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CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data.

CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.

CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time (T1, srT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).

These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.

CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and Siemens 3T MRI scanners.

CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.

Metrics produced by CoverScan can be used by healthcare professionals (HCPs) in a clinical setting for the purposes of assessing multiple organs.

CoverScan v1.1 is a new version of CoverScan that supports the use of Siemens 3T scan data to enable more scan sites to utilise CoverScan.

The provided text is a summary of the FDA 510(k) clearance for CoverScan v1.1. It primarily focuses on demonstrating substantial equivalence to a predicate device (CoverScan v1.0) due to an expanded compatibility with Siemens 3T MRI scanners. The document outlines the device's intended use, functions, and the types of data it processes (T1, T2, PDFF, etc.).

However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance study specifics. It mentions "performance testing" and "extensive validation testing" but does not provide the specific metrics, sample sizes, ground truth establishment methods, or human reader study details you've asked for.

It states: "The change to add the Siemens 3T Scan data was made and performance testing using well established methods demonstrated equal performance between the subject and the predicate. In summary, CoverScan v1.1 is substantially equivalent to the predicate device CoverScan v1.0 (K212565)." This implies that the performance was compared to the predicate, but the specific performance results and acceptance criteria are not elaborated upon in this summary document.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.

Here's what can be extracted and what cannot:

What can be extracted:

• Device Name: CoverScan (CoverScan v1.1)
• Predicate Device: CoverScan v1.0 (K212565)
• Purpose of the change (v1.0 to v1.1): To support Siemens 3T scan data.
• General mention of testing: "Performance testing using well established methods demonstrated equal performance between the subject and the predicate." and "Internal verification and validation testing confirms that the product specifications are met."
• Ground Truth Type (Inferred, not explicitly stated as "ground truth"): Device performance was assessed with "purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for sT1, cT1, T1 and PDFF." This suggests comparison against known phantom properties and physiological values, but the direct "ground truth" establishment method for patient data is not detailed.
• Standards referenced: IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485.

What cannot be extracted (due to lack of information in the document):

• Table of Acceptance Criteria and Reported Device Performance: No specific quantitative acceptance criteria or reported performance values are provided.
• Sample sizes: No sample size is given for the test set or training set.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Number of experts and qualifications for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC study: Not mentioned.
• Standalone (algorithm only) performance: Not explicitly detailed with metrics.
• How ground truth for the training set was established: Not mentioned.

In summary, the provided document is an FDA clearance letter focusing on substantial equivalence based on implied equivalent performance rather than a detailed performance study report with specific metrics and methodologies.

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