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 following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Mesynthes Endoform™ Reconstructive Template surgical mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance against those criteria in the way a novel device might.

Therefore, the information you're requesting regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of specific performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not apply directly to this 510(k) summary.

Instead, the submission focuses on demonstrating that the new device has "technological characteristics and substantial equivalence" to existing predicate devices.

Here's an breakdown based on the information provided, keeping in mind the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the format of defined metrics and targets for clinical performance that the device directly "meets." Instead, the acceptance is based on demonstrating similarity to predicate devices through a series of non-clinical performance tests and animal testing.

The "performance" described is about demonstrating similarity or equivalence to predicates, rather than achieving specific quantitative clinical thresholds.

Test Type	Comparison/Performance Description
Non-Clinical Biophysical Tests	The Endoform™ Reconstructive Template performed similarly to its predicate devices in:
- Ball burst strength
- Uniaxial strength
- Suture retention strength
Biocompatibility Tests	The product meets biocompatibility requirements of the ISO standard (ISO10993-1) for:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Subacute Toxicity
- Genotoxicity (Ames, chromosomal aberration and mouse lymphoma)
- Implantation
Animal Testing (In vivo studies)	The performance was substantially equivalent to the predicate device based on:
- Incorporation into new tissue
- Inflammatory response
- Strength of the graft

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

The document does not specify the exact sample sizes for the individual biophysical, biocompatibility, or animal tests. It only states that these tests were "performed on finished, terminally sterilized product" and in "a model of soft tissue reinforcement" for animal studies. The data provenance is implied to be from internal lab testing by Mesynthes Ltd.

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

This information is not applicable/not provided in the context of this 510(k) submission. "Ground truth" established by experts is typically relevant for studies validating diagnostic algorithms or clinical evaluations, which were not conducted here as per Section 9.

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

This information is not applicable/not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which were not part of this 510(k) 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on the impact of a device on human performance, often in diagnostic imaging, which is not relevant for a surgical mesh device.

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

This concept is not applicable to a surgical mesh device. Standalone performance refers to the accuracy of an automated system without human intervention, typically in AI/diagnostic applications.

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

For the non-clinical and animal studies, "ground truth" implicitly refers to the established scientific and engineering standards for measuring device properties (e.g., strength, biocompatibility), and histopathological or physiological assessment in animal models for tissue integration and inflammatory response. These are not typically established via expert consensus in the same way as clinical diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. "Training set" is a concept related to machine learning and AI development, which is outside the scope of this medical device submission.

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

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

Summary

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510(k) Summary for Mesynthes Endoform™ Reconstructive Template 5

1. Submitter/510(k) Holder

MAY 3 1 2013

Mesynthes Ltd 69 Gracefield Road Lower Hutt Wellington New Zealand 5010

Contact Person Nancy Yopp Telephone: +64 4 931-3512 Date Prepared: 25 February 2013

2. Device Name

Proprietary Name: Endoform™ Reconstructive Template Common/Usual Name: Surgical Mesh Classification Name: FTL

3. Predicate Devices

. SurgiSIS® 1- and 4-ply (Cook Biotech) (K980431)
SIS Hernia Repair Device, SurgiSIS® Gold Hernia Repair Graft, 8-ply (Cook Biotech) � (K062697)
Strattice® LTM Surgical Mesh (LifeCell) (K070560) ●

4. Device Description

The Mesynthes Endoform™ Reconstructive Template (ERT) is a surgical mesh comprising either a single layer of decellularized extracellular matrix (ECM) or alternatively, multiple layers (2- to 10- layers) of ECM bonded together by dehydrothermal lamination and polyglycolic acid (PGA) suture material. The ECM component of the proposed device has received FDA clearance (K092096 and K101546) for dermal applications. The use of PGA spans a range of superficial and implantable applications including absorbable sutures (e.g. Sutrazorb® Absorbable PGA Suture, K102592) and surgical meshes (e.g. Dexon® PGA Mesh. K830889).

5. Intended Use

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K130547 Page 2/3

allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.

6. Technological Characteristics and Substantial Equivalence

Endoform™ Reconstructive Template and predicate devices are all primarily composed of mammalian collagens and are used for soft tissue reinforcement. They share similar indications for use, physical properties and biochemical composition. The technological characteristics of Endoform™ Reconstructive Template are substantially equivalent to other legally marketed predicate devices in terms of intended uses and indications, biological and physical performance data. Table 1 compares the ERT device and its predicates.

Manufacturer	Mesynthes	Cook Biotech	Cook Biotech	LifeCell
510K Number	proposed	K980431	K062697	K070560
Device name	Endoform™ ReconstructiveTemplate	SurgiSIS® 1- and 4-ply	SurgiSIS® 8-ply (SISHernia Repair Device,SurgiSIS® Gold HerniaRepair Graft)	LTM Surgical Mesh (Strattice®)
Classification	Surgical mesh (FTL)21 CFR 878.3300Class II	Surgical Mesh (FTM)21 CFR 878.3300Class II	Surgical mesh (FTL)21 CFR 878.3300Class II	FTM
Intended use	Endoform™ ReconstructiveTemplate is intended for use as asurgical mesh to reinforce and/orrepair soft tissue where weaknessexists. Indications for use include,but are not limited to the followingprocedures; hernioplasty and repairof body wall defects. The deviceallows reinforcement or bridging ofa deficit to obtain the desiredsurgical outcome. Endoform™Reconstructive Template isintended for single use only.	SurgiSIS® is intended to beused for implantation toreinforce soft tissue. It isintended for one-time use.	The SIS Hernia RepairDevice is intended to beimplanted to reinforcesoft tissue whereweakness exists.Indications for useinclude the repair of ahernia and body walldefect. The device isintended for one-timeuse.	LTM Surgical Mesh (LTM) isintended for use as a soft tissuepatch to reinforce soft tissuewhere weakness exists and for thesurgical repair of damaged orruptured soft tissue membranes.Indications for use include therepair of hernias and /or bodywall defects which require the useof reinforcing or bridging materialto obtain the desired surgicaloutcome. LTM is intended forsingle patient use only.
Animal origin	Ovine	Porcine	Porcine	Porcine
Tissue type	Forestomach	Small intestine	Small intestine	Dermal
Nominal sizes	Variety of shapes and sizes, up to200 cm²	Variety of shapes and sizes,up to 400 cm²	Variety of shapes andsizes, up to 400 cm²	5 x 16 cm - 20 x 25 cm
Thickness	Approx. 0.15 - 1.2 mm (1-, 2-, 4-,6-, 8- and 10-ply)	Approx. 0.1 - 0.4 mm (1-and 4-ply)	Approx. 0.8 mm (8-ply)	Approx. 1.4 mm
Presentation	Sterile, lyophilized sheets in peelpouch	Sterile lyophilized sheets inpeel pouch	Sterile lyophilized sheetsin peel pouch	Sterile hydrated sheets packagedin a double peel pouchconfiguration
Components	Ovine derived collagen andassociated ECM components-collagen I-collagen III-polyglycolic acid (PGA) suturematerial	Porcine derived collagen andassociated ECM components-collagen I-collagen III	Porcine derived collagenand associated ECMcomponents-collagen I-collagen III	Porcine derived collagen andassociated ECM components-collagen I-collagen III

TABLE 5-1. Substantial Equivalence Comparison

7. Non Clinical Performance Testing

Testing has been carried out to demonstrate that the product meets the performance specifications for its intended use; including biocompatibility, biophysical, viral inactivation and equivalence testing.

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K130547 Page 3/3

The following biophysical tests were performed on finished, terminally sterilized product:

. Ball burst strength
Uniaxial strength .
Suture retention strength ●

These tests provided evidence that Endoform™ Reconstructive Template performed similarly to its predicate devices.

The following biocompatibility tests were performed on finished sterilized product (according to ISO10993-1 standard).

. Cytotoxicity
. Sensitization
Irritation .
Systemic Toxicity .
Subacute Toxicity ◆
Genotoxicity (Ames, chromosomal aberration and mouse lymphoma)
Implantation .

The results of these tests provided evidence that the product meets biocompatibility requirements of the ISO standard.

8. Animal Testing

In vivo studies have demonstrated the safety and effectiveness of the Endoform™ Reconstructive Template in a model of soft tissue reinforcement. The performance was substantially equivalent to the predicate device based on incorporation of the device into new tissue, inflammatory response and strength of the graft.

9. Clinical Performance Testing

There was no clinical testing required to support the indications for use as they are equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing. The verification and validation testing was found to be comparable to predicates and supports the claims of substantial equivalence, product safety and effectiveness.

10. Conclusions Drawn

Based on the testing completed and the comparisons with predicate devices, Endoform™ Reconstructive Template does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

May 31, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Mesynthe, Ltd. % Aptiv Solutions Mr. Ronald Warren 11440 West Bernardo Court, Suite 300 San Diego, California 92127

Re: K130547

Trade/Device Name: Endoform™ Reconstructive Template Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: February 25, 2013 Received: March 04, 2013

Dear Mr. Warren:

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

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Page 2 - Mr. Ronald Warren

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, For

Peter D. Rumm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4

510(k) Number (if known): K130547

Endoform™ Reconstructive Template Device Name:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130547 ·

Mesynthes Limited, Traditional 510(k) Endoform Reconstructive Template™

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.