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The VeriSight/VeriSight Pro ICE catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm.
The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide.
The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

Based on the provided FDA 510(k) clearance letter for the Philips VeriSight Intracardiac Echocardiography Catheters, the device is not an AI/ML-based device. The submission focuses on adding pediatric indications to an existing, cleared device, and thus, the information requested about acceptance criteria and a study proving an AI device meets those criteria is not applicable to this specific submission.

The document explicitly states:

• "The purpose of this submission is solely to add pediatric indications to the currently cleared VeriSight/VeriSight Pro ICE catheters (cleared under K200812)." (Page 6)
• "No additional non-clinical performance testing was executed for this change." (Page 6)
• "The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence." (Page 6)

Therefore, the document does not contain details regarding acceptance criteria, performance data, test sets, ground truth establishment, or any other aspects related to the validation of an AI/ML device. The clearance is based on the substantial equivalence to a predicate device for the expanded indications, rather than a new technological performance validation.

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The VeriSight VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Intracardiac Echocardiography (ICE) System comprises of the VeriSight Pro ICE Catheters, the ICE PIM, and the EPIQ Diagnostic Ultrasound System (cleared under K202216).

The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm.

The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide.

The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

The provided document, a 510(k) Summary for the Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, indicates that clinical data was not required to establish substantial equivalence for this device. Therefore, there is no study detailing acceptance criteria or device performance in a clinical setting for this submission.

The manufacturer states: "The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence." (Page 8).

Instead, the submission relies on the substantial equivalence to a predicate device (Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F, cleared under K170263) and extensive non-clinical performance testing to demonstrate safety and effectiveness.

Here's a breakdown of the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Since a clinical study was not conducted to establish performance metrics like sensitivity, specificity, or accuracy against an established ground truth, there is no direct table of acceptance criteria and reported device performance in the context of clinical outcomes. The "performance" in this context refers to the successful completion of engineering design verification and validation tests.

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

Not applicable, as no clinical test set was used for the purpose of demonstrating device performance against clinical acceptance criteria. The testing listed above refers to engineering and bench testing, for which specific sample sizes are not detailed in this summary but are generally conducted on a representative number of devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as no ground truth was established by experts in a clinical context for this submission. The "ground truth" for the non-clinical tests would have been the established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical data was not required.

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

Not applicable. The device is a physical intracardiac echocardiography catheter, not an AI algorithm. Its function is to provide imaging capabilities for human interpretation.

7. The Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" was defined by:

• Engineering design specifications and performance requirements for the device.
• Established national and international voluntary standards for medical devices, electrical safety, electromagnetic compatibility (EMC), and diagnostic ultrasound safety (e.g., EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-37, IEC 62359).
• Results from preclinical animal testing for safety and function.

8. The Sample Size for the Training Set:

Not applicable, as this device does not involve a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Reconnaissance PV .018 Digital IVUS catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicted for use in cerebral vessels.

The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reconnaissance PV .018 OTW IVUS Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end and has a transducer that utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The catheter has 150cm working length and a hydrophilic coating at the distal 40 cm to assist the clinician in advancing the catheter to the desired location. The minimum guide sheath is 5F (0.074") and the maximum guide wire Outer Diameter (OD) is 0.018" (0.46 mm).

At the proximal end, there is a PIM Connector and Y Connector (aka Y-Arm). The Y-Arm allows the catheter to incorporate the PIM Connector while still serving as an over-the-wire design. A Luer/hub fitting (aka the Y-Arm) is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the scanner lead wires, routed from the cylindrical ultrasound transducer array, to interface electrically with the patient interface module (PIM) connector. The Visions® PV 0.018 Catheter may only be used with Philips Imaging Systems, such as the CORE Series Precision Guided Therapy Systems such as the IntraSight System.

I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific performance criteria. The text describes the product, its indications for use, and a comparison to predicate devices, but lacks the specific data points needed to answer your questions.

Here's what I can tell you based on the provided text, and what is missing:

Missing Information:

• Detailed Acceptance Criteria and Reported Device Performance Table: The document states "Based on the testing results, the Reconnaissance Digital IVUS Catheter is substantially equivalent to the predicates. The data support the performance and safety of the device. Verification/validation demonstrate that the Reconnaissance catheter will perform as intended in the defined conditions." However, it does not provide a table outlining specific acceptance criteria (e.g., image resolution, penetration depth, signal-to-noise ratio) and the corresponding reported performance values for the Reconnaissance PV .018 OTW Digital IVUS Catheter.
• Sample Size for Test Set and Data Provenance: This information is not explicitly stated.
• Number of Experts and Qualifications for Ground Truth of Test Set: This information is not provided.
• Adjudication Method for Test Set: This information is not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of an MRMC study or any comparison of human reader performance with and without AI assistance.
• Standalone Performance Study: The document does not explicitly detail a standalone performance study of the algorithm without human-in-the-loop.
• Type of Ground Truth Used: The document mentions "testing results" and "verification/validation" but does not specify the type of ground truth used (e.g., another imaging modality, histological analysis, clinical outcomes).
• Sample Size for Training Set: This information is not provided.
• How Ground Truth for Training Set was Established: This information is not provided.

The document primarily focuses on the regulatory submission (510(k)) and establishing substantial equivalence to existing predicate devices based on design, indications for use, and principle of operation, rather than providing a detailed technical performance study in this summary. It mentions that "Verification/validation demonstrate that the Reconnaissance catheter will perform as intended," implying that studies were conducted, but the specifics are not included in this document.

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