The Lyoplant® device is a lyophilized dura substitute of pure collagen derived from bovine pericardium. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device (Lyoplant Dura Substitute) meets those criteria, based on the provided text:

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in the format of a typical clinical trial report. As such, explicit quantitative acceptance criteria for device performance (e.g., a specific percentage of success for a given outcome) are not defined in the text. Instead, the document focuses on demonstrating that the device meets the general requirements for a dura substitute and is comparable to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) summary, specific numerical acceptance criteria for clinical efficacy are not detailed. The criteria are qualitative, focusing on biocompatibility, handling, and functional equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility:
* Non-sensitizing	Found not to be a sensitizing agent under standard test procedures.
* Non-toxic	Found to be non-toxic.
* Weak/non-reactive immunogenic potential	Possesses a weak or virtually non-reactive immunogenic potential.
* Well-tolerated by tissues (no adverse cellular/allergic rxns)	Animal studies have shown Lyoplant to be extremely well tolerated by tissues. No adverse cellular or allergic reactions were observed.
* No foreign body reaction (absence of giant cells)	The absence of giant cells demonstrates that Lyoplant is not recognized as a foreign body by the host.
* Integration into connective tissue	The implant is integrated completely into connective tissue. (Animal Studies) The implants showed development of connective tissue with no immunological or adverse response. (Human Clinical Investigation)
Functional Characteristics (as a dura substitute):
* Sterile	Product is supplied sterile, non-pyrogenic. (Device Description) Confirmed by Final product microbiological testing. (Manufacturing) Performance data... relative to... sterility... have been performed. (Performance Data)
* Non-pyrogenic	Product is supplied sterile, non-pyrogenic. (Device Description) Performance data... relative to... pyrogenicity... have been performed. (Performance Data)
* Adequate tear resistance	Available as sterile, thin flexible sheets with adequate tear resistance and handling properties... (Technological Characteristics - comparison to predicates).
* Satisfactory handling properties	Available as sterile, thin flexible sheets with adequate tear resistance and handling properties... (Technological Characteristics - comparison to predicates). A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use. (Clinical Studies)
* Impermeability to CSF	Available as sterile, thin flexible sheets with adequate tear resistance and handling properties, impermeability to CSF... (Technological Characteristics - comparison to predicates).
* Equivalence to predicate devices	The study establishes that Lyoplant is equivalent to predicate devices in its biocompatibility and its safety and effectiveness as a dura substitute. (Conclusion) The technological differences between Lyoplant and the predicate devices do not raise new types of safety or effectiveness issues. The technological differences have been assessed by valid scientific and clinical methods. (Technological Characteristics)

2. Sample Size Used for the Test Set and Data Provenance

Preclinical Studies (Animal Studies): The text states "Animal studies have shown the Lyoplant to be extremely well tolerated by tissues." It does not specify the number of animals or the type of animal used.
Clinical Studies (Human): The text states "A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use." No sample size for this human clinical investigation is provided.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the "clinical investigation" implies prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The studies described are preclinical (animal) and a human clinical investigation, focusing on direct observation of tissue response and handling rather than interpretation by experts.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the studies (biocompatibility, tissue integration), formal adjudication methods like 2+1 or 3+1 are typically not applicable. Outcomes would likely be based on direct observation, histological analysis, and clinical assessment by the researchers/clinicians involved.

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

This is not applicable. The device is a physical dura substitute, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

This is not applicable. As a physical medical device (dura substitute), the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

Preclinical (Animal Studies):
- Direct observation: Absence of adverse cellular or allergic reactions.
- Histology: Absence of giant cells, complete integration into connective tissue.
Clinical Studies (Human):
- Clinical observation: Excellent biocompatibility and handling properties.
- Histology/Pathology (implied): Development of connective tissue with no immunological or adverse response.
Bench Testing: Analytical, physical, and microbiological testing (for manufacturing and final product quality).

8. The Sample Size for the Training Set

This is not applicable. The Lyoplant device is a physical product, not an algorithm that requires a "training set" in the context of machine learning. The term "training set" is not relevant to its development or evaluation as described in this 510(k) summary.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as point 8.

Summary

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K970851

DEC - 9 1997

510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

Lyoplant® Dura Substitute March 6, 1997

Submitted by:

Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon (415) 876-7000 x346 Phone: (415) 589-3007 FAX:

Lyoplant® Dura substitute Product Name: Common Name: Dura substitute

Device Description

Intended Use

Lyoplant is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.

Predicate Devices

Predicate devices are available in synthetic and organic materials (see table below).

Device	Material Composition
Dura-Guard™ Dural Repair Patch(by Bio-Vascular, Inc.)	Glutaraldehyde cross-linked bovinepericardium.
Peri-Guard® Pericardium(by Bio-Vascular, Inc.)	Glutaraldehyde cross-linked bovinepericardium.
Neuro-Patch Dura Substitute	Polyesterurethane (PUR)
Preclude Dura Substitute(by W.L. Gore)	expanded polytetrafluoroethylene(ePTFE)
Dura Film (by Codman)	Silicone rubber sheet reinforced withDacron® polyester.
Tutoplast® Dura substitute(by Biodynamics, Inc.)	Human dura composed of collagenousconnective tissue.

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LYOPLANT. S&E Summary, page 2.

Technological Characteristics

Lyoplant and its predicates have similar technological characteristics. All of these devices are available as sterile, thin flexible sheets with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute.

The technological differences between Lyoplant and the predicate devices do not raise new types of safety or effectiveness issues. The technological differences have been assessed by valid scientific and clinical methods. Physical, laboratory, animal and human clinical test methods have been performed and have proven the ability of Lyoplant to function as a dura substitute.

Performance Data

Performance data and test findings relative to the biocompatibility, pyrogenicity, toxicity, sterility and clinical safety have been performed and are provided in the this document. A summary of these findings are noted below.

Preclinical Studies and Results 1.

The biocompatibility of Lyoplant has been thoroughly evaluated and addressed in numerous preclinical studies.

Through various sensitization, toxicity, and immunogenic testing, Lyoplant was found not to be a sensitizing agent under standard test procedures. The device was also found to be non-toxic and possess a weak or virtually non-reactive immunogenic potential.

Animal studies have shown the Lyoplant to be extremely well tolerated by tissues. No adverse cellular or allergic reactions were observed. The absence of giant cells demonstrates that Lyoplant is not recognized as a foreign body by the host. The implant is integrated completely into connective tissue.

2. Clinical Studies and Results

A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use. The implants showed development of connective tissue with no immunological or adverse response.

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Lyoplant, S&E Summary, page 3.

Manufacturing and Final Product Quality Testing 3.

Lyoplant is manufactured in compliance with Good Manufacturing Practice Regulations. In process and final product analytical, physical and microbiological testing assures that Lyoplant conforms to specifications prior to release.

The test data from the extensive in vitro and in vivo preclinical testing, and human clinical findings presented in the submission establish that Lyoplant is equivalent to predicate devices in its biocompatibility and it safety and effectiveness as a dura substitute.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1997

Ms. Victoria Mackinnon ·Manager, Regulatory Affairs AESCULAP® 1000 Gateway Boulevard South San Francisco, California 94080-7030

K970851 Re: Trade Name: Lyoplant Dura Substitute Regulatory Class: II Product Code: GXQ Dated: September 29, 1997 Received: October 1, 1997

Dear Ms. Mackinnon

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 requirements , 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 - Ms. Victoria Mackinnon

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 1 of 1

INDICATION FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Lyoplant Dura Substitute

Indication for Use:

Lyoplant Dura Substitute presented in this submission is intended as a dura Lyoplant Dura Substitute presented in this Cashinotation of ' damaged, impaired, or missing tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Division Sign-Off)
Division of Cardiovascular Respiratory,
and Nepratica: Dove ας
510 Num
K970851

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).