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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 Ultreon™ Software for Ultiri™ Measurement System is intended to be used only with compatible Ultiri™ Measurement Systems.

The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if thervention is indicated.

Indications for Use (capital equipment hardware)

The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if thervention is indicated.

The Ultiri™ Measurement System is a diagnostic computer designed to record, compute, display and store data received wirelessly from the PressureWire™ guidewire and Wi-box. The system's main component is an all-in-one personal computer (AiO-PC) operating Ultreon™ Software for Ultiri™ Measurement System. It is compatible with the PressureWire X Guidewire and Wi-Box AO Transmitter. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR). The physician may use FFR, Pd/Pa at rest and RFR parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The Ultreon™ Software provides guided instructions for the physician to setup a physiology procedure. The display of the user interface can be output to an external video monitor. Additional functions allow the user to import patient lists from the hospital's DICOM (Digital Imaging Communications server) system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick. Ultiri™ Measurement System is not intended for patient contact and is a non-sterile device that can be draped for sterile interaction. Ultir™ Measurement System is distributed as a package with the following components: ● All-in-One PC (with Ultreon Software) DC power supply ● AC power cords ● Instructions for use ● . USB flash drive ● Video output adapter(s)

The Ultiri™ Measurement System, which includes the Ultreon™ Software, is a diagnostic computer designed to record, compute, display, and store data received wirelessly from the PressureWire™ guidewire and Wi-box. The system measures and displays physiological parameters such as systolic, diastolic, and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR). These parameters help assess the severity of coronary lesions by measuring the pressure drop across them.

Here's an analysis of the acceptance criteria, study details, and ground truth establishment:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the device's physiological measurements. Instead, it relies on demonstrating substantial equivalence to predicate devices through design characteristics and non-clinical bench performance testing.

The "Comparison of Subject to Predicate Device" table on page 5 details the functional equivalences, which serve as the implicit acceptance criteria for technological characteristics.

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

• Sample Size for Test Set: Not specified in the provided documents. The filing states that "non-clinical bench performance testing" was conducted. This typically involves a set of predefined test cases rather than patient data.
• Data Provenance: Not applicable in the context of clinical data for the 510(k) submission. The testing was non-clinical bench testing. There is no mention of country of origin or whether it was retrospective or prospective, as it was not a clinical study involving patient data.

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

• Number of Experts: Not applicable. Since no clinical testing was performed or relied upon, there was no ground truth established by experts on patient data for the purpose of demonstrating device performance in this 510(k). The "ground truth" for bench testing would be defined by engineering specifications and expected output values in controlled environments, verified by engineers.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set requiring expert adjudication was utilized for this 510(k) submission. Bench testing results would be compared against expected outputs and engineering specifications.

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:

• MRMC Study: No. The document explicitly states: "No clinical testing was completed, nor relied upon, in support of this Traditional 510(k)." Therefore, no MRMC study, or any clinical study involving human readers and AI assistance, was performed or presented.

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

• Standalone Performance: The core of the device's functionality is a standalone algorithm that computes and displays physiological parameters. The non-clinical bench performance testing would have validated the accuracy of these computations in a standalone manner, generating outputs that are then interpreted by a physician. While not explicitly termed "standalone performance" in the document, the "Measurement & Display Features" and "Physiology Functionality" sections imply that the algorithms for FFR, RFR, and other parameters were validated for their accuracy in processing input data.

7. The Type of Ground Truth Used:

• Type of Ground Truth: For the non-clinical bench performance testing, the ground truth would be based on:
  • Engineering specifications and controlled inputs: Known pressure/flow values (simulated or generated) fed into the system.
  • Mathematical accuracy: Verification that the algorithms correctly calculate FFR, RFR, and other parameters based on the known inputs and established physiological models used in the predicate devices.
  • Comparison to predicate device outputs: Direct comparison of the Ultiri™ Measurement System's output to the known outputs or established performance of the legally marketed predicate devices under identical simulated conditions.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a diagnostic computer that computes physiological parameters using established algorithms. It does not appear to employ machine learning or AI that requires a "training set" in the conventional sense for image recognition or predictive modeling. The algorithms are based on scientific principles and, as stated, are the "Same algorithms as used in the predicates."

9. How the Ground Truth for the Training Set was Established:

• Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for machine learning/AI. The algorithms themselves, derived from scientific understanding of physiology and validated in predicate devices, form the basis of the device's functionality.

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