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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.

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The catheter is intended for temporary use in electrophysiological stimulation (pacing) and/or recording of electrical potentials.

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. 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 thumb-slide 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 document is a 510(k) summary for the Polaris X™ Unidirectional Steerable Diagnostic Catheter. This document asserts substantial equivalence to a predicate device and includes performance data related to device safety and functionality, but it does not present a study with specific acceptance criteria and reported performance for diagnostic accuracy or effectiveness in a clinical context that would typically involve a test set, ground truth established by experts, or MRMC studies.

This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, especially when the technological characteristics are very similar. The performance data provided is primarily engineering, biological, and sterility testing to ensure the device performs as intended and is safe for use.

Therefore, many of the requested categories related to diagnostic performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the information presented in this 510(k) summary.

Here's a breakdown of the relevant information from the document:

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests without explicitly stating numerical acceptance criteria or detailed quantitative results in a table format. Instead, it states that "The following performance data were provided in support of the substantial equivalence determination" and later concludes that "The performance data, including biocompatibility, sterilization and design verification testing supports that the subject catheter is as safe and effective as its predicate device."

Summary of Performance Data provided:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The reported performance data are primarily laboratory and bench testing, not clinical studies involving "test sets" in the diagnostic sense, expert interpretation, or patient data. The "test sets" would refer to the samples or units of product subjected to the engineering, biological, and sterility tests. The document does not specify the number of units tested for each specific test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is an electrode recording catheter, and the 510(k) pertains to its substantial equivalence based on safety and basic functional performance, not on direct diagnostic interpretation by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This device is a steerable diagnostic catheter, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (catheter), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of diagnostic "ground truth." The "ground truth" for the performance data presented would be the established scientific and engineering standards and specifications (e.g., ISO, ANSI/AAMI standards, internal product specifications).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

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