Restrata™ Wound Matrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

Device Description

The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur. Restrata™ is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata™ is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

AI/ML Overview

The provided text is a 510(k) Summary for the Acera Surgical Restrata™ Wound Matrix. This document describes the device, its intended use, and its technological characteristics as part of a premarket notification to the FDA to demonstrate substantial equivalence to an already legally marketed predicate device.

Key takeaway: This document is not a study proving a device meets acceptance criteria, but rather a submission to the FDA demonstrating substantial equivalence. Therefore, much of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment will not be found in this type of regulatory submission. The 510(k) process focuses on demonstrating similarity to an existing device, rather than proving a device meets specific, predefined performance metrics through a clinical study with acceptance criteria.

However, I can extract the information that is present and explain why other information is not available:

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

The document does not present a table of specific, numeric acceptance criteria with corresponding device performance metrics. Instead, it demonstrates equivalence through comparative tables of characteristics and references to performance data.

From the "Technological Characteristics" section, a comparative table is provided:

Characteristic	Restrata™ Wound Matrix (subject device)	GORE® BIO-A® Wound Matrix (K132397) (predicate device)	Cook Biotech, Oasis® Wound Matrix (K061711) (reference device)	Comparison
Principles of Operation	Device serves to protect a wound and facilitate a moist environment for natural healing to occur by forming a physical barrier over the wound bed and providing a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis.	Device serves to protect a wound and facilitate a moist environment for natural healing to occur by forming a physical barrier over the wound bed and providing a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis.	Provides physical scaffold for wound repair.	Equivalent to predicate device
Material of Construction	Resorbable synthetic polymer matrix Dual polymer matrix comprised of polyglactin 910 and polydioxanone fibers (PGLA 90:10 / PDO)	Resorbable synthetic polymer matrix Copolymer matrix comprised of polyglycolic acid and trimethylene carbonate (PGA:TMC)	Minimally processed Porcine SIS Animal-derived, extracellular matrix	Although resorbable polymers used are different, the biocompatibility, performance and safety are equivalent to predicate
Intended Use	Restrata™ Wound Matrix is intended for use in the management of wounds.	The GORE® BIO-A®B Wound Matrix is intended for use in the management of wounds.	Oasis® Wound Matrix is indicated for the management of wounds.	Equivalent to predicate device
Size	2.5cm x 2.5cm (1"x1"), 2.5cm x 7.5cm (1"x3"), 5.0cm x 5.0cm (2"x2"), 7.5cm x 7.5cm (3"x3"), 10.0cm x 12.5cm (4"x5"), 12.5cm x 17.5cm (5"x7")	7.0cm x 10.0cm, 8.0cm x 8.0cm, 9.0cm x 15.0cm, 10.0cm x 30.0cm, 20.0cm x 20.0cm, 20.0cm x 30.0cm	3.0cm x 3.5cm, 3.0cm x 7.0cm	Equivalent to range set by predicate and reference device
Material Composition	Porous, non-woven PGLA:PDO matrix	Porous, non-woven PGA:TMC matrix	Bovine collagen matrix	Equivalent to predicate device
Surgical Application Restrictions	Device does not have requirement for specific orientation	Device does not have requirement for specific orientation	Device does not have requirement for specific orientation	Equivalent to predicate device
Sterility	Sterile, SAL 10-6	Sterile	Sterile	Equivalent
Packaging	Double sterile pack. Nested pouch configuration within a chipboard envelope.	Unknown	Double sterile pack. Nested pouch within a chipboard unit box.	Equivalent to reference device
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic	Equivalent
Resorbable	Yes	Yes	Not Applicable	Equivalent to predicate device
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Equivalent

Performance Data Summary:

"The subject device has mechanical properties (tensile strength and suture pull-out strength) equivalent or superior to the reference device." (No specific numerical values or acceptance criteria are stated).
"The subject device was also tested against a commercially available wound dressing with the same intended use in a clinically relevant full thickness porcine wound model. Analysis included an assessment of biocompatibility, along with macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology. Test results showed that the subject device had an equivalent wound healing response compared to the control article, and exhibited no adverse tissue responses." (Again, no specific numerical outcomes or acceptance criteria are provided; the finding is "equivalent").

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

Sample size: Not explicitly stated. The "Performance Data" section mentions a "clinically relevant full thickness porcine wound model," implying animal testing, but the number of animals or wounds tested is not specified.
Data provenance: The performance data comes from non-clinical testing (mechanical properties and a porcine wound model). The country of origin for the data is not specified, nor is whether the study was retrospective or prospective (though animal model studies are inherently prospective).

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

This information is not provided. Since the described tests are primarily non-clinical (mechanical and animal model), the concept of "experts establishing ground truth for a test set" in the context of human data (e.g., radiologists for imaging) does not directly apply. For the animal study, the assessment of "equivalent wound healing response" and "no adverse tissue responses" would have been made by researchers/veterinarians/pathologists, but their number and specific qualifications are not detailed in this summary.

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

This information is not provided and is generally not applicable to the non-clinical tests described in this 510(k) summary. Adjudication methods are typically used in clinical studies involving interpretation of human data.

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

No MRMC study was performed or described. This document is for a physical medical device (wound matrix), not an AI/software device that assists human readers.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

For the mechanical properties, the "ground truth" would be established by standardized mechanical testing methods.
For the porcine wound model, the "ground truth" was established through "macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology." This is effectively a combination of direct observation, quantitative measurement, and microscopic pathology, as assessed by the researchers of that study.

8. The sample size for the training set

Not applicable. This is a physical device being submitted via 510(k), not an AI/machine learning algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.

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

Not applicable, as there is no training set for a physical device.

Summary

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December 15, 2022

Acera Surgical, Inc. % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188

Re: K170300

Trade/Device Name: Restrata™ Wound Matrix Regulatory Class: Unclassified Product Code: QSZ

Dear Dr. Linda Braddon:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 26, 2017. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

April 26, 2017

Acera Surgical, Inc % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highwav, Suite 120 Woodstock, GA 30188

Re: K170300

Trade/Device Name: Restrata Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: January 30, 2017 Received: January 31, 2017

Dear Dr. Braddon:

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

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the quality systems (OS) 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/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,

David Krause -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration
Indications for Use	Expiration Date: January 31, 2017
510(k) Number (if known)	See PRA Statement on last page.
K170300
Device Name

Restrata™ Wound Matrix

Indications for Use (Describe)

Restrata™ Wound Matrix is intended for use in the management of wounds, including:

Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

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

区 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 FDA 3881 (1/14)

PSC Publishing Services(301)443-6740 EF

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510(k) Summary of Safety and Effectiveness 6

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In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) Summary for the Acera Surgical Restrata™ Wound Matrix is provided below.

Date Summary Prepared	April 25, 2017
Submitted by	Acera Surgical, Inc.10880 Baur BlvdSt. Louis, MO 63132Phone 844-879-2237
510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681 (direct)855-MED-DEV1 (office)LGB@SecureBME.com
Trade Name	Restrata™ Wound Matrix
Common Name	Wound Dressing
Code Classification	FRO, Unclassified
Primary Predicate Device	GORE®, BIO-A® Wound Matrix (K132397)
Reference Devices	Cook Biotech, Oasis® Wound Matrix (K061711)Acera Surgical, Cerafix® Dura Substitute (K161278)

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Device Description

Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

Intended Use

Restrata™ Wound Matrix is intended for use in the management of wounds, including:

Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-laser surgery, post-Mohs surgery, podiatric wound dehiscence), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Technological Characteristics

The Restrata™ Wound Matrix is composed of a non-woven "fleece" of polymer fibers composed of fully resorbable synthetic polymers. The fibers comprising Restrata™ Wound Matrix are produced from polyglactin 910 (PGLA) and polydiaxonone (PDO), both bioabsorbable polymers utilized in FDA cleared dura substitutes, resorbable sutures, orthopedic implants and other medical devices. Following implantation, both the PGLA and PDO are gradually hydrolyzed and absorbed over time, as new tissue forms in their place.

The subject device, predicate device (GORE® BIO-A® Wound Matrix) and reference device (Oasi® Wound Matrix) are all wound dressings indicated for the management of wounds. The subject device and predicate device are both composed of fully degradable biocompatible polymer materials. The subject device has the same technological characteristics as the predicate device and reference device in terms of principles of operation, intended use, material performance, and biocompatibility.

The subject device is also substantially equivalent to the reference device, Cerafix® Dura Substitute, in terms of design and composition, illustrating its biocompatibility and safety.

The subject device has the same characteristics as the predicate and reference device as follows:

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Characteristic	Restrata™ WoundMatrix(subject device)	GORE® BIO-A® WoundMatrix (K132397)(predicate device)	Cook Biotech, Oasis®Wound Matrix(K061711)(reference device)	Comparison
510(k)	K170300	K132397	K061711	N/A
Principles ofOperation	Device serves toprotect a wound andfacilitate a moistenvironment fornatural healing tooccur by forming aphysical barrier overthe wound bed andproviding a scaffold forcellular infiltration andvascularization beforecompletely degradingvia hydrolysis.	Device serves toprotect a wound andfacilitate a moistenvironment fornatural healing tooccur by forming aphysical barrier overthe wound bed andproviding a scaffold forcellular infiltration andvascularization beforecompletely degradingvia hydrolysis.	Provides physicalscaffold for woundrepair.	Equivalent topredicatedevice
Material ofConstruction	Resorbable syntheticpolymer matrixDual polymer matrixcomprised ofpolyglactin 910 andpolydioxanone fibers(PGLA 90:10 / PDO)	Resorbable syntheticpolymer matrixCopolymer matrixcomprised ofpolyglycolic acid andtrimethylenecarbonate (PGA:TMC)	Minimally processedPorcine SISAnimal-derived,extracellular matrix	Althoughresorbablepolymers usedare different,the biocompat-ibility,performanceand safety areequivalent topredicate
Intended Use	Restrata™ WoundMatrix is intended foruse in themanagement ofwounds.	The GORE® BIO-A®BWound Matrix isintended for use in themanagement ofwounds.	Oasis® Wound Matrixis indicated for themanagement ofwounds.	Equivalent topredicatedevice
Size	2.5cm x 2.5cm (1"x1")2.5cm x 7.5cm (1"x3")5.0cm x 5.0cm (2"x2")7.5cm x 7.5cm (3"x3")10.0cm x 12.5cm (4"x5")12.5cm x 17.5cm (5"x7")	7.0cm x 10.0cm8.0cm x 8.0cm9.0cm x 15.0cm10.0cm x 30.0cm20.0cm x 20.0cm20.0cm x 30.0cm	3.0cm x 3.5cm3.0cm x 7.0cm	Equivalent torange set bypredicate andreferencedevice
MaterialComposition	Porous, non-wovenPGLA:PDO matrix	Porous, non-wovenPGA:TMC matrix	Bovine collagen matrix	Equivalent topredicatedevice
SurgicalApplicationRestrictions	Device does not haverequirement forspecific orientation	Device does not haverequirement forspecific orientation	Device does not haverequirement forspecific orientation	Equivalent topredicatedevice
Sterility	Sterile, SAL 10-6	Sterile	Sterile	Equivalent
Packaging	Double sterile pack.Nested pouchconfiguration within achipboard envelope.	Unknown	Double sterile pack.Nested pouch within achipboard unit box.	Equivalent toreferencedevice
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic	Equivalent
Resorbable	Yes	Yes	Not Applicable	Equivalent topredicatedevice
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Equivalent

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The following technological differences exist between the subject and predicate devices:

. Although the subject device and predicate device are both manufactured from resorbable polymers, the subject device is composed of PGLA and PDO fibers, while the predicate device is composed from PGA and TMC fibers.
Although the polymers differ between the subject device and predicate device, both sets of polymers have a long-standing track record in medical device applications, including use in dural substitutes, resorbable sutures, orthopedic implants, and other medical devices. Each of the polymers were proven fully biocompatible, including; non-pyrogenic, non-genotoxic, non-hemolytic, and nonmutagenic. Both the subject device and predicate device are porous, non-woven matrices that serve to protect a wound and facilitate a moist environment for natural healing to occur by forming a physical barrier over the wound bed and providing a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. So, despite the difference in polymer composition, the subject device is equivalent in function, indication for use, product code, environment of use, and principles of operation to the predicate device.

Performance Data

The subject device has mechanical properties (tensile strength and suture pull-out strength) equivalent or superior to the reference device.

The subject device was also tested against a commercially available wound dressing with the same intended use in a clinically relevant full thickness porcine wound model. Analysis included an assessment of biocompatibility, along with macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology. Test results showed that the subject device had an equivalent wound healing response compared to the control article, and exhibited no adverse tissue responses.

Conclusions

The subject device and the predicate device were initially compared based on product code and intended use and found to be equivalent. Next, the subject device, predicate device, and reference device underwent non-clinical evaluation that confirms equivalence in the intended use of each device, biocompatibility, safety, efficacy, environment of use, and the principles of operation. Therefore, the subject device demonstrates substantial equivalence to the predicate and reference devices.

Regulation Number and Section

N/A