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The Hansen Medical Sensei® 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 a series of software enhancements and a new E-Stop button.

The provided document is a 510(k) summary for the Hansen Medical Sensei X Robotic Catheter System. It describes a device that is an updated version of a previously cleared device. Therefore, the "study" described is a design verification and validation testing to confirm that the modifications do not alter the substantial equivalence of the device to its predicate.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All of the pre-determined acceptance criteria were met." However, it does not explicitly list the acceptance criteria themselves or the specific quantitative results for each test. It only lists the types of testing performed.

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

The document does not specify the sample sizes used for the software, E-Stop, or system testing. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

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

This information is not mentioned in the provided text. The testing described appears to be engineering verification and validation against design specifications, rather than clinical efficacy studies requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the tests described are engineering and functional checks, not involving interpretation by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted (or at least, not described in this document). The document explicitly states: "No additional clinical evaluation of the Sensei X Robotic Catheter System is required as a result of these changes." This indicates that no studies comparing human readers with and without AI assistance were performed or deemed necessary for this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This is not applicable as the Sensei X Robotic Catheter System is a robotic control system for catheters, inherently designed for human-in-the-loop operation, not a standalone AI algorithm. The described testing is primarily focused on the functional performance of the system and its components (software, E-Stop).

7. Type of Ground Truth Used

The "ground truth" for the tests mentioned (Software Testing, E-Stop Button functional testing, System testing) would be based on the design specifications and requirements of the device. For example, for software testing, the ground truth would be that the software performs according to its functional and performance specifications. For E-Stop testing, the ground truth would be that the button successfully halts the system as designed. This is engineering verification, not clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not describe an AI model with a training set. The Sensei X Robotic Catheter System is a robotic control system with software enhancements, but it's not presented as an AI/ML device that learns from a training dataset in the way a diagnostic algorithm would.

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

This is not applicable as no training set for an AI model is described.

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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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