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The Ablamap® System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The Ablacon Ablamap System is an electrophysiology mapping system used during electrophysiology procedures for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and a workstation with proprietary patented mapping software. Electrogram (EGM) signals are detected by 64-electrode mapping "basket" catheters which are input into, sampled, and amplified by the system's amplifier. The data is transmitted via fiber-optic cable from the amplifier to the workstation and processed by the system's mapping software with the results displayed on the monitor.

The system also accepts EGM data files recorded by EP amplifier recording systems from 64-electrode unipolar "basket" mapping catheters. The EGM data files are electrophysiology (EP) recordings that contain electrogram signals recorded by EP recording systems using 64-electrode "basket" mapping catheters. Compatible EP recording systems are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto the workstation and processed by the mapping software.

Compatible catheters are 64-electrode mapping "basket" catheters with the following dimensions: 50mm and 60mm sizes; an 8 spline x 8 electrode configuration with nominal electrode spacing of 0.354'' and 0.440" for 50mm and 60mm basket sizes respectively.

Through the software user interface, the user selects to record streamed EGM data from the Ablamap System signal amplifier that is saved to the workstation or the user selects an EGM data file recorded by an EP Recording System that has been saved to the workstation. The data file is processed by the Ablamap System software where the EGM signals are converted into electrographic flow® (EGF®) maps indicating flow consistency and direction of the action potential wave propagation during pre-defined time intervals. The resulting EGF® film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate.

A Summary Map is displayed that is the graphical representation of the summation of the activity of EGF® sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF® with respect to the catheter electrodes.

These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.

The provided text, a 510(k) summary for the Ablamap® System, does not contain specific details about a clinical study involving human readers or comparative effectiveness for diagnostic performance. The document focuses on technological characteristics and engineering performance (verification and validation testing, usability testing) to demonstrate substantial equivalence to previously cleared devices.

Therefore, many of the requested details about a study proving the device meets acceptance criteria related to diagnostic performance cannot be extracted from this text. The acceptance criteria mentioned are general (e.g., "meets the specification requirements and performs as designed," "met the user needs and was found to be clinically acceptable").

However, I can extract the information that is present according to your numbered list:

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

Based on the provided text, a direct quantitative table of acceptance criteria and reported device performance for diagnostic accuracy in a clinical setting is not available. The performance discussions relate to engineering verification and validation.

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

This information is not provided in the text for any clinical performance test. The document mentions "Verification Testing," "Validation Testing," and "Usability Testing," which typically involve engineering and usability evaluations rather than large-scale clinical accuracy studies with patient data.

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 provided. While "evaluators" are mentioned for validation testing ("found to be clinically acceptable by all evaluators"), their number or qualifications are not specified. This typically refers to internal evaluators, not independent experts establishing ground truth for diagnostic accuracy.

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

This information is not provided.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence primarily through technological characteristics and engineering performance, rather than a direct comparison of human reader performance with and without AI assistance.

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

The text states the system "assists in the diagnosis of complex cardiac arrhythmias" and "display results in a visual format for evaluation by a physician." This implies a human-in-the-loop use case. While the software processes EGM signals into EGF® maps, a standalone performance assessment of the algorithm's diagnostic accuracy without human interpretation is not described in this document.

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

The specific type of ground truth for diagnostic accuracy is not specified in the provided text, as a clinical performance study demonstrating diagnostic accuracy is not detailed. The "ground truth" implicitly referred to in the context of engineering verification and validation would be the design specifications and user needs.

8. The sample size for the training set:

Information regarding a "training set" (implying a machine learning or AI model development) and its sample size is not provided. The device processes EGM data and converts it into "electrographic flow® (EGF®) maps" using a "proprietary algorithm" and "Optical Flow" as the computation method (page 5). This description does not explicitly detail a neural network or machine learning model that would require a distinct "training set" in the context of typical AI device submissions.

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

As no training set is described, information on how its ground truth was established is not provided.

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For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.

The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system. The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes.

This document describes the premarket notification for the Ablacath™ Mapping Catheter, a Class II medical device. The information provided outlines the device's technical specifications, intended use, and substantial equivalence to a predicate device (FIRMap® Catheter K163709). The document focuses on performance data derived from bench testing, preclinical animal studies, biocompatibility testing, and sterilization validation to demonstrate the device's safety and effectiveness.

Acceptance Criteria and Device Performance:

The document primarily relies on the concept of "substantial equivalence" to a predicate device (FIRMap® Catheter K163709) and the fulfillment of predefined acceptance criteria for various tests. The general statement "All tests met the predefined acceptance criteria" indicates the device performance and acceptance.

Table of Acceptance Criteria and Reported Device Performance:

While a direct quantitative table of acceptance criteria and specific numerical reported device performance for all tests is not explicitly provided in the excerpt, the document states that all tests met their predefined acceptance criteria. The comparison table (page 5-6) implicitly serves as a comparison of characteristics against the predicate, which can be seen as meeting the criteria of "similar technological characteristics."

Study Details:

The provided document describes pre-clinical studies, primarily bench testing and animal studies, rather than a clinical study evaluating human patient outcomes or a comparative effectiveness study involving human readers and AI. Thus, several of the requested points are not applicable or cannot be extracted from this specific 510(k) summary.

1. Sample Size Used for the Test Set and Data Provenance:

   • Bench Testing: The document does not specify exact sample sizes for each type of bench test (e.g., number of catheters tested for tensile strength). It implies that sufficient samples were used to demonstrate adherence to acceptance criteria.
   • Preclinical Animal Studies: A "swine model" was used. The specific number of animals is not provided.
   • Data Provenance: The preclinical animal studies were conducted in accordance with "CFR 21 Part 58" guidelines, which suggests they were conducted in the US or under US regulatory standards. The document does not specify if these were retrospective or prospective studies, but GLP (Good Laboratory Practice) validation and usability testing are typically prospective.

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

   • For the preclinical animal studies, "physician end-users" were involved as evaluators. The number of physicians and their specific qualifications (e.g., number of years of experience, sub-specialty) are not specified.

3. Adjudication Method for the Test Set:

   • Not described. For the preclinical animal studies, it states "found to be clinically acceptable by all evaluators," implying consensus rather than formal adjudication by differing opinions. However, the exact adjudication method is not provided.

4. 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 described. This clearance is for a mapping catheter, not an AI-assisted diagnostic imaging device. Therefore, a study of human readers' improvement with AI assistance is not relevant to this submission and was not performed.

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

   • Not applicable. This is a hardware device (catheter) for mapping, not a standalone algorithm.

6. The Type of Ground Truth Used:

   • Bench Testing: Ground truth is defined by engineering specifications, material properties, and physical performance standards (e.g., ASTM, ISO standards).
   • Preclinical Animal Studies: "Acute safety attributes" and "performance requirements" were evaluated against predefined endpoints and comparison to the predicate device's expected performance in a simulated clinical environment. The "ground truth" here would be the successful demonstration of functionality and safety in a living system according to expert clinical assessment and observed physiological responses.

7. The Sample Size for the Training Set:

   • Not applicable. As this is a hardware device and not an AI/ML algorithm requiring a training set, this question is not relevant to the information provided.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. (See point 7).

In summary, the document demonstrates the device's substantial equivalence to a legally marketed predicate through adherence to predefined acceptance criteria in rigorous bench testing and preclinical animal studies. It does not involve AI or human reader studies.

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The Ablamap® Software is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The Ablacon Ablamap® Software is a stand-alone software device that uses a proprietary patented algorithm to process electrogram (EGM) signals from data files. The EGM data files are electrophysiology (EP) recordings that contain intra-cardiac electrogram signals recorded by EP recording systems using Abbott Electrophysiology FIRMap™ Catheters, 50mm and 60mm sizes; cleared under 510(k) K163709; a 64-electrode "basket" mapping catheter. The EP recording systems used are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto a computer with the Ablamap® Software installed.

The user selects an EGM data file through the software user interface and the file is processed by the software where the EGM signals are converted into electrographic flow (EGFTM) maps indicating relative velocity and direction of the action potential wave propagation during predefined time intervals. The resulting EGF™ film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate.

A prevalence map is displayed that is the graphical representation of the activity of EGF™ sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF™ with respect to the catheter electrodes.

These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.

The Ablamap® Software may be installed on any commercially available workstation personal computer (PC) with a Linux Ubuntu 18 LTS operating system and that meets minimum requirements for CPU and GPU processing, random access memory (RAM), and hard drive size.

The provided text does not contain detailed information about specific acceptance criteria and a structured study proving the device meets these criteria in the format requested.

The document is a 510(k) premarket notification summary for the Ablamap® Software, which primarily focuses on demonstrating substantial equivalence to a predicate device (Abbott Electrophysiology RhythmView™ Workstation). While it mentions "Performance testing was completed on the Ablamap® Software which verified that the software device meets the specification requirements and performs as designed," and "Testing demonstrated that the software met design requirements and functioned as intended," it does not provide:

• A table of specific numerical acceptance criteria and reported performance values.
• Details on the sample size used for the test set or its provenance.
• The number or qualifications of experts used for ground truth establishment.
• Adjudication methods.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Standalone algorithm performance data.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size or ground truth establishment methods for a training set.

The document refers to software design verification and validation testing, which indicates that internal testing was performed to ensure the software met its design specifications and complied with relevant standards (IEC 62304, ANSI/AAMI/IEC 62366-1, ISO 14971). However, these are general statements about internal quality assurance and regulatory compliance, not a detailed clinical performance study with defined acceptance criteria and results as typically released for AI/ML medical devices where clinical efficacy is a primary concern.

Therefore, based on the provided text, it's not possible to answer the requested questions about acceptance criteria and the study that proves the device meets them with specific details. The filing demonstrates equivalence based on intended use, indications for use, and technological characteristics, rather than a quantifiable clinical performance study against specific metrics.

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