The PRECLUDE ACUSEAL Dura Substitute is composed of expanded polytetrafluoroethylene (ePTFE) and an amorphous fluoropolymer (PATT) layer positioned within the plane of the device. This device is intended to be used for temporary or permanent repair of dura mater during neurosurgery.

AI/ML Overview

The provided text is a Premarket Notification Summary (510(k)) for the PRECLUDE® ACUSEAL Dura Substitute. This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove that the device meets specific acceptance criteria through a clinical trial with a predefined set of performance metrics. Therefore, much of the requested information regarding acceptance criteria and performance data in a structured study format is not explicitly present in the provided text.

However, I can extract information related to the device's demonstrated safety and effectiveness, which serves a similar purpose in the context of a 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

As this is a 510(k) submission focusing on substantial equivalence, explicit "acceptance criteria" for a specific study are not defined in the provided text. Instead, the device's performance is reported in terms of its demonstrated safety and effectiveness through various studies and clinical history.

Performance Aspect	Reported Device Performance	Comments
Biocompatibility	Possesses the requisite characteristics to function safely in its intended uses.	Demonstrated through biocompatibility data.
In Vivo Animal Testing	Functions safely and effectively as a dura substitute.
Mechanical Strength	Performs in a substantially equivalent manner when compared to cited predicates.	Indicated by mechanical strength data and numerous comparative studies.
Clinical Performance (Predicate Device)	Performs safely and effectively as a dura substitute; no known adverse reactions in various patient populations (adults/children, male/female) for cranial and spinal dural repair.	Demonstrated by over 40,000 dural implants of the PRECLUDE® Dura Substitute over the past decade.
Structural, Biocompatibility, Biomechanical Characteristics (Predicate Device)	Has the necessary characteristics to function effectively as a dura substitute.	Demonstrated by collected clinical data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The text mentions "clinical experience with more than 40,000 dural implants" over the past decade for the PRECLUDE® Dura Substitute (predicate device). This serves as the primary "test set" for demonstrating clinical performance, even though it's related to the predicate. For the applicant device (PRECLUDE® ACUSEAL Dura Substitute), animal testing was conducted, but a specific sample size for that is not provided.
Data Provenance: Not specified in terms of country of origin. The clinical data on the predicate device is implied to be retrospective, referring to "clinical experience" and data collected over a decade. The animal testing on the applicant device would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not explicitly stated. The "clinical experience" and "clinical series" referenced for the predicate device would involve medical professionals, but their specific number, roles in establishing ground truth, or qualifications are not detailed in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not explicitly stated. This level of detail regarding clinical study design for data adjudication is not typically included in a 510(k) summary focused on substantial equivalence.

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

Not applicable. This device is a dura substitute, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, an MRMC study or AI assistance related to human readers is not relevant.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

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

For the in vivo animal testing for the applicant device, the ground truth would be based on direct observation of the animal's physiological response and the device's function as a dura substitute.
For the clinical experience with the predicate device, the "ground truth" is implied to be real-world clinical outcomes and observations by treating physicians, potentially corroborated by patient follow-up data. The text mentions "no known adverse reactions" and that the device "performs safely and effectively."

8. The sample size for the training set

The concept of a "training set" is not applicable in the context of this traditional medical device submission. This refers to physical implant studies and clinical experience, not machine learning.

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

Not applicable, as there is no "training set" in the machine learning sense. The "ground truth" for the demonstrations of safety and efficacy (clinical experience, animal studies) was established through direct observation, medical assessments, and long-term follow-up in the respective studies.

Summary

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3/15/99

K984534

SECTION 2

Premarket Notification Summary

1. Submitter:	W. L. Gore & Associates, Inc.3750 West Kiltie LaneFlagstaff, Arizona 86002Phone: (520) 779-2771FAX: (520) 779-1456
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John W. Nicholson, Regulatory Affairs Contact: December 18, 1998 Preparation Date:
1. Applicant PRECLUDE® ACUSEAL Dura Substitute Trade Name: Device: Common Name: Dura Substitute

3. Substantially Equivalent Devices:

GORE cites the following as predicate devices to which the applicant device will be shown to be substantially equivalent:

W.L. Gore & Associates, Inc. PRECLUDE® Dura Substitute .
Dow Corning Silastic® Reinforced Sheeting .
Bio-Vascular Inc. DuraGuard® .
Aesculap Inc.- Neuro-Patch .

4. Device Description:

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Widely regarded as an inert biomaterial, ePTFE has established a successful clinical history of use in cardiac, vascular, dural, dental and a broad range of general surgical applications for more than two decades. The expanded PTFE portion of the device which contacts the cranial soft tissue structures is essentially unchanged; the proposed modification simply entails the interposition of a PATT material between the ePTFE components. The PATT component's industrial counterparts, perfluorelastomers, have a long history of commercial applications and the PATT material in the applicant device has successfully undergone an extensive array of biocompatibility evaluations. The PATT component material has also been thoroughly reviewed by CDRH's Office of Science and Technology and MAF-1024 has been developed. The PRECLUDE® ACUSEAL Dura Substitute is provided sterile in the same configurations as the predicate GORE device. It is intended for dural repair applications and is resterilizable.

5. Intended Use:

The PRECLUDE ACUSEAL Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery. The labeling reveals that the applicant and all predicate devices have the same intended use as dura substitute prostheses. Like the predicate devices, the PRECLUDE ACUSEAL Dura Substitute is intended for use in both cranial and spinal dura repair applications.

6. Technological Characteristics:

More than 5,000,000 clinical implants of GORE-TEX® Medical Products in a diverse array of biological environments have served to substantiate the safety and efficacy of these devices. The technical, preclinical, biocompatibility, descriptive and performance data in this Premarket Notification demonstrate that the applicant device is substantially equivalent to its cited predicate devices and that it is safe and effective for its intended use.

The biocompatibility data included in this submission reveal that the PRECLUDE® ACUSEAL Dura Substitute possesses the requisite characteristics to function safely in its intended uses. The in vivo animal testing demonstrates that the applicant device functions

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safely and effectively as a dura substitute. The mechanical strength data and numerous comparative studies indicate that the applicant device performs in a substantially equivalent manner when compared to its cited predicates.

The clinical experience with more than 40,000 dural implants during the past decade demonstrates that the PRECLUDE® Dura Substitute device performs safely and effectively as a dura substitute. Male and female patients, as well as adults and children, were involved in clinical series assessing this device in cranial and spinal dural repair applications, and there were no known adverse reactions. The clinical data collected demonstrate that the device has the necessary structural, biocompatibility and biomechanical characteristics to function effectively as a dura substitute.

® PRECLUDE is a registered trademark of W.L. Gore & Associates DuraGuard® is a registered trademark of Bio-Vascular, Inc. Neuro-Patch is a trademark of B. Braun Melsungen AG Silastic® is a registered trademark of Dow Corning Corporation

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three parallel lines curving upwards, resembling an abstract representation of a human figure or a flame.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Mr. John W. Nicholson Regulatory Affairs W. L. Gore & Associates, Inc. 3750 West Kiltie Lane Flagstaff, Arizona 86002

K984534

Re:

Trade Name: PRECLUDE® ACUSEAL Dura Substitute Regulatory Class: II Product Code: GXQ Dated: December 18, 1998 Received: December 21, 1998

Dear Mr. Nicholson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -- Mr. John W. Nicholson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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Page / of /

510(k) NUMBER (IF KNOWN) : K984534

DEVICE NAME: PRECLUDE ACUSEAL Dura Substitute

INDICATIONS FOR USE:

For use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices, K984534

510(k) Numb

Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).