Search Results

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.

Ask a specific question about this device

CMS-View provides a means for the playback and/or review of medical images or imaging sequences by physicians, scientists or other medical personnel. These medical images may originate from different imaging modalities (x-ray, MRI, ultrasound, nuclear, etc.) and are inpul to the CMS-VIEW system via industry standard formats (DICOM) or by creating a digital equivalent of a video-format (via frame-grabber). Standard image review tools are provided, including zoom, brightness and contrast controls.

The review of medical images is suitable for use by physicians and scientists in the following applications:

1. Scientific and research studies, selecting and assessing medical images that are of interest,

2. Review and analysis of patient medical images, providing physicians and administrators with convenient access and review features/capabilities.

CMS-View is a professional state-of-the-art DICOM Review Station, designed for use with Microsoft Windows operating systems (preferably, Windows NT). CMS-View facilitates the import and visualization of medical images from a range of different image sources (DICOM-CD, network, VCR, etc.) for use by trained medical personnel (technologists, radiologists, other physicians, etc.). CMS-View may be used either independently or in conjunction with other software products from MEDIS.

I am sorry, but based on the provided document, I cannot extract the detailed information requested regarding the acceptance criteria, study design, and performance metrics.

The document is a 510(k) summary for the "CMS - View" device, which is described as a DICOM Review Station for medical image visualization. It outlines the device's intended use and claims substantial equivalence to a predicate device (RadWorks Medical Imaging Software).

However, the provided text does not contain any information about:

1. Specific acceptance criteria or reported device performance metrics. The document states that "Potential hazards are controlled by a risk management plan for the software development process (see Appendix C), including hazard analysis, verification and validation tests and evaluations by hospitals," but it does not detail the results or criteria used in these tests.
2. Sample size used for the test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a performance study with detailed clinical or technical endpoints. It confirms the FDA's clearance of the device based on this substantial equivalence claim.

Ask a specific question about this device

The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.

The RadWorks Quality Control Module is intended to be used by authorized staff to perform various quality control operations on RadWorks imaging studies before they are made available to other locations on the network. These operations include confirming or editing patient characteristics, reviewing the status history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

The provided text does not contain information about specific acceptance criteria or an explicit study proving that the device meets those criteria. The submission is focused on demonstrating substantial equivalence to a predicate device, as confirmed by the FDA's letter (K982862).

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document describes the "RadWorks Medical Imaging Software with Quality Control Module" as having various quality control operations (confirming/editing patient characteristics, reviewing status history, adding/removing images, combining studies, renumbering images, editing orientation, setting/editing routing information). However, it does not state specific performance metrics (e.g., accuracy, speed, user-friendliness) for these operations, nor does it define acceptance criteria for such metrics.

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

Not explicitly provided. The document mentions "Software testing of the new module followed Applicare's normal procedures" and that "a software test plan is developed, containing a detailed description of relevant test procedures." However, it does not specify the details of the test set, including its sample size or data provenance (e.g., country of origin, retrospective/prospective nature).

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

Not applicable/Not explicitly provided. Since no specific performance claims or a detailed test set are described for the Quality Control Module's operations, there's no mention of experts being used to establish a "ground truth" for the test set. The module's functions are primarily for data manipulation and quality control, not diagnostic interpretation requiring expert consensus on complex medical conditions.

4. Adjudication Method for the Test Set

Not applicable/Not explicitly provided. As no expert review or diagnostic assessment is detailed, an adjudication method is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC study typically compares human readers' diagnostic performance with and without AI assistance. The RadWorks Medical Imaging Software with Quality Control Module is described as a tool for managing and manipulating medical images, not for diagnostic interpretation. Therefore, an MRMC study is not relevant to its stated function and was not conducted or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not explicitly provided within the context of performance metrics. The software performs operations for authorized staff, implying a human-in-the-loop interaction rather than a fully autonomous diagnostic or analytical algorithm. The testing described focuses on software functionality, not algorithmic performance in a standalone capacity.

7. The Type of Ground Truth Used

Not explicitly provided. Given the nature of the software (image management and quality control), "ground truth" would likely relate to the correct execution of software functions (e.g., if an image was successfully moved, if patient characteristics were correctly edited, if routing information was accurately set). This would be verified through functional testing rather than clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The RadWorks Quality Control Module is described as software for performing various operations on imaging studies. It is not an AI/ML algorithm that learns from a "training set" in the conventional sense (i.e., a dataset used to train a predictive model). Its functions are programmed, not learned.

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

Not applicable. As it's not a machine learning model, there is no "training set" or ground truth establishment for such a set.

Summary of what is present:

• The 510(k) submission is for a modification to an existing device (K962699).
• The modified device (RadWorks Medical Imaging Software with Quality Control Module) adds specific quality control operations (confirming/editing patient characteristics, reviewing status history, adding/removing images, combining studies, renumbering images, editing orientation, setting/editing routing information).
• The submission asserts that the technological characteristics of the modified device are "identical" to the original.
• Software testing followed Applicare's internal procedures, including a test plan describing what to test, expected results, when, by whom, resources used, and how results are recorded.
• The conclusion is that the intended use is the same as the predicate, and technological characteristics are sufficient to demonstrate substantial equivalence.

In essence, this 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device and adherence to internal software testing procedures, rather than presenting a performance study with specific acceptance criteria, ground truth, or statistical analysis of algorithmic performance.

Ask a specific question about this device