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The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Sheath is a single-use percutaneous catheter indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Sheath has a guidewire lumen for the introduction of various types of pacing or defibrillator leads and catheters. The sheath is designed to be splittable, thereby allowing its removal from the lead, and a slitter is provided with the device.

This document is a 510(k) summary for the Acumen Sheath from Acumen Medical, Inc. It describes the device, its intended use, and states that substantial equivalence to a predicate device has been affirmed.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics, especially those related to AI or algorithm performance.

The document states:

• "Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This is a general statement and does not provide specifics.

Therefore, I cannot fulfill your request for the detailed table and study information because it is not present in the provided text. The device described appears to be a physical medical instrument (an introducer catheter or sheath), not an AI/algorithm-based device, and the 510(k) focuses on substantial equivalence to a predicate device rather than performance metrics of an algorithm.

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