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Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The provided text is a 510(k) Pre-Market Notification for the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than a clinical study proving device performance against specific acceptance criteria.

Therefore, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or information related to AI/algorithm performance. The submission relies on the device being "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria & Reported Device Performance: Not mentioned. The focus is on substantial equivalence, not a direct performance comparison against predefined metrics in a clinical study.
• Sample size for test set & data provenance: Not applicable. This isn't a clinical trial with a test set of patient data.
• Number of experts for ground truth & qualifications: Not applicable for a 510(k) that isn't a clinical study.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. This device is not an AI-assisted diagnostic tool.
• Standalone algorithm performance: Not applicable. This is a physical medical device, not an algorithm.
• Type of ground truth: Not applicable.
• Sample size for training set & how ground truth was established for training set: Not applicable, as this is not an AI/ML device.

Instead, the document states:

• "The components of the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been a Electrophysiology Catheter has passed the biocompatibility and performance test."
• "Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process."
• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the "proof" for this submission is biocompatibility testing, performance testing (likely bench testing or non-clinical trials demonstrating functionality), adherence to manufacturing standards, and comparison to existing, legally marketed predicate devices. It is not a clinical study with detailed acceptance criteria as one would expect for a novel diagnostic algorithm.

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The IBI-1100" Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.

The Irvine Biomedical, Inc. IB1-1100" Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The provided text describes a medical device, the Irvine Biomedical, Inc. IBI-1100 Steerable Electrophysiology Catheter System, and asserts its safety and effectiveness. However, it does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/device performance evaluation.

The text focuses on:

• Device Description: What the IBI-1100 is (electrophysiology recording catheter) and its components (multiple electrodes, connecting cable, dimensions).
• Intended Use: For electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies, typically placed in the high right atrium, right ventricular apex, and HIS bundle.
• Safety and Effectiveness Claims: Based on biocompatibility, performance tests, and material similarity to predicate devices already approved by the FDA. It also mentions compliance with manufacturing practices and sterilization processes.

Therefore, I cannot populate the requested table or answer the specific questions below based on the provided input. The document is a summary of safety and effectiveness, not a detailed study report on device performance against specific acceptance criteria.

If this were an AI device, the information you're asking for would be crucial for its evaluation. However, the IBI-1100 is a physical medical catheter, and its "performance" is assessed through traditional biocompatibility, sterility, and functional tests, not through AI-specific metrics like AUC, sensitivity, or specificity against a ground truth dataset.

To illustrate what the answers would look like if the document did contain the necessary information (for an AI device), here's a hypothetical structure:

Hypothetical Description if the input was an AI device performance study:

This document describes the Irvine Biomedical, Inc. IBI-1100 Steerable Electrophysiology Catheter System, which in this hypothetical scenario, incorporates an AI component for [e.g., automated arrhythmia detection, signal quality assessment]. The following sections outline the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 500 patient ECG recordings, totaling 10,000 ECG segments.
• Data Provenance: Retrospective data collected from five major cardiology centers across the United States (Massachusetts, California, Texas, Florida, and New York) and three centers in Europe (Germany, France, UK).

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 5
• Qualifications: All experts were board-certified electrophysiologists with an average of 15 years of experience in cardiac arrhythmia diagnosis and management, specializing in electrophysiology study interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: 2+1. Each case was independently reviewed by two electrophysiologists. If their interpretations differed, a third senior electrophysiologist (the "tie-breaker") reviewed the case and made the final determination.

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

• Was an MRMC study done? Yes.
• Effect Size: The AI assistance improved human reader diagnostic accuracy by an average of 12% (absolute increase in AUC from 0.82 to 0.94) compared to human readers without AI assistance, particularly in complex or noisy ECG segments. The average time to diagnosis was reduced by 25% with AI assistance.

6. Standalone Performance Study

• Was a standalone study done? Yes.
  • The algorithm-only performance (without human-in-the-loop) achieved a sensitivity of 90.1% and specificity of 86.5% for atrial fibrillation detection on the test set.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert Consensus, validated against patient outcomes data (e.g., successful ablation procedures, confirmed diagnoses from follow-up).

8. Sample Size for the Training Set

• Training Set Sample Size: 5,000 patient ECG recordings, totaling 50,000 ECG segments.

9. How Ground Truth for the Training Set was Established

• Ground Truth Establishment: Ground truth for the training set was established through a combination of automated annotations derived from established clinical reporting systems (e.g., confirmed diagnoses in electronic health records) and further independent review by 3 experienced cardiology fellows. A smaller subset (10%) was also adjudicated by the same panel of 5 expert electrophysiologists used for the test set, to ensure consistency and quality.

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