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.

AI/ML Overview

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.

Summary

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Acumen Medical, Inc.

K051515

SEP - 1 2005

510(k) Summary

General Information
Date Compiled	June 7, 2005
Classification	Class II
Trade Name	Modified Acumen SheathModel TTW 10-65
Submitter	Acumen Medical, Inc.1400 Terra Bella Ave., Suite AMountain View, CA 94043
Contact	Marybeth GamberDirector, Regulatory Affairs
	tel: 650-352-5700, ext. 226
	fax: 650-352-5700

Intended Use

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

Predicate Devices Acumen Sheath, TTW 0767 Manufactured by Acumen Medical, Inc.

K050015

Device Description

Device Dossellibrient types of pacing or defibrillator leads and catheters.

Materials

All materials used in the manufacture of the Acumen Sheath are suitable for this use and have been used in numerous previously cleared products.

Testing

Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

Summary of Substantial Equivalence

Summary or Duestantial Dollywers Sheath is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.

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SEP - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acumen Medical, Inc. c/o Ms. Marybeth Gamber Director, Regulatory Affairs 1400 Terra Bella Ave., Suite A Mountain View, CA 94043

Re: K051515 Modified Acumen Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: August 4, 2005 Received: August 5, 2005

Dear Ms. Gamber:

We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 910(x) premained is substantially equivalent (for the indications ferenced above and nave determined the arredicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Devices Amendmants for use stated in the encrosule) to regary manced promotical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 20, 1770, the characted in accordance with the provisions of the Federal Food, Drug, devices that have been recassince in accerdance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act. and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the devices, belyer to the manual registration, listing of general controls provisions of the fret meride sequences against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controlls) or class III (PMA), it If your device is classified (sec above) this exist on the sifecting your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such adultional controller. Extrong may be of 898. In addition, FDA may be found in the Ood of receits concerning your device in the Federal Register.

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Page 2 -- Ms. Marybeth Gamber

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-100. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device to regarity your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2125) Pro Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the Division of Sillan
(201) 442-6507 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Vochner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Ko51515

510(k) Number (if known):	This application
Device Name:	Acumen Sheath
Indications for Use:	The Acumen Sheath is indicated for the introduction of varioustypes of pacing or defibrillator leads and catheters.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number K051515

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).