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The IVUS modality of the iLab Polaris Multi-Modality Guidance 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.

Indications for Auto Pullback Use

Automatic Pullback is indicated when the following occurs:

• The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

· The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

· Two-dimensional, longitudinal reconstruction of the anatomy is desired.

The FFR modality of the Lab Polaris Multi-Modality Guidance System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

This modality is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters, Fractional Flow Reserve (FFR).

The iLab Polaris Multi-Modality Guidance System is a diagnostic device designed to provide both intravascular ultrasound imaging (IVUS) and fractional flow reserve (FFR) modalities. Only one modality can be used at a time and are independent of one another.

The IVUS modality allows the application of ultrasound technology to see from inside blood vessels out through the surrounding blood column, enabling the physician to visualize the coronary or peripheral vasculature. The IVUS functionality consists of two non-sterile compact PC units (one for imaging processing and one for data acquisition) and two non-sterile display monitors (for the integrated system -one primary and an optional secondary). It also consists of a non-sterile Motordrive Unit (MDU), sterile bag which covers the MDU and a sterile disposable sled. The iLab Polaris Multi-Modality Guidance System interfaces with BSC imaging catheters at the Motordrive Unit (MDU), which provides the electro-mechanics for the rotating parts of the imaging catheter, and the interface between the catheter and the console and BSC proprietary software. The Motordrive Unit provides the rotation of the imaging catheter core required for cross-sectional imaging. An electro-mechanical connector interface at the proximal end of the imaging catheter makes the connection to the MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection. The MDU is the primary control for catheter positioning and movement through the vessel.

The FFR modality measures the pressure gradient across lesions to determine lesion severity and thus, in conjunction with other tools help guide physicians in making treatment decisions. FFR is defined as the ratio of pressure distal of a lesion (Pd) to the pressure proximal of a lesion (Pa-aortic pressure) during maximum blood flow. Maximum blood flow is achieved by injection of a vasodilator to open up the distal arteriole bed.

The FFR modality will also utilize the two non-sterile compact PC units (one displays the physiological parameters and one for data acquisition) and two non-sterile display monitors (for the integrated system -one primary and an optional secondary). In addition the FFR modality consists of a Signal Processing Module (SPM- commercial name FFR Link), Bluetooth Communication Module (BCM) and Hemodynamic Cable Kit.

The iLab Polaris Multi-Modality Guidance System console interfaces with BSC's Pressure Guidewire through the optical cable connector of the pressure guidewire, the FFR Link and the Bluetooth Communication Module (BCM).

The Pressure Guidewire sensor is designed to output an optical signal that corresponds to the pressure distal (Pd) of a lesion in a blood vessel. This optical signal is acquired and processed by the FFR Link. The FFR Link also acquires and processes the patient's aortic pressure signal (Pa) obtained from a resistive bridge IBP transducer. The FFR Link processes, digitizes and wirelessly streams by Bluetooth the aortic pressure (Pa) and distal pressure (Pd). These wirelessly streamed pressure signals are received by the iLab Polaris Multi-Modality Guidance System console through the BCM. BSC's proprietary software processes the pressure signals received via the BCM for display of Pa and Pd waveforms, Pa. Pd and Pd/Pa (FFR calculation) for physician interpretation. Additionally the FFR Link provides an analog, BP-22 compliant, signal which passes the IBP measurement, unchanged, to the catheterization lab's hemodynamic system.

The provided text describes the iLab Polaris Multi-Modality Guidance System, which includes both Intravascular Ultrasound (IVUS) and Fractional Flow Reserve (FFR) modalities. The information available predominantly focuses on the FFR modality's performance testing.

Here's an analysis of the acceptance criteria and study in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for all aspects. However, for the FFR modality, it references compliance with specific IEC and ANSI/AAMI standards, which inherently contain performance requirements.

Note: The document states that the system "performed as intended" and "demonstrates substantial equivalence" for these tests, implying that the acceptance criteria for these standards were met. Specific numerical values for accuracy or frequency response are not provided in this summary.

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

• FFR Modality (Animal Study):

  • Test Set Sample Size: 2 pigs.
  • Data Provenance: Prospective animal study in swine model, conducted with invasive blood pressure measurements.

• Bench Testing: No specific sample size is mentioned for the various bench tests, but they are described as "bench testing." Data provenance for bench tests is typically in-house laboratory testing.

• Software Verification and Validation: No specific sample size is mentioned.

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

• FFR Modality (Animal Study): The ground truth was established by invasive blood pressure (aortic pressure) measurements in the swine model, not by human experts. Therefore, the number of experts and their qualifications for establishing ground truth are not applicable in this context.

4. Adjudication Method for the Test Set

• FFR Modality (Animal Study): The adjudication method is not explicitly stated, but the comparison was made against direct, invasive aortic pressure measurements, which typically serve as the reference standard without further adjudication.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed for human readers with and without AI assistance. The device is a diagnostic guidance system, not an AI-assisted interpretation tool in the manner implied by MRMC studies of AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone study was done. The "Performance Testing-Bench" and the "Animal Study" evaluate the device's performance (FFR modality) in isolation, specifically its ability to measure pressure accurately compared to known standards or direct invasive measurements. This represents standalone performance.
  • The "Software Verification and Validation Testing" also assesses the algorithm's functionality and adherence to requirements in a standalone context.

7. Type of Ground Truth Used

• FFR Modality (Animal Study): Outcomes data in the form of invasive blood pressure (aortic pressure) in a swine model. This is considered a gold standard for pressure measurement in such studies.
• Bench Testing: Ground truth was established by reference standards outlined in the cited IEC and ANSI/AAMI documents, and presumably by calibrated test equipment.

8. Sample Size for the Training Set

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than details of internal algorithm development. Therefore, the sample size for the training set is not provided or discussed in this document. This device is described as processing physiological parameters and displaying them, and interfaces with hardware, rather than being a "machine learning" based AI system that would typically have a distinct training set.

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

As the sample size for the training set is not provided, how the ground truth for a training set (if one existed in the context of an ML/AI algorithm) was established is also not discussed in this document. Given the description of the device (processing and displaying physiological parameters), it's highly likely that traditional signal processing and hardware integration, rather than a machine learning approach with a "training set," was used.

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