MTF Fascia is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

MTF Fascia is for single patient use only.

Device Description

MTF Fascia is dehydrated, decellularized human allograft fascia minimally processed to preserve the extracellular matrix of the fascia. The fascia is reinforced with a resorbable Poly-L-Lactic Acid (PLLA) fiber woven into the fascia to enhance suture retention of the fascia. MTF Fascia is aseptically processed-no terminal sterilization is conducted. The device passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for medical devices. The device must be rehydrated prior to use following the procedures described in the Instructions for Use.

AI/ML Overview

This document is a 510(k) summary for the MTF Fascia device. It is a premarket notification for a medical device seeking clearance from the U.S. Food and Drug Administration (FDA) and is not a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic device, for example.

The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device. This means it is as safe and effective as another legally marketed device. The acceptance criteria in this context are related to demonstrating this substantial equivalence, rather than a quantifiable performance metric for a specific medical condition.

Here's a breakdown of the requested information based on the provided text:

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

For a 510(k) submission for a surgical mesh, the "acceptance criteria" are implicitly defined by the requirements for demonstrating substantial equivalence to predicate devices regarding material composition, biocompatibility, and biomechanical properties. The "reported device performance" refers to the results of tests demonstrating these aspects.

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicates)	Reported Device Performance (MTF Fascia)
Material Composition Equivalence	MTF Fascia is composed of dehydrated, decellularized human allograft fascia reinforced with a resorbable Poly-L-Lactic Acid (PLLA) fiber. This is explicitly stated to be substantially equivalent to Synthasome X-Repair in material and to OrthADAPT PR in being a collagen matrix reinforced with a polymer component.
Biocompatibility	Demonstrated through: - ISO 10993 testing of the PLLA fiber. - Cytotoxicity Study Using the ISO Elution Method (demonstrated not cytotoxic). - Risk Analysis for MTF Fascia. - Subchronic toxicity tests (animal studies). - Established history of using the material components.
Biomechanical and Histologic Outcomes Equivalence	Demonstrated through: - Clinical (cadaver) studies. - Preclinical in vivo models. - Data presented in peer-reviewed journals and submitted within the 510(k) supported substantial equivalencies between MTF Fascia and Synthasome X-Repair in these outcomes. - Not intended to provide full mechanical strength, but for reinforcement; sutures provide biomechanical strength.
Sterility	Aseptically processed. Passes USP <71> Sterility Tests. Satisfies FDA requirements for LAL endotoxin limit.
Intended Use Equivalence	Intended for reinforcement of soft tissues during tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, etc.). Stated to be substantially equivalent to OrthADAPT PR in indication for use.

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

The document mentions "clinical (cadaver)" and "preclinical in vivo models" for biomechanical and histologic outcomes, and "animal studies" for subchronic toxicity. However, specific sample sizes for these tests are not provided in the summary.

Test Sets: Cadaver studies, preclinical in vivo models (animals), and in-vitro tests (ISO 10993, Cytotoxicity).
Data Provenance: Not explicitly stated, but typically these types of studies are conducted in laboratories or research institutions, potentially in the USA or internationally. The document does not specify if data was retrospective or prospective.

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 type of information (expert involvement in establishing ground truth) is usually found in clinical trials or diagnostic accuracy studies. For a 510(k) for a surgical mesh, "ground truth" is typically established through:

Standardized testing procedures: e.g., ISO, USP standards.
Histopathology analysis: Performed by qualified pathologists, but the number and qualifications are not specified here.
Biomechanical testing protocols: Carried out by engineers or researchers in controlled environments.

This 510(k) summary does not mention a number of experts or their specific qualifications for establishing ground truth for any test sets.

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

Adjudication methods are typically associated with resolving discrepancies in expert interpretations, common in diagnostic imaging studies. For a surgical mesh, the "adjudication" (if any) would be embedded within the scientific rigor of the laboratory testing and pathology review processes. The document does not describe any specific adjudication method for the test sets.

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 or any study involving human readers/AI assistance was not done for this device. This type of study is relevant for diagnostic devices that interface with human interpretation (e.g., radiology AI). The MTF Fascia is a surgical implant.

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

This question is not applicable to a surgical implant device like MTF Fascia. "Standalone" performance with an algorithm relates to AI/software as a medical device (SaMD).

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

The types of "ground truth" used for demonstrating substantial equivalence for MTF Fascia primarily include:

Standardized material properties: Measured against established industry standards (e.g., ISO for PLLA fiber).
Biocompatibility test results: Based on standardized cytotoxicity assays and animal studies.
Histologic outcomes: Likely assessed by comparing tissue responses in animal or cadaver models to known characteristics, implying pathology review (though not explicitly detailed regarding how it established ground truth).
Biomechanical test results: Measured tensile strength, suture retention, etc., in cadaveric or in-vitro models.
Compliance with FDA regulations: (e.g., USP sterility tests, LAL endotoxin limits).

8. The sample size for the training set

This concept (training set) is primarily relevant for machine learning/AI models. As MTF Fascia is a physical surgical implant and not an AI-driven diagnostic or therapeutic system, there is no "training set" in this context.

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

As there is no training set for MTF Fascia, this question is not applicable.

Summary

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NOV

8 2012

K120479 510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

Name: Contact:

Musculoskeletal Transplant Foundation Nancy Joy Senior Regulatory Affairs Submission Specialist

Address:

125 May Street Edison, NJ 08837 USA

Telephone: Fax:

(732) 661-2381 (732) 661-2189

Date Prepared

November 5, 2012

General Device Information

Product Name:

MTF Fascia

Classification:

Surgical Mesh 21 CFR §878.3300 - Product codes: OWY, OWW Class II

Predicate Devices

OrthADAPT® PR Pegasus Biologics, Inc 510(k) K090288

Synthasome X-Repair Synthasome, Inc. 510(k) K083307

Description

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Intended Use (Indications)

MTF Fascia is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. It is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. MTF Fascia is for single patient use only.

Substantial Equivalence

This submission supports the position that the MTF Fascia is substantially equivalent to two previously cleared devices:

OrthADAPT® PR - Pegasus Biologics, Inc. [K090288] Synthasome X-Repair - Synthasome. Inc. [K083307]

MTF Fascia is substantially equivalent to Synthasome X-Repair in material and biomechanical and histologic outcomes obtained from both clinical (cadaver) and preclinical in vivo models. MTF Fascia is substantially equivalent to OrthADAPT PR in indication for use, and both devices are composed of a collagen matrix reinforced with a polymer component.

The clinical (cadaver) and preclinical tests demonstrated the biocompatibility and substantial equivalence of MTF Fascia in comparison to its predicate devices:

ISO 10993 testing of the PLLA fiber .
Cytotoxicity Study Using the ISO Elution Method .
Risk Analysis for MTF Fascia .
. Established history of using the material components of the device
. Published literature
Animal studies were included in this 510(k) submission to serve as . subchronic toxicity tests for MTF Fascia. In addition, a cytotoxicity study has demonstrated that MTF Fascia is not cytotoxic.
Data presented in peer-reviewed journals and submitted within this 510(k) . supported a finding of substantial equivalencies between MTF Fascia and Synthasome X-Repair.

The MTF Fascia has been demonstrated to be substantially equivalent to its predicate devices.

Safety Information

MTF Fascia is single-donor processed. This device was not subjected to terminal sterilization. MTF Fascia is aseptically processed and passes USP <71> Sterility Tests. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1271 Human Cells, Tissues, And Cellular and Tissue Based Products, as applicable.

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Conclusion

Musculoskeletal Transplant Foundation believes that the information provided in this 510(k) submission establishes that similar legally marketed devices have been used for the same clinical applications as MTF Fascia. The materials from which MTF Fascia is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.

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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 a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Musculoskeletal Transplant Foundation % Hogan and Hartson, LLP Ms. Nancy Joy Senior Regulatory Affairs Submission Specialist 555 Thirteenth Street, Northwest Washington, District of Columbia 20004-5794

Re: K120479

Trade/Device Name: MTF Fascia Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OWY, OWY, OWW Dated: September 27, 2012 Received: September 28, 2012

November 8. 2012

Dear Ms. Joy:

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 - Ms. Nancy Joy

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,

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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V. INDICATIONS FOR USE

510(k) Number (if known): not known

Device Name: MTF Fascia

Indications for Use:

MTF Fascia is for single patient use only.

Prescription Use X OR (Per 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krave for WM
(Division Sign-Off)

Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K120479

Confidential

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.