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

The Gentuity® 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 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 Console and the Vis-Rx® Catheter.
• 2. Vis-Rx® Micro-Imaging Catheter: The Vis-Rx 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 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 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.

The provided document (K242239) is a 510(k) summary for the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter. This particular 510(k) states that "No additional non-clinical and clinical performance testing was required to support review of this 510(k) Premarket Notification" as the proposed device is identical to the predicate device (K230620).

Therefore, the acceptance criteria and study information would be found in the 510(k) for the predicate device (K230620), not in the provided document (K242239).

As this document does not contain the information requested regarding acceptance criteria and performance testing for the current device, I cannot provide an answer based solely on the provided text.

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The Gentuity® HF-OCT Imaging System with Vis-Rx® 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 Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx 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 with Vis-Rx® Micro-Imaging Catheter (herein the "Gentuity 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 Imaging System consists of the Gentuity Imaging Console, Vis-Rx Micro-Imaging Catheter, and Optional Gentuity Review Station.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only discusses the device performance for the AI feature designed to identify "B-Mode with Stent & Guide Catheter." It specifies performance targets and the achieved performance within a table. Note that the other new software features (Stent Expansion View Mode, Longitudinal Zoom & Zoom Indicator, Training Mode, Image Display Speed Optimization, and Angle measurement tool) are verified and validated but their specific performance metrics are not explicitly detailed as acceptance criteria in the same way as the AI feature.

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

• Test Set Sample Size: The text indicates that the test set included 25 patients. The "Patient population included the following" table shows age, sex, and BMI distribution for 25 patients in the test set.
• Data Provenance: The HF-OCT images used for the AI training and test data sets included "clinical data acquired with the Gentuity HF-OCT Imaging System and Vis-Rx catheters." The study population consisted of participants "already scheduled for a visit to the catheterization laboratory and were candidates for transluminal interventional procedures." This strongly suggests the data is retrospective clinical data from an unspecified country, likely where the Gentuity system is used.

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

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing the ground truth on the test set.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set. It mentions "ground truth for the test data was established by expert consensus," but no details on the consensus process (e.g., 2+1, 3+1) are provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the performance of the AI algorithm in isolation (standalone). There is no mention of comparing human readers with and without AI assistance or any effect size for human improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done for the AI feature. The acceptance criteria and reported performance metrics (Accuracy, Sensitivity, Specificity for B-Mode with Stent & Guide Catheter detection, and overall image annotation accuracy) are for the algorithm's performance without direct human intervention in the interpretation phase for these specific AI tasks.

7. The Type of Ground Truth Used

The ground truth for the test set was established by expert consensus. The text states: "The ground truth for the test data was established by expert consensus."

8. The Sample Size for the Training Set

The training set included 20 patients. The "Patient population included the following" table shows age, sex, and BMI distribution for 20 patients in the training set.

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

The document states, "The ground truth for the training data was established by expert consensus." No further details on the specific experts or the consensus method are provided.

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The Gentuity® HF-OCT Imaging System with Vis-Rx® 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 Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

The Gentuity® 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 images. The Gentuity Imaging System consists of the Gentuity Imaging Console, Vis-Rx® Micro-Imaging Catheter, and optional Gentuity Review Station. The console houses the Optical Engine, Computer and application software, and Probe Interface Module (PIM). The Vis-Rx catheter is a sterile, single-use catheter with an external sheath and an optical imaging core. The Gentuity Review Station is an optional stand-alone computer for analysis and review.

This document, K192922, is a 510(k) Premarket Notification for the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter. It establishes substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating the device's meeting of specific acceptance criteria.

While the document references "performance testing" and "design verification and validation," it does not present a formal clinical study with a predefined test set, ground truth establishment, or specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) typical of AI/CADe submissions. Instead, the performance testing focuses on engineering specifications, physical properties of the catheter, and a comparison of image quality with a predicate device.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be directly extracted from this 510(k) summary. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than establishing de novo performance thresholds.

However, based on the provided text, here's an attempt to address the points where information is available or can be inferred:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for diagnostic accuracy or clinical performance metrics in the way a de novo device with AI might. Instead, performance testing focused on engineering specifications, physical characteristics, and image quality comparison to a predicate device.

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

• Test Set (Image Quality Assessment): While an exact number of images/cases is not specified for the "Third-Party Image Quality Assessment," it involved "cross-sectional images extracted from pullbacks with Vis-Rx and with the predicate device." The data provenance for this assessment is not specified (e.g., country of origin, retrospective/prospective), but the context of "animal studies" suggests it was likely derived from the animal testing conducted.
• Animal Testing: Two animal studies were conducted. No specific number of animals or cases is provided.

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

• For the "Third-Party Image Quality Assessment," "Two independent end user reviewers viewed cross-sectional images." Their specific qualifications (e.g., number of years of experience, specific specialty like cardiology/interventional radiology) are not stated beyond being "end user reviewers."
• There's no mention of ground truth established by experts for algorithmic performance in terms of diagnostic accuracy, as this is not an AI/CADe device being assessed for diagnostic performance.

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

• No adjudication method is described for the image quality assessment. The document simply states "Each cross-sectional image was scored by each reviewer." It does not mention how disagreements were resolved or if a consensus mechanism was employed.

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 a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance was reported. This device is an imaging system, not an AI/CADe device intended to assist human interpretation in that manner. The "Third-Party Image Quality Assessment" was a comparison of image quality between two devices, not an evaluation of human reader performance with or without AI.

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

• This is not applicable, as the device is an imaging system, not a standalone AI diagnostic algorithm. The software features mentioned (automatic lumen detection, lumen measurements, etc.) are image processing features within the system, not standalone diagnostic algorithms evaluated for their own performance metrics against ground truth.

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

• For the Third-Party Image Quality Assessment, the "ground truth" was essentially the subjective scores given by the two independent reviewers based on predefined attributes and artifacts. This is not a clinical ground truth like pathology or outcomes.
• For the Animal Testing (Safety), histomorphology findings (presumably from pathology of animal tissues) were used as the basis for comparison of safety and bio-response between the Gentuity system and the predicate. This could be considered a form of ground truth for safety evaluation.
• For Lumen Segmentation and Measurement Accuracy (under "System: Console, SW, PIM, Catheter"), the ground truth would likely be established through phantom studies or calibrated measurements where the true dimensions are known. This is a technical ground truth, not a clinical one.

8. The sample size for the training set

• The document does not detail any "training set" for an AI algorithm in the context of diagnostic performance. The software development and testing were performed in compliance with IEC 62304, which focuses on software lifecycle processes and safety, not on statistical performance of machine learning models.

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

• As no training set for an AI algorithm (in the diagnostic sense) is described, this question is not applicable based on the provided document. The "ground truth" for verifying the system's various engineering functions would typically be established through calibrated instruments, known reference standards, or direct physical measurements during bench testing.

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