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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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