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Cornaris Intravascular Imaging System with Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. LumenCross Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The LumenCross Imaging Catheter (referred to as LumenCross) with the Cornaris Intravascular Imaging System produced by Vivolight, which is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The LumenCross intended for use in vessels 2.0~3.5mm in diameter. The LumenCross is not indicated for use in the left main coronary artery or in a target vessel that has undergone a previous bypass procedure.

Cornaris Intravascular Imaging System are cart-mounted computer and Imaging Engin(or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. There are two models, P80-E is mainly composed of trolley, mouse, keyboard, two display monitors, optical engine, computer. Mobile-E is mainly composed of trolley, mouse, keyboard, one display monitor, monitor bracket, optical engine, computer. The both also includes the catheter connection unit (PIU), which provides the interconnection between the Cornaris Intravascular Imaging System and the LumenCross Imaging Catheter.P80-E and Mobile-E has the same software features.

The imaging catheter contains two main components: the catheter body and imaging core (internal rotating fiber optic). The outer diameter of the distal shaft of the catheter was 2.67 F (0.89 mm, 0.035 in.), and the length of the distal shaft was 280mm. The imaging catheter has a working length of 1350mm. The imaging catheter is compatible with 0.014" (0.356 mm) guidewire, which with a guidewire lumen length of 16 mm, the guidewire enters through tip entrance and exit through the RX port. The hydrophilic coating is applied on the outer surface of distal shaft. The LumenCross Imaging Catheter is a single use device. The LumenCross Imaging Catheter is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of two years.

The provided FDA 510(k) clearance letter and its summary do not contain detailed information regarding the acceptance criteria, nor the specific study design and results typically associated with proving a device meets those criteria, especially in terms of algorithm performance for an imaging system. The submission focuses more on general product specifications, non-clinical bench testing, and animal studies related to the physical and material performance of the imaging catheter and system, rather than the quantitative performance of any imaging interpretation algorithm or AI component.

However, based on the information provided, we can infer some aspects and highlight what is missing for a complete answer to your request.

Here's a breakdown based on the provided text, with explicit notes where information is missing:

Overview of Device and Purpose

The Cornaris Intravascular Imaging System (P80-E, Mobile-E) and LumenCross Imaging Catheter (F2) are intended for imaging coronary arteries during transluminal interventional procedures. The system utilizes Optical Coherence Tomography (OCT) to visualize vessel structures. The 510(k) submission focuses on demonstrating substantial equivalence to predicate devices (ILUMIEN OPTIS and DRAGONFLY OPTIS IMAGING CATHETER).

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes various performance tests conducted. These are primarily for hardware, optical parameters, and catheter physical characteristics, rather than interpretive accuracy.

Crucially, this submission does not describe acceptance criteria or performance for an AI algorithm's interpretation of images. It focuses on the hardware's ability to produce images and the catheter's physical characteristics. If there were an AI component for image analysis (e.g., automated lumen segmentation, plaque characterization), specific performance metrics (e.g., accuracy, sensitivity, specificity, Dice score for segmentation) would be listed here, along with their acceptance thresholds. This information is not present in the provided document.

Specific Study Details (as inferable from the document, with noted gaps):

Since the document focuses on showing substantial equivalence through non-clinical and pre-clinical tests, and explicitly states "No clinical study is included in this submission," most of the questions about AI algorithm performance studies cannot be answered from this text.

2. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not specified for a data-driven algorithm test set. The pre-clinical animal study "conducted to support substantial equivalence" did involve a "test set" of animal cases, but the exact number of animals or images generated from that study is not provided.
* Data Provenance: The animal study is an in vivo (likely prospective) study, but the country of origin is not specified. It's safe to assume it was conducted under the company's control, likely in China given their location.
* Retrospective/Prospective: The biological and pre-clinical studies were prospective tests on either ex-vivo materials or in-vivo animal models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable / Not Specified: The ground truth for the biological and physical properties was established by adherence to ISO standards and direct measurements. For the animal study performance metrics, "no significant differences" were found, implying comparison to a predicate device or expert assessment, but the number or qualifications of experts involved in this specific assessment are not detailed. An AI study would typically involve expert readers.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not Applicable / Not Specified: For the physical and biological tests, adjudication methods are not relevant. For the animal study, it's not specified how the "no significant differences" conclusion was reached, or if formal adjudication was used for subjective performance measures like "ease of operation."

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 MRMC Study: The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Indicated: The submission does not describe any standalone algorithm performance testing. This suggests that the device, as cleared, does not include an AI algorithm that performs any automated image analysis or diagnosis requiring such testing. The "Software Features for Imaging" mentioned seem to refer to basic imaging display and system control, not AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Defined Standards/Measurements & Comparative Animal Study:
* For the physical and biological tests, ground truth was implicitly defined by the relevant ISO standards (e.g., ISO 10993-1) and direct physical measurements.
* For the pre-clinical animal study, the "ground truth" was the observed performance of the device and its direct comparison to a predicate device (e.g., "Clear Image Length (CIL)" and "in vivo thrombus formation"). This is an in-vivo assessment.

8. The sample size for the training set:
* Not Applicable / Not Specified: Since no AI algorithm training is described, there is no mention of a training set.

9. How the ground truth for the training set was established:
* Not Applicable / Not Specified: As no AI training data is mentioned, the method for establishing its ground truth is also not.

Conclusion:

The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of the Cornaris Intravascular Imaging System and LumenCross Imaging Catheter to existing predicate devices based on physical, mechanical, optical, biological, and pre-clinical animal performance. It does not present any information related to the performance of an artificial intelligence (AI) component for image interpretation or analysis. Therefore, it cannot address the questions concerning acceptance criteria and study details for an AI algorithm's performance. The "device performance" described pertains to the system's ability to acquire and display images, and the catheter's physical safety and functionality, rather than any automated interpretive function.

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