The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.

Device Description

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects. The device can be applied as an onlay matrix or sutured in place. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.

AI/ML Overview

The provided text describes the Cerafix® Dura Substitute, a medical device for dura mater repair, and its equivalence to predicate devices, particularly focusing on expanding its indicated defect size and application method. The document, however, does not contain a detailed study proving acceptance criteria for an AI/ML device. Instead, it discusses the substantial equivalence of the Cerafix® Dura Substitute based on technological characteristics and animal studies, which is typical for a 510(k) submission for a non-AI medical device.

Therefore, many of the requested points regarding AI/ML device acceptance criteria and studies cannot be answered from this document. I will focus on the information that is present regarding the non-AI device.

Acceptance Criteria and Device Performance (Based on the non-AI device context):

The document describes "Indications for Use" and "Technological Characteristics" which serve as the de facto acceptance criteria for the expanded use of the Cerafix® Dura Substitute via a 510(k) submission. The "reported device performance" is primarily demonstrated through equivalence to a predicate device and side-by-side animal studies.

Acceptance Criteria (from Proposed Indications for Use)	Reported Device Performance
Indicated as a dura substitute for the repair of dura mater.	Subject device (Cerafix® Dura Substitute) has identical technological characteristics, principles of operation, material performance, and biocompatibility to the reference device (previously approved Cerafix® Dura Substitute, K153613, K161278). The reference device was indicated for dura mater repair. Side-by-side animal studies in a canine duraplasty model (dural defects 18 mm x 25 mm) showed "equivalent safety and performance between the subject and predicate device."
Indicated for defects of 4.9 in² (31.7 cm²) or less in area.	Previously, the device was indicated for defects of 4.4 in² (28.3 cm²). The submission includes "Data included in this submission to justify defect increase" (though the data itself is not presented in this summary). The side-by-side animal study utilized dural defects of 18 mm x 25 mm (equal to 4.5 cm² or ~0.7 in²), which is consistent with the general purpose of evaluating a dura substitute but is smaller than the maximum defect size being justified. The equivalence argument for the larger defect size relies on "Data included in this submission to justify defect increase" in comparison to the reference device, which had a slightly smaller indicated defect size.
May be applied as an onlay matrix or sutured in place.	The previous version (reference device) was applied with "tensionless suture application." The primary predicate device (DuraMatrix™ Collagen Dura Substitute) "can be cut by surgeon and placed on dural defect and used as an onlay membrane or sutured in place." The subject device has "Equivalent" principles of operation to the predicate regarding application methods. Side-by-side animal implantation studies were performed with the subject and predicate device "utilizing dural defects (18 mm x 25 mm) without the use of suture (onlay)." Results showed "equivalent safety and performance."
Biocompatibility: Biocompatible	Biocompatibility testing was previously submitted for K153613 and K161278 and confirmed. "Biocompatible" is listed as a common characteristic with both the reference and predicate devices.
Sterility: Sterile, SAL 10⁻⁶	"Sterile, SAL 10⁻⁶" is listed as a common characteristic with the reference device. "Sterile" is listed for the predicate.
Pyrogenicity: Non-pyrogenic	"Non-pyrogenic" is listed as a common characteristic with the reference and predicate devices.
Resorbable: Yes	"Yes" is listed as a common characteristic with the reference device. The predicate is listed as "Not Applicable," but the subject device's resorbable nature is considered "Equivalent to reference device."

Regarding AI/ML Specific Information (points 2-9):

The provided document describes a 510(k) submission for a physical medical device (Cerafix® Dura Substitute), not an AI/ML driven software device. Therefore, the following points are not applicable to this submission based on the provided text:

Sample size used for the test set and the data provenance: Not applicable, as this is a physical device, not an AI/ML algorithm requiring a test set for performance evaluation in the described manner.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm's predictions is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. The "ground truth" for this physical device's performance is derived from biological/physiological responses in animal models and comparison to known predicate device performance.
The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Relevant "Study" for the physical device:

Study Type: Side-by-side animal implantation studies.
Model: Canine duraplasty model.
Procedure: Dural defects (18 mm x 25 mm) created. Both the subject device (Cerafix® Dura Substitute) and the predicate device were implanted without the use of suture (onlay).
Outcome Measured: "Equivalent safety and performance" between the subject and predicate devices.
Conclusion: This animal study supported the expanded indication for onlay application and reinforced the safety and performance for dura repair. The justification for the increased defect size (from 4.4 in² to 4.9 in²) is stated as "Data included in this submission to justify defect increase," but the specific data from that justification is not detailed in this summary.

Summary

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November 27, 2017

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

Re: K172603

Trade/Device Name: Cerafix Dura Substitute Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: August 29, 2017 Received: August 30, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172603

Device Name Cerafix Dura Substitute

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Transactional Use (Per 31 CFR 990.3, Subject to Change)	For The Institution (Per 31 CFR 990.3, Subject to Change)
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|× | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary of Safety and Effectiveness

Image /page/3/Picture/1 description: The image shows the logo for Acera Surgical. The logo consists of a stylized triangle on the left, with the text "ACERA" in large, sans-serif font to the right of the triangle. Below "ACERA" is the word "SURGICAL" in a smaller, sans-serif font. The triangle is a gradient of light green and blue, and the text is a light green color.

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Acera Surgical Cerafix® Dura Substitute is provided below.

Date Summary Prepared	November 24, 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	Cerafix® Dura Substitute
Common Name	Dura substitute
Code -Classification	GXQ 21 CFR 882.5910 : Class II
Primary Predicate Device	K040888 DuraMatrix™ Collagen Dura Substitute Membrane
Reference Device	K153613, K161278 Cerafix® Dura Substitute

Device Description

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Indications for Use

The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in2 (31.7 cm²) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.

Technological Characteristics

The subject device is the exact same device as the previously approved Cerafix® Dura Substitute (K161278, K153613). The only updates pertain to: 1) the method of fixation / application as cited in the surgical technique guide, and 2) the acceptable defect size within the indications for use. Now, the subject device may be applied as an onlay matrix, as well as sutured in place, and utilized in defects up to 4.9 in2 (31.7 cm²). This instruction is consistent with the method of fixation used by the primary predicate device as well as other commercially available dural substitutes.

The subject device has identical technological characteristics to the reference device, including the principles of operation, indications for use, sizing, material performance and biocompatibility. The subject device is equivalent to the reference device in terms of materials of construction. Additionally, side-by-side animal studies show the subject device performed equivalently to the predicate device when applied without suture (onlay) in a canine duraplasty model.

The subject device has the following technological characteristics in common with the predicate and reference devices:

Characteristic	Cerafix® DuraSubstitute(subject device)	Cerafix® DuraSubstitute(Reference Device)	DuraMatrix™Collagen DuraSubstitute(PrimaryPredicate)	Comparison
510(k)	N/A	K153613, K161278	K040888	N/A
Principles ofOperation	Device can be cut bysurgeon and placed ondural defect and usedas an onlay matrix orsutured in place. Ifsutured, suture lineshould be 2-3 mmfrom edge of implant.Implant should belarge enough tooverlap edge of theremaining dura by atleast one (1)centimeter.	Device can be cut bysurgeon and placed ondural defect withtensionless sutureapplication. Suture lineshould be 2-3 mm fromedge of implant.Implant should be largeenough to overlap edgeof the remaining duraby at least one (1)centimeter.	Device can becut by surgeonand placed ondural defectand used as anonlaymembrane orsutured inplace.	Equivalent
Material ofConstruction	Porous PGLA / PDOpolymer matrix	Porous PGLA / PDOpolymer matrix	Bovine collagenmatrix	Equivalent toreferencedevice

Indications forUse	Indicated as a durasubstitute for therepair of dura mater.This device is indicatedfor defects of 4.9 in²(31.7 cm²) or less inarea. For example, 4.0in x 1.2 in (10.0 cm x3.1 cm) would be anacceptable defect size.	Indicated as a durasubstitute for the repairof dura mater. Thisdevice is indicated fordefects of 4.4 in²(28.3cm²) or less inarea. For example, 4.0in x 1.1 in (10.1 cm x2.8 cm) would be anacceptable defect size.	Indicated as adura substitutefor the repair ofdura mater.	Data includedin thissubmission tojustify defectincrease
Sizing	1"x1"1"x3"2"x2"3"x3"4"x5"5"x7"	1"x1"1"x3"2"x2"3"x3"4"x5"5"x7"	1"x1"1"x3"2"x2"3"x3"4"x5"5"x7"	Equivalent
ApplicationRestrictions	Device does not have arequirement forspecific orientation	Device does not have arequirement forspecific orientation	Device does nothave arequirementfor specific	Equivalent
Sterility	Sterile, SAL 10⁻⁶	Sterile, SAL 10⁻⁶	Sterile	Equivalent
Packaging	Double sterile pack.Nested pouchconfiguration within achipboard envelope.	Double sterile pack.Nested pouchconfiguration within achipboard envelope.	Double sterilepack. Nestedpouchconfigurationwithin achipboardenvelope.	Equivalent
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic	Equivalent
Resorbable	Yes	Yes	Not Applicable	Equivalent toreferencedevice
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Equivalent

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There are no technological differences between the subject and the reference device.

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Non-Clinical Testing – Mechanical

No new mechanical testing was conducted for this submission. All mechanical testing for the Cerafix® Dura Substitute device was submitted in K153613 and K161278.

Non-Clinical Testing - Biocompatibility

No new biocompatibility testing was conducted for this submission. All biocompatibility testing for the Cerafix® Dura Substitute device was submitted in K153613 and K161278.

Non-Clinical Testing – Side-by-Side Animal Study Comparison

Side-by-side animal implantation studies were performed between the subject and predicate device in a canine duraplasty model utilizing dural defects (18 mm x 25 mm) without the use of suture (onlay). Results show equivalent safety and performance between the subject and predicate device.

Conclusions

The subject and predicate device underwent non-clinical evaluation that confirmed device equivalency in the indication for use, device classification, product code, biocompatibility, safety, efficacy, environment of use, and the principles of operation. Therefore, the subject device demonstrates equivalence to the predicate device in dural defects, and can be applied as an onlay matrix or sutured in place.

Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).