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The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only the Stereotaxis Tangent® Electrophysiology Catheter of 7F shaft diameter and 8F tip. The Cardiodrive® is intended to advance the Stereotaxis Tangent® Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent® Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.

The Cardiodrive® advances or retracts a compatible magnetic electrophysiology [EP] catheter, through a hemostasis introducer, remotely via a User Interface (UI) located either at the patient table or in the control room.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Stereotaxis Cardiodrive® Catheter Advancement System, specifically for modifications made to an already marketed device. As such, it's a submission for clearance, not typically a detailed study report demonstrating acceptance criteria for an entirely new device. The focus is on demonstrating "substantial equivalence" to a predicate device rather than fulfilling new, specific performance acceptance criteria.

However, I can extract information related to the device's performance claims and the study type conducted to support the modifications.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states "Bench testing and pre-clinical testing." It does not specify the sample size for these tests.
• The data provenance (country of origin, retrospective/prospective) is not mentioned. It is implied to be internal testing by Stereotaxis, Inc.

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

• This information is not provided. The document describes physical and performance testing by the company, not expert-adjudicated test sets for an AI/algorithm.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. There's no mention of an adjudication method as the testing described is primarily physical and pre-clinical performance testing of a mechanical device, not expert review of AI outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The device is a mechanical catheter advancement system, not an AI or imaging diagnostic tool that would typically involve human readers.
• The document explicitly states: "No clinical studies were needed to support the modifications described herein."

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

• Not applicable. This device is a mechanical system, not an algorithm in the context of AI. Its operation is "intended for automatically advancing and retracting," implying a standalone mechanical function, but not in the AI sense of "algorithm only performance."

7. The Type of Ground Truth Used

• For the physical and performance testing, the "ground truth" would be established by engineering specifications, design input criteria, and comparison to the performance of the legally marketed predicate device. The document states the device "met design input criteria" and "performs in an equivalent manner" to the predicate.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical system and does not involve AI or machine learning that would require a "training set."

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

• Not applicable. As there is no training set mentioned or implied for this mechanical device, there's no ground truth to establish for it.

In summary:

This document describes a 510(k) submission for a mechanical device (catheter advancement system) with minor modifications. The "acceptance criteria" revolve around demonstrating that the modified device still meets its design specifications and performs equivalently to its predicate device, without requiring new clinical studies. The testing performed was "bench testing and pre-clinical testing," which are internal validation steps for mechanical devices, not typically involving the extensive data set, expert validation, or AI-specific criteria you've asked about.

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