SyntheCel® Dura Onlay is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Onlay functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Onlay is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

AI/ML Overview

The provided document is a 510(k) summary for the SyntheCel® Dura Onlay device. It primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone study proving those criteria.

Therefore, many of the requested items cannot be definitively extracted from this document, as the submission relies on previous studies for the predicate device to establish safety and effectiveness.

Here's what can be gathered:

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

The document does not list specific numeric acceptance criteria for performance such as sensitivity, specificity, or AUC, as it's not a performance study of a diagnostic AI device. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device in terms of technological characteristics and safety/effectiveness data.

Acceptance Criteria Category	Reported Device Performance (SyntheCel® Dura Onlay)
Material	Biosynthesized cellulose
Dimensions	1in x 1in (2.5cm x 2.5cm), 1in x 3in (2.5cm x 7.5cm), 2in x 2in (5.0cm x 5.0cm), 3in x 3in (7.5cm x 7.5cm), 4in x 5in (10.0cm x 12.0cm)
Function	Conforms to contours of brain. Functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. Immunologically inert and has demonstrated minimal foreign body response.
Resorbability	Non-resorbable
Sterilization	Sterilized by irradiation
Biocompatibility	Demonstrated to be non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic (based on prior testing for predicate).
Pyrogenicity	< 0.06 EU/ml (Endotoxin Units / ml) using Limulus Amebocyte Lysate (LAL) test (based on prior testing for predicate).
Mechanical Strength	Tensile strength and burst strength demonstrated to be substantially equivalent to predicate devices (based on prior testing for predicate).
Indications for Use	Intended for use as a dura replacement for the repair of dura mater in adults.
Clinical Performance	No new clinical data collected. Relies on data from predicate K113071, which evaluated SyntheCel® Dura Replacement Devices (including SyntheCel® Dura Repair and SyntheCel® Dura Onlay) for safety and effectiveness compared to a Control, demonstrating substantial equivalence to other legally marketed dura replacement products.

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

No new test set was used for this specific 510(k) submission. The document states: "No new clinical performance data were collected in support of this submission." and "No new non-clinical performance data were collected in support of this submission."

The previous clinical data referenced was for the predicate device (K113071), but details about its sample size, country of origin, or retrospective/prospective nature are not provided in this document.

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

Not applicable, as no new clinical or performance test set was developed for this submission. The ground truth for the predicate device's studies is not detailed here.

4. Adjudication method for the test set

Not applicable, as no new test set was used for this submission.

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.

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

Not applicable. This is a medical implant device, not an algorithm.

7. The type of ground truth used

For the predicate device's studies, the ground truth would typically be based on clinical outcomes relevant to dura repair (e.g., successful dural closure, lack of CSF leakage, absence of adverse reactions, foreign body response, inflammation) observed in patients. Mechanical testing used measurable physical properties (tensile strength, burst strength). Biocompatibility relied on established in-vitro and in-vivo tests aligned with ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is a medical implant, not an AI algorithm requiring a training set.

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

Not applicable. This is a medical implant, not an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small registered trademark symbol is located to the right of the word. A horizontal line is located underneath the word.

DEC 16 2013

510(k) Summary -- SyntheCcl® Dura Onlay

Date Prepared	November 13, 2013
Submitter	Synthes
	1301 GOSHEN PARKWAY
	West Chester, PA 19380
	United States of America
Contact	Heather L. Guerin, Ph.D., P.E.
	guerin.heather@synthes.com
	phone: (610) 719-5432
Device Name	SyntheCel® Dura Onlay
Classification	21 CFR 882.5910 (Dura Substitute)
Device Class	2
Product Code(s)	GXQ
Predicate Devices	SyntheCel Dura Replacement Devices (K113071)
Device Description	SyntheCel® Dura Onlay is composed of biosynthesized cellulose and
	water with a unique construction of non-woven, interconnected
	cellulose fibers. SyntheCel® Dura Onlay functions as a mechanical layer
	which protects and repairs the dural defect while preventing furtherCSF leakage. SyntheCel® Dura Onlay is immunologically inert and has
	demonstrated minimal foreign body response. It is non-resorbable.
Indications for Use	SyntheCel® Dura Onlay is intended for use as a dura replacement for
	the repair of dura mater in adults.
TechnologicalCharacteristics		SyntheCel® Dura Onlay(K131792)	SyntheCel DuraReplacement Devices(K113071)


	Indicationsfor Use	SyntheCel® Dura Onlay isintended for use as adura replacement for therepair of dura mater inadults.	SyntheCel® is intendedfor use as a durareplacement for therepair of dura mater.SyntheCel® Dura Onlay isindicated for use inadults for the repair ofdural defects and it canbe placed withoutsutures.SyntheCel® DuraSubstitute is indicatedfor use in adults for therepair of dural defectsand it can be sutured

	Contra-indications	Must not be implanted inpatients who have knownallergy or sensitivity tothe implant materials(cellulose).	into place.Same
	Material	Biosynthesized cellulose	Same
	Dimensions	1in x 1in (2.5cm x 2.5cm)1in x 3in (2.5cm x 7.5cm)2in x 2in (5.0cm x 5.0cm)3in x 3in (7.5cm x 7.5cm)4in x 5in (10.0cm x12.0cm)	Same.
	Function	Conforms to contours ofbrain.	Same
	Resorbability	Non-resorbable	Same
	Sterilization	Sterilized by irradiation	Same
ClinicalPerformance Data	No new clinical performance data were collected in support of thissubmission. Clinical data were previously collected to evaluate thesafety and effectiveness of the SyntheCel® Dura Replacement Devices(including SyntheCel® Dura Repair and SyntheCel® Dura Onlay) ascompared to the Control. This data was included in K113071. TheSyntheCel® Dura Replacement Devices (including SyntheCel® DuraRepair and SyntheCel® Dura Onlay) were demonstrated to besubstantially equivalent to other legally marketed dura replacementproducts in terms of safety and efficacy.
Non-ClinicalPerformance Data	No new non-clinical performance data were collected in support of thissubmission.Mechanical testing data were previously collected to supportsubstantial equivalence of SyntheCel® Dura Onlay to predicate devices.This data was included in K113071. Tensile strength, and burst strengthwere tested and SyntheCel® Dura Onlay was demonstrated to besubstantially equivalent to predicate devices.Biocompatibility testing according to standards set forth in ISO 10993previously demonstrated that the material is non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic. This data was included in K113071.Pyrogenicity was evaluated using the Limulus Amebocyte Lysate (LAL)test on the final sterilized SyntheCel® device and found to be less than0.06 EU/ml (Endotoxin Units / ml) per FDA's Guidance Document forDura Substitute Devices.

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@ SYNTHES®

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and the comments of the comments of the comments of the comments of

1999 - 1999 - 1999

SubstantialEquivalence toPredicate Devices	Based on the information presented in this submission, the proposedchanges to SyntheCel® Dura Onlay do not raise new questions of safetyand effectiveness. Therefore, it can be concluded that the SyntheCel®Dura Onlay is substantially equivalent to the predicate device.
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1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

and the control control control control controllers and

and the same of the same of the same

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three curved lines resembling a stylized human figure. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

December 16, 2013

Synthes® (USA) % Heather Guerin, Ph.D., P.E. Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380

Re: K131792

Trade/Device Name: SyntheCel® Dura Repair and SyntheCel® Dura Onlay Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXO Dated: November 13, 2013 Received: November 14, 2013

Dear Dr. Guerin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Heather Guerin, Ph.D., P.E.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Carlos Peña, Ph.D. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131792

Device Name: SyntheCel® Dura Repair and SyntheCel® Dura Onlay

Indications For Use:

ంగా విశాఖ ?

SyntheCel® Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

SyntheCel® Dura Onlay is intended for use as a dura replacement for the repair of dura mater in adults.

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

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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).