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The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary interventional (PCI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.

The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Console, as well as angiographic monitor(s). Commercially available guidewires and balloon/stent catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the balloon/stent catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CorPath 200 System:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on the clinical outcomes of the PRECISE Clinical Study and a subsequent study evaluating radial access. It doesn't explicitly state quantitative acceptance criteria for each- metric prior to the study. Instead, the reported results are presented as evidence of safety and effectiveness, implying that these results met internal criteria for substantial equivalence.

Note: The document does not clearly define numerical acceptance criteria that were pre-specified for these metrics. The reported performance is the evidence evaluated for substantial equivalence.

2. Sample sizes used for the test set and data provenance:

• PRECISE Clinical Study:
  • Sample Size: 164 subjects
  • Data Provenance: Prospective, multi-center, single-arm study. The country of origin is not explicitly stated, but clinical studies for FDA submissions are typically conducted in the US or in countries with comparable regulatory standards.
• Radial Access Study:
  • Sample Size: 30 patients, treating 36 lesions.
  • Data Provenance: Clinical study. The country of origin is not explicitly stated. It's prospective.

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

The document mentions that "post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory)" was a key outcome.

• Number of experts: Not specified, but "Core Laboratory" implies a group of trained professionals.
• Qualifications of experts: Not specified beyond being a "Core Laboratory," which denotes a specialized group performing standardized, blinded assessments in clinical trials. They would typically involve experienced interventional cardiologists or cardiovascular imaging specialists.

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

The document does not explicitly state an adjudication method for the clinical endpoints such as MACE or stenosis evaluation. The use of a "Core Laboratory" suggests standardized assessment protocols, which often include blinded, independent review, but the specific adjudication process (e.g., how disagreements were resolved) is not detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, the provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI-assisted vs. non-AI-assisted human readers. The CorPath 200 System is a robotic system that assists a single operator, not an AI for image interpretation or diagnosis that would typically be evaluated with MRMC studies. The "PRECISE Trial demonstrated a reduction of radiation exposure to the primary operator," which is a comparative benefit to traditional manual PCI, but not an MRMC study in the typical sense of evaluating diagnostic accuracy with and without AI.

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

The CorPath 200 System is a robotic device designed for human interaction and control (physician sends commands via joysticks/touch screen). It is not an "algorithm only" device that operates autonomously or performs diagnostic tasks. Therefore, a standalone performance evaluation in the context of an AI algorithm is not applicable or described. The performance data presented (clinical outcomes, technical success) are inherently "human-in-the-loop."

7. The type of ground truth used:

• Clinical Outcomes (PRECISE Study & Radial Access Study):
  • Stenosis < 30%: Evaluated by a "Core Laboratory," likely using quantitative coronary angiography (QCA) or similar imaging analysis, which serves as an established expert consensus-based ground truth.
  • MACE (Major Adverse Cardiac Events): Clinical events, typically adjudicated by an independent clinical events committee based on pre-defined clinical definitions and patient outcomes data. This represents outcomes data.
  • Procedural Success/Technical Success: Based on intra-procedural observations and immediate post-procedural assessments, reflecting clinical and technical outcomes.

8. The sample size for the training set:

The document describes the CorPath 200 System as a robotic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense of data used to train a model. Therefore, a sample size for a training set is not applicable to the description of this device. The development process would involve engineering, bench testing, and optimization, not data-driven machine learning training.

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

As the CorPath 200 System is not an AI/machine learning algorithm requiring a "training set," this question is not applicable. The "ground truth" for its development would be engineering specifications, performance benchmarks from predicate devices, and user requirements, rather than a labeled dataset.

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