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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 FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.

The FIRMap Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli. The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.

The furnished document is a 510(k) summary for the FIRMap Catheter, which is an electrode recording catheter used in cardiac electrophysiology procedures. It states that "No animal or clinical testing was conducted." Therefore, there is no study described that proves the device meets specific acceptance criteria based on performance with human or animal subjects.

However, the document lists several performance data tests and concludes that these tests demonstrate substantial equivalence to the predicate device and assure conformity to appropriate requirements. This represents the "study" that was performed and its findings regarding acceptance.

Here is an attempt to structure the requested information based on the provided text, while noting the absence of clinical performance data in the traditional sense:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific acceptance criteria values were explicitly stated for the listed tests, and the "reported device performance" is a general statement of success rather than quantitative results, I will infer the acceptance criterion as "conforms to requirements" and the performance as "met this standard."

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

• Sample Size: Not specified for the listed tests (Radial Strength, Lateral Strength, etc.). These appear to be bench or engineering tests where "sample size" might refer to the number of catheters tested, which is not provided.
• Data Provenance: The tests are likely retrospective bench/engineering tests conducted in a lab setting by the manufacturer (Abbott Electrophysiology) to demonstrate the physical properties and functional aspects of the device, rather than involving patient data. Country of origin not specified, but likely where Abbott Electrophysiology's R&D is located.

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

Not applicable. For bench/engineering tests like Radial Strength or Torque, "ground truth" is typically established by engineering specifications, material properties, and relevant industry standards, not by human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As these were non-clinical bench tests, adjudication methods like 2+1 or 3+1 (common in image interpretation or clinical trials) are not relevant. Test results would be compared against predefined engineering specifications or performance limits.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No animal or clinical testing was conducted." Therefore, no MRMC study involving human readers or AI assistance was performed or described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The FIRMap Catheter is a physical medical device, not a software algorithm or AI. Performance is related to its physical and functional characteristics, not algorithm capability.

7. Type of Ground Truth Used

The ground truth for the performance data (Radial Strength, Lateral Strength, etc.) would be established by engineering specifications and recognized industry standards (e.g., ISO and IEC standards listed in the document), rather than expert consensus, pathology, or outcomes data, as no clinical testing was performed.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve engineering and material testing, but not a data-driven training set.

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

Not applicable, as there is no training set for this type of device.

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

The catheter is used in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli.

The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.

The provided text is a 510(k) Summary for the FIRMap Catheter, which outlines the device's technical characteristics and the performance testing conducted to demonstrate its substantial equivalence to a predicate device. This document describes a medical device, not an AI/ML powered device, and therefore the relevant information for an AI/ML acceptance criteria and study cannot be extracted.

Reasoning for inability to extract AI/ML specific information:

The document describes the FIRMap Catheter, an electrode recording catheter used in cardiac electrophysiology procedures. The testing described is focused on the mechanical integrity and functionality of the catheter's basket subassembly, which are hardware-related aspects (e.g., radial force, spline stiffness, introduction/withdrawal cycling, and in-vivo testing in a "Pancake Atrium").

There is no mention of:

• An algorithm or AI/ML model.
• Data provenance, test sets, or training sets in the context of an AI/ML model.
• Expert interpretation of AI/ML outputs or ground truth establishment for AI/ML.
• Multi-reader multi-case studies related to AI/ML assistance.
• Standalone performance of an algorithm.

The document entirely focuses on the physical device and its mechanical/electrical performance, not on software or AI capabilities.

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

The FIRMap™ Catheter is comprised of these major components,
• Handle
• Handle Strain Relief
• Introducer Tool
• Catheter Shaft
• Basket

The FIRMap™ Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The distal, expandable basket assembly is, in essence, eight miniature octapolar catheters that are arranged into a three dimensional "basket" shape.. The basket assembly contains an array of 64 electrodes mounted onto eight support structures called splines.

The provided text describes the regulatory clearance of the FIRMap™ Catheter, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way envisioned by the posed questions (e.g., regarding performance metrics like accuracy, sensitivity, or specificity for a diagnostic device).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. The "Performance data" section only states that various tests (biocompatibility, dimensional, mechanical integrity, mate/de-mate, electrical safety, and GLP animal study) were performed to support substantial equivalence. It does not provide specific acceptance criteria or the results of these tests in a quantifiable manner relevant to clinical performance.

Therefore, I cannot populate most of the requested table or answer the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance studies from the provided text.

Here's what I can extract based on the provided text, and where gaps exist:

Acceptance Criteria and Device Performance

Explanation of Gaps: The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and safety testing (biocompatibility, mechanical, electrical). It does not detail specific acceptance criteria for diagnostic capability (e.g., accuracy in identifying arrhythmias) or present data from a study that quantifies the device's performance against such criteria.

Study Details

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

   • Not provided. The document mentions "GLP animal study" but gives no details about sample size, design, or data provenance. There is no mention of human clinical trial data for performance evaluation in this 510(k) summary.

2. 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 provided. Since no specific clinical performance study is detailed, there's no mention of experts establishing ground truth for a test set.

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

   • 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 such study is mentioned. The device is a catheter for recording electrical potentials and delivering pacing stimuli, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable/Not provided. The FIRMap™ Catheter is a medical device (electrode recording catheter), not an algorithm or standalone AI system. Its performance would be evaluated in terms of its ability to accurately record electrical signals, not as an "algorithm only" system.

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

   • Not provided. As no specific performance study against a clinical ground truth is detailed, this information is absent. The "GLP animal study" would likely involve physiological measurements as ground truth, but specific details are missing.

7. The sample size for the training set

   • Not applicable/Not provided. The FIRMap™ Catheter is a hardware device; it does not explicitly use a "training set" in the context of machine learning.

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

   • Not applicable/Not provided.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through comparison of technological characteristics and general safety/performance testing (biocompatibility, mechanical, electrical). It does not contain the detailed clinical performance study data, acceptance criteria, or ground truth methodologies that would be typical for evaluating a diagnostic algorithm's accuracy, sensitivity, or specificity.

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