Search Results

• This application software is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
• This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images.
• This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.

Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image.
CT Dual kV is a new image processing tool of Ziostation2
The added capabilities provided by this additional image processing tool for use with CT DICOM compliant images are:
Generating and manipulating further images using volume data of two different tube voltage CT scans:

• O Blend image
• Subtraction image
• 0 Virtual non-contrast image
• lodine distribution map
• O 2-Material decomposition image

The provided text is a 510(k) Summary for the Ziostation2 device. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, device performance metrics, the studies conducted (including sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or any mention of MRMC comparative effectiveness studies or standalone performance evaluations.

Therefore, I cannot provide the requested information based solely on the given text. The text only mentions "integration testing/verification testing" and "regression testing" without elaborating on their specifics or results against defined acceptance criteria.

Ask a specific question about this device

• This application is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
• This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images.
•This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
• Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which this application is being offered.

Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image.

The Ziostation2 is an image processing application software for viewing, quantifying, manipulating, communicating, printing, and managing medical images from various modalities. The 510(k) summary (K181892) indicates that several new functionalities and enhancements were added to the Ziostation2, building upon the features of the previously cleared Ziostation2 (K151212) and other predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

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

The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the Ziostation2 software itself. Instead, the document focuses on demonstrating substantial equivalence to predicate devices for its new functionalities and enhancements. The acceptance criteria appear to be based on the functional similarity and safety of the new features compared to already legally marketed devices.

However, based on the text, we can infer that the general "acceptance criterion" is that the new functionalities (LAA analysis, Lung Lobes, Virtual Bronchoscopy, CT Lung Resection Planning, MR Myocardial T1 Mapping) perform similarly to their counterparts in the predicate devices and do not introduce new safety or effectiveness concerns.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on establishing substantial equivalence to predicate devices, implying that testing focused on confirming functional similarity and safety, rather than a separate clinical performance study with a distinct test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the number or qualifications of experts used to establish ground truth for a test set. This type of information is typically part of a clinical performance study, which is not described here.

4. Adjudication method for the test set

The document does not describe an adjudication method for a test set. As no specific clinical test set is elaborated upon, neither is an adjudication method.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no indication of an assessment of human readers' improvement with or without AI assistance. The submission is for an image processing application, which may include AI components, but a specific MRMC study is not detailed.

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

The document does not provide details about a standalone (algorithm-only) performance study. The device is an "image processing application software" intended for "trained medical professionals to supplement generally accepted methods of interpreting radiological images," implying a human-in-the-loop context.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. Given the nature of a 510(k) summary focused on substantial equivalence to predicate devices across various image processing functions, the "ground truth" would likely be implied by the established and accepted performance of the predicate devices themselves, or by standard clinical and radiological interpretation methods. It does not mention pathology or outcomes data as explicitly used for a test set's ground truth.

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. This information would typically be relevant for machine learning or AI components, but it is not detailed in this submission.

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

The document does not describe how ground truth for any training set was established. Similar to point 8, this information is absent.

Ask a specific question about this device

MR Cardiac Function Analysis

The MR Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac MR images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

MR Cardiac Function Analysis is an add-on software package designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by this new device are:

MR Cardiac Function Analysis software post-processes ECG-gated cardiac MR images and extracts the following left ventricular parameters from multi-phase data.

• · Left ventricular ejection fraction
• End diastolic volume
• End systolic volume
• Stroke volume
• Cardiac output
• Cardiac Index
• Wall thickness
• Wall thickness ratio
• Wall movement
• Volume Curve
• Peak Ejection Rate
• Peak Filling Rate

The provided text describes the MR Cardiac Function Analysis software and its functionality butlacks detailed information regarding specific acceptance criteria, a formal study proving device performance against those criteria, or specific data pertaining to the accuracy and reliability of the measurements.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established, as this information is not present in the provided text.

Based on the available text, here's what can be inferred:

Acceptance Criteria and Device Performance Study Details:

As per the provided 510(k) summary, detailed acceptance criteria and a formal study demonstrating the device's performance against these criteria are not explicitly described. The text mentions "integration testing/verification testing prior to Beta validation" and "Software Beta testing/validation will be successfully completed prior to release," along with addressing "potential hazards by the Ziosoft Risk Management process." However, these statements refer to internal development and validation processes rather than a structured study proving specific performance metrics against clinical acceptance criteria for the parameters calculated by the device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not specified or indicated.
• Effect Size: Not applicable, as no MRMC study details are provided.

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

• Standalone Performance Study: The document describes the software as semi-automatically calculating and displaying parameters "to assist the clinician in a cardiac evaluation," implying a human-in-the-loop scenario. A standalone performance study without a human is not explicitly mentioned or detailed.

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

• Type of Ground Truth: Not specified.

8. The sample size for the training set:

• Sample Size: Not specified.

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

• Method for Establishing Ground Truth: Not specified.

Summary of what is known from the document:

The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Medis Medical Imaging Systems B.V.'s MRI-FLOW Analytical Software Package, K994282) rather than providing detailed clinical validation study results. It outlines the device's intended use, its ability to post-process DICOM compliant cardiac MR images to calculate various functional parameters, and its software-only nature. Regulatory compliance and general software testing (integration, verification, beta testing) are mentioned, but specific performance data or a formal clinical efficacy study is not provided in this summary.

Ask a specific question about this device

Cardiac Function Analysis: The Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

Calcium Scoring: The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

Cardiac Function Analysis and Calcium Scoring are add-on software packages designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by these two new devices are:

Cardiac Function Analysis software post-processes ECG-gated cardiac CT images and extracts the following left ventricular parameters from multi-phase data.

• Left ventricular ejection fraction
• End diastolic volume
• End systolic volume
• Stroke volume
• Cardiac output
• Cardiac Index
• Wall thickness
• Wall thickness ratio
• Wall movement .
• . Volume Curve

Calcium Scoring software post-processes DICOM-based cardiac CT images and evaluates calcified plaque in the coronary arteries, providing the clinician with both Agatston and Volume calcium scores. These regions of interest are selected by the user.

The provided text does not contain detailed acceptance criteria for the "Cardiac Function Analysis" and "Calcium Scoring" software, nor does it describe a specific study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, or agreement with ground truth.

The document mainly focuses on the regulatory submission process, intended use, device description, and substantial equivalence to predicate devices, rather than detailed performance studies against specific acceptance criteria.

Therefore, many of the requested sections cannot be filled from the given text.

Here's what can be extracted based on the provided information:

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

No explicit acceptance criteria (e.g., minimum accuracy, sensitivity, or agreement percentages) are stated, and no specific performance metrics are reported in the provided text. The document states "The Cardiac Function Analysis and Calcium Scoring software packages will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release." This indicates that internal testing was conducted, but no results are presented.

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

Not mentioned in the document.

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)

Not mentioned in the document.

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

Not mentioned in the document.

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

Not mentioned in the document.

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

The "Intended Use" section for both Cardiac Function Analysis and Calcium Scoring states that the software is intended for semi-automatic calculations and is a post-processing software tool where "regions of interest are selected by the user." This implies that the device is not purely standalone but is designed to assist a human user (human-in-the-loop). However, no standalone performance study results are provided.

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

Not mentioned in the document.

8. The sample size for the training set

Not mentioned in the document.

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

Not mentioned in the document.

Ask a specific question about this device

Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication:

The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion Option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

CT Brain Perfusion for Ziostation is an add-on software feature designed to provide a color map of cerebral blood flow and pictorial illustration of perfusion-related parameters obtained on CT images of the brain. This software is designed to work within the currently cleared Ziostation image management device.

The provided text does not contain detailed information about specific acceptance criteria, comprehensive study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or adjudication methods. The document is primarily a 510(k) summary for a "CT Brain Perfusion for Ziostation" software, describing its intended use, predicate device, and confirming substantial equivalence.

Here's an analysis of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "All devices met the required specifications for the completed tests." However, it does not detail what those specifications or acceptance criteria were, nor does it provide specific metrics for device performance beyond this general statement.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "1000" under the "Testing Summary" section, but it's unclear if this refers to the number of tests performed, the size of a dataset, or something else entirely. It does not explicitly state it as the test set sample size.
• Data Provenance (country of origin, retrospective/prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Adjudication method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• The document does not mention an MRMC comparative effectiveness study. The device is described as an "image analysis software package providing additional image processing capabilities" and "pictorial illustration...to aid in the assessment," suggesting it's a tool for professionals rather than a standalone diagnostic or a direct comparison of human performance with vs. without AI. No effect size is provided.

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

• The document does not explicitly state whether a standalone performance study was conducted. Given its description as "image analysis software package providing additional image processing capabilities" and intended "to aid in their reading and review," it implies human-in-the-loop use.

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

• Type of Ground Truth: Not specified.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified.

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

• Ground Truth Establishment for Training Set: Not specified.

In summary, the provided 510(k) summary is very high-level regarding testing and validation. It states that all specifications were met but does not offer the granular detail about the study methodology, data characteristics, or performance metrics that your questions are looking for.

Ask a specific question about this device

ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammograpic 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.

ZIOSTATION is a software-only imaging workstation that installs on one or more of a customer's standard PCs and integrates with a customer's 'off the shelf' PC-based computer components to provide viewing, quantification, manipulation, communication, printing, and management capabilities for medical images. It provides access to both local and centralized (networked) image data.

ZIOSTATION can acquire and work with image data from multiple DICOM-compliant modalities and image archives. It provides querying and listing based on user-selected criteria. It provides for multiple types of 2D and 3D image displays. It provides interactive menus and tools for image manipulation and measurement. ZIOSTATION provides workflow enhancement and optional specialist tools for clinical applications.

ZIOSTATION uses only lossless compression for images used for diagnostic purposes. It does use lossy compression when exporting to JPEG and AVI files, but its labeling indicates that those files are not to be used for clinical evaluations.

The ZIOSTATION is a PACS system that has not conducted any clinical studies to establish specific acceptance criteria or performance metrics directly from the provided text. The document states that the device has been "thoroughly tested by Ziosoft in accordance with their software development and validation procedures" and "independently evaluated by trained physicians specializing in medical imaging disciplines." However, no specific acceptance criteria or performance data from these evaluations are presented in the document.

Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device, the Barco Voxar 3D Enterprise (K061326). The "acceptance criteria" in this context are implicitly met by showing that ZIOSTATION's features and intended use are essentially identical to the predicate device, and that it does not introduce any new safety or efficacy concerns.

Given the information in the provided text, the specific details requested for a study proving device adherence to acceptance criteria (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not available. The document focuses on regulatory clearance through substantial equivalence rather than explicit performance evaluation against predefined numerical criteria.

Therefore, the table of acceptance criteria and reported device performance cannot be filled with numerical values, and many of the questions regarding study design cannot be answered from this document.

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

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, no specific numerical acceptance criteria or performance metrics are reported for ZIOSTATION. The submission relies on substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

• Not specified. The document mentions internal testing and independent evaluation by physicians but provides no details on sample size or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. The document vaguely states "independently evaluated by trained physicians specializing in medical imaging disciplines" but does not quantify the number of experts or their specific qualifications (e.g., years of experience, subspecialty). No explicit "ground truth" establishment process for a test set is described.

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

• Not specified. No details on adjudication methods for any evaluation are provided.

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 indication of an MRMC study. The ZIOSTATION is an image processing workstation, not specifically an AI-driven diagnostic aid that would typically undergo such a study to measure reader improvement. The document does not describe AI functionality or a reader improvement study.

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

• Not applicable/Not specified as a standalone algorithm. ZIOSTATION is described as an "image processing workstation software package" intended for use by "trained medical imaging professionals to aid in their reading and review." It is not presented as a standalone diagnostic algorithm.

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

• Not specified. Since no specific performance study with a test set is detailed, the type of ground truth used is not mentioned. The primary argument is substantial equivalence to a predicate, not performance against a ground truth dataset.

8. The sample size for the training set

• Not applicable/Not specified. ZIOSTATION is an image processing and visualization system, not an AI/machine learning model where a distinct "training set" would typically be referenced for model development. The document does not mention any machine learning components requiring a training set.

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

• Not applicable/Not specified. As there's no mention of a training set, the method of establishing ground truth for it is also not discussed.

Ask a specific question about this device