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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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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 right atrium, right ventricular apex, and HIS bundle.

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) 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 at the proximal end of the catheter.

This document is a 510(k) premarket notification for a reprocessed medical device, specifically the Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheter. It focuses on demonstrating substantial equivalence to predicate devices and detailing the reprocessing procedures and validation, rather than an AI/ML device or a comparative effectiveness study involving human readers.

Therefore, many of the requested categories for AI/ML device studies - such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set size, and ground truth for training set - are not applicable to this type of regulatory submission.

The document primarily describes the safety and functional testing performed to demonstrate that the reprocessed device performs as intended and is safe.

Here's the information available and a clear indication of what is not applicable:

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

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a series of bench and laboratory tests described under "Functional and Safety Testing." These tests were conducted to demonstrate the performance (safety and effectiveness) of the Reprocessed Inquiry Steerable Diagnostic EP Catheter.

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

• Sample Size for Test Set: Not specified in this document. The testing describes procedures like "cleaning validation," "sterilization validation," and various "functional testing" aspects (visual, dimensional, electrical, simulated use, mechanical, electrical safety, packaging). These tests would involve specific numbers of reprocessed units, but the exact sample sizes are not provided in this summary.
• Data Provenance: Not applicable/not specified. This is a premarket notification for a reprocessed device, not a data-driven AI/ML study. The data arises from internal bench and laboratory testing conducted by Innovative Health, LLC.

3. 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 applicable. This is not an AI/ML device and does not involve establishing ground truth from expert consensus on medical images or clinical data. The "ground truth" for this device's performance comes from engineering and quality control specifications and tests.

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

• Not applicable. This is not an AI/ML device and does not involve clinical data adjudication.

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

• Not applicable. This is a conventional medical device (reprocessed catheter), not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable in the context of typical AI/ML ground truth. The "ground truth" for this device's performance is established by engineering specifications, validated test methods, and compliance with recognized standards for medical device safety and functionality (e.g., electrical safety standards, biocompatibility standards, cleaning efficacy standards). The control group for comparison is the original, new device and the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device and therefore does not have a training set.

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

• Not applicable. This is not an AI/ML device.

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The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart.

The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology (EP) 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 at the proximal end of the catheter.

The provided text is a 510(k) summary for a reprocessed medical device, specifically, the Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device or an AI/ML powered device.

Therefore, the information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML powered device is not available in this document. The document describes a traditional medical device (a catheter) and its reprocessing.

However, I can extract the safety and functional testing performed for this reprocessed device, which serves as its "demonstration of performance" to support its substantial equivalence claim.

Device Type: Reprocessed Steerable Diagnostic Electrophysiology Catheters (not an AI/ML powered device).

Summary of Device Performance and Testing (as described in the document):

The document lists "Functional and Safety Testing" conducted to demonstrate the performance, safety, and effectiveness of the reprocessed catheters. This is the closest equivalent to "proving the device meets acceptance criteria" for this type of device.

Additional Details from the Document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document only states that "Bench and laboratory testing was conducted."
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 applicable for this type of device and testing. The testing is laboratory-based physical and electrical property assessment rather than expert evaluation of diagnostic output.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/ML powered device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the tests performed (e.g., electrical continuity, mechanical characteristics), the "ground truth" would be established engineering specifications, performance standards, and established laboratory test methodologies for the predicate device.
7. The sample size for the training set: Not applicable. This is not an AI/ML powered device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered device.

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