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Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices.

Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries.

The software enables post processing of images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present, including editing of contrasted lumen and artery boundaries.

Any processed artery can be selected to view: the vessel in 3D; color-coded interactive data maps displayed on the 3D vessel; curved, straightened and cross-sectional MPR views of the vessel; and quantitative data from regions of interest. Data includes standard 2D distance measurements as well as stenosis, Hounsfield unit statistics, and tissue volumes.

Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software.

Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation.

Mosaic V1.0.1 is a post-processing tool used to analyse arterial diseases. It reads in computed tomography angiography (CTA) scans and users can process the scans to aid clinicians in their analysis of anatomy and pathology. Processing CTA with Mosaic enables the creation of vessel centrelines from which measurements and image reformatting is possible. The outputs of the software include visual images, measures of diameter, distance, volume, including plaque volumes, positive remodelling of the arterial wall, and stenosis. These measurements are based on user segmentation. Outputs from Mosaic, including the saved analysis file and PDF report, can be used to assist with the decision-making process and clinical management of the patient, but Mosaic is not intended to be used as a sole source of clinical data to determine diagnosis and/or treatment pathways.

This FDA 510(k) clearance letter and summary statement for Mosaic V1.0.1 provides information about the device and its performance testing. Here's a breakdown of the acceptance criteria and study details based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance metrics, which show bias and RMSE within specific ranges for various measurements. The study aims to demonstrate that Mosaic V1.0.1's performance is substantially equivalent to the predicate device, ElucidVivo.

The "acceptance criteria" are not explicitly stated as distinct thresholds but are inferred from the reported performance itself, which is presented as the achieved bias and RMSE within specific ranges. The overarching acceptance criterion is that these measurements demonstrate substantial equivalence to the predicate device, ElucidVivo.

Study Details

Here's an analysis of the study details based on the provided text:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document states that "Clinical images with 0.54 x 0.54 mm pixel resolution were evaluated." However, the exact number of clinical images or cases used in the test set is not specified in the provided text.
   • Data Provenance: The document mentions "clinical images" and "phantom images." The country of origin and whether the clinical data was retrospective or prospective are not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document states that measurements were evaluated "relative to ground truth measurements." However, it does not specify the number of experts used to establish this ground truth or their qualifications. It only mentions that the software is intended to assist "trained medical professionals, including radiologists and clinicians."

3. Adjudication method for the test set:

   • The adjudication method (e.g., 2+1, 3+1) used to establish the ground truth is not specified in the provided text.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • The document describes "Performance testing... Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions." It explicitly states that "Measurements from Mosaic were shown to be substantially equivalent to ElucidVivo." However, this describes a standalone performance evaluation against a predicate device's characteristics, not an MRMC study designed to evaluate human reader performance with and without AI assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance was not explicitly described in the provided text. No effect size for human reader improvement is mentioned.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance study was conducted. The "Performance testing" section quantifies the bias and RMSE of Mosaic's measurements (Diameter, Tissue Volume, Stenosis, Positive Remodeling Index) against "ground truth measurements." This indicates the algorithm's performance independent of real-time human interaction during measurement generation, though the inputs for analysis would come from human-identified areas for processing. The core claim is that "Measurements from Mosaic were shown to be substantially equivalent to ElucidVivo," which suggests a direct comparison of the algorithm's output to established benchmarks or the predicate's outputs.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document refers to "ground truth measurements" used for comparison. The specific type of ground truth (e.g., expert consensus, independent gold-standard imaging, direct pathology correlation, or clinical outcomes) is not explicitly specified. It only implies that a reliable reference was available for comparison. Given the context of image analysis and measurements, it's likely a form of expert-derived or reference-standard measurements.

7. The sample size for the training set:

   • The document provides details about the validation and performance testing phases. However, the sample size for the training set used to develop the Mosaic V1.0.1 algorithm is not specified in this FDA clearance letter summary.

8. How the ground truth for the training set was established:

   • Similar to the training set size, the method for establishing ground truth for the training set is not specified in the provided text. The document focuses on the validation against ground truth for the test set.

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