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The Provisio™ SLT IVUS™ System is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature.

The Provisio™ SLT IVUS™ System is designed for use as an adjunct to conventional angiographic procedures to evaluate the vessel lumen and provide dimensional measurements.

The SLT IVUS™ Support Crossing Catheter also guides and supports a guidewire during access of the vasculature and provides a conduit for the delivery of saline solutions or radiopaque contrast agents.

The Provisio™ Sonic Lumen Tomography Intravascular Ultrasound ("SLT IVUS™") System is an IVUS system that utilizes A-mode ultrasound operation to evaluate the vessel lumen and provide dimensional measurements in real time. The Provisio™ SLT IVUS™ System comprises the SLT IVUS™ Support Crossing Catheter and the SLT IVUS™ P1 System, which includes the Pulser Receiver Unit, the Display Unit, and a Cart.

The SLT IVUS™ Support Crossing Catheters, provided sterile for single use, are over-the-wire intravascular ultrasound catheters with a digital ultrasound transducer array at the distal end. The information from the echoes is used to generate real-time dimensions and representations of the peripheral vessel's flow lumen. If required clinically, the SLT IVUS™ Support Crossing Catheter also functions as a support crossing catheter and may be used for the infusion of saline or radiopaque contrast agents.

The Provisio™ SLT IVUS™ System may be used in peripheral vascular procedures to generate real-time measurements of the vessel flow lumen dimensions, while also providing the functionality of the support crossing catheter in the same procedure. The cross-sectional parameters of diameter and area are displayed as numbers; additionally, the diameter measurement is graphically displayed as a representation of the flow lumen. The cross-sectional area measurements are displayed over time on a timeline display. As the catheter is moved by the operator through the vessel lumen, new crosssectional measurements are obtained and displayed. Adjacent cross-sectional measurements can be compiled and displayed over a period of time to create an orthogonal graphical display of the vessel lumen (called RunView™).

Here's a breakdown of the acceptance criteria and the study information for the Provisio™ SLT IVUS™ System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document provides a general statement about meeting performance specifications and specific non-clinical tests, but it does not contain a table explicitly defining numerical acceptance criteria (e.g., "Accuracy must be >X%"). Instead, it describes comparative testing against a predicate device and states that the device meets "all performance specifications necessary to achieve its intended use."

However, based on the non-clinical testing summary, we can infer some of the performance aspects that were evaluated and determined to be acceptable:

Study Information

The document focuses on non-clinical testing rather than a large-scale clinical trial.

1. Sample size used for the test set and the data provenance:

   • Agar Phantoms: The sample size for the agar phantom study is not explicitly stated. The provenance is likely a laboratory setting, as phantoms are simulated environments.
   • Human Cadaver Study: The sample size (number of cadavers or vessels) is not explicitly stated. The data provenance is human cadaveric peripheral vessels. This is considered a retrospective use of biological material.
   • GLP Animal Study: The sample size (number of animals) is not explicitly stated. The provenance is an animal model, likely for pre-clinical evaluation.

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

   • This information is not provided in the document. For the agar phantom study, ground truth would typically be established by precise physical measurements. For the cadaver study and animal study, it would likely involve established metrology techniques or histological analysis, but the specific experts and their qualifications are not detailed.

3. Adjudication method for the test set:

   • This information is not provided. Given the nature of the studies (benchtop, cadaver, animal), formal adjudication by multiple experts (like 2+1, 3+1) is less common than in clinical image interpretation studies. Ground truth would likely be established through direct measurement or pathological assessment.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers improving with AI assistance was not mentioned or conducted. The device is an IVUS system that provides measurements and visual representations, but the document does not describe an AI interpretation component where human readers would interpret images with AI assistance and without AI assistance.

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

   • The document implies standalone performance testing for the measurement accuracy of the device's algorithms in the agar phantom and cadaver studies. The SLT IVUS System "analyzes ultrasound signal reflections (echoes) from the vessel wall to yield vascular morphology information" and displays "cross-sectional parameters of diameter and area." These are algorithmic outputs that would have been evaluated directly. The human factors study evaluates the usability of the system by human users, not their diagnostic performance with the system's output.

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

   • Agar Phantoms: Likely precise physical measurements based on known phantom dimensions.
   • Human Cadaver Study: Likely high-precision measurements (e.g., calipers, micro-CT, or histological assessment) of the actual vessel dimensions.
   • GLP Animal Study: Likely histological analysis and pathology reports to assess vascular damage and tissue reaction.

7. The sample size for the training set:

   • The document does not specify a training set size. This type of device, based on A-mode ultrasound, may rely more on physics-based algorithms and signal processing rather than extensive machine learning models that require large training datasets in the conventional sense. If machine learning was used for measurement extraction or image enhancement, the training data details are not provided.

8. How the ground truth for the training set was established:

   • Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided.

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