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The iLab™ Ultrasound Imaging 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.

The iLab™ Ultrasound Imaging System is a combination of proprietary hardware and software that has been designed for real-time viewing of intravascular anatomies and is intended to be a basic diagnostic tool for imaging and evaluation of patients who are candidates for transluminal procedures. The iLab™ System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging intravascular anatomies with transducer ranges of 9 to 40 MHz. The iLab™ System is also designed to be compatible with multiple Ultrasound Imaging Catheters manufactured by BSC used in different anatomies throughout the body. The system is also supported by a MotorDrive Unit that is compatible with all existing BSC Intravascular Ultrasound (IVUS) catheter products. The iLab™ System consists of two compact PC units (one for Image Processing and one for Data Acquisition), up to two displays, control devices, media storage devices, and a printer. The Data Acquisition PC (front-end PC) digitizes the RF Ultrasound echo, performs digital signal processing, and stores IVUS frames in a vector-based format. Once saved, the vectorbased frame of data is packetized and sent over a private Local Area Network (LAN) connection onto the Image Processing PC (back-end PC) subsystem. The real-time vector data is unpacked and the frame data is converted from vector-based to raster-based frame, which can then be displayed on the primary and secondary (optional) displays. The iLab™ System is available in two configurations: a Cart-based Configuration and an Installed Configuration. There is no functional or electrical difference between the Cart-Based and Installed Configurations; differences are limited to cable lengths and the location of the modules of the system.

Here's a summary of the acceptance criteria and study information for the iLab™ Ultrasound Imaging System based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (Galaxy® Intravascular Ultrasound System) for market clearance. The acceptance criteria are therefore implicitly tied to meeting similar safety and performance standards as the predicate, rather than specific numerical thresholds presented as acceptance criteria for the iLab™ System's performance in isolation.

Here's the additional information requested, based on the provided text:

• 1. Table of Acceptance Criteria and Reported Device Performance: See table above.

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

  • Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data or case numbers. The testing described is primarily focused on bench testing of the system's electrical, acoustic, and functional components.
  • Data Provenance: The provenance of data for these tests is implicitly from the Boston Scientific Corporation's internal testing labs ("Bench testing was performed... This testing included hardware unit-level tests, software unit-level test, and system-level tests.") and independent test facilities for electrical safety. It is not based on clinical patient data or a clinical study.

• 3. 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 as the testing described is primarily technical and bench-based, not involving expert interpretation of clinical images for ground truth establishment.

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

  • This information is not applicable as the evaluation did not involve human interpretation of images requiring adjudication. The assessment was against technical specifications and predicate device equivalence.

• 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 comparative effectiveness study was not done. The document describes a 510(k) submission focused on demonstrating substantial equivalence through technical and bench testing, not a clinical study comparing human reader performance with or without AI assistance. The device itself is an imaging system, not explicitly described as having AI assistance for interpretation.

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

  • The document describes the iLab™ Ultrasound Imaging System as a complete hardware and software system for real-time imaging, intended as a basic diagnostic tool. The performance evaluations discussed (electrical, acoustic, functional) are for the system itself in a standalone manner, but not as an "algorithm only" in the context of automated interpretation or decision support. It's a fundamental imaging device, not an AI-driven interpretive algorithm.

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

  • Internal specifications and predicate device characteristics served as the "ground truth" for the technical and functional tests. For example, electrical safety was validated against EN standards, and acoustic output was deemed equivalent to the predicate device due to identical components and signal generation. There is no mention of pathology, expert consensus on clinical images, or outcomes data being used as ground truth for this submission.

• 8. The sample size for the training set:

  • Not applicable. The document describes a medical device clearance based on substantial equivalence, primarily through bench testing comparing it to a predicate device. It does not mention any "training set" in the context of machine learning or AI development.

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

  • Not applicable. As no training set is mentioned, the method for establishing its ground truth is not provided.

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