Search Results

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 and a lumen for the introduction of various types of pacing or defibrillator leads and catheters. The delivery lumen is coated with a lubricious coating to aid in device delivery. The sheath is designed to be splittable, thereby allowing its removal from the lead, and a slitter is provided with the device.

The provided text is a 510(k) summary for the Acumen Sheath. It describes a medical device and its intended use, but it does not contain information about acceptance criteria, device performance, a study design (including sample sizes, ground truth, expert qualifications, or adjudication methods), or any comparative effectiveness studies (MRMC) or standalone algorithm performance.

The text states: "In-vitro and in-vivo testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide any details about these "required specifications" or the results of the tests.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove device performance. The provided document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study results against specific criteria.

Ask a specific question about this device