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The RemotEye Viewer software product is intended to be used as a fully functional, web-based medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format, also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

The RemotEye Viewer software product is a feature-rich, diagnostic-level, web-based DICOM medical image viewer that allows downloading, reviewing, interpreting, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. The DICOM images may be physically remote with respect to the viewing client, but reachable through a network.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

The provided text describes a 510(k) premarket notification for the "RemotEye Viewer" device, which is a medical image viewer. However, it does not include detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for performance-based AI/CAD devices.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (eFilm Workstation) based on intended use, technological characteristics, and functionality. It does not present a performance study with defined metrics, sample sizes, expert ground truth, or comparative effectiveness.

Therefore, many of the requested sections will state that the information is not provided in the given text.

Here's a breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or report specific performance metrics for the RemotEye Viewer in the context of diagnostic accuracy, sensitivity, specificity, etc. The "Testing" section broadly mentions that the device is "tested according the specifications that are documented in 013-139 and 009_Al Verification and Validation document." These internal documents are not provided.

The document's primary claim related to performance is that its "different technological characteristics" (web-based, multi-platform, no local storage) "don't constitute any new intended use and don't raise new questions of safety and effectiveness." This implies that its core viewing and manipulation functions are expected to perform similarly to the predicate device.

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

The document does not describe a test set in the context of diagnostic performance evaluation. It mentions "Testing" as an integral part of their software development process, but no details regarding specific test datasets, their size, or provenance are included.

• Sample Size for Test Set: Not provided.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not provided.

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

Since no specific diagnostic performance test set is described, there's no mention of experts establishing ground truth. The device is a viewer for images that are "interpreted by a trained physician" to "be used as an element for diagnosis," implying human interpretation is central, not an automated diagnostic output requiring ground truth.

• Number of Experts: Not applicable/Not provided.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Not applicable, as no diagnostic performance test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device itself is a viewer, not an AI/CAD system providing interpretations.

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

Not applicable. The RemotEye Viewer is a medical image viewing software intended for use by "trained professionals" to review and interpret images. It is not an algorithm designed for standalone diagnostic performance.

7. The Type of Ground Truth Used

Not applicable, as no diagnostic performance evaluation requiring ground truth is described for the device itself. The primary function is image display and manipulation, not automated diagnosis.

8. The Sample Size for the Training Set

Not applicable. The RemotEye Viewer is a software viewer, not a machine learning model that requires a training set in the conventional sense for diagnostic performance. Its development involves software engineering, testing, and validation, not training on medical images for algorithmic performance.

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

Not applicable, as there is no mention of a training set or ground truth in the context of machine learning model development.

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The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, DR, CT, MRI, US, RF units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD.

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.

Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.

The Hipax Medical Imaging Software is an autonomous software with the exception of a dongle for copy protection. It is running under Microsoft Windows 2000/XP operating system. The Hipax Medical Imaging Software has an open system architecture consisting of a basic module and modules for the research and the image acquisition, storage and communication to be added as an option. The functions of the Hipax Medical Imaging Software correspond to the features described for the Predicate Devices. Displaying any medical image, for example, from CT, MRI, CR, US, endoscopy, gastroscopy, and other medical specialists (e.g. window leveling, ROIs, edge enhancement, scaling, cine-loop, measurement, writing and marking, Child-Pugh score, histogram etc.). Multiplanar Reconstruction is available as an option. Like the Predicate Devices, the Radworks Medical Imaging Software or the eFilm Workstation, the Hipax Medical Imaging Software offers modules for image acquisition from video sources (Video Module), digitizers (X-ray Digitizing Module), or CR systems (CR-Connection Module). Within a network DICOM worklists can be received and images can be sent and received using the DICOM protocol. Image exchange between two remote Hipax workstations or other Hipax programs via phone lines, broadband, satellite, etc. can be carried out using the Hipax DICOM Communication Software. The DICOM Email module, which is also part of the Radworks Modules, is available to transmit images as Emails. Images can be compressed and encrypted. The DICOM Print Module supports DICOM 3.0 primary. Using the Patient CD Module, images can be written on CD to be handed out to patients on digital media, e.g. DVD. To burn CDs or DVDs automatically, a CD/DVD robot can be connected.

This 510(k) submission (K052411) for the Hipax Medical Imaging Software does not contain a study that proves the device meets specific acceptance criteria.

Instead, this submission is a Premarket Notification (510k) Summary which aims to demonstrate substantial equivalence to existing, legally marketed predicate devices rather than proving a device meets predefined acceptance criteria through a specific performance study.

Therefore, many of the requested sections below cannot be fully populated as there is no performance study detailed in this document.

Here's the breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not describe specific acceptance criteria or report performance metrics from a formal study. It primarily focuses on comparing the Hipax software's functions and technological characteristics to its predicate devices to demonstrate substantial equivalence.

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

• Cannot be provided. There is no mention of a test set, sample size, or data provenance in the context of a performance study. The document mentions "Testing is an integral part of the software development process of Steinhart Medizinsysteme GmbH (see documents in G 2 and G 4)," but details of this testing are not included in the provided summary.

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. Since no specific test set or ground truth establishment is described, details about experts cannot be extracted.

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

• Cannot be provided. No adjudication method is mentioned as there is no described test set with ground truth establishment requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The Hipax Medical Imaging Software is a Picture Archiving Communications System (PACS) component used for processing and displaying medical images, not an AI-powered diagnostic tool. The document does not describe any AI component or human-in-the-loop performance study.

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

• Not applicable in the context of a diagnostic algorithm. The device is "autonomous software" for image management and display. While it performs functions independently, it is not a standalone diagnostic algorithm in the way that would typically be evaluated for performance metrics like sensitivity or specificity. Its "performance" is about its functional capabilities matching the predicate devices (e.g., displaying images, performing measurements).

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

• Cannot be provided. No ground truth is described as no performance study is detailed.

8. The sample size for the training set

• Cannot be provided. No training set is mentioned, as the device is not described as involving machine learning or AI models that require specific training data.

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

• Cannot be provided. No training set or associated ground truth establishment is mentioned.

Summary of Device and its Basis for Substantial Equivalence:

The Hipax Medical Imaging Software is a Picture Archiving Communication System (PACS). Its submission for 510(k) clearance relies on demonstrating substantial equivalence to two predicate devices: Radworks Medical Imaging Software (K962699) and eFilm Workstation (K012211).

The core argument for substantial equivalence is based on the device having:

• Same indications for use: Medical image processing and communication.
• Same target population: Trained medical professionals (radiologists, orthopedists, clinicians, technologists, etc.).
• Same technological characteristics: Autonomous software for displaying and managing medical images, offering features like window leveling, ROIs, measurements, MPR, etc., similar to the predicate devices.
• Compliance with general controls: The FDA letter confirms the device can be marketed under the general controls provisions of the Act.

The document states, "The Hipax Medical Imaging Software is tested according to the specifications that are documented in an own description (Description of the software test procedures) and the corresponding Softwaretest forms. Testing is an integral part of the software development process of Steinhart Medizinsysteme GmbH (see documents in G 2 and G 4)." However, the specifics of these tests, including acceptance criteria and detailed results, are not part of the provided 510(k) Summary. Their purpose would likely be to confirm functional requirements and safety rather than clinical performance against specific metrics.

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MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a software application for viewing medical images. Typical MedCommons Gateway™ users are healthcare professionals, such as, clinicians, radiologists, and technologists.

MedCommons Gateway™ receives, communicates, and displays digital images and data from various types of imaging and image processing system, such CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways and image processing sources). MedCommons Gateway™ can be integrated with an institution's HIS or RIS, linking or transferring images and data into electronic patient records.

MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a component of a Picture Archiving and Communications System (PACS). MedCommons Gateway™ is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other proprietary formats. MedCommons Gateway™ can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in JPEG and/or proprietary formats.

The provided text is a 510(k) summary for the MedCommons Open Radiology™ Gateway. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (eFilm Workstation) based on device description, intended use, and similar features. It is a regulatory submission for market clearance, not a report of a performance study with specific acceptance criteria.

Therefore, I cannot provide the requested table and study details. The document explicitly states:

• Substantial Equivalence: The MedCommons Open Radiology™ Gateway is substantially equivalent to the eFilm Workstation, which was cleared in 510(k)'s K020995 and K012211.
• Comparison to the predicate device: The MedCommons Open Radiology™ Gateway and the eFilm Workstation are both software applications intended for viewing medical images stored in PACS systems. They have similar features and are substantially equivalent in safety and effectiveness.

This indicates that the clearance was based on similarity to an already approved device, rather than a new clinical performance study with defined acceptance criteria and subsequent testing against them for this specific device.

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