The Modified Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable. The Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 9F. The Modified Acumen Single-Lumen Delivery Sheath is available in straight and multiple curved configurations.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device and is not a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would. It's a regulatory submission asserting substantial equivalence to existing devices. Therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable or available within this document.

However, I can extract the relevant information from the provided text based on the 510(k) process.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, "acceptance criteria" and "reported device performance" are primarily framed around substantial equivalence to predicate devices rather than a direct clinical performance study with numerical criteria. The acceptance criteria for the FDA in a 510(k) is whether the new device is "substantially equivalent" to a legally marketed predicate device.

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (vs. Predicate)
Intended Use is identical or substantially equivalent	"The Modified Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters," which is equivalent to the predicate.
Technological Characteristics are identical or substantially equivalent (e.g., materials, design, method of operation)	Materials: "All materials used in the manufacture of the Modified Acumen Single-Lumen Delivery Sheath are identical to the predicate device."Method of Operation: "identical or substantially equivalent to existing legally marketed predicate products."Construction: "methods of construction...are either identical or substantially equivalent to existing legally marketed predicate products."Design: The new device is "available in straight and multiple curved configurations" (an addition), but this is considered substantially equivalent to the predicate's overall design for its stated purpose.
Performance Data (e.g., in-vitro testing) demonstrates substantial equivalence and safety/effectiveness	"In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (Specific "specifications" are not detailed in this summary, but the general statement indicates compliance.)

Study Proving Substantial Equivalence:

The "study" in this context is the 510(k) Premarket Notification itself, which argues for substantial equivalence based on a comparison to predicate devices and in-vitro testing.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable (N/A) in the context of a 510(k) summary relying on substantial equivalence and in-vitro testing. The document states "In-vitro testing has been performed," but does not provide the sample size of tested devices.
Data provenance: N/A. The in-vitro testing was likely conducted by Acumen Medical, Inc. or a contracted lab. The document does not specify country of origin or whether it was retrospective/prospective in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: N/A, as clinical "ground truth" establishment by experts is not described for a test set in this type of submission. The evaluation for substantial equivalence is primarily based on regulatory standards, engineering testing, and comparison to predicate devices by the manufacturer and the FDA.
Qualifications of experts: N/A.

4. Adjudication method for the test set

Adjudication method: N/A. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. This device is a physical delivery sheath, not an AI or imaging diagnostic device.
Effect size: N/A.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone study: No. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: N/A in the clinical sense. For the in-vitro testing, the "ground truth" would be the pre-defined engineering specifications and performance requirements for the device components and full assembly. The primary "ground truth" for the 510(k) submission is the documented characteristics and performance of the predicate devices to which it is being compared.

8. The sample size for the training set

Sample size for training set: N/A. This term is relevant for machine learning algorithms, not for the development and testing of a physical medical device described here.

9. How the ground truth for the training set was established

Ground truth establishment for training set: N/A.

Summary

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Acumen Medical, Inc. Premarket Notification - Special 510(k) Revision Date: February 21, 2008

5. 510(k) Summary General Information

Date Compiled	February 21, 2008	MAR 13 2008
Classification	Class II
Trade Name	Modified Acumen Single-Lumen Delivery Sheath
Submitter	Acumen Medical, Inc.275 Santa Ana CourtSunnyvale CA 94085Tel: 408-530-1810Fax: 408-530-1811
Contact	Kevin MacDonald (415-609-9875)

Intended Use

The Modified Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Predicate Devices

Acumen Single-Lumen Delivery SheathManufactured by Acumen Medical, Inc.	K053400
Modified Acumen Single-Lumen Delivery SheathManufactured by Acumen Medical, Inc.	K070396

Device Description

Materials

All materials used in the manufacture of the Modified Acumen Single-Lumen Delivery Sheath are identical to the predicate device.

Testing

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

Summary of Substantial Equivalence

Acumen Medical, Inc. believes the Modified Acumen Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure, composed of three curved lines.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Acumen Medical, Inc. c/o Mr. Kevin MacDonald Regulatory Consultant 275 Santa Ana Court Sunnydale, CA 94085

Re: K080500

Modified Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: February 21, 2008 Received: February 25, 2008

Dear Mr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kevin MacDonald

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 and thus, permits 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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4. Indications for Use Statement

510(k) Number (if known):	This application KO80500
Device Name:	Modified Acumen Single-Lumen Delivery Sheath
Indications for Use:	The Modified Acumen Single-Lumen Delivery Sheath isintended for the introduction of various types of pacing ordefibrillator 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)

(Division Sig

(Division Sig)
Division of Caraiova
510(k) Number K080500

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).