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HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartScan is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Morpheus HeartScan is a web-accessible image analysis software application. The application is intended to visualize and quantify cardiac-specific MRI data in DICOM format. HeartScan has features for loading, saving, generating screen displays, and aggregating flow statistics.

Pre-existing MR images are uploaded via the web to the HeartScan software application where image corrections (specific to aliasing errors) are applied to the set of images prescribed by the user. Automatic or manual vessel segmentation is performed and advanced analysis algorithms are applied to quantify blood flow. The images and blood flow can be simultaneously visualized at any plane using multi-planar reconstruction (MPR) with color flow fusion. Reproducible test results are produced and stored in the image study.

HeartScan does not interface directly with any MR or data collection equipment, instead HeartScan imports data files previously generated by such equipment. The software application applied advanced automated methods to avoid tedious, time-consuming manual methods. The software does not perform any functions which cannot be accomplished by a trained user utilizing manual tracing methods; the purpose of the software is to save time and automate potential error-prone manual tasks.

The provided text describes the Morpheus HeartScan Software, a web-accessible image analysis application intended to visualize and quantify cardiac-specific MRI data. The document focuses on demonstrating its substantial equivalence to a predicate device, MedVoxel HeartPro Software System (K103565).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present explicit "acceptance criteria" in a quantified table format for each feature. Instead, the performance is demonstrated through a comparison to a predicate device, aiming to show that the HeartScan device performs "as well as" the predicate device and generates "clinically acceptable reproducible data."

However, we can infer some criteria from the "Performance Data" section and the comparison table. The primary performance claim is that the device generates reproducible data and that "HeartScan outputs were within a clinically acceptable range compared to that of the predicate."

Based on the provided text, the most direct 'acceptance criteria' and 'reported device performance' can be summarized as follows:

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

• Sample Size for Test Set: The document mentions "the same datasets" and "multiple analysis of the same ROI" but does not specify the number of datasets or ROIs used in the test set.
• Data Provenance: The document states that the software has been "tested and validated on MR images acquired from both 1.5T and 3.0T MR Scanners." It does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The validation appears to rely on a comparison to "clinically acceptable range" relative to the predicate device, rather than a hard "ground truth" established by experts.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not discussed or conducted according to the provided text. The evaluation focuses on the standalone device's performance in comparison to a predicate, not human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire "Performance Data" section describes nonclinical verification and validation tests performed on the HeartScan software itself, comparing its outputs for reproducibility and against a predicate device. This confirms an "algorithm only" evaluation.

7. Type of Ground Truth Used

The primary "ground truth" or reference standard for comparison appears to be:

• Internal Consistency/Reproducibility: The device producing "the same output within an acceptable criterion" when analyzing the same ROI multiple times.
• Comparison to a Predicate Device: HeartScan outputs being "within a clinically acceptable range compared to that of the predicate."

There is no mention of pathology, outcomes data, or expert consensus establishing a definitive absolute ground truth for the measurements. The focus is on consistency and similarity to an already approved device.

8. Sample Size for the Training Set

The document does not specify any sample size for a training set. As the device's description highlights "advanced automated methods" and its purpose to "automate potential error-prone manual tasks," it implies an algorithm, but details about its development (and thus, a training set) are not provided in this 510(k) summary. The summary focuses on verification and validation, not model development.

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

Since no training set is mentioned or described, the method for establishing its ground truth is not provided in the document.

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