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

The provided text from K051515, a 510(k) premarket notification for the "Modified Acumen Sheath," does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a 510(k) summary and the FDA's clearance letter. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove adherence to specific performance metrics through a clinical trial or detailed performance testing with acceptance criteria.

Here's a breakdown of why this information is missing based on the provided text:

• No Acceptance Criteria or Performance Data: The document explicitly states under "Testing" that "Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not disclose what these "required specifications" were (i.e., the acceptance criteria) or the reported device performance against them.
• Focus on Substantial Equivalence: The "Summary of Substantial Equivalence" section emphasizes that the device is "substantially equivalent to the predicate product" based on "intended use, method of operation, methods of construction and materials used." This reinforces that the primary goal of the 510(k) was to compare it to an existing device, not necessarily to establish new, quantitative performance benchmarks.
• Limited Detail in 510(k) Summary: 510(k) summaries are often high-level and do not typically include detailed test protocols, raw data, or specific acceptance criteria that would be found in the full 510(k) submission.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or comparative effectiveness studies because this information is not present in the provided text. The document is primarily a regulatory clearance notification and a brief summary of the device's characteristics and its equivalence to a predicate.

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