(68 days)
The CS REFSTAR Catheter is indicated for electrophysiological mapping of cardiac structures ie, recording and stimulation, including the Coronary Sinus. In addition the CS REFSTAR Catheters are used with compatible CARTO EP Navigation Systems to provide catheter tip location information.
The Biosense Webster CS REFSTAR Catheter has been designed to be used with the CARTO 3 EP Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The CS REFSTAR Catheters have a high-torque 7 Fr shaft with a deflectable tip section containing an array of ten platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. In addition, there is a single eleventh electrode located on the shaft. This Porterfield type electrode is designed to be positioned in the Vena Cava during use where it will perform as a reference unipolar electrode. The catheter has a location sensor embedded in the tip section that transmits location information to the CARTO 3 EP Navigation System. The shaft has a working length of 115 cm. The CS REFSTAR Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in two curve types. D and F. The plane of the curved tip can be rotated during use. The CS REFSTAR Catheter interfaces with standard recording equipment and the CARTO 3 EP Navigation System via interface cables with the appropriate connectors.
The provided document is a 510(k) summary for the Biosense Webster CS REFSTAR Catheter. It describes the device, its indications for use, and concludes its substantial equivalence to predicate devices based on various testing. However, it does not contain the detailed information needed to fill out all the requested categories in your prompt. Specifically, there is no mention of acceptance criteria, a study that proves the device meets specific acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document focuses on "extensive bench (mechanical, electrical and simulated use) testing" and "animal testing" to demonstrate safety and function, but it does not quantify performance against specific, pre-defined acceptance criteria with numerical results that would typically be found in a detailed performance study report.
Therefore, I can only fill in the parts of your request that are directly available in the provided text.
Here's the information extracted from the provided document, with notes where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "The catheter passed all testing in accordance with appropriate test criteria and standards." |
| Not specified in document | "Animal testing... demonstrated that the catheter was safe for use in the coronary sinus and that it is capable of functioning within the CARTO 3 EP Navigation System." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "extensive bench (mechanical, electrical and simulated use) testing" and "animal testing" but does not provide specific sample quantities for these tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Animal testing is mentioned, implying controlled experimental conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable/Not specified. The testing described (bench and animal) would typically involve engineering and veterinary expertise, but not "expert ground truth" for diagnostic accuracy in the way it's usually defined for AI/imaging studies.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. This is typically relevant for studies involving human interpretation or grading, which is not described here.
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
- MRMC Study: No. The document describes a medical device (catheter), not an AI algorithm for diagnostic interpretation that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For the "bench testing," the "ground truth" would be established engineering standards, design specifications, and physical measurements. For the "animal testing," the "ground truth" for safety and function would be physiological responses observed during the animal study and potentially post-mortem analysis.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. This is a medical device, not a machine learning model, so there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Tt was Established: Not applicable. As above, there is no "training set." The device's design and manufacturing are based on established engineering principles, material science, and regulatory standards.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).