The Miromatrix Biological Mesh TW is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Device Description

The Miromatrix Biological Mesh TW is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The Miromatrix Biological Mesh TW provides a scaffold during tissue repair and is designed to be an interface between the tendon and tendon sheath or the surrounding tissues. The Miromatrix Biological Mesh TW is designed for placement under, around or over the injured tendon. The device is terminally sterilized by electron beam irradiation in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 10 cm x 20 cm, and may be trimmed or cut as required before being sutured to the surgical site.

AI/ML Overview

The provided text is a 510(k) premarket notification letter and a 510(k) summary for a medical device called the "Miromatrix Biological Mesh TW." This document is used by the FDA to determine substantial equivalence to a legally marketed predicate device, not to prove that a device meets specific acceptance criteria through a clinical or algorithmic performance study in the way an AI/ML medical device would.

Therefore, many of the requested details, such as:

Acceptance criteria (in the context of an AI/ML study)
Study that proves the device meets acceptance criteria (in the context of an AI/ML study)
Sample sizes for test sets, data provenance
Number of experts and their qualifications for ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone algorithm performance
Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Sample size for training set
How ground truth for the training set was established

are not applicable to the information provided in this document.

This document describes a surgical mesh product, which is a physical implant, not a software algorithm or an AI/ML medical device. The "performance data" mentioned refers to bench testing (tensile strength, suture pullout strength) and animal studies (tissue attachment, healing response) conducted to demonstrate the physical and biological performance of the mesh, not the performance of an AI algorithm.

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device based on:

Identical Indications for Use.
Similar Technological Characteristics (design, materials, performance). The key point here is that if there are differences, they must not raise new questions of safety and effectiveness.

Here's a summary of the information that is present in the document, framed in the context of device approval, though not directly corresponding to AI/ML acceptance criteria:

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

Acceptance Goal (Substantial Equivalence): The Miromatrix Biological Mesh TW must perform comparably to the predicate device (Integra Tendon Wrap™ Tendon Protector) in terms of safety and effectiveness for its intended use, and any differences in technological characteristics must not raise new questions of safety or effectiveness.
Performance Metrics (from animal/bench testing):
- Tensile Strength & Suture Pullout Strength: The Miromatrix Biological Mesh TW was shown to have higher tensile and suture pullout strength than the predicate device. The conclusion states these differences "do not have any impact on safety and effectiveness, and therefore, on substantial equivalence."
- Tissue Attachment (animal study): After 4 and 10 weeks, the average tissue attachment was comparable between the Miromatrix Biological Mesh TW and the predicate device in an Achilles tendon defect model.
- Healing Response (animal study): The healing response at 4 and 10 weeks was also comparable.
- Biocompatibility: Established based on the identical material (porcine liver tissue) to a previously cleared reference device (Miromatrix Biological Mesh, K134033). No new biocompatibility testing was required.
- Shelf Life: Shelf life testing was performed to establish the proposed shelf life.

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

No specific "test set" in the AI/ML sense. The document mentions "bench and animal data."
- Animal study: A "4 and 10-week partial Achilles tendon defect model" was used. The specific number of animals is not provided.
- Bench testing: Performed for tensile and suture pullout strength. The number of samples tested is not provided.
Data Provenance: Not specified, but generally, studies for FDA submissions are expected to follow good laboratory practices.

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)

Not applicable. Ground truth in this context would refer to the validated physical and biological properties of the mesh and the animal model outcomes, which are measured or observed by scientific/technical personnel, not "experts" establishing a diagnostic "ground truth."

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

Not applicable. This methodology is for assessing subjective human interpretation, not for objective measurements or animal study outcomes.

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 relates to AI assistance for human interpretation, which is not relevant to a surgical mesh.

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

Not applicable. This is for AI algorithms.

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

No "ground truth" in the AI/ML sense. The "truth" is established by direct measurement of physical properties (e.g., tensile strength) and observation of biological responses in animal models (e.g., tissue attachment, healing response) according to established scientific methods.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device in this context.

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

Not applicable. See point 8.

Summary

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

February 16, 2017

Miromatrix Medical Inc. % Miriam Provost, Ph.D. Biologics Consulting Group, Inc. 400 N. Washington St., Suite 100 Alexandria, Virginia 22314

Re: K162570

Trade/Device Name: Miromatrix Biological Mesh TW Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OWW Dated: January 16, 2017 Received: January 18, 2017

Dear Dr. Provost:

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 of medical devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jennifer R. Stevenson -S

For 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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Indications for Use

510(k) Number (if known) K162570

Device Name Miromatrix Biological Mesh TW

Indications for Use (Describe)

The Miromatrix Biological Mesh TW is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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In accordance with 21 CFR 807.97(h) and 21 CFR 807.92, the 510(k) Summary for the Miromatrix Biological Mesh TW is provided below.

1. SUBMITTER

Miromatrix Medical Inc. 10399 West 70th Street Eden Prairie, MN 55334

Contact Person: Jeff Ross, Ph.D. Phone: 763-458-8801 Email: jross@miromatrix.com Date Prepared: September 13, 2016

DEVICE 2.

510(k) Number: K162570 Name of Device: Miromatrix Biological Mesh TW Common Name: Surgical Mesh Classification Regulation: 21 CFR 878.3300 Regulatory Class: II Product Code: FTM, OWW Panel: General and Plastic Surgery

PREDICATE DEVICE 3.

Predicate Device: Integra Tendon Wrap™ Tendon Protector (K053655)

Reference Device: Miromatrix Biological Mesh (K134033)

DEVICE DESCRIPTION 4.

5. INDICATION FOR USE

The Miromatrix Biological Mesh TW is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

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This indication for use is identical to that of the predicate device, the Integra Tendon Wrap™ Tendon Protector (K053655).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The similarities and differences in technological characteristics between the subject Miromatrix Biological Mesh TW and the predicate mesh are summarized below.

Similarities 6.1.

The Miromatrix Biological Mesh TW is similar in design to the predicate Integra Tendon Wrap™ Tendon Protector (K053655). Both are designed to provide a protective environment while the tendon is healing for the management and protection of the tendon injuries in which there has been no substantial loss of tendon tissue.

In addition, the Miromatrix Biological Mesh TW is identical in materials (i.e., porcine liver tissue) to the reference device, the Miromatrix Biological Mesh (K134033).

6.2. Differences

Although similar in design, there are minor differences in dimensions between the subject Miromatrix Biological Mesh TW and the predicate Integra Tendon Wrap™ Tendon Protector (K053655). The Miromatrix Biological Mesh TW has a thickness of 0.1-1.5 mm and sizes from 1x2 cm to 10x20 cm. Based on Miromatrix's own measurements, the predicate Integra Tendon Wrap™ Tendon Protector has a thickness range that slightly exceeds that of the subject device. Based on publically available information, the sizes of the predicate are similar, i.e., 5x5cm and 10x12.5cm.

When compared to the reference device (i.e., the Miromatrix Biological Mesh of K134033), the only difference in design are a slight change in dimensions, i.e., a reduction in the mesh thickness (i.e., from 0.5-3 mm to 0.1-1.5 mm) and a reduction in the maximum mesh size (i.e., from 20x30 cm to 10x20 cm).

In terms of materials, the predicate Integra Tendon Wrap™ Tendon Protector is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosanminoglycan (GAG). While the predicate material is different from the porcine liver tissue that comprises the subject device, the difference does not raise a new question of safety and effectiveness.

The subject device has the same material as the reference device (K134033). Thus, the biocompatibility of the subject device material (i.e., porcine liver) and, therefore, its safety for the proposed intended use has already been established as part of K134033.

7. PERFORMANCE DATA

Because the materials of the subject Miromatrix Biological Mesh TW are identical to that of the reference device, the Miromatrix Biological Mesh (K134033), no new biocompatibility testing is required to demonstrate substantial equivalence.

Shelf life testing was performed to establish the proposed shelf life of the device.

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Bench and animal data show that the subject Miromatrix Biological Mesh TW is substantially equivalent to the predicate Integra Tendon Wrap™ Tendon Protector with regard to performance. Specifically:

. The total tensile strength and suture pullout strength were evaluated and measured for both the Miromatrix Biological Mesh TW and the predicate device. The Miromatrix Biological Mesh TW was shown to have higher tensile and suture pullout strength than the predicate device. These differences do not have any impact on safety and effectiveness, and therefore, on substantial equivalence.
. Animal testing comparing the subject and predicate devices in a 4 and 10-week partial Achilles tendon defect model was performed. After 4 and 10 weeks, the average tissue attachment was comparable. The healing response at 4 and 10 weeks was also comparable.

8. CONCLUSIONS

The Miromatrix Biological Mesh TW is identical in indications to the predicate Integra Tendon Wrap (K053655).

The Miromatrix Biological Mesh TW is similar in design to the predicate Integra Tendon Wrap (K053655). In terms of materials, the Integra Tendon Wrap is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosanminoglycan (GAG). While the Integra Tendon Wrap material is different from the porcine liver tissue that compromises the subject device, the difference does not raise a new question of safety and effectiveness. The biocompatibility of the subject device material (i.e., porcine liver) has already been established as part of K134033.

Performance testing (bench and animal testing) of the subject device versus the predicate device was performed and the results demonstrate that the subject device is substantially equivalent to the predicate device for the proposed indication for use.

In conclusion, based on the exact same indication for use and comparable design and performance to the predicate Integra Tendon Wrap (K053655) and based on the same materials and comparable design to the reference device Miromatrix Biological Mesh (K134033), as well as favorable preclinical testing, the subject Miromatrix Biological Mesh TW may be found substantially equivalent.

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.