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The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.

The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.

The LASSO 2515 NAV Variable Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart with the Carto 3 Navigation System and a reference device. It is deployed in the right or left atrium through an 8F guiding sheath. This deflectable catheter consists of a 4F circular spine on its distal tip, with platinum / iridium electrodes that can be used for stimulation and recording.

The LASSO 2515 NAV Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).

The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.

Here's a breakdown of the acceptance criteria and the study information for the Lasso 2515 NAV Variable Catheter, based on the provided text:

Important Note: The provided 510(k) summary is for a medical device (catheter) used for electrophysiological mapping, not an AI/ML powered device. Therefore, many of the requested fields (e.g., sample size for AI test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of traditional medical device submission. The information below focuses on what is available in the document for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "bench and animal testing" but does not provide specific sample sizes for these tests.
• Data Provenance: Not explicitly stated. The testing was conducted by or for Biosense Webster, Inc., with manufacturing sites in the USA and Mexico. The regulatory submission is to the US FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. This is a physical medical device; the concept of "ground truth" established by experts in the context of an algorithmic diagnostic performance is not directly applicable. Performance was likely evaluated against engineering specifications, physiological measurements, and comparison to predicate devices by qualified engineers and scientists.

4. Adjudication method for the test set

• N/A. Not applicable for this type of device and testing.

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. This is not an AI-powered device.

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

• N/A. This is not an AI-powered device.

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

• Bench and Animal Testing Results/Engineering Specifications/Predicate Device Performance Comparison. The document states: "The Lasso 2515 NAV Variable Catheter underwent bench and animal testing. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards." This implies the "ground truth" was based on established engineering specifications, performance metrics validated in preclinical (bench and animal) settings, and ultimately, by demonstrating equivalence to previously cleared predicate devices.

8. The sample size for the training set

• N/A. This is not an AI/ML powered device, so there is no "training set."

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

• N/A. This is not an AI/ML powered device, so there is no "training set" or "ground truth" for it in this context.

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