(29 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly listed) | All pre-determined acceptance criteria were met for: |
| - Software Testing | |
| - E-Stop Button functional testing | |
| - System testing |
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.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).