Ovine Tissue Matrix is intended for use as a surgical mesh to repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

Device Description

The OTM family is comprised of ovine derived extracellular matrix devices combined with polypropylene. The device is individually packaged and supplied sterile in various sizes and thicknesses to address the complexity of the soft tissue repair. The device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device is supplied "ready to use" in a peel pouch, and does not require rehydration or soaking prior to implant.

AI/ML Overview

The provided documentation (K141053) describes the TELA Bio Incorporated Ovine Tissue Matrix (OTM), a surgical mesh. This document is a 510(k) summary, which establishes substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, training set details) are not explicitly present in the provided text, as they are typically found in detailed study reports.

However, based on the information available, here's what can be extracted:

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

The document does not provide a table of explicit, quantitative acceptance criteria for each performance metric, nor does it report specific numerical performance results against such criteria. Instead, it states that the device's performance is "acceptable" or "equivalent" to the predicate.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Acceptable per ISO 10993-1:2009	"acceptable"
Cytotoxicity	Passed	Conducted
Sensitization	Passed	Conducted
Irritation	Passed	Conducted
Acute Systemic Toxicity	Passed	Conducted
Implantation	Passed	Conducted
Chronic Toxicity	Passed	Conducted
Pyrogenicity	Passed	Conducted
Viral Inactivation	Acceptable levels	"safety testing included a viral inactivation study"
Residual Chemical Assessment	Acceptable levels	"safety testing included ... residual chemical assessment"
Biomechanical Bench Testing	Equivalent to predicate and meets requirements for intended use	"equivalent to the predicate device and meet the requirements for their intended use."
Uniaxial Tensile Strength	Equivalent to predicate	Conducted
Ball Burst Strength	Equivalent to predicate	Conducted
Suture Retention	Equivalent to predicate	Conducted
In Vivo Performance (Safety & Effectiveness)	Safety and effectiveness demonstrated in a model	"demonstrated the safety and effectiveness"

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

The document mentions "Biomechanical bench, and in vivo performance testing have been conducted," but does not specify the sample sizes for these tests. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.

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)

This information is not provided in the document. The document refers to "in vivo study" and "biomechanical bench testing" but does not detail how "ground truth" or performance assessment was established by experts.

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

This information is not provided in the document.

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 surgical mesh, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in this context.

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

This is not applicable as it's a physical surgical mesh, not an algorithm.

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

For biocompatibility, the ground truth was established by adherence to ISO 10993-1:2009 standards and testing protocols.
For biomechanical testing, the ground truth was defined by comparison to the predicate device and meeting the "requirements for their intended use".
For the "in vivo study," the ground truth for "safety and effectiveness" would likely be based on histopathological evaluation, clinical observations, and potentially macroscopic assessment in the animal model, but this is not explicitly detailed.

8. The sample size for the training set

This is not applicable as the device is a physical product and not an AI algorithm that requires a training set.

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

This is not applicable for the same reason mentioned above.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

December 11, 2014

TELA Bio Incorporated Ms. Donna Stauffer Senior Regulatory Affairs Specialist 1 Great Valley Parkway, Suite 24 Malvern, Pennsylvania 19355

Re: K141053

Trade/Device Name: Ovine Tissue Matrix (OTM) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: November 19, 2014 Received: November 20, 2014

Dear Ms. Stauffer:

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

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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 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.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141053

Device Name

Ovine Tissue Matrix (OTM)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Image /page/4/Picture/0 description: The image shows the logo for "TELA BIO, INC. SURGICAL RECONSTRUCTION COMPANY". The logo features a stylized "T" with a circular design on the left side that has red accents. The rest of the logo is in black except for the "BIO" which is in red. The words "SURGICAL RECONSTRUCTION COMPANY" are in a smaller font and are located below the "BIO".

510(k) Number:

of of of Page

510(k) Summary

Submitted By: TELA Bio, Inc. 1 Great Valley Parkway, Suite 24 Malvern, PA 19355

Contact Person: Donna M. Stauffer, RAC Sr. Requlatory Affairs Specialist E: dstauffer@telabio.com P: (484) 320-2932 F: (610) 644-3769

Date Prepared: April 22, 2014

Device Information:

Trade Name:	Ovine Tissue Matrix (OTM) Reinforced Bioscaffold
Common or Usual Name:	Surgical Mesh
Classification Name:	Mesh, Surgical (21 CFR §878.3300, Product Code FTM)
Predicate Device:	Endoform Reconstructive Template (K130547)

Device Description:

The device is supplied "ready to use" in a peel pouch, and does not require rehydration or soaking prior to implant.

Intended Use:

Ovine Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or body wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.

The device is supplied sterile and is intended for single use only.

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Image /page/5/Picture/0 description: The image shows the logo for "OTELA BIO INC. SURGICAL RECONSTRUCTION COMPANY". The logo features a stylized "O" with red accents, followed by the letters "TELA" in black. To the right of "TELA" is the word "BIO" in red, with "INC." in smaller font above the words "SURGICAL RECONSTRUCTION COMPANY".

510(k) Number:

Page _ of _ of _ of

Summary of Technological Characteristics:

Device	Ovine Tissue Matrix	Endoform ReconstructiveTemplate
Manufacturer	TELA Bio, Inc.	Mesynthes, Ltd.
510(k) Number	Proposed	K130547
Indications for Use	Ovine Tissue Matrix is intendedfor use as a surgical mesh toreinforce and/or repair soft tissuewhere weakness exists.Indications for use include therepair of hernias and/or body walldefects that require the use ofreinforcing or bridging material toobtain the desired surgicaloutcome.	Endoform ReconstructiveTemplate is intended for use as asurgical mesh to reinforce and/orrepair soft tissue whereweakness exists. Indications foruse include, but are not limitedto, the following procedures:hernioplasty and repair of bodywall defects. The device allowsreinforcement or bridging of adeficit to obtain the desiredsurgical outcome.
Material	Ovine derived collagen andassociated ECM componentsCollagen ICollagen IIIPolypropylene	Ovine derived collagen andassociated ECM componentsCollagen ICollagen IIIPolyglycolic acid (PGA)
Design	Terminally sterilized	Terminally sterilized
Dimensions	Various sizes, up to 1000 cm²	Various sizes, up to 200 cm²
Thickness	Approx. 0.15-1.2 mm	Approx. 0.15-1.2 mm

Biocompatibility and Performance Data:

Biocompatibility, biomechanical bench, and in vivo performance testing have been conducted to evaluate the safety and performance characteristics of Ovine Tissue Matrices.

Biocompatibility testing was completed on the finished, sterile device in accordance with the requirements of ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, implantation, chronic toxicity, and pyrogenicity. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.

Biomechanical testing included uniaxial tensile strength, ball burst strength, and suture retention. Results indicate that Ovine Tissue Matrices are equivalent to the predicate device and meet the requirements for their intended use.

An in vivo study has demonstrated the safety and effectiveness of Ovine Tissue Matrix in a model of soft tissue reinforcement.

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Image /page/6/Picture/0 description: The image shows the logo for "Tela Bio Surgical Reconstruction Company". The logo consists of the word "TELA" in large, bold, black letters, followed by the word "BIO" in red. Below the word "BIO" are the words "Surgical Reconstruction Company" in smaller, black letters. To the left of the word "TELA" is a circular graphic with a red section.

510(k) Number:
Page	of

Conclusion:

Ovine Tissue Matrix is substantially equivalent to Mesynthes' Endoform Reconstructive Template (K130547), which has been cleared by FDA for the same intended use and indications. In addition, OTM has similar technological characteristics and principles of operation as the predicate device.

The minor technological differences between OTM and the predicate device do not raise new questions of safety and effectiveness. Performance and preclinical data demonstrate that OTM is as safe and effective as the predicate device.

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.