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The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheters are indicated for multiple electrode electrophysiological mapping of the heart, i.e. recording or stimulation only. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheters are designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed LASSO NAV and Reprocessed LASSO 2515 NAV eco Variable Catheters provide location information when used with compatible CARTO 3 EP Navigation Systems. (These catheters are not compatible with CARTO 3 EP Navigation Systems prior to Version 2.3.)

The Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter have been designed to facilitate electrophysiological mapping of the atria of the heart with the CARTO 3 EP Navigation System and a reference device. Both catheters are deployed in the right or left atrium through an 8F quiding sheath. Both deflectable catheters consists of a 4.5 F (Lasso NAV eco) or 4 F (LASSO NAV eco Variable) circular spine on the distal tip, with platinum/iridium electrodes that can be used for stimulation and recording.

The Reprocessed LASSO 2515 NAV eco 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 Reprocessed LASSO NAV eco Catheter is a fixed catheter with three fixed catheter sizes, namely 15, 20, 25 mm loop sizes to accommodate different vein sizes, Each loop size will be available with either 10 or 20 electrodes.

This document is a 510(k) premarket notification for a reprocessed medical device, specifically the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheter. The purpose of this type of submission is to demonstrate that a new or reprocessed medical device is substantially equivalent to a predicate device already legally marketed. Therefore, the "study" referred to in the prompt is actually the bench and laboratory testing performed to demonstrate that the reprocessed device is as safe and effective as the original, legally marketed predicate device.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format for each performance metric, nor does it provide specific numerical results for each test. Instead, it lists the types of tests performed and concludes that the reprocessed devices are "as safe and effective as the predicate devices."

However, based on the types of functional and safety testing listed, we can infer the general categories of acceptance criteria:

Note: The document explicitly states: "The purpose, design, materials, function, and intended use of the Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation." This implies that the acceptance criteria for the reprocessed device would be to meet the specifications and performance of the original, new device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • The document does not specify the sample size (number of reprocessed catheters) used for any of the individual tests. It only states that "Bench and laboratory testing was conducted."
• Data Provenance:
  • The testing was conducted by Innovative Health, LLC., based in Scottsdale, Arizona, USA. The data would therefore be considered prospective as it was generated specifically for this 510(k) submission to demonstrate the performance of the reprocessed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable in the context of this device. This is a reprocessed electrophysiology catheter, and the "ground truth" for its performance is established by comparing its physical and functional characteristics to the original, new device specifications and performance. There isn't a "test set" of clinical data for which experts establish a diagnostic ground truth, as would be the case for an AI-powered diagnostic device.

4. Adjudication Method for the Test Set

Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are making interpretations (e.g., reading medical images) and their decisions need to be reconciled to establish a ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically used for diagnostic or imaging devices to assess the performance of different readers or different technologies (e.g., with or without AI assistance) on a set of cases. This document concerns the reprocessing of an electrophysiology catheter, which is an interventional/diagnostic tool, not an imaging interpretation device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question applies to AI algorithms. The device in question is a physical medical catheter.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device is the established specifications and performance characteristics of the legally marketed predicate devices (the original, new LASSO NAV eco and LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters). The testing aims to demonstrate that the reprocessed device performs equivalently to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth in that context.

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