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The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.

The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf PCs running Windows 2000/XP operating systems and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Angiography MIP, Vessel Tracking and Tissue Definition.

This submission is a Special 510(k) for software modifications to an existing device, MediPrime, a Radiology Reading and Reporting Station. The modifications include added features for Angiography MIP, Vessel Tracking, and Tissue Definition. The summary does not contain information on acceptance criteria or a study proving device performance because the modifications do not affect the intended use, alter the fundamental scientific technology, or raise new issues of safety or effectiveness. Therefore, a comprehensive study as typically described for new device clearances demonstrating performance against acceptance criteria is not provided.

Specifically, the document states: "The modified device contains added features, including Angiography MIP, Vessel Tracking and Tissue Definition." and "The modifications to the MediPrime do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification was to software. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness."

Because this is a Special 510(k) for minor software modifications to an already cleared device, detailed performance metrics against acceptance criteria and dedicated clinical study data for device performance as a standalone algorithm are generally not required or provided in the summary. The focus is on demonstrating that the modifications do not introduce new risks or alter the previously established substantial equivalence.

Therefore, the requested information elements related to acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are largely not applicable or not provided in this type of submission.

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The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.

The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf Windows 2000 computers and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Multi-Planar Reformatting (MPR).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MediPrime device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain any specific acceptance criteria or quantitative performance metrics for the MediPrime device. It describes the device as a "Radiology Reading and Reporting Station" and states that "The modifications to the MediPrime do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification was to software. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness."

This suggests that the 510(k) submission was for a modification (addition of Multi-Planar Reformatting (MPR)) to an already cleared device (K002894). Therefore, the "acceptance criteria" likely revolved around demonstrating that the new software feature did not introduce new safety or effectiveness concerns and maintained substantial equivalence to the predicate device. Without specific performance claims or a formal study outlining acceptance criteria, a table like the one requested cannot be generated from the given information.

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

The provided text does not mention any specific sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). Given that this is a Special 510(k) for a software modification to an existing device, it's possible that a formal clinical validation with a new test set wasn't required or documented in this summary if the changes were deemed not to significantly impact clinical performance. The focus appears to be on demonstrating that the modification itself did not negatively affect safety or effectiveness.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention any experts being used to establish ground truth or their qualifications. This is consistent with the lack of a detailed clinical study described in this summary.

4. Adjudication Method

The provided text does not mention any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.

6. Standalone Performance Study

The provided text does not indicate that a standalone (algorithm only) performance study was done. The device itself is described as an "interactive tool for analyzing radiological data," implying human interaction is integral to its intended use, rather than being a fully automated standalone algorithm.

7. Type of Ground Truth Used

The provided text does not specify the type of ground truth used.

8. Sample Size for the Training Set

The provided text does not mention a sample size for a training set. The device is a radiology reading station, not an AI algorithm that learns from a training set in the typical sense. The software modification (MPR) is a feature, not a machine learning model.

9. How Ground Truth for the Training Set Was Established

The provided text does not mention how ground truth for a training set was established.

Summary of what can be gleaned from the text:

The provided document is a summary of a Special 510(k) premarket notification for a minor software modification (addition of Multi-Planar Reformatting, MPR) to an already cleared radiology reading and reporting station called MediPrime. The core argument for substantial equivalence relies on the assertion that the modification does not affect the intended use, alter fundamental scientific technology, or raise new issues of safety or effectiveness. As such, the document does not contain details about formal clinical studies, acceptance criteria, test sets, ground truth establishment, or performance metrics typically associated with novel device submissions or significant clinical claims. The FDA's clearance indicates that they agreed with the manufacturer's assessment that the modification did not warrant extensive new performance data.

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ProVision is an independent diagnostic viewing and processing workstation. It is based on a Silicon Graphics Workstation running under Unix. ProVision communicates with imaging systems of different modalities (currently CT, MRI, CR, RF, NM) utilizing the DICOM - 3 standard. Connection may also be made to any other DICOM device. ProVision functions include :Archiving, displaying, manipulation, filming, 2and 3-dimensional processing. ProVision employs a graphical multi -Window, icon and mouse driven user interface. It is designed to ensure maximum flexibility on the one hand, and intuitive operation on the other.

The ProVision is a multi-modality diagnostic Workstation for processing and archiving radiological images. It is based on off-the shelf Silicon Graphics UNIX based computers that comply with the accepted international standards for computer systems. The systems also comprises software developed and validated by Algotec Systems Ltd.

The provided text does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria. The document is a 510(k) summary for a software update to a diagnostic workstation (ProVision) and focuses on demonstrating substantial equivalence to a predicate device.

However, based on what is provided, here's a breakdown of the requested information, acknowledging the limitations of the input text:

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

The document states: "The new updates simply provide quicker methods to reach results that would have been time consuming on the previous version of Pro Vision software. The addition of these software updates raises no new issues of safety or effectiveness."

This implies that the key performance criteria for the update are related to efficiency/speed and maintaining safety and effectiveness at least equivalent to the predicate device. However, no quantitative acceptance criteria or specific performance metrics are reported in this document.

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

This information is not provided in the given text.

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)

This information is not provided in the given text. The document refers to the system's intended use "by radiologists as an interactive tool for analyzing radiological data," but doesn't detail any expert involvement in a study.

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

This information is not provided in the given text.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The document focuses on software updates for an existing diagnostic workstation, emphasizing efficiency improvements and substantial equivalence, not the comparative performance of human readers with vs. without AI assistance. The device is described as "an interactive tool for analyzing radiological data," implying human-in-the-loop, but no comparative study is mentioned.

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

The device, ProVision, is described as an "independent diagnostic viewing and processing workstation" and an "interactive tool for analyzing radiological data." This inherently implies a human-in-the-loop system. Therefore, a standalone (algorithm only) performance study would likely not be relevant or described for this type of device, and there is no mention of one.

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

This information is not provided in the given text.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence for software updates to an existing diagnostic workstation. It asserts that the updates improve efficiency and do not introduce new safety or effectiveness issues. However, it lacks detailed information regarding specific study designs, acceptance criteria, sample sizes, expert involvement, or ground truth establishment that would typically be found in a comprehensive performance study report. The claims are high-level and refer to the inherent nature of the updates within the existing system.

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