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Cardiac Scoring from whole body computed tomography derived measurements. For non-invasive detection and quantification of atherosclerotic plaque.

The Vitrea 1.3 Coronary Artery Calcification Scoring (CACS) module is an additional software feature/option to K963697, Advanced Diagnostic Viewer (ADV). ADV was subsequently marketed as Vitrea - Image Processing Software by Vital Images, Inc. This feature provides visualization, quantification and reporting of the amount of calcium detected in the coronary arteries by processing data from Electron Beam or spiral/helical scanning image data.

The provided 510(k) summary for Vitrea 1.3 Image Processing Software (K990442) outlines various aspects of the device and its regulatory submission. However, it does not contain specific details about acceptance criteria, the study proving the device meets them, or many of the specific study design elements requested in the prompt.

The document primarily focuses on establishing substantial equivalence to a predicate device (Elscint, Inc.'s Cardiac Scoring Option K970980) and mentions general software development and testing procedures.

Here's a breakdown of what can and cannot be extracted from the provided text, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• None explicitly stated in the provided text. The document states "Performance Testing: All software testing specified in the Software Development and Test Plan will be successfully completed prior to market release" and "Clinical Evaluation: Software Beta testing will be successfully completed validating feature/performance prior to market release." This implies acceptance criteria exist in internal documents but are not disclosed in the 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Not explicitly stated in the provided text. The document mentions "Clinical Evaluation: Software Beta testing," but the sample size, type of data (retrospective/prospective), and country of origin are not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not explicitly stated in the provided text. There is no mention of experts establishing ground truth for a test set. The submission focuses on the algorithm's performance against the Agatston method.

4. Adjudication Method for the Test Set:

• Not explicitly stated in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• Not explicitly stated in the provided text. The document describes comparisons in terms of intended use and computing method with the predicate, but not a comparative effectiveness study involving human readers.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

• Implied, but not detailed as a formal study. The device calculates a score based on the Agatston method. The "Performance Measurement Testing" section for the predicate device (Elscint) refers to "Attached Clinical Comparison Summary/Data," which might contain standalone performance data, but this is not provided for the Vitrea 1.3 in this specific document. The "Computing Method: Agatston method for quantification of high density structures" for Vitrea 1.3 suggests an algorithmic, standalone calculation.

7. The Type of Ground Truth Used:

• Implied to be the Agatston method. The document states the device uses the "Agatston method for quantification of high density structures" and is for "non-invasive detection and quantification of atherosclerotic plaque." For this type of device (early 1999), the Agatston score itself, derived from CT data, would be considered the benchmark or "ground truth" for calcification quantification. It's improbable that pathology or long-term outcomes data would have been a direct ground truth for a 510(k) submission for a calcification scoring tool at that time.

8. The Sample Size for the Training Set:

• Not explicitly stated in the provided text.

9. How the Ground Truth for the Training Set was Established:

• Not explicitly stated in the provided text. Given the device is based on the Agatston method, it's likely that the "ground truth" for any training or validation would involve application of the Agatston algorithm to known CT datasets.

Summary of what is available from the document:

The 510(k) submission for Vitrea 1.3 primarily relies on demonstrating substantial equivalence to an existing predicate device (Elscint's Cardiac Scoring Option K970980). The key elements of equivalence highlighted are:

• Intended Use: Cardiac scoring from whole body CT derived measurements.
• Data Source: CT Scanner.
• Computing Method: Agatston method for quantification of high density structures.

The document states that "All software testing specified in the Software Development and Test Plan will be successfully completed prior to market release" and "Software Beta testing will be successfully completed validating feature/performance prior to market release." However, the details of these tests, including specific acceptance criteria, sample sizes, expert involvement, and ground truth methodologies, are not included in this publicly available 510(k) summary. These details would typically be found in internal design controls and verification/validation documents submitted to the FDA but not necessarily released in the public summary.

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