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The Reprocessed Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

The Reprocessed Torqr Diagnostic EP Catheter is a flexible, radiopaque catheter constructed of extruded polyurethane over stainless steel braid and platinum electrodes. The catheter is of high torque construction to aid in precise catheter placement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Torqr Diagnostic EP Catheter, formatted to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly list acceptance criteria in a quantitative, pass/fail manner with specific numerical targets. Instead, it details the types of functional and safety testing performed to demonstrate that the reprocessed catheter is "as safe and effective as the predicate devices." The "reported device performance" is described qualitatively as having successfully undergone these tests.

Study Proving Device Meets Acceptance Criteria:

The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Catheter." This "Functional and Safety Testing" section (on page 6) lists the tests performed, which collectively constitute the study. The conclusion is that these tests showed the reprocessed catheter to be "as safe and effective as the predicate devices."

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

The document does not specify the exact sample sizes used for each of the functional and safety tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective. Given the nature of the device (reprocessed catheter) and the tests listed (bench and laboratory), the data would inherently be prospective in the sense that the tests were conducted specifically for this submission.

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

This information is not provided in the document. The "ground truth" for this type of medical device (a reprocessed catheter) would primarily be established through objective engineering and scientific measurements and analyses against established performance standards and predicate device specifications rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., imaging) where multiple human readers' opinions need to be reconciled to form a ground truth. For bench and laboratory testing of a physical medical device, the criteria are usually objective (e.g., does it meet a specific resistance value, does it withstand a certain pull force).

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

An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic tools or systems where human performance is enhanced by AI assistance. The Reprocessed Torqr Diagnostic EP Catheter is a physical medical device, not an AI diagnostic tool.

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

A standalone performance study of an algorithm was not done. Again, this device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance of the Reprocessed Torqr Diagnostic EP Catheter is based on a combination of:

• Engineering Specifications: Adherence to design requirements, such as dimensional accuracy, electrical properties (continuity, resistance, dielectric, leakage), and mechanical characteristics.
• Predicate Device Equivalence: The reprocessed device is deemed safe and effective if its performance during these tests is comparable to the original, legally marketed predicate device (Torqr Series Diagnostic EP Catheters, K923915).
• Validation Standards: Compliance with established validation protocols for biocompatibility, cleaning, sterilization, and packaging.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Training sets are used for machine learning algorithms. The studies performed were bench and laboratory tests on physical units of the reprocessed catheter.

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

Since there was no training set for a machine learning algorithm, the question of how its ground truth was established is not applicable.

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