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The Cordis Webster REF-STAR Ex Surface Reference Device is indicated for use with the NAVI-STAR®, NOGA-STAR™, or REF-STAR catheters and the CARTO™ and NOGA ™ systems to provide catheter tip location.

The Cordis Webster REF-STAR Ex Surface Reference Device has been designed to be placed externally on the patient's back in order to compensate for movement during electrophysiological and electromechanical mapping of the heart. The Cordis Webster REF-STAR Ex Surface Reference is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology known as CARTO™ and NOGA ™. When used with the CARTO and NOGA system, the location of the mapping catheter tip, the NAVI-STAR, NOGA-STAR or REF-STAR is compared to the location of the reference device. This reference device consists of a sensor embedded in a polyurethane shaft, which is connected to a handle that houses the printed circuit board.

This 510(k) summary describes a substantial equivalence determination for the Cordis Webster REF-STAR Ex Surface Reference Device, comparing it to a predicate device. The information provided focuses on the nonclinical testing performed to demonstrate this equivalence, rather than a clinical study with detailed acceptance criteria and performance metrics in the way a new, innovative device might be evaluated for efficacy.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria in the typical format of a new product performance study (e.g., sensitivity > X%, accuracy > Y%). Instead, the acceptance criterion for this 510(k) submission is "no significant differences in the outcome of the tests...that would affect the safety and effectiveness of the device" compared to the predicate device.

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

The document describes nonclinical testing. Therefore, there are no human subject sample sizes or data provenance in terms of country of origin or retrospective/prospective clinical data mentioned. The "tests" refer to laboratory or bench tests.

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)

This information is not applicable as the evaluation was based on nonclinical performance testing, not human expert interpretation or ground truth establishment in a clinical context.

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

This information is not applicable as the evaluation was based on nonclinical performance testing, not human expert adjudication.

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

This information is not applicable. The device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

This information is not applicable. The device is a physical surface reference device, not an algorithm. The testing described is nonclinical performance testing comparing the device to a predicate.

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

For the nonclinical performance testing, the "ground truth" would be the expected performance specifications and measurements defined for the device and its predicate. The performance of the REF-STAR Ex Surface Reference Device was compared directly against the performance of the predicate device (Cordis Webster REF-STAR catheter) in a controlled test environment. The implicit ground truth is that the predicate device is considered safe and effective, and thus the new device must perform comparably.

8. The sample size for the training set

This information is not applicable. The device is not an AI algorithm requiring a training set. The testing was nonclinical comparative performance testing of a physical device.

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

This information is not applicable for the same reason as above; there is no training set for a physical device undergoing nonclinical performance testing.

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