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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 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 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 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™+ Multi-Modality Guidance System is used by physicians to obtain physiologic, intravascular, and/or intracardiac anatomical information. The system utilizes an interactive display that displays information and allows the physician to:

• Perform intravascular physiology assessment by making measurements with a pressure ● wire that invasively obtains pressure readings from the vessels, and an FFR Link that retrieves the information from the pressure wire and transfers the information wirelessly to the interactive display, and/or
• Perform intravascular or intracardiac ultrasound imaging using a specially designed . catheter with a miniaturized ultrasound probe attached to the distal end and a Motor Drive. A PC is used for data acquisition and processing to visualize ultrasound images of selected anatomical structures.

The AVVIGO™+ Multi-Modality Guidance System hardware has been modified to include a V4 Acquisition PC for IVUS image processing, updates to the mobile pole, and a Table Side Controller user interface for user control access near the patient bedside.

The AVVIGO™+ Multi-Modality Guidance System software includes updated vessel and lumen border trace functionality to improve ease of use. Additionally, the AVVIGO+ Multi-Modality Guidance System GUI includes visual display of frame markers as well as graphical display of DFR with pullback support.

The AVVIGO™+ Multi-Modality Guidance System underlying fundamental principles and technology supporting IVUS and Physiology modalities are unmodified from that of the predicate. IVUS and FFR/DFR remain identical to that of the predicate device, AVVIGO Guidance System II.

AVVIGO™ + Multi-Modality Guidance System modifications do not raise any new issues of safety and effectiveness.

The user is asking for specific details about the acceptance criteria and the study proving the device meets these criteria. However, the provided document (FDA 510(k) clearance letter and summary for the AVVIGO+ Multi-Modality Guidance System) explicitly states:

"Clinical Performance Data: Not applicable; determination of substantial equivalence is not based on clinical performance data. Substantial equivalence is based on an assessment of non-clinical performance data."

This means that a clinical study with human patients, including elements like a test set, expert readers, ground truth establishment, MRMC studies, or standalone performance, was not performed or at least not required for the 510(k) clearance of this device. The modifications to the AVVIGO+ system were deemed substantially equivalent to its predicate (AVVIGO Guidance System II) based on non-clinical performance data (hardware, software, electrical safety, packaging verification and validation against recognized standards).

Therefore, I cannot provide the requested information for acceptance criteria related to a clinical study because the document states no clinical performance data was used for this clearance.

I can, however, extract information about the non-clinical performance data and the type of evaluation performed.

Here's a summary based on the provided document, addressing what information is available and indicating what is not:

Acceptance Criteria and Device Performance Study (as per provided document)

The provided documentation states that no clinical performance data was used for the determination of substantial equivalence for the AVVIGO+ Multi-Modality Guidance System. Therefore, the device performance was assessed through non-clinical performance data, focusing on compliance with recognized safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was performed for this clearance, there isn't a table of clinical performance metrics like sensitivity, specificity, or accuracy derived from a test set. Instead, the acceptance criteria are based on compliance with various engineering, safety, and quality standards for medical devices.

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

• Not Applicable. No clinical test set data was used for this 510(k) clearance determination. The evaluation was based on non-clinical performance testing and compliance with recognized standards.

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

• Not Applicable. No clinical test set and thus no ground truth established by experts was used for this 510(k) clearance.

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

• Not Applicable. No clinical test set was used for this 510(k) clearance.

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. An MRMC study was not stated as being performed for this 510(k) clearance.

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

• Not Applicable / No. The document focuses on the system's compliance with safety and performance standards for its intended functions (IVUS imaging and FFR/DFR physiological parameters), not on an "algorithm only" performance study in a clinical context.

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

• Not Applicable. No clinical ground truth was used for this 510(k) clearance. The "ground truth" for the non-clinical evaluation was adherence to the specifications defined by recognized medical device standards and the device's own design documentation.

8. The sample size for the training set:

• Not Applicable. This 510(k) clearance is for a medical device that includes imaging and physiological measurement capabilities, but the document does not describe it as an AI/ML device requiring a distinct "training set" in the context of learned models. The software updates mentioned are for "vessel and lumen border trace functionality" and GUI improvements, but no details of an AI/ML model's training process are provided or implied to be part of the substantial equivalence determination.

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

• Not Applicable. (See point 8).

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