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The NovaCross CTO Microcatheter is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond the stenotic lesions, including chronic total occlusions (CTOs), and prior to PTCA or stent intervention. It is also intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

The NovaCross™ CTO Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention and to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature. The NovaCross™ CTO Microcatheter consists of stainless steel shaft, Over Tube, and a proximal Handle Body that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and collapsible distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site.

Here's a breakdown of the acceptance criteria and study details for the NovaCross™ CTO Microcatheter, based on the provided FDA 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 186 subjects across two cohorts (Cohort A: 145, Cohort B: 41).
• Data Provenance: Not explicitly stated, but the submission mentions "10 investigational sites," implying the study was conducted at various clinical locations. The document refers to the submitter's location as Israel, and the regulatory consultant in the US, but the study locations are not detailed. It is a prospective study as it's an "IDE Clinical Study" and a "pivotal study" conducted to assess safety and efficacy.

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

This information is not provided in the document. The study involved subjects undergoing Percutaneous Cardiac Intervention (PCI) for CTO, and the endpoints were clinical outcomes (MI rate, technical success). The determination of these outcomes would have been based on standard clinical practices, lab results (CK-MB), and interventional cardiologist assessment, but the specific number and qualifications of "experts" for ground truth adjudication are not detailed.

4. Adjudication Method for the Test Set

This information is not explicitly detailed for the clinical endpoints. Clinical trial data typically involves a Clinical Events Committee (CEC) for endpoint adjudication, but the specific method (e.g., 2+1, 3+1) is not mentioned in this summary.

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 done. The study described is a single-arm clinical trial assessing the device's safety and effectiveness, not comparing human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical medical device (microcatheter) and not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance study is not applicable here. The study assesses the performance of the device in a clinical setting with human operators.

7. The Type of Ground Truth Used

• For the primary safety endpoint (MI rate): Outcomes data based on clinical events and objective biomarker measurement (CK-MB > 3X ULN) and urgent revascularization.
• For the primary effectiveness endpoint (technical success): Expert assessment/outcomes data based on the ability to successfully facilitate guidewire placement beyond the CTO in the true vessel lumen, as determined by the interventional cardiologists performing the procedure.

8. The Sample Size for the Training Set

This information is not applicable as the NovaCross™ CTO Microcatheter is a physical medical device and not an AI/machine learning algorithm that requires a training set. The "training" for this device would refer to its design, engineering tolerances, and preclinical testing.

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

This information is not applicable for the same reason as above. The "ground truth" for the device's development and preclinical validation would involve engineering specifications, material properties, and various bench testing results (e.g., dimensional, torque response, tensile strength, scaffold durability) against predefined design criteria.

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