(479 days)
The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures.
The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.
The CardioNXT iMap™ 3D Mapping and Navigation System (iMap™ System) is a catheter navigation and mapping system, capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as electroanatomical maps of the cardiac chamber. The contoured surfaces of these threedimensional maps are based on the anatomy of the patient's cardiac chamber. The iMap™ System utilizes electromagnetic tracking and impedance tracking to track conventional catheters and paint the surfaces of cardiac chambers in 3D to generate a patient-specific image of the heart, also called a geometry. The iMap System measures cardiac electrogram (EGM) information from navigated catheter electrodes throughout the heart and displays this information on the patient-specific geometry. The iMap System utilizes a Coronary Sinus(CS)catheter with both electromagnetic sensors and electrodes as a reference for its navigation coordinate system.
The provided text describes the CardioNXT iMap™ 3D Mapping & Navigation System, but it does not contain acceptance criteria and specific study results in the format requested. Instead, it lists various types of testing performed and concludes that the device meets performance specifications and is substantially equivalent to predicate devices.
Here's a breakdown of what is and isn't present, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided. The document states that bench testing demonstrates the system meets performance specifications, but it does not list those specifications or the quantitative results against them.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample size for test set: Not explicitly stated. The document mentions a "GLP animal study" and "bench testing," but doesn't give specific numbers of animals or test items.
- Data provenance: "GLP animal study" implies prospective animal data. "Bench testing" would be laboratory-based. No mention of human data, retrospective or prospective, for performance evaluation against acceptance criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not provided. The document mentions "usability testing demonstrating usability by licensed cardiac electrophysiologist physicians," but this is for usability, not for establishing ground truth for device performance metrics.
4. Adjudication Method:
- Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not performed/reported. The document does not mention an MRMC study or any effect sizes of human reader improvement with AI assistance.
6. Standalone Performance:
- A standalone performance study was likely done as part of the "bench testing demonstrating substantially equivalent safety, performance, and accuracy to predicate" and the "GLP animal study." However, the specific metrics and results of this standalone performance are not detailed in the provided text. The overall conclusion is that it meets specifications, but the specifics are absent.
7. Type of Ground Truth Used:
- For the "GLP animal study" and "bench testing," the ground truth would typically be established through direct measurements, established physiological parameters, or physical phantom models with known properties. However, the document does not explicitly specify the type of ground truth (e.g., direct measurement, histological analysis, etc.) for each performance metric evaluated.
8. Sample Size for the Training Set:
- Not provided. The document does not mention any "training set." The iMap™ System is described as a "programmable diagnostic computer" and a "mapping and navigation system," implying it might use algorithms, but no details on machine learning model training or associated datasets are given.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. Since no training set is mentioned, the method for establishing its ground truth is also not mentioned.
In summary, the provided document focuses on regulatory clearance and substantial equivalence by listing various types of testing performed (bench, animal, electrical safety, biocompatibility, etc.) and concluding that the device meets requirements. However, it lacks the detailed quantitative acceptance criteria and specific study results that you requested to demonstrate how those criteria were met.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).