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The LassoStar™ Circular Mapping Catheter is indicated for multiple electrophysiological recording and stimulation of the atrial region of the heart. The catheter is designed to obtain electrograms in the heart.

The Biosense Webster LassoStar™ Circular Mapping Catheter is a multi-electrode circular diagnostic catheter designed to facilitate electrophysiological mapping of the atria of the heart (recording and stimulation). The catheter's distal end is a circular spine with ten ring electrodes located circularly that are used for stimulation and recording within the atria. The loop is available in multiple diameters (15 mm, 20 mm and 25 mm) to achieve optimal contact in variably sized pulmonary veins. The device is provided sterile (EtO) and intended for single use.

This document is a 510(k) summary for the LassoStar™ Circular Mapping Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device. This is primarily a regulatory submission, not a detailed clinical study report on device performance based on specific acceptance criteria for diagnostic output.

Based on the provided text, there is no information present regarding specific acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or a study proving the device meets such criteria in terms of diagnostic effectiveness.

The "Performance Data" section describes bench and animal testing related to the device's physical and functional integrity, not its diagnostic performance in identifying cardiac electrograms with a certain level of accuracy compared to a ground truth.

Here's a breakdown of why the requested information cannot be fully provided from this document:

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

   • Acceptance Criteria: No specific performance acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) are mentioned. The document states "similar pre-determined acceptance criteria as the predicate device" were used for bench and animal testing, which refers to physical and functional aspects like buckle force, tensile strength, impedance, etc.
   • Reported Device Performance: The document generally states that "The results of the testing demonstrate the device in scope of this Premarket notification meet the product requirements." No specific quantitative performance metrics related to diagnostic accuracy are provided.

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

   • No information about a "test set" for diagnostic performance is provided. The tests mentioned are for physical and functional characteristics (e.g., "Buckle force", "Tensile strength").
   • There is a "GLP animal study" mentioned, but its sample size for evaluating "mapping capabilities" is not specified.

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

   • Not applicable as there is no mention of a diagnostic performance test set requiring expert ground truth.

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 an electrophysiological catheter, not an AI diagnostic tool.

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

   • Not applicable.

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

   • For the physical/functional tests, the "ground truth" would be engineering specifications and standards. For the animal study evaluating mapping capabilities, the "ground truth" would likely be the direct physiological recordings from the animal model, though this is not explicitly detailed.

8. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or diagnostic image analysis.

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

   • Not applicable.

Summary of available information related to performance:

The document focuses on establishing substantial equivalence to an existing predicate device (Lasso™ Deflectable Circular Mapping Catheter K002333) based on similar technology, intended use, and method of operation. The performance data presented relates to the safety and functional efficacy of the device's physical attributes, demonstrating that the design modifications (smaller outer diameter, different shaft material, no deflection) do not compromise safety or the ability to perform its intended function of "electrophysiological recording and stimulation of the atrial region of the heart" and "obtain electrograms."

Specific tests performed:

• Visual Inspections
• Electrical
• EEPROM Burn checks
• Buckle force
• Insertion
• Torque
• Tensile strength
• Impedance and resistance
• Visualization
• Packaging Sterile Barrier Gross Leak
• Transportation
• Biocompatibility
• Sterilization
• Simulated Use
• A GLP animal study to evaluate mapping capabilities (details not provided beyond its purpose).

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Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text, a 510(k) summary for Reprocessed Electrophysiology Catheters, does not explicitly define quantitative acceptance criteria for device performance in a table format. Instead, it broadly states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."

The closest approximations to "acceptance criteria" are the types of tests performed. Since specific numerical targets for these tests are not provided, I will present the tests as the criteria implied to demonstrate safety and effectiveness.

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

The document does not provide specific sample sizes for the test sets used in biocompatibility, reprocessing validation, sterilization validation, function tests, or packaging validation. It only states that "Bench and laboratory testing was conducted." The data provenance is also not specified beyond being "bench and laboratory testing," implying it was conducted by Ascent Healthcare Solutions, likely in a controlled, prospective manner to demonstrate equivalence. There is no mention of country of origin of the data.

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

This information is not provided in the document. The study described is a series of bench and laboratory tests to demonstrate device performance and equivalence to predicate devices, not a clinical study involving diagnosis or interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is focused on bench and laboratory testing of the reprocessed device itself, not on human interpretation or diagnostic accuracy where adjudication would be relevant.

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

An MRMC comparative effectiveness study was not conducted. The device is a reprocessed medical catheter, not an AI-assisted diagnostic or interpretative system.

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 medical instrument, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.

7. The Type of Ground Truth Used

For the performance testing (biocompatibility, reprocessing, sterilization, function, packaging), the ground truth was established through validated laboratory methods and engineering specifications designed to ensure the reprocessed device meets the original design requirements and safety standards of the new predicate devices. For demonstrating equivalence, the ground truth was the specifications and performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This document describes the re-processing of medical devices, not the development or training of an AI algorithm.

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

This information is not applicable as there is no training set mentioned or implied in the context of this device.

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