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The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and catheters through the 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 Control Console, as well as angiographic monitor(s). Commercially available guidewires and rapid exchange 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 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, focusing on the acceptance criteria and study data for the CorPath 200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device needed to meet. Instead, it presents the reported performance directly from two clinical studies. However, based on the studies' objectives and reported outcomes, we can infer the implicit "acceptance criteria" related to safety and effectiveness.

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

• PRECISE Clinical Study (PCI):
  • Sample Size: 164 subjects.
  • Data Provenance: Prospective, multi-center, non-randomized study. The document does not explicitly state the country of origin, but "nine (9) clinical sites" typically implies a domestic (US) study for FDA submissions unless otherwise specified.
• RAPID Study (PVI):
  • Sample Size: 20 Rutherford Class 2 to 5 subjects (with 29 treated lesions).
  • Data Provenance: Prospective, non-randomized feasibility evaluation. The document does not explicitly state the country of origin.

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

• PRECISE Clinical Study (PCI):
  • Specifics of ground truth experts are not explicitly detailed. However, it mentions "post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory)." A Core Laboratory implies a specialized facility with imaging experts (e.g., interventional cardiologists, radiologists) responsible for standardized, blinded evaluation of angiographic images. The number and specific qualifications (years of experience) are not provided.
• RAPID Study (PVI):
  • Specifics of ground truth experts are not explicitly detailed. Angiographic assessments (e.g., <50% residual stenosis) would typically be made by the interventional cardiologists or radiologists involved in the study, likely with independent verification, but this is not explicitly stated.

4. Adjudication Method for the Test Set

• PRECISE Clinical Study (PCI):
  • The document refers to a "Core Laboratory" for stenosis evaluation. Core laboratories typically employ adjudicated methods to ensure consistency and minimize bias, often involving multiple readers and consensus, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly mentioned.
• RAPID Study (PVI):
  • The document does not describe the adjudication method for the performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostic devices, was explicitly described. The provided studies (PRECISE and RAPID) evaluated the robotic system's performance during the procedure, not as an AI diagnostic tool assisting human readers in interpreting medical images.
• The PRECISE trial did demonstrate "a reduction of radiation exposure to the primary operator," which is a beneficial effect related to using the robotic system, allowing the operator to be further from the radiation source. This is a safety benefit for the human operator, not an improvement in diagnostic accuracy or speed for human readers.

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

• No, a standalone algorithm performance study was not done because the CorPath 200 System is a robotic-assisted catheter control system designed for human-controlled manipulation during procedures, not a diagnostic AI algorithm. Its function is to execute the physician's commands remotely, not to provide independent analysis or decisions. The performance metrics reflect the combined performance of the system and the physician using it.

7. The Type of Ground Truth Used

• PRECISE Clinical Study (PCI):
  • Expert Consensus/Clinical Outcomes: This includes evaluation by a "Core Laboratory" for angiographic stenosis, and clinical endpoints like Major Adverse Cardiac Events (MACE) and overall procedural success. MACE is an important clinical outcome.
• RAPID Study (PVI):
  • Clinical Outcomes/Procedural Success: This includes successful cannulation, <50% residual stenosis, absence of device-related SAEs, and absence of angiographic complications, all as determined by clinical assessment during and after the procedure.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. The CorPath 200 System, as described, is a robotic control system for physical manipulation of medical devices, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "software continuously monitors the communication," but this refers to operational control, not a learning algorithm that processes data to improve its diagnostic or predictive capability. Therefore, there is no mention of a "training set" for the device's core functionality.

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

• Not Applicable / Not Provided. As there is no described training set for an AI algorithm, the method for establishing its ground truth is not relevant to this device's description.

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

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and 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 Control 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 a breakdown of the acceptance criteria and study information for the Corindus CorPath® 200 System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list "acceptance criteria" with specific thresholds in a tabular format. Instead, it presents the results of a clinical study that demonstrates the device's acceptable performance. The key performance metrics and their reported outcomes are summarized below:

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

• Sample Size for the Test Set: 164 subjects
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, and the study was multi-center, implying it could be within the U.S. or internationally.
  • Retrospective or Prospective: Prospective

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

• The document mentions "as evaluated by a Core Laboratory" for post-procedure stenosis. However, it does not specify the number of experts or their qualifications (e.g., years of experience, specialty) involved in establishing the ground truth for this evaluation or any other endpoint.

4. Adjudication Method for the Test Set

• The document does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the clinical study endpoints. It mentions that post-procedure stenosis was evaluated by a Core Laboratory, which typically implies a standardized, objective assessment, but the exact method for resolving discrepancies (if any) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned for human readers with and without AI assistance. The study described (PRECISE Clinical Study) was a single-arm study evaluating the device itself, not comparing human reader performance with and without AI.

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

• This device is a physical robotic system (CorPath® 200 System) that assists a human physician in performing PCI procedures. It is not an AI algorithm in the typical sense that operates standalone. Therefore, a "standalone algorithm only" performance study is not applicable and was not reported. The performance reported (e.g., clinical procedural success) directly reflects the human-in-the-loop performance using the device.

7. The Type of Ground Truth Used

• Clinical Outcomes Data: The ground truth for effectiveness was based on clinical outcomes data collected from the 164 subjects, including:
  • Clinical procedural success (a composite endpoint likely based on successful completion of the PCI and patient status).
  • Post-procedure stenosis (<30%) evaluated by a Core Laboratory (objective measurement).
  • Absence of Major Adverse Cardiac Events (MACE) (clinically defined events).

8. Sample Size for the Training Set

• The document does not explicitly state a sample size for a "training set." The CorPath 200 System is a robotic device, not a machine learning algorithm that undergoes a distinct "training phase" with a labeled dataset in the way AI/ML software devices often do. Its development involved "design and development" supported by GLP animal studies and non-clinical bench testing.

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

• As the device is a robotic system and not an AI/ML algorithm with a traditional "training set," the concept of "ground truth for the training set" as it applies to AI/ML is not directly applicable.
• The closest equivalent would be the validation and verification activities that informed its design and performance specifications. These included:
  • Non-clinical testing (bench testing): Various force, velocity, accuracy, torque, and wear tests were conducted to verify physical performance characteristics against engineering specifications. These tests generate their own "ground truth" based on controlled experimental conditions and instrumentation.
  • GLP animal studies: These studies evaluated the "performance of the CorPath 200 System for Delivery and Deployment of Standard PTCA Devices in a porcine model." The "ground truth" here would be the anatomical and physiological outcomes observed during and after the procedures in the animal models, assessed by veterinary or medical experts.

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