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Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians. Neurovascular Insight V1.0 is intended to:

• Display and, if necessary, export neurological DICOM series and outputs provided by compatible processing docker applications, through the technical integration environment.
• Allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided by the technical integration environment as inputs to the docker application to reprocess the outputs. When available, Neurovascular Insight V1.0 display can be updated with the reprocessed outputs.
• If requested by an application, allow the user to confirm information before displaying associated outputs and export them.

The device does not alter the original image information and is not intended to be used as a diagnostic device. The outputs of each compatible application must be interpreted by the predefined intended users, as specified in the application's own labeling. Moreover, the information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging.

Trained professionals are responsible for viewing the full set of native images per the standard of care.

Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians.

It is worth noting that Neurovascular Insight V1.0 is an evolution of the FDA cleared medical device Olea S.I.A. Neurovascular V1.0 (K223532).

Neurovascular Insight V1.0 does not contain any calculation feature or any algorithm (deterministic or AI).

The provided FDA 510(k) clearance letter for Neurovascular Insight V1.0 states that the device "does not contain any calculation feature or any algorithm (deterministic or AI)." Furthermore, it explicitly mentions, "Neurovascular Insight V1.0 provides no output. Therefore, the comparison to predicate was based on the comparison of features available within both devices. No performance feature requires a qualitative or quantitative comparison and validation."

Based on this, it's clear that the device is a user interface and does not include AI algorithms or generate outputs that would require a study involving acceptance criteria for AI performance (e.g., sensitivity, specificity, accuracy). Therefore, the questions related to AI-specific performance criteria, ground truth establishment, training sets, and MRMC studies are not applicable to this particular device.

The "study" conducted for this device was a series of software verification and validation tests to ensure its functionality as a user interface and its substantial equivalence to its predicate.

Here's a breakdown of the requested information based on the provided document, highlighting where the requested information is not applicable due to the device's nature:

1. A table of acceptance criteria and the reported device performance

Note: As the device is a user interface without AI or output generation, there are no quantitative performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI algorithms. The acceptance criteria relate to the successful execution of software functionalities.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a number of patient cases or images, as the testing was focused on software functionality rather than AI performance on a dataset. The testing refers to "software modules verification tests" and "software validation test."
• Data Provenance: Not applicable in the context of clinical data for AI development/validation, as the device doesn't use or produce clinical outputs requiring such data. The testing was internal software validation.

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

• Not Applicable: Given that the device is a user interface and does not utilize AI or produce diagnostic outputs, there was no need to establish clinical ground truth for a test set by medical experts in the traditional sense. The "ground truth" for its functionality would be the design specifications and successful execution of intended features. The document mentions "operators" who "reported no issue" during usability testing, but these are likely system testers/engineers, not clinical experts establishing diagnostic ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable: No clinical ground truth was established, so no adjudication method was required.

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

• No: The document explicitly states, "Neurovascular Insight V1.0 does not contain any calculation feature or any algorithm (deterministic or AI)." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• No: The device does not contain an algorithm, only a user interface. Standalone algorithm performance testing is not applicable.

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

• Not Applicable: No clinical ground truth was established, as the device is a user interface without AI or diagnostic output generation. The "ground truth" for its validation was adherence to software specifications and intended functionalities.

8. The sample size for the training set

• Not Applicable: The device does not contain any AI algorithms, therefore, no training set was used.

9. How the ground truth for the training set was established

• Not Applicable: No training set was used.

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