The IVUS modality of the 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. FFR and DFR™ are 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. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

Refer to the Catheter Instructions for Use provided with all Boston Scientific Ultrasound Imaging Catheters to determine compatibility with the Polaris System. All Ultrasound Imaging Catheters will be referred to as Imaging Catheters throughout the remainder of this User Guide. The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Instructions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

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 AVVIGO Guidance System II is a non-patient contacting medical device system that consists of hardware and software components which aid in supporting Intravascular Ultrasound (IVUS) Fractional Flow Reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities.

The AVVIGO 2.0 software update maintains the current FFR/DFR functional modality of the AVVIGO Guidance System (K201713) and introduces the equivalent IVUS functional modality of the iLab Polaris Multi-Modality Guidance System (K210889).

The provided text does not contain information about the acceptance criteria and the study that proves a device meets specific acceptance criteria in the way typically required for AI-driven medical devices (e.g., performance metrics like sensitivity, specificity, or AUC).

Instead, this document is a 510(k) Substantial Equivalence Determination for the AVVIGO Guidance System II. The key takeaway from the "Clinical Performance Data" section is:

"Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data. Substantial Equivalence is based on non-clinical performance data."

This statement explicitly indicates that no clinical performance study (like an MRMC study or a standalone algorithm performance study with ground truth establishment) was conducted or provided for this 510(k) submission to demonstrate the device's efficacy based on specific performance criteria. The approval is based on its substantial equivalence to predicate devices and evidence from non-clinical performance data (software, hardware, packaging, electrical safety verification and validation), adherence to relevant standards (e.g., IEC 62304, ANSI AAMI ES 60601-1, IEC 60601-1-2), and FDA guidance documents.

Therefore, for your specific request about "acceptance criteria and the study that proves the device meets the acceptance criteria," with details like sample size, experts, adjudication, MRMC studies, standalone performance, and ground truth establishment:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document. The acceptance criteria for this submission appear to be related to substantial equivalence to predicate devices and meeting performance, safety, and electrical standards, rather than specific diagnostic accuracy metrics.
• 2. Sample size used for the test set and the data provenance: Not applicable/not provided for clinical performance testing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
• 4. Adjudication method for the test set: Not applicable/not provided.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states that the determination of substantial equivalence is not based on clinical data.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not for clinical performance.
• 7. The type of ground truth used: Not applicable/not provided for clinical performance.
• 8. The sample size for the training set: Not applicable/not provided. This device is primarily a guidance system that incorporates existing functionalities (IVUS and FFR/DFR) from predicate devices; it's not described as an AI/ML algorithm that would typically require a large training set for its core function in the context of this submission.
• 9. How the ground truth for the training set was established: Not applicable/not provided.

In summary, this document pertains to a 510(k) clearance based on substantial equivalence and non-clinical data, not on a clinical performance study demonstrating the kind of acceptance criteria and results you've inquired about for AI/ML-driven diagnostic devices.

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FFR and DFR™ are 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.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

The AVVIGO Guidance System is a medical device system that consists of a touchscreen tablet with battery, a digital pen, a power supply and cable which can be mounted to a mobile pole via the pole docking station or set on tabletop via the desktop docking station. The tablet is a nonsterile, non-implantable tablet computer controlled by a graphic user interface (GUI) displayed on a touchscreen. The tablet is powered by either AC line power or a lithium polymer battery.

The system software displays patient's blood pressure measurements that are received from the coronary pressure guidewire and transducer that is connected to a FFR Link. The FFR Link digitizes and wirelessly streams the data which is displayed on the tablet.

The provided text describes the AVVIGO™ Guidance System, a medical device intended for use in catheterization laboratories to compute and display physiological parameters like FFR (Fractional Flow Reserve) and DFR (Diastolic Hyperemia-free Ratio). The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the iLab™ Polaris Multi-Modality Guidance System, rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the AVVIGO™ Guidance System's diagnostic accuracy.

Therefore, the requested information specifically regarding acceptance criteria for a diagnostic performance study, reported device performance against those criteria, sample sizes, ground truth establishment methods for test and training sets, expert qualifications, and MRMC study details cannot be fully extracted from this document, as it emphasizes non-clinical performance and substantial equivalence.

However, based on the non-clinical performance mentioned, here's what can be inferred and what information is missing:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) for FFR/DFR calculation. Instead, it refers to conformity with standards and successful completion of verification and validation testing for software, hardware, packaging, and electrical safety.

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document states "Non-clinical Performance" and explicitly says "Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data. Substantial Equivalence is based on non-clinical performance data." This indicates that no clinical test set for FFR/DFR diagnostic performance was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set with ground truth for diagnostic performance was described.

4. Adjudication method for the test set:
Not applicable, as no clinical test set with ground truth for diagnostic performance was described.

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 MRMC study was mentioned or performed, as the substantial equivalence determination was based on non-clinical performance. The device is a computational system for physiological parameters, not an AI to assist human readers in interpreting images or complex data in an MRMC setting.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone algorithm/system for computing and displaying FFR/DFR. The non-clinical performance testing validated its functionality against technical requirements and standards. However, the document doesn't provide specific standalone performance metrics like accuracy against a gold standard for FFR/DFR values, but rather confirms its compliance with relevant engineering and software standards for operation and display.

7. The type of ground truth used:
For the non-clinical performance, the "ground truth" would be the expected output or behavior according to the design specifications and applicable medical device standards (e.g., correct calculation of FFR from simulated pressure inputs, accurate display of waveforms). No clinical ground truth (like pathology, expert consensus on disease presence based on FFR/DFR, or outcomes data) was used for this 510(k) submission.

8. The sample size for the training set:
Not applicable. The document describes a "Guidance System" that calculates and displays physiological parameters, not an AI/machine learning model that would typically undergo a training phase with a dedicated dataset. The software development likely involved unit testing, integration testing, and system validation, but not in the context of a "training set" for an AI model.

9. How the ground truth for the training set was established:
Not applicable, as there was no described training set for an AI/machine learning model. The software's functionality is based on established physiological equations and data processing methods, not learned patterns from a training dataset.

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