novel claims requiring new clinical evidence.

Therefore, the requested information elements cannot be extracted from the provided text as the document does not include data from a performance study comparing the device against specific acceptance criteria.

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Stentors' iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology images.

iSite Radiology is designed as a Diagnostic reading workstation. iSite Radiology is capable of receiving and displaying DICOM images. Images sent to ISite Radiology are converted into formats suitable for viewing in its framework, and stored in a local cache. ISite Radiology is used by ISite Radiology to view JPEG and wavelet images follow known and accepted protocols. Images sent to ISite Radiology can be viewed using an executable that is installed on a Personal Computer equipped with the appropriate hardware. ISite Radiology uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.

The provided text is a 510(k) summary for the Stentor iSite Radiology software, specifically focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document primarily states that the iSite Radiology software is "designed, developed, tested and validated according to written procedures" and that "Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers." However, it does not detail the nature, outcome, or specific metrics of these tests.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical report of performance testing.

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Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.

Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.

The provided text does not describe acceptance criteria for device performance or any study conducted to prove the device meets such criteria.

The document is a 510(k) summary for the Stentor PageView software, submitted to the FDA in 1999. Its primary purpose is to demonstrate substantial equivalence to previously cleared devices, not to present performance data against specific acceptance criteria.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The document states that the software was "designed, developed, tested and validated according to written procedures" and that "Extensive testing of the software package has been performed." However, it does not provide any specific quantitative performance metrics (e.g., accuracy, speed, uptime, image fidelity measures) that would constitute acceptance criteria, nor does it report the results of any such tests.
• Focus on Substantial Equivalence: The bulk of the "Safety and Effectiveness" section and the "Substantial Equivalence Chart" (Section 1.9) compare the PageView's features and technological characteristics to predicate devices (Mitra-Exhibit and PACScache). The conclusion is that differences have "no significant influence on safety or effectiveness," which is a regulatory argument for equivalence, not a detailed performance study.
• No Mention of Specific Study Design: There is no description of a study (retrospective/prospective, sample sizes, data provenance, expert roles, adjudication methods, MRMC studies, or standalone performance) that would be typically conducted to prove performance against specific criteria.
• Ground Truth: Since no performance study is described, there's no mention of how ground truth would be established for any test or training set.
• Training Set Information: There is no information about a training set, as the document does not describe the development or validation of an AI/ML algorithm that would typically require one. The software's function is described as converting DICOM images for display, not a diagnostic algorithm.

In summary, the provided text does not contain the information required to populate the requested table or answer the specific questions about acceptance criteria and performance studies because the document's intent is to establish substantial equivalence based on feature comparison, not to report on quantitative performance metrics.

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