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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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