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The Peel-Away Introducers are intended to provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system.

The Peel-Away introducers provide cardiovascular leads and catheters access to the venous vascular system for cardiac surgery procedures. Peel-Away Introducer sheaths haft. The sheath is the outer component and the dilator fits inside the sheath with the distal end protruding out. A needle, which is connected to the syringe, is used to gain access to the vessel. After blood flow is established, the syringe is removed and a quidewire is inserted through the needle and advanced into the vessel. The assembled sheath/dilator combination is advanced over the guidewire into the vessel. At the proximal end of the sheath is a t-handle hub, which is designed to splitand facilitate the peeling action of the sheath tubing is designed to peel continuously and symmetrically for safe removal of the introducer while maintaining venous access.

This FDA 510(k) summary for the Abbott Medical "Peel-Away Introducer" does not contain the detailed information necessary to answer your questions about acceptance criteria and the study proving the device meets those criteria, as typically found in submissions for AI/ML devices.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Seal Away CS Introducer Kit, K013029) for a traditional medical device (catheter introducer). The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section is very brief and only mentions:

• "The addition of the Exel syringe and modification of the packaging, biocompatibility, and sterilization testing."
• "Completion of all verification and validation activities demonstrated that the syringe meets its predetermined design and performance specifications, and that the peel-away introducer with the new syringe accessory is substantially equivalent to the predicate device."

This type of submission for a conventional device typically relies on design verification and validation testing to ergonomic, material, and functional specifications, rather than a performance study against specific acceptance criteria for a diagnostic or AI/ML device.

Therefore, I cannot provide the specific tables and details you requested. The document does not describe the following aspects which are crucial for AI/ML device evaluations:

• A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, accuracy, etc.)
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

This device is a physical medical instrument (a introducer for catheters), not an AI/ML-driven diagnostic or prognostic tool. Hence, the regulatory submission and the underlying data would not involve AI-specific evaluation methodologies.

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