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Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.

The Libby IAAA v1.0 platform is a web-accessible post-processing analysis device used for viewing and quantifying intravascular OCT images. The device is intended to visualize and quantify OCT pullback data in raw OCT file format. The device enables lumen, stent, and stent strut detection and has features for loading, saving, and report generation of aggregated quantitative data. The device allows for analysis of raw Intravascular optical coherence tomography (OCT) files obtained from the Abbott Laboratories C7-XR system and compatible imaging catheters.

The web-based platform can be used in common desktop web browsers. A user opens an intravascular image pullback file using the platform and has the ability to use various modules to perform image analysis on areas of interest. The platform includes the following module panels for visualization, quantification, and report generation:

Visualization:

• 2D cross-sectional view
• 2D longitudinal view
• Image navigation tools
• Measurement and annotation tools
• Bookmark areas of interest

Quantification:

• Distance and area measurements
• Guidewire detection
• Lumen and Stent area quantification
• Stent and strut detection (pullback level and frame level)
• Strut classification (covered versus uncovered, apposed, and malapposed)

Data Reporting:
Study information, lumen areas, stent areas, reference areas, percent stenosis, along with usercreated annotations are displayed to the user within the software automatically saves all data and the user has the option to generate a report in .xlsx format.

The product is intended to be used by or under supervision of a board-certified Cardiologist.

Here's an analysis of the acceptance criteria and study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes a standalone performance test where the device's output was compared against analyses performed by expert cardiologists. The conclusion states that the device "raises no different questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance," implying that the device's performance was deemed acceptable relative to expert cardiologists.

Based on the text, the acceptance criteria implicitly involve the device's automated quantification of artery and/or stent dimensions aligning sufficiently with expert manual analysis.

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

• Sample Size for Test Set: The document mentions "a generalized dataset" but does not provide a specific number for the sample size used in the standalone performance test.
• Data Provenance: Not explicitly stated. The term "generalized dataset" suggests it might be diverse, but there's no mention of country of origin or whether it was retrospective or prospective.

3. Number of Experts and Qualifications

• Number of Experts: The document refers to "expert cardiologists" (plural), but does not specify the exact number of experts used to establish the ground truth for the test set.
• Qualifications of Experts: The document states "expert cardiologists." It doesn't provide specific details like years of experience, subspecialty certifications, or affiliations.

4. Adjudication Method for the Test Set

The document describes the test as a "head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm." This implies that the experts' manual analyses served as the reference against which the algorithm was compared. However, it does not explicitly mention an adjudication method (e.g., 2+1, 3+1 consensus) among the experts themselves if multiple experts were involved in the manual analysis. It's possible each expert's analysis was independently compared, or a consensus was reached, but this detail is missing.

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

• Was an MRMC study done? No. The document describes a "standalone performance test" comparing the algorithm against expert manual analysis. It does not mention a comparative effectiveness study where human readers' performance with and without AI assistance was evaluated.
• Effect size of human reader improvement: Since an MRMC study was not described, there is no information on the effect size of human readers improving with AI assistance.

6. Standalone Performance

• Was standalone (algorithm-only) performance done? Yes. The document explicitly states: "Standalone performance testing consisted of a head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm." This confirms an algorithm-only evaluation.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the standalone performance test was established through expert consensus/manual analysis ("manually analyzed by expert cardiologists").

8. Sample Size for the Training Set

The document does not provide any information about the sample size for the training set. It focuses solely on the performance testing.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information about how the ground truth for the training set was established, as it does not discuss the training process or dataset.

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