(204 days)
Navik 3D is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps.
Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed. Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care.
The provided text describes the Navik 3D device's performance data and its comparison to a predicate device, the CARTO 3 System V3.0. However, the document does not provide specific acceptance criteria or detailed results of a study demonstrating the device meets quantified acceptance criteria. Instead, it outlines a series of non-clinical performance tests and concludes that the Navik 3D's performance was "substantially equivalent" to the predicate device.
Given the information in the provided document, the following answers are based on what is available. Many fields will be marked as "Not provided" or "Not applicable" as the source text does not contain that level of detail.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not list specific quantitative acceptance criteria. Instead, it reports that the device's performance was "substantially equivalent" to a predicate device (CARTO 3 System V3.0) through comparative studies, particularly focusing on tip location accuracy. Without explicit numerical acceptance thresholds, a table with specific criteria and results cannot be fully constructed.
| Acceptance Criteria (Not explicitly stated in document - assumed based on "Substantial Equivalence") | Reported Device Performance (as per "Substantial Equivalence Conclusion") |
|---|---|
| Catheter Tip Location Accuracy (comparable to predicate device) | Demonstrated "substantially equivalent" accuracy to CARTO in a phantom study. |
| Cycle Length (CL) Measurement Accuracy (comparable to reference signals) | Demonstrated "substantially equivalent" accuracy in an electrogram analysis and ECG gating study. |
| Local Activation Time (LAT) Measurement Accuracy (comparable to reference signals) | Demonstrated "substantially equivalent" accuracy in an electrogram analysis and ECG gating study. |
| EGM Voltage Measurement Accuracy (comparable to reference signals) | Demonstrated "substantially equivalent" accuracy in an electrogram analysis and ECG gating study. |
| Navigation and Mapping Capabilities (comparable to predicate device) | Demonstrated "substantially equivalent" performance to CARTO in extensive animal testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a phantom study" and "extensive animal testing" without providing specific sample sizes for these tests.
- Sample Size (Test Set): Not provided (for phantom study or animal testing).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are described as "non-clinical performance tests," implying they were specifically conducted for the device's evaluation, likely prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the tests mentioned. The comparison was primarily against the predicate device's performance or "reference signals," rather than a panel of human experts.
4. Adjudication Method for the Test Set
Not applicable. The reported studies were technical performance comparisons (e.g., accuracy against a predicate device or reference signals), not expert-adjudicated clinical case reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes non-clinical performance tests (phantom and animal studies) and electrogram analysis, not a multi-reader, multi-case clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, the studies described are standalone performance evaluations of the device, comparing its output directly to a predicate device or reference signals. The "phantom study," "electrogram analysis and ECG gating study," and "extensive animal testing" appear to assess the algorithm's performance and the device's capabilities in a controlled environment without human-in-the-loop clinical interpretation as the primary endpoint.
7. The Type of Ground Truth Used
- For Catheter Tip Location Accuracy: The "ground truth" was established by simultaneously comparing measurements from the Navik 3D system against the predicate device (CARTO) in a phantom study. This implies the CARTO system's output served as the comparative reference.
- For Electrogam Analysis (CL, LAT, EGM voltage): "Reference signals" were used for comparison. The nature of these reference signals (e.g., gold standard recordings, manually generated data) is not further specified.
- For Navigation and Mapping Capabilities: The "ground truth" was established through direct comparison of capabilities between Navik 3D and the predicate device during animal testing.
8. The Sample Size for the Training Set
Not provided. The document outlines performance testing (validation) but does not detail the development or training of the device's algorithms.
9. How the Ground Truth for the Training Set Was Established
Not provided. Information regarding the training set's ground truth establishment is not included in the document.
§ 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).