Search Results

The Reprocessed 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed 2515 NAV Variable EP Catheter provides location information when used with compatible CARTO® EP Navigation Systems version 1.0 or higher.

The Reprocessed 2515 NAV Variable Electrophysiology (EP) Catheter is specially designed for electrophysiological mapping of the atria of the heart when used with the CARTO® 3 EP Navigation System and a reference device. The 2515 NAV Variable EP Catheter has platinum electrodes positioned on the distal end that can be used for stimulation and recording. The Nitinol loop design allows for the expansion and contraction of the loop to fit veins ranging from 25mm to 15mm diameter (±15%).

The provided text describes Stryker Sustainability Solutions' Reprocessed 2515 NAV Variable Electrophysiology Catheter. It outlines the device's description, indications for use, and a summary of performance testing.

Here's an analysis of the acceptance criteria and the study as per your request:

Acceptance Criteria and Device Performance (Table)

The document does not explicitly state quantitative "acceptance criteria" for specific performance metrics that a study would prove the device meets. Instead, it outlines categories of testing performed to demonstrate that the reprocessed device performs as originally intended and is substantially equivalent to predicate devices. The "reported device performance" is a general statement of success in these categories.

Study Details

Based on the provided text, the "study" conducted for this device is a series of bench and laboratory tests rather than a clinical trial or a multi-reader, multi-case study.

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

   • Sample Size: Not specified. The document states "Each individual 2515 NAV Variable EP Catheter is tested for appropriate function of its components prior to packaging and labeling operations." This suggests that every reprocessed unit is functionally tested, but the sample size for the broader "Biocompatibility Validation," "Sterilization Validation," and "Packaging Validation" studies is not disclosed.
   • Data Provenance: Not explicitly stated, but given it's a reprocessed medical device, the testing would likely have occurred in a controlled laboratory environment. It is not indicated whether human subject data (clinical data like country of origin, retrospective/prospective) was used for these tests, as they are bench and lab-based.

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

   • Not applicable. The tests described are primarily engineering and laboratory validations (biocompatibility, sterilization, function) against established technical specifications, not human interpretation tasks requiring expert ground truth in the sense of medical diagnosis.

3. Adjudication Method for the Test Set:

   • Not applicable. This concept typically applies to studies where human readers or algorithms make classifications that need to be compared against a consensus ground truth. The described tests are objective measurements and validations against predefined specifications.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through bench and laboratory testing, not on comparing human reader performance with or without AI assistance.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, in a metaphorical sense for a physical device. The "device" in this context is the reprocessed catheter. The performance data is derived from direct testing of the device itself (its physical and functional properties), demonstrating its standalone performance against design specifications, without a human "reading" or "interpreting" its output in a diagnostic context. This is not an "algorithm" in the typical software sense but refers to the device's intrinsic mechanical and material performance.

6. Type of Ground Truth Used:

   • Technical Specifications and Regulatory Standards: The "ground truth" for the performance evaluations (biocompatibility, sterilization, function, packaging) would be based on established engineering specifications, material science standards, and regulatory requirements applicable to medical devices and reprocessing. For example, sterilization validation would verify that the reprocessed device meets sterility assurance levels (SALs). Functional tests would verify that it operates within the same parameters as the original device.

7. Sample Size for the Training Set:

   • Not applicable. This device is a reprocessed physical medical instrument, not an AI/ML algorithm whose performance depends on a training dataset.

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

   • Not applicable, as there is no "training set" in the context of this reprocessed physical device.

Ask a specific question about this device