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FLOW has been developed for the objective and reproducible analysis of velocity-encoded cine MR imaging studies of arterial vessels and heart valves. Intended purposes are:

1. supporting clinical diagnoses about the status of the function of the cardiac cambers:
2. supporting clinical diagnoses about the flow velocity and volume flow through cardiac and peripheral vessels, both under basal and increased flow conditions;
3. supporting subsequent clinical decision making purposes;
4. supporting the use in clinical research trials, directed at studying changes in function of the heart chambers and in the flow through cardiac and peripheral vessels as a result of interventions.

The FLOW software package enables to sem-automatically calculate and display of various parameters such as : Mean velocity (also minimum, maximum and Standard deviation) and volume flow in different reqion of interest (ROI); Velocity and volume . unction of time; Stroke volume and cardiac but put When interpreted by a trained physician these ameters may be useful in supporting the determination of a diagnosis .

FLOW is a state-of-the-art analytical software tool designed for UNIX as well as Linux platforms. FLOW facilitates the import and visualization of velocity-encoded cine MRI imaging studies via CD-ROM and digital network. This FLOW functionality is independent of the MRI equipment vendor. FLOW provides objective and reproducible data on velocity and volume flow as a function of time, and other derived data such as mean velocity and volume flow, stroke volume and cardiac output. FLOW is intended to support all clinicians, i.e. cardiologists, and referring physicians involved in the noninvasive assessment of flow and flow velocity in arterial vessels and at heart valves.

The provided text describes the regulatory submission for the "MRI-FLOW analytical software package" (FLOW), but it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

The document is a 510(k) Premarket Notification summary and an FDA clearance letter. It mainly focuses on:

• Device Description: What the device is and what it does (analyzes velocity-encoded cine MRI for flow and velocity in vessels/heart valves).
• Intended Use: The clinical purposes for which the device is designed (supporting diagnoses, clinical decision making, research).
• Substantial Equivalence: Arguing that FLOW is substantially equivalent to a predicate device (General Electric K924605 "Flow Analysis Option for Advantage Windows™ 2.0 and 3.1") based on similar technological characteristics and intended use.
• Safety and Effectiveness Conclusion: Stating that the manufacturer believes FLOW is safe, hazards are controlled by a risk management plan (including hazard analysis, verification, and validation tests), and is supported by "Evaluation by hospitals and literature."

The key missing elements for your request are: defined quantifiable acceptance criteria for performance metrics and details of a specific study designed to test against those criteria.

While the text mentions "verification and validation tests" in Appendix E, the content of these tests and their results are not provided in this summary. Similarly, "Evaluation by hospitals and literature" is mentioned as support, but without specific study designs, methodologies, or results.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text, as this information is not present.

However, I can extract what little information is available:

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, although "Evaluation by hospitals and literature" is mentioned as supportive information. The specific test set used for verification and validation is not detailed.

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

• Not specified. The document mentions the device is intended to be interpreted by a "trained physician," but does not detail how ground truth for verification/validation was established by experts.

4. Adjudication method for the test set

• 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

• Not specified. The document implies the software provides objective data to support clinical diagnoses, but does not describe a study comparing human performance with and without the software.

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

• The device is described as "analytical software package" that "enables to semi-automatically calculate and display of various parameters." The results are then "interpreted by a trained physician." This suggests it's a standalone analytical tool, but its performance alone (without a human interpreting) is not quantified or formally tested in a reported study within this document. The manufacturer states "the level of concern for the standalone software to view images is 'minor'," which implies it functions independently for image viewing/analysis.

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

• Not specified.

8. The sample size for the training set

• Not specified. (It's also unclear if machine learning/AI in the modern sense was used, as this is a 1999 submission for "analytical software" for "semi-automatic" calculation).

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

• Not specified.

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