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The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

The Gentuity® HF-OCT Imaging System provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to deliver near-infrared light and receive light reflected from coronary tissue to produce high resolution, real-time images. The Gentuity HF-OCT Imaging System consists of the following components:

1. The Gentuity Imaging Console: A mobile system that houses the Optical Engine, the Computer and application software, and the Probe Interface Module (PIM). It also includes two monitors, keyboard, mouse, and cord storage as well as external interfaces to the system. The PIM provides the interconnection between the Gentuity Imaging System and the Vis-Rx® Prime Micro-Imaging Catheter.
2. Vis-Rx Prime Micro-Imaging Catheter: The Vis-Rx Prime Micro-Imaging Catheter is a sterile, single-use catheter that consists of an external sheath and an optical imaging core. The external sheath facilitates placement of the device into the coronary artery and houses the optical imaging core. An optical fiber and lens assembly rotates inside the optical imaging core. The optical fiber and lens deliver near-infrared light to the tissue and receive reflected light. The Vis-Rx Prime Micro-Imaging Catheter is a rapid exchange design, compatible with an 0.014" guidewire. The catheter attaches to the PIM, which is mounted outside the sterile field on the table bed rail. A sterile 3 ml purge syringe is provided with the Vis-Rx Prime Micro-Imaging Catheter.
3. Optional Gentuity Review Station: The Gentuity Review Station (GRS) is an optional standalone computer with the Gentuity application software that provides analysis and review capabilities similar to what may be performed on the Gentuity Console. The GRS allows physicians to review images for research, presentation and publication preparation outside the catheterization lab without the Gentuity Console.

This FDA 510(k) summary does not contain the detailed performance study information typically found in acceptance criteria and validation studies for medical devices, particularly those involving AI or imaging interpretation. This document primarily describes the device, its intended use, and substantial equivalence to a predicate device based on bench and animal testing.

Therefore, many of the requested points cannot be answered from the provided text.

Here is what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding reported device performance metrics. Instead, it lists the types of performance testing conducted and states that "All [type of test] validation results met applicable acceptance criteria." without specifying what those criteria or results were.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions an "Animal Study" which was a GLP (Good Laboratory Practice) nonclinical laboratory study. It does not specify the sample size (number of animals) used, nor does it detail the specific data collected from this study in a way that would relate to device performance metrics, image quality, or diagnostic accuracy. There's no information about human test sets, data provenance, or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The document does not describe any studies involving human experts interpreting images or establishing ground truth.

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

This information is not provided.

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

There is no mention of an MRMC study and no indication that this device involves AI assistance for human readers in its primary function as described in this 510(k) summary. The device is an imaging system (Optical Coherence Tomography) for intravascular imaging.

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

This information is not provided. The document focuses on the hardware and basic system functionality, not on advanced algorithmic performance or automated interpretation.

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

For the animal study, the "ground truth" would likely be the direct physiological and histological findings from the animals, but the document does not specify this or link it to any performance claims. For other tests (biocompatibility, particulate, sterilization), the ground truth is against established standards and validated methods.

8. The sample size for the training set

This is not applicable as the document does not describe any machine learning or AI components requiring a training set.

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

This is not applicable.

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