Endoform® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Device Description

Endoform® Plastics and Reconstructive Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen. Endoform® Plastics and Reconstructive Matrix is designed to be fixed, via sutures, staples or tacks to the surrounding tissue, at the discretion of the attending physician for applications in plastic and reconstructive surgery. For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs. Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Endoform® Plastics and Reconstructive Matrix) and primarily focuses on proving its substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as a predicate device, rather than proving de novo safety and efficacy through extensive clinical trials for novel devices.

Therefore, the information you've requested about acceptance criteria, efficacy studies, expert adjudication, MRMC studies, standalone algorithm performance, and training set details are not applicable in the context of this 510(k) submission as it is not a study proving the device meets acceptance criteria for a novel AI/software medical device.

The "acceptance criteria" presented here are in the context of bench testing and biocompatibility, not "device performance" in the sense of diagnostic accuracy or clinical outcomes that typically require such detailed study methodologies.

Let's break down what is available in the provided document, and then explain why the requested information is absent.

1. Table of acceptance criteria and reported device performance (based on the provided text):

The document does not explicitly present acceptance criteria in a quantitative table with corresponding "reported device performance" in the way one would for a diagnostic or AI device's clinical performance. Instead, it describes bench tests performed to demonstrate that the device meets "all product specifications for the intended use." The "acceptance criteria" for these tests would be the pre-defined product specifications, which are not detailed numerically in this summary.

Acceptance Criteria (Implied / Test Performed)	Reported Device Performance (Summary in Document)
Tensile Strength (Product Specification)	Meets product specifications
Suture Retention (Product Specification)	Meets product specifications
Biochemical Composition (Product Specification)	Meets product specifications
Endotoxin Levels (Product Specification)	Meets product specifications
Dimensional Verification (Product Specification)	Meets product specifications
Ball Burst (Product Specification)	Meets product specifications
Modulus of Elasticity (Product Specification)	Meets product specifications
Delamination Evaluation (Product Specification)	Meets product specifications
Sterility Assurance Level (SAL) of 10⁻⁶	Achieved
Biocompatibility (ISO 10993-1)	Concluded biocompatible (based on reference device safety)

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

Sample Size: The document does not specify the sample sizes used for each of the bench tests mentioned (tensile strength, suture retention, etc.).
Data Provenance: Not applicable in the context of this submission. The tests are bench tests of the manufactured device, not retrospective or prospective clinical data from human patients.

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

Not applicable. Ground truth, in the sense of clinical diagnoses or outcomes, is not being established for bench tests of a surgical mesh. The "truth" for these tests are the physical/material properties of the device itself.

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

Not applicable. This concept is for clinical or image-based studies where human readers might disagree. Bench tests rely on standardized measurement methods.

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 surgical mesh, not an AI or diagnostic tool. No MRMC study was performed or required.

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

Not applicable. This device is a surgical mesh, not an algorithm.

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

For the bench tests, the "ground truth" refers to the established physical and chemical properties measured according to standardized methods. For biocompatibility, it's assessed against ISO 10993-1 standards and by leveraging the established safety of a reference device. For the overall submission, the "ground truth" for substantial equivalence relies on the regulatory approval and safety profile of the predicate device.

8. The sample size for the training set:

Not applicable. There is no AI model or algorithm being trained for this device.

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

Not applicable. There is no training set for this device.

Explanation of the 510(k) Process and Why This Information is Absent:

The document is a 510(k) Pre-Market Notification. For a device submitted under a 510(k), the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device. This means the device is as safe and effective as another legally marketed device, and does not raise new questions of safety and effectiveness.

No De Novo Clinical Efficacy Study: The document explicitly states: "There was no clinical testing required to support the indications for use as they are equivalent to the predicate device." This is a key characteristic of the 510(k) pathway for devices like surgical meshes that are considered "well-understood" and have similar predicate devices.
Focus on Bench Testing and Biocompatibility: The "performance testing" described is confined to bench tests (tensile strength, suture retention, etc.) and biocompatibility. These tests confirm that the manufacturing process is consistent and that the material properties are similar to the predicate, and that the material does not pose new biological risks.
Leveraging Predicate Device Data: The safety and performance of the proposed device are "based on the in vivo performance of the predicate and reference devices." This means the FDA relies on the existing track record and regulatory history of the predicate devices rather than requiring new, extensive clinical trials for the new device.
Not an AI/Software Device: The concepts of "multi-reader multi-case studies," "standalone algorithm performance," "training set," and "adjudication methods" are typically relevant for Software as a Medical Device (SaMD) or AI-powered devices where the performance criterion is diagnostic accuracy, image interpretation, or clinical decision support. The Endoform® Plastics and Reconstructive Matrix is a physical surgical mesh, not a software product.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2016

Aroa Biosurgery c/o Gordon MacFarlane, Ph.D., RAC ICON PLC 62 Forest Street, Suite 300 Marlborough, MA 01752

Re: K162461

Trade/Device Name: Endoform Plastics and Reconstructive Matrix Regulation Number: 21 CFR §878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: November 17, 2015 Received: November 21, 2016

Dear Dr. MacFarlane:

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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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 1000-1050.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162461

Device Name

Endoform® Plastics and Reconstructive Matrix

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

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510(k) Summary for the Aroa Biosurgery Endoform® Plastics and Reconstructive Matrix (per 21CFR 807.92)

1. SUBMITTER/510(K) HOLDER

Aroa Biosurgery, Limited 2 Kingsford Smith Place Auckland 2022 New Zealand

Contact Person:	Tina O'Brien
	Director, Regulatory Affairs
	tina.obrien@aroabio.com
Telephone:	+64 9 8693035
Date Prepared:	August 19, 2016

2. DEVICE NAME

Proprietary Name:	Endoform® Plastics and Reconstructive Matrix
Common/Usual Name:	EndoGraft
Device Class:	Surgical Mesh
Product Code:	FTM

3. PREDICATE / REFERENCE DEVICES

Predicate Device:

· SIS Plastic Surgery Matrix (Cook Biotech) (K034039)
· Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221)

Reference Devices:

· Endoform® Reconstructive Template (Aroa Biosurgery) (K130547/K156366)

4. DEVICE DESCRIPTION

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For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs.

Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.

5. INDICATIONS FOR USE

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

The predicate and reference devices are listed in the table below. The predicate and reference devices serve to support substantial equivalence for the technological characteristics. The technological characteristics of Endoform® Plastics and Reconstructive Matrix and SIS Plastic Surgery Matrix are equivalent in that they are both primarily composed of mammalian collagens and are indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Device Status	Proposed Device	Predicate	Predicate	Reference Predicate
Manufacturer	Aroa	Cook Biotech	Cook Biotech	Aroa
510K Number	Proposed	K034039	K161221	K130547/K153633
Device name	Endoform® Plastics & Reconstruction Matrix	SIS Plastic Surgery Matrix	Biodesign Plastic Surgery Matrix	Endoform® Reconstructive Template
Classification Name	Surgical mesh (FTM)21 CFR 878.3300Class II	Surgical mesh (FTM)21 CFR 878.3300Class II	Surgical mesh (FTM)21 CFR 878.3300Class II	Surgical mesh (FTL/FTM)21 CFR 878.3300Class II
Intended use	Endoform® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in	The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.	For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.	Endoform® Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the

Side-by-Side Comparison of the Proposed Device and the Predicate and Reference Devices

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Device Status	Proposed Device	Predicate	Predicate	Reference Predicate
Manufacturer	Aroa	Cook Biotech	Cook Biotech	Aroa
	plastic andreconstructive surgery.The device is suppliedsterile and is intendedfor one-time use.	The device is suppliedsterile and is intendedfor one-time use.		following procedures;hernioplasty and repairof body wall defects.The device allowsreinforcement orbridging of a deficit toobtain the desiredsurgical outcome.Endoform®ReconstructiveTemplate is intendedfor single use only.
Animal origin	Ovine	Porcine	Porcine	Ovine
Tissue type	Forestomach	Small intestinalsubmucosa	Small intestinalsubmucosa	Forestomach
Nominal sizes	Sizes ranging from 1cm² to 400 cm²,lugged	2 to 70 mm widthup to 200 mm length	2 to 70 mm widthup to 200 mm length	Sizes ranging up to400 cm²
Thickness	0.15 – 1.5 mm	0.1 – 1.5 mm	100 to 1500 µm thick	Approximately 0.15 –1.20 mm
Presentation	Sterile, lyophilized,multi-laminate luggedsheets in a peel pouch	The device is suppliedsterile in double pouchsystem.	The device is suppliedsterile in double pouchsystem.	Sterile, lyophilizedsheets in peel pouch
Components	Ovine derivedcollagen	Porcine derivedcollagen	Porcine derivedcollagen an	Ovine derivedcollagen andpolyglycolic acid(PGA) suture material

The technological characteristics of Endoform® Plastics and Reconstructive Matrix and the reference device Endoform® Reconstructive Template are equivalent in that they are both primarily composed on ovine ('sheep') collagen and indicated for implantation for soft tissue repair or reinforcement in plastic and reconstructive surgery. Both surgical mesh devices are manufactured from the same ovine source material using an identical manufacturing process.

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7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Bench testing was conducted on the Endoform® Plastics and Reconstructive Matrix to support the substantial equivalence of the proposed device to the predicate device, as detailed below:

tensile strength ●
suture retention ●
biochemical composition ●
endotoxin
dimensional verification ●
ball burst
modulus of elasticity ●
delamination evaluation

In addition to bench testing, validation of the manufacturing process, labeling, packaging transportation, and sterilization to achieve a sterility assurance level (SAL) of 10° were performed. Results of the testing demonstrate that the proposed device meets all product specifications for the intended use.

Biocompatibility of the proposed device has been assessed via ISO 10993-1 and has been concluded that the device is biocompatible based on the established safety of the reference device.

As the proposed predicate and reference devices are technologically equivalent, safety and performance of the proposed device is based on the in vivo performance of the predicate and reference devices.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

There was no clinical testing required to support the indications for use as they are equivalent to the predicate device.

9. SUMMARY OF OTHER INFORMATION

No additional information was provided.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the non-clinical and animal testing completed, and the comparisons with the predicate and reference devices, Endoform® Plastics and Reconstructive Matrix does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.