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Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

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I'm sorry, but this document does not contain the information requested regarding acceptance criteria and device performance for an AI/ML-based medical device study.

The provided text is a 510(k) clearance letter from the FDA for an "Introducer Sheath Kit" (product code DYB). This is a physical medical device (a catheter introducer), not an AI/ML-based software device.

Therefore, I cannot extract details about:

1. A table of acceptance criteria and reported device performance for an AI model.
2. Sample size, data provenance, expert qualifications, or adjudication methods for an AI test set.
3. MRMC studies or standalone AI performance.
4. Ground truth types or training set details for an AI model.

The letter focuses on the substantial equivalence of the "Introducer Sheath Kit" to legally marketed predicate devices, and discusses general regulatory requirements for medical devices.

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Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

Not Found

The provided document is an FDA 510(k) clearance letter for an "Introducer Sheath Kits." This type of document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical imaging device utilizing AI.

The letter focuses on the regulatory clearance process, establishing substantial equivalence to a predicate device, and outlining general controls and regulations that the manufacturer must adhere to. It concerns a physical medical device (introducer sheath kits) used for facilitating the introduction of guidewires and catheters.

Therefore, I cannot provide the requested information based on the given text.

To answer your questions about acceptance criteria and device performance studies, you would typically need a clinical study report or a data summary from a premarket submission (e.g., PMA or 510(k) summary for an AI/ML medical device), which would detail:

1. Acceptance criteria and reported performance: Specific metrics (e.g., sensitivity, specificity, AUC) and predefined thresholds.
2. Sample size and data provenance: Details of the dataset used for validation.
3. Experts for ground truth: Number and qualifications of readers/experts.
4. Adjudication method: How disagreements were resolved.
5. MRMC study information: If applicable, details on human reader performance with and without AI.
6. Stand-alone performance: Algorithm-only performance metrics.
7. Type of ground truth: How the "truth" was established for the test data.
8. Training set size: Number of cases used for model training.
9. Training set ground truth: How ground truth was established for the training data.

Ask a specific question about this device