Search Results

The Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.

The Polaris X Unidirectional Steerable Diagnostic Catheter is a sterile, single use, unidirectional, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter consists of a distal electrode segment, a shaft and a handle. The distal electrode segment consists of 10 electrodes (decapolar); 1 tip electrode that is 2 mm in length and 9 ring electrodes in a variety of electrode spacings, as detailed in Table 1. The distal electrode segment is capable of forming a 270° standard curve configuration. The shaft of the Polaris X catheter has a 6 French (F) outer diameter and a useable length of 105 cm. The proximal end of the shaft is connected to a handle, which contains a patented thumbslide steering control that actuates the curve. This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.

The provided text is a 510(k) Summary for a medical device called the Polaris X™ Unidirectional Steerable Diagnostic Catheter. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, this document does not contain information about the device's acceptance criteria, performance against those criteria, or details of a study (such as a clinical trial or performance investigation) that proves the device meets specific acceptance criteria.

The section titled "8. Performance Data" explicitly states "Not applicable for Special 510(k)." This indicates that for this type of submission (a Special 510(k)), the FDA did not require new performance data to demonstrate safety and effectiveness, as it relies on the substantial equivalence to a previously cleared predicate device.

Therefore, I cannot provide the requested information based on the given text. The text does not describe an AI/Software as a Medical Device (SaMD), but rather a physical diagnostic catheter. As such, concepts like "ground truth," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "training set," or "adjudication methods" are not applicable in this context.

Ask a specific question about this device