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The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the hight atrium, right ventricular apex, and HIS bundle.

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle of the proximal end of the catheter.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Reprocessed Inquiry Steerable Diagnostic EP Catheter." The submission aims to increase the allowed reprocessing cycles for the device from one to three.

However, the document does not contain information about a study that compares the performance of the reprocessed device against specific acceptance criteria in terms of diagnostics or clinical outcomes, particularly involving AI/human reader studies, expert consensus, or specific diagnostic performance metrics like sensitivity, specificity, or AUC. The document focuses on showing substantial equivalence to predicate devices through bench and laboratory testing related to the reprocessing process itself, rather than diagnostic accuracy or effectiveness in clinical reading scenarios.

Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

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

The document outlines functional and safety testing performed for the reprocessed device to demonstrate its performance (safety and effectiveness) for three reprocessing cycles. However, it does not provide specific quantitative acceptance criteria or reported values for these tests in a table format. It lists categories of tests.

• Acceptance Criteria (Categories):

  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional Testing (Visual Inspection, Dimensional Verification, Electrical Continuity and Resistance, Simulated Use, Mechanical Characteristics)
  • Electrical Safety Testing (Dielectric and Current Leakage)
  • Packaging Validation

• Reported Device Performance:
  The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Inquiry Steerable Diagnostic EP Catheter for three (3) reprocessing cycles." It concludes: "Innovative Health concludes that the Reprocessed Inquiry Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein." However, no quantifiable results for these tests are presented.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the document. The testing described is bench and laboratory testing on the physical device, not a diagnostic study with a dataset of patient cases.
• Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to results from physical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" here is established by the specifications and performance metrics of the device itself through engineering and laboratory testing, not by expert interpretation of diagnostic images or data.

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

• Not applicable. This applies to expert reading studies, not device functional testing.

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:

• No, an MRMC study was NOT done. This document is for a medical device (catheter), not an AI diagnostic software.

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

• No, a standalone algorithm performance study was NOT done. This document is for a medical device (catheter), not an AI diagnostic software.

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

• Ground Truth Type: For the device's performance, the "ground truth" is defined by established engineering standards, material properties, electrical specifications, and functional benchmarks for the specific medical device (electrophysiology catheter). For example, electrical continuity is measured against a known standard of what constitutes an intact circuit, and sterilization validation against accepted sterility assurance levels.

8. The sample size for the training set:

• Not applicable. This document describes a physical medical device, not a machine learning model. There is no "training set" in this context.

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

• Not applicable. As above, no training set or machine learning model.

In summary: The provided FDA 510(k) clearance letter and summary are for a reprocessed electrophysiology catheter. The "studies" mentioned are bench and laboratory tests to demonstrate the safety and effectiveness of the reprocessed device, particularly regarding the increase in allowed reprocessing cycles. The document does not pertain to an AI diagnostic device and therefore does not include the types of studies, acceptance criteria, or ground truth establishment methods typically associated with such systems (e.g., MRMC studies, expert consensus, AUC, sensitivity/specificity).

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