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The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.

The provided text is a 510(k) summary for a medical device called the "RithmID-SD Steerable Diagnostic Electrophysiology Catheter". This document focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility testing, and comparisons of technical characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria for each test in a separate column. Instead, for most tests, it states "All test samples met the acceptance criteria," indicating that the criteria were satisfied. The performance results are qualitative; for a few tests, comparative statements are made relative to the reference device.

Here's a compilation of the tests and their reported performance:

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

The document consistently states "All test samples met the acceptance criteria" for various bench tests and indicates "All test samples" for packaging and sterilization validations. However, it does not specify the exact numerical sample size (e.g., "n=5" or "n=10") for any of these tests.

Regarding data provenance:

• Country of Origin: Not specified in the provided text.
• Retrospective or Prospective: The studies are described as "Performance Bench Testing and Animal Testing," "Biocompatibility Testing," "Accelerated Shelf-Life Testing," "Packaging validation," and "Sterilization validation." These are all standard types of prospective pre-market validation studies conducted specifically for regulatory submission, rather than retrospective data analysis.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable for this device. This document describes the 510(k) submission for an electrophysiology catheter, not an AI/ML-driven diagnostic device. The performance data presented are primarily from physical, chemical, and biological bench tests and animal studies, not clinical studies involving human observers or interpretative tasks where "ground truth" would be established by experts like radiologists.

4. Adjudication Method for the Test Set

• Not applicable. As stated above, this is not a study involving human interpretation or subjective assessments that would require adjudication.

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

• No, an MRMC study was not done. MRMC studies are typically conducted for imaging devices or AI algorithms where human readers' performance (with or without AI assistance) is evaluated. The RithmID-SD is a physical diagnostic catheter. The "Usability" test mentioned is likely a bench test or simulated use to assess the device's functional handling, not a human reader study.

6. Standalone (Algorithm Only) Performance

• Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

• Engineering specifications and standards: For most bench tests (e.g., dimensional verification, electrical safety, fatigue tolerance, tensile force, buckling force), the "acceptance criteria" are derived from the device's design specifications and often relevant international standards for medical devices (though the specific standards beyond ISO 10993 for biocompatibility and ASTM for packaging aren't explicitly listed for every bench test).
• Biocompatibility standards: ISO 10993 series for the biocompatibility tests.
• Sterilization standards: For bacterial endotoxin levels and residuals (ISO 10993-7).
• Animal testing: The document mentions "Animal Testing" and specifically for hemocompatibility, "Thrombogenicity in Canine (GLP)" was performed. This forms part of the "ground truth" for biocompatibility.
• Physical measurements and objective criteria: For tests like torque strength, specific physical properties are measured.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. No training set was used.

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