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Cardiac scoring from whole body computed tomography derived measurements

The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.

This document is a 510(k) premarket notification for Elscint Inc.'s "Cardiac Scoring option," a software feature for CT scanners. It focuses on the device's substantial equivalence to a predicate device, rather than providing a detailed study proving its meeting of specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific study designs, and quantitative performance metrics is not present in the provided text.

Based on the provided information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics like sensitivity, specificity, or accuracy. The "Effectiveness" section broadly states:

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

This information is not provided in the document. There is no mention of a test set, patient data, country of origin, or retrospective/prospective nature of any data related to performance evaluation.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided. The document makes no mention of experts or a process for establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Since no test set or ground truth establishment is described, no adjudication method is mentioned.

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

This information is not provided. The document does not describe any study comparing human readers with and without AI assistance, nor does it mention any effect size.

6. Standalone (Algorithm Only) Performance Study

This information is not provided. The document describes the software's functionality but does not present data from a standalone performance study in terms of quantifiable metrics. The "Effectiveness" section is descriptive rather than quantitative.

7. Type of Ground Truth Used

This information is not provided. As no specific study data is presented, the type of ground truth used is not described.

8. Sample Size for the Training Set

This information is not provided. There is no mention of a training set or its size.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. Since no training set is mentioned, the method for establishing its ground truth is also not described.

Summary of what the document does claim regarding "effectiveness":

The core claim for effectiveness is that the "Cardiac Scoring option quantifies calcifications by a weighted number instead of manual calculation of area x density products. As such it is easier to use." The basis for this claim, and the overall "effectiveness" of the device, is its substantial equivalence to predicate devices (specifically, the Histogram and ROI functions of the CT Twin flash, K945512). The document suggests that the device performs a similar function (quantifying high-density structures) but in a more user-friendly way. The effectiveness is therefore asserted through a comparison to a known, legally marketed predicate device rather than through a rigorous, quantitative study with specific acceptance criteria.

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