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The ACS ANCHORTM Exchange Device is used within a guiding catheter to facilitate the exchange of an interventional device while maintaining the position of a guide wire within the vasculature.

The ACS ANCHORTM Exchange Device consists of a proximal control handle and a superelastic core wire within a single lumen hypotube approximately 96 cm. long. The control handle provides the userinterface to control the movement of the hypotube and the core wire. During an exchange procedure, the distal end of the core wire is wrapped around the guide wire to lock its position in the vasculature. The ACS ANCHOR™ Exchange Device is compatible with 0.010" through 0.018" diameter non-hydrophilic-coated guide wires and associated interventional devices (except the ROTOBLATOR® Rotational Angioplasty System) when at least 0.015" free space is available within the guiding catheter.

The provided text describes a medical device, the ACS ANCHOR™ Exchange Device, and its comparison to a predicate device. However, it does not include detailed acceptance criteria or a study designed to prove the device meets specific performance criteria in the way a clinical trial for an AI diagnostic device would.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes tests performed rather than explicit numerical acceptance criteria. The acceptance is broadly stated as "acceptable for its intended use" or "substantially equivalent."

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

The document does not specify exact sample sizes for the "bench" or "in vivo" testing.

• Bench Testing: No specific numbers provided.
• In vivo Testing: "In vivo testing was conducted to substantiate the use..." No specific sample size or details on data provenance (e.g., animal model, human cadaver, specific country of origin) are given.
• Retrospective/Prospective: Not applicable or specified. This device is a mechanical tool, not an AI diagnostic, so these terms don't directly apply in the same way.

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

Not applicable. This is a medical device for facilitating procedures, not an AI diagnostic tool requiring expert interpretation of images or data to establish a "ground truth" in the diagnostic sense. The "ground truth" here is functional performance.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

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

Not applicable. An MRMC study is relevant for evaluating the impact of an AI diagnostic tool on human readers' performance. This device is a procedural accessory, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is primarily engineering specifications and functional performance metrics.

• For biocompatibility: Adherence to ISO standards.
• For mechanical tests (tensile, torsional, locking, fatigue): Measurement against design specifications and comparison to a predicate device.
• For in vivo testing: Successful demonstration of intended function within a living system (though details are sparse).
• For sterility: Achievement of a validated sterility assurance level.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. See point 8.

Summary of what the document does provide:

The document functions as a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device, the Magnet Exchange Device. The "studies" described are focused on:

• Biocompatibility against international standards.
• Bench testing of mechanical properties (tensile, torsional, locking force, fatigue).
• In vivo testing to show compatibility with various interventional devices.
• Sterilization validation.

The "acceptance criteria" are implied by successful completion of these tests and the conclusion that the device is "acceptable for its intended use" and "substantially equivalent" to its predicate. It lacks the detailed, quantitative acceptance criteria and rigorous study design typically expected for an AI-powered diagnostic device clinical validation.

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