(219 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text for clinical or diagnostic performance benchmarks. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to verify its conformance to the requirements for its intended use." (This is a general statement, not specific performance data.) |
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
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided.
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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.
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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.
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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.
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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.
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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.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).