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The PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150 Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.

This device is a software-only version of the Spencer Technologies digital Transcranial Doppler ultrasound system, the TCD100M/PMD150, and is described as the PMD Viewer.

The modification of the TCD100M/PMD150 implemented in the PMD Viewer provides physicians and technologists with the same data viewing, playback, and report generation features of the TCD100M/PMD150 off-line on a standard PC utilizing Windows XP SP2 or VISTA. All software features can be controlled with a standard keyboard and wheel mouse. Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150.

This 510(k) summary is for a software-only medical device (PMD Viewer) that displays previously acquired ultrasound data. As such, the acceptance criteria and study data provided in the document focus on ensuring the software accurately reproduces the data from the original device without degradation.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic task. This is because the PMD Viewer is a display and review tool, not a diagnostic algorithm that makes interpretations or classifications.

Instead, the acceptance criteria are implicitly met by demonstrating that the PMD Viewer accurately replicates the functionality and image quality of the predicate (parent) device (TCD100M/PMD150) when viewing its proprietary binary file formats. The core acceptance criterion is accurate and faithful reproduction of the original data and images without degradation or alteration.

The reported device performance is described as:

• "Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150."
• "All functions for the review of the PMD device files are the same as reviewing the files on the predicate (parent) device, TCD100M/PMD150, with respect to intended use and indications for use, principles of operation, and technological characteristics and design."

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

The document does not specify a separate "test set" in the context of diagnostic performance. Instead, it refers to the ability of the PMD Viewer to read and accurately display "the proprietary binary file formats" of the TCD100M/PMD150. This implies that the testing involved using existing data files generated by the predicate (parent) device.

• Sample Size: Not explicitly stated, as the nature of the device (viewer) means the "test set" is the range of files it's designed to read. The implication is that it can handle any file generated by the TCD100M/PMD150.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data would be "previously acquired information on cerebral arterial blood flow velocity measurements and the occurrence of micro-embolic signals" from TCD100M/PMD150 studies. It is implied to be retrospective, as it's "previously acquired" data.

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

Not applicable in the traditional sense for a diagnostic AI. The "ground truth" for this device is the fidelity of the displayed data compared to the original data on the TCD100M/PMD150. This is a technical validation, not a clinical diagnostic validation requiring expert interpretation for ground truth. The validation would involve technical verification to ensure that data displayed on the PMD Viewer is identical to how it appears on the TCD100M/PMD150, likely performed by engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical adjudication required for a software viewer that simply displays existing data.

5. 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

Not applicable. The PMD Viewer is a standalone software for viewing and playback, not an AI or CAD (Computer-Aided Detection/Diagnosis) system that assists human readers in diagnostic tasks. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the PMD Viewer is a standalone software product in the sense that it operates independently on a standard PC to display data. However, it's not a standalone prescriptive algorithm or AI that provides a diagnosis. Its standalone performance is defined by its ability to accurately read and display the proprietary file formats without degradation, replicating the functionality of the original device. This is implicitly what the substantial equivalence claim is based upon.

7. The Type of Ground Truth Used

The "ground truth" for the PMD Viewer is the original, uncompressed digital data and the visual representation of that data as it appears on the TCD100M/PMD150 diagnostic ultrasound system. Essentially, the ground truth is the primary source data itself, and the PMD Viewer's task is to reproduce that ground truth faithfully.

8. The Sample Size for the Training Set

Not applicable. The PMD Viewer is not an AI/machine learning algorithm that requires a "training set." It is a software application designed to read and display specific file formats.

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

Not applicable, as there is no training set for this type of software.

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