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QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries. QVA-CMS analytical software is intended to support clinicians. i.e. cardiologists. radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.

QVA-CMS is a state-of-the-art analytical software tool designed for Windows operating systems. QVA-CMS analytical software facilitates the import and visualization of X-ray images via CD-ROM and digital network. The QVA-CMS functionality is independent of the X-ray acquisition equipment vendor. QVA-CMS, performing automated contour detection, provides quantitative analysis with objective and reproducible assessment of vascular lesions in selected regions of interest. The analysis results of user's selection can be reported in user-defined configuration, exported in general formats and transported for storage via communication with standard Microsoft office packages.

The provided document, a 510(k) notification for the QVA-CMS analytical software package, is a regulatory submission to the FDA. It declares the device's substantial equivalence to a predicate device (QCA-CMS, K993763) and outlines its intended use and safety. However, this document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's an analysis of what can and cannot be extracted from the provided text based on your request:

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

• The document states: "It is the opinion of MEDIS medical imaging systems B.V. that QVA-CMS is safe and potential hazards are controlled by the risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E)."
• It also mentions: "Evaluation by hospitals and literature (see Appendix F) supports this statement."

Missing Information: The actual acceptance criteria (e.g., specific quantitative thresholds for accuracy, precision, sensitivity, specificity) and the reported performance values that demonstrate these criteria were met are not detailed within this document. Appendices C, D, E, and F are referenced as containing this information, but they are not included in the provided text.

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

Missing Information: The document explicitly mentions "verification and validation tests" and "Evaluation by hospitals and literature," but it does not specify the sample size of any test set, the provenance of the data (e.g., country of origin), or whether the study was retrospective or prospective.

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)

Missing Information: The document describes the device's function as providing "objective and reproducible assessment of vascular lesions" and improving "interpretation of vascular images for decisions by the clinicians." It also mentions "reducing the risks, due to user variability associated with conventional visual assessment." However, it does not detail the number or qualifications of experts used to establish ground truth for any validation study.

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

Missing Information: The document does not describe any adjudication method used for establishing ground truth or evaluating test set results.

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 states: "The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment." and "QVA-CMS analytical software is intended to support clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process."

Missing Information: While the text hints at a reduction in inter-observer variability, it does not explicitly describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was measured. Therefore, an effect size for human improvement with AI cannot be determined from this text. The statement about reduced variability suggests that such a study might have been performed (or is conceptually implied), but the details are not here.

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

• The document describes QVA-CMS as "performing automated contour detection, provides quantitative analysis with objective and reproducible assessment of vascular lesions." This implies the algorithm's ability to operate in a standalone capacity to perform its core function.
• "It is the opinion of MEDIS medical imaging systems B.V. that QVA-CMS is safe and potential hazards are controlled by the risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E)." This "verification and validation tests" section would likely include evaluation of the algorithm's standalone performance.

Partial Information: The core function of "automated contour detection" and "quantitative analysis" inherently refers to the algorithm's standalone capability. The document alludes to "verification and validation tests" which would assess this, but does not provide direct results or details of a specific standalone study.

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

Missing Information: The document mentions "objective and reproducible assessment" and "quantify medical images," but does not specify how the ground truth for comparison was established (e.g., whether it was expert consensus, invasive measurement, pathology, or clinical outcomes).

8. The sample size for the training set

Missing Information: The document is primarily focused on regulatory submission and equivalency. It does not provide any details regarding the training set's sample size used for the development of the automated contour detection algorithms.

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

Missing Information: Similar to point 8, the document does not detail how ground truth was established for any training data used in the development of the QVA-CMS software.

In summary:

This 510(k) submission establishes the device's intended use and its substantial equivalence to a predicate device. It references internal validation and testing documents (Appendices C, D, E, F) that would likely contain the specifics requested. However, the provided text itself lacks the detailed technical and clinical study information required to populate a comprehensive table of acceptance criteria, study methodologies, and results. You would need to access those referenced appendices or a more detailed technical report to get this information.

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