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The iLab™ Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

The iReview Software accessory does not change the iLab indications for use.

The iLab™ Ultrasound Imaging System with the iReview™ Software accessory, is designed for realtime viewing of intravascular anatomies and is intended to be a basic diagnostic tool for imaging and evaluation of patients who are candidates for transluminal procedures.

The iLab™ System with the iReview Software accessory consists of two compact PC units (one for lmage Processing and one for Data Acquisition), up to two displays (one primary and an optional secondary) and the iReview Software contained on a separate CD. The iReview Software utility can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The iLab System imaging and processing PC are used during an intravascular procedure, at the end of the IVUS procedure, the processing PC supports the archiving of the images obtained during the procedure. The iLab System processing PC converts the native iLab images into DICOM format images prior to archiving to removal media such as a CD, DVD or removable hard disk cartridge. Images can also be archived to a DICOM network server.

The iReview™ Software utility enables the off-line review of the archived iLab System images, including the Longview™ reconstructed images, Dynamic Review™ of the IVUS image runs, area and distance measurements, book marked images, image graphics, bio-signals such as ECG and the broadcast of any audio recording acquired during the IVUS procedure. The iReview Software also supports the creation of new area and distance measurements and the ability to export images to external printers. The iReview Software utility, using the iLab proprietary GUI look and feel, is a simple easy to use, image viewing software for iLab IVUS images.

The provided text describes the iReview™ Software, an accessory to the iLab™ Ultrasound Imaging System. The assessment focuses on the software's verification and validation rather than clinical performance against specific metrics for disease detection or diagnosis.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical performance data used for algorithm evaluation. The testing described is primarily focused on software verification and validation, rather than a clinical study evaluating diagnostic accuracy.

• Test Set Sample Size: Not applicable/not explicitly stated in terms of a clinical image dataset. The testing was performed on "multiple configurations of PC systems." (Page 2)
• Data Provenance: Not applicable. The software reviews archived images from the iLab™ Ultrasound Imaging System, which captures intravascular ultrasound images. The document does not specify the origin (country, etc.) or whether these archived images were retrospective or prospective for the purpose of this software testing.

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

• This information is not provided. The testing described focuses on software functionality and usability, not on diagnostic accuracy requiring expert ground truth for interpretation. Software validation was performed by "testers with iLab clinical experience." (Page 2) However, this refers to their experience in operating the iLab system, not necessarily their role as medical experts establishing ground truth for diagnostic image interpretation.

4. Adjudication Method for the Test Set

• Not applicable. As described, the testing is for software functionality and verification, not for diagnostic performance that would require adjudication for discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not done. The document does not mention any studies evaluating human reader performance with or without AI assistance. This submission is for an accessory software designed for viewing and reviewing archived images, not for an AI-powered diagnostic tool.

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

• Not applicable. The iReview™ software is an accessory for displaying and reviewing images from an existing ultrasound system. It is not a standalone diagnostic algorithm. Its function is to allow "off-line review of the archived iLab System images." (Page 1)

7. The Type of Ground Truth Used

• For the software verification and validation, the "ground truth" was the predefined Product and Marketing Requirements, and Software Requirements Specifications. The software's ability to correctly display images, perform measurements, and archive data according to these specifications was the "truth" against which its performance was measured. There is no mention of clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. The iReview™ Software is described as a utility for viewing and reviewing pre-existing images; it is not an AI/machine learning algorithm that requires a training set in the typical sense for image analysis.

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

• Not applicable, as there is no mention of an AI/machine learning algorithm requiring a training set with established ground truth for learning purposes.

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