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1. Digitization of VCR recordings of ICUS (Intra Coronary Ultra Sound ) or IVUS (Intra Vascular Ultra Sound) examinations of patients to the (IVUS) DICOM 3 format
2. Quantitative analysis of artery and stent dimensions.

The Quantitative Intra Vascular Analysis software offers digitization of VCR recordings of IVUS pullback examinations, semi-automatic contour detection of the lumen, vessel and stent structures in different user definable regions and quantitative analysis of the dimensions of all structures. Contours can be saved and the results of the analysis can be presented in printed reports or saved to a spreadsheet file. QIVA has been developed for Windows 2000 and NT.

The provided text is a 510(k) summary and FDA clearance letter for the QIVA device, which is quantitative intravascular ultrasound analysis software. It does not contain a detailed study report with specific acceptance criteria and performance metrics in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided text.

However, I can extract the information that is present:

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

This information is not present in the provided 510(k) summary. The document focuses on "substantial equivalence" rather than reporting specific performance metrics against pre-defined acceptance criteria for a new clinical study.

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 present in the provided 510(k) summary.

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 present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary.

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:

This information is not present in the provided 510(k) summary.

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

The device description indicates it is "semi-automatic contour detection" and "quantitative analysis," implying a standalone algorithm. However, no specific standalone performance study details are provided. The clearance is based on substantial equivalence to a predicate device.

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

This information is not present in the provided 510(k) summary. For devices of this type (quantitative analysis), ground truth is often established by manual measurements by experts or comparison to a gold standard imaging modality, but this is not specified here.

8. The sample size for the training set:

This information is not present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary.

Summary of what is available in the provided text:

• Device Name: QIVA
• Intended Use:
  1. Digitization of VCR recordings of ICUS (Intra Coronary Ultra Sound) or IVUS (Intra Vascular Ultra Sound) examinations of patients to the (IVUS) DICOM 3 format.
  2. Quantitative analysis of artery and stent dimensions.
• Technological Characteristics: Offers digitization, semi-automatic contour detection of lumen, vessel, and stent structures, and quantitative analysis of dimensions.
• Predicate Device: OCU-CMS software package (FDA number K011582).
• Basis for Clearance: Substantial equivalence to the predicate device, using the same technological characteristics and intended use.

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