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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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The Hansen Medical Sensel® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei X Robotic Catheter System include an enhancement to the motion scaling feature.

The provided document is a 510(k) summary for the Hansen Medical Sensei® X Robotic Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a performance study in the way one would expect for a new, non-substantially equivalent device.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this 510(k) summary.

Key takeaways from the document:

• Device: Hansen Medical Sensei® X Robotic Catheter System.
• Purpose: To facilitate manipulation, positioning and control of robotically steerable catheters for collecting electrophysiological data within the heart atria.
• Modification: An enhancement to the motion scaling feature.
• Predicate Device: Earlier Sensei System (K091808).
• Basis for Approval: Substantial equivalence, meaning the modified device performs as safely and effectively as the previously cleared (predicate) device, and the modifications do not affect its intended use or fundamental scientific technology.

Since the submission is a "Special 510(k)" for a modification, the focus is on demonstrating that the change does not raise new safety or effectiveness concerns, rather than conducting a full performance study as if it were a novel device. The FDA typically relies on the established safety and effectiveness of the predicate device.

To directly answer your questions based only on the provided text, many fields will be "Not Reported" or "Not Applicable" for this type of submission:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not reported.
• Data Provenance: Not reported. (For a Special 510(k) focusing on a modification, often internal verification and validation data are used rather than clinical studies in the traditional sense, but the specifics are not disclosed here.)

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

• Not applicable/Not reported. This type of performance study for ground truth establishment is typically not part of a Special 510(k) submission for a device modification.

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

• Not applicable/Not reported.

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

• Not applicable. This device is a robotic catheter system, not an AI-assisted diagnostic tool. No human reader study is mentioned.

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

• Not applicable. This is a robotic system, not a standalone algorithm. The performance evaluation focuses on the safety and functionality of the robotic system itself and its interaction with compatible catheters, implicitly with a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable/Not reported. The submission focuses on demonstrating substantial equivalence, often through engineering and functional testing rather than direct clinical ground truth comparison in the context of diagnostic accuracy.

8. The sample size for the training set

• Not applicable/Not reported. (This is not an AI/machine learning device that would have a "training set" in that context.)

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

• Not applicable/Not reported.

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