Search Results

Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Reprocessed electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

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 handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.

The provided text details the FDA clearance for Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. However, it does not contain a specific "acceptance criteria" table with numerical performance metrics or a detailed study description with sample sizes, ground truth establishment, or expert qualifications as requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with quantitative performance data against predefined acceptance criteria.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly present in the provided document. The document states: "Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended." and "Alliance Medical Corporation concludes that the modified device the Reprocessed Electrophysiology (EP) Catheter is safe, effective and substantially equivalent to the predicate devices as described herein." This implies that the reprocessed devices met certain performance expectations, but the specific, quantifiable acceptance criteria and the numerical results against them are not provided.

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

• Test Set Sample Size: Not specified in the document. The document mentions "Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations," but it does not provide the sample size of catheters used for the performance testing cited in the submission.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "Bench and laboratory testing."

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

Not applicable or not specified. The document describes "Bench and laboratory testing" and "Function test(s)." This suggests instrumental testing rather than expert-derived ground truth based on clinical interpretation (e.g., radiologists interpreting images). If "ground truth" refers to the original device specifications or functionality, it was likely established by the manufacturer's engineering and quality control departments.

4. Adjudication Method for the Test Set:

Not applicable or not specified. The nature of the testing (bench and laboratory) does not suggest a need for an adjudication method in the way one would for clinical imaging studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. The device described is a reprocessed medical catheter, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical instrument (catheter), not a standalone algorithm. Its performance is inherent in its physical and electrical characteristics.

7. The Type of Ground Truth Used:

The "ground truth" for this type of device would typically be the original manufacturer's specifications for new, equivalent devices, and possibly established performance benchmarks for functionality, electrical integrity, and material properties. The document states: "Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended" and implies they are "substantially equivalent to the predicate devices." This suggests the ground truth for their "performance" is derived from the expected function and specifications of the original, new devices.

8. The Sample Size for the Training Set:

Not applicable. This is a reprocessed physical device, not a machine learning model, so there is no training set in the AI sense.

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

Not applicable for the same reason as above.

Summary of what is present:

• Device: Reprocessed Electrophysiology (EP) Catheters.
• Indication for Use: "temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures."
• Performance Data: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters. Biocompatibility Validation of reprocessing Sterilization Validation Function test(s)."
• Conclusion: The reprocessed device "is safe, effective and substantially equivalent to the predicate devices."
• Key tests performed: Biocompatibility, reprocessing validation, sterilization validation, function tests.

In conclusion, while the document confirms that performance testing was done and the devices were deemed "safe, effective and substantially equivalent," it lacks the detailed quantitative acceptance criteria and study particulars (like sample sizes, ground truth establishment methods, and expert involvement) commonly found in submissions for AI/ML-based medical devices or diagnostic tools.

Ask a specific question about this device