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The Biosense Webster RefStar External Reference Patch is indicated for use with Biosense Webster navigation catheters and the CARTO and NOGA Systems to provide a reference point for catheter tip location.

The Biosense Webster RefStar External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to a handle that houses the printed circuit board.

The provided text is a 510(k) summary for the RefStar External Reference Patch. This submission describes a modification to the labeling of an already cleared device, specifically adding the use of the EsophaStar Esophageal Mapping Catheter. The key takeaway is that no new performance studies were conducted because the device itself and its performance characteristics remain unchanged from its predicate.

Therefore, many of the requested details about acceptance criteria, study findings, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as they pertain to new device testing.

Here's a breakdown of what can be gleaned from the provided text:

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

• Acceptance Criteria: Not explicitly stated in this 510(k) summary. Given that this is a labeling modification, performance acceptance criteria would have been established and met during the original clearance of the predicate device (RefStar External Reference Device, K982415, August 10, 1998).
• Reported Device Performance: The document states, "All testing previously submitted for the RefStar External Reference Patch still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device." This implies that the device performance met the criteria of its original clearance, but no specific performance metrics are reported in this document.

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

• Not applicable for this 510(k) submission. No new testing was performed.

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 for this 510(k) submission. No new testing was performed.

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

• Not applicable for this 510(k) submission. No new testing was performed.

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

• No MRMC study was done. This device is an external reference patch used in conjunction with a catheter tip location system, not an AI-powered diagnostic tool. The concept of "human readers improving with AI" does not apply here.

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

• Not applicable. This is a hardware device (an external reference patch), not an algorithm or software.

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

• Not applicable for this 510(k) submission. No new testing was performed. For the original clearance of the predicate device, ground truth would likely have been established through methods verifying the accuracy of catheter tip location relative to the reference patch, potentially using phantoms or in vivo models with known reference points.

8. The sample size for the training set

• Not applicable. This device is a hardware component and does not involve AI or machine learning algorithms that require a "training set."

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

• Not applicable. As above, no training set is relevant for this device.

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