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Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using IST image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.

PC based software only application

This FDA document is a 510(k) clearance letter for the Voxar Calcium Scoring Product and does not contain the detailed study information required to answer your request. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document mentions that the device uses "clinically accepted calcium scoring algorithms" but does not detail the specific performance metrics, study design, or validation data that would demonstrate how the device meets acceptance criteria. To obtain this information, you would typically need to refer to the full 510(k) submission, scientific publications, or product documentation from Voxar, Ltd.

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