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The Viatronix V3D Calcium Scoring System is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.

The V-3D Calcium Scoring System for Coronary Artery Calcification Scoring is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. The V-3D Calcium Scoring is an anatomy specific software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer. Upon receipt of a multi-slice CT scanner image for coronary arteries through DICOM, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. The V-3D viewer provides interactive 2D and 3D views from the V-3D viewer and determines the density and location of calcium deposits within the coronary arteries and also scores measurements of calcium deposits. The calcium score provides a quantitative evaluation of the extent of plaque accumulation in the coronary arteries.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• t-tests concluded that the difference between the means of the V3D Calcium Scoring application and the predicate device was "zero or insignificant with a 99% level of confidence" for both volumetric and Agatston scores.
• F-tests concluded that the two sets of scores did "not differ in variability with a 99% level of confidence" for both volumetric and Agatston scores.
• For simulated phantom datasets, the output results "correlated perfectly to the pre-calculated score values." |
  | Reliability | "The product has shown itself to be reliable, easy to use and capable of calculating useful Calcium Score values." |
  | Usability | "The product has shown itself to be reliable, easy to use and capable of calculating useful Calcium Score values." |
  | Ability to Review and Analyze CT Images for Cardiac Calcium Scoring | Demonstrated through statistical equivalence to the predicate device in calculating calcium scores, which is a core function for reviewing and analyzing images for this purpose. |

Explanation of "Implicit" Acceptance Criteria: The document does not explicitly list numerical acceptance criteria (e.g., "accuracy must be >95%"). Instead, the primary acceptance criterion is substantial equivalence to existing predicate devices. This means the Viatronix V3D Calcium Scoring System must perform comparably to the predicate devices in terms of its ability to calculate calcium scores. The statistical tests performed (t-test and F-test) are designed to demonstrate this equivalence.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document mentions "Patients' Calcium Scoring Cases" were used for the clinical evaluation, but it does not specify the number of cases used.
• Data Provenance: The data comes from "Patients' Calcium Scoring Cases." It does not explicitly state the country of origin. The study appears to be retrospective, as "Same Cases were loaded into the Viatronix V3D Calcium Scoring application" after being evaluated with the predicate device.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not explicitly state the number of experts used to establish the ground truth for the test set.
• It implies that the "predicate device" was used to establish the initial scores, which were then compared to the scores from the Viatronix device. Therefore, the "ground truth" for the comparison was based on the performance of an already cleared device, not human experts providing a "true" score independently. This is a common approach for demonstrating substantial equivalence.

4. Adjudication Method:

• None directly stated. The "ground truth" for comparison was generated by the predicate device. The study design involved comparing the new device's output to the output of the predicate device, not adjudicating discrepancies between multiple human readers or between human and AI.

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

• No, an MRMC comparative effectiveness study was not done. The study's focus was on the equivalence of the device's numerical calculation output compared to a predicate device, not on how the device assists human readers or improves their performance.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The entire clinical study described involved the algorithm (Viatronix V3D Calcium Scoring application) calculating scores, which were then compared to scores calculated by the predicate device. There is no mention of human interaction during the Viatronix device's scoring process for the purpose of the study.
• Additionally, simulated "phantom" datasets with "known values" were used, where the device's output "correlated perfectly to the pre-calculated score values." This demonstrates standalone performance against an ideal, theoretical ground truth.

7. Type of Ground Truth Used:

• For the clinical evaluation, the ground truth was essentially the scores generated by the predicate device. This is a form of "reference standard" comparison to an already accepted technology.
• For the non-clinical tests, the ground truth was pre-calculated theoretical values derived from "known values" in simulated phantom datasets.

8. Sample Size for the Training Set:

• The document does not specify the sample size for the training set. It only mentions development and testing.

9. How Ground Truth for Training Set Was Established:

• The document does not provide details on how ground truth was established for any training data. It primarily focuses on the validation of the final product against predicate devices and simulated data.

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