The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 in2 (28.3 cm2) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.

Device Description

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. 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 document is a 510(k) summary for the Cerafix Dura Substitute. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the acceptance criteria and study information provided:

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

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance values for each criterion in the way one might expect for a diagnostic or AI device. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device.

The primary "acceptance criteria" implicitly revolve around demonstrating equivalent performance to the predicate device in terms of:

Safety and Efficacy: No significant differences in adverse events or repair outcomes.
Biocompatibility: No new biocompatibility concerns.
Mechanical Properties: Equivalent per unit area to the predicate.
Neoduralization and Resorption: Similar mechanisms and timelines to the predicate.
Absence of Complications: No CSF leaks, hydrocephalus, hemorrhage, or infection.

The reported device performance is that the subject device (new Cerafix Dura Substitute) was found to be equivalent to the predicate device (previously cleared Cerafix Dura Substitute - K153613) in all these aspects.

Key Comparison Points and Performance (Implicit Acceptance Criteria and Reported Performance):

Acceptance Criteria (Implicit)	Reported Device Performance (Subject Device)
Principles of Operation: Cut by surgeon, placed with tensionless suture, 2-3mm suture line, 1cm overlap.	Equivalent to predicate device.
Material of Construction: Porous polymer matrix, Porous PGLA / PDO matrix.	Equivalent to predicate device.
Surgical Application Restrictions: No specific orientation requirement.	Equivalent to predicate device.
Sterility: Sterile, SAL 10-6.	Equivalent to predicate device.
Packaging: Double sterile pack, nested pouch in chipboard envelope.	Equivalent to predicate device.
Pyrogenicity: Non-pyrogenic.	Equivalent to predicate device.
Resorbable: Yes.	Equivalent to predicate device.
Biocompatibility: Biocompatible.	Equivalent to predicate device (no new biocompatibility testing was conducted; relied on previous submission for predicate).
Mechanical Properties: Equivalent per unit area.	Equivalent to predicate device (no new mechanical testing was conducted; relied on previous submission for predicate).
Clinical Performance (Animal Study): Absence of CSF leaks, hydrocephalus, hemorrhage, infection.	No CSF leaks observed in either group throughout the duration of both studies. All animals appeared healthy with normal neurological evaluations.
Clinical Performance (Animal Study): Neoduralization and absorption mechanism.	Similar in the mechanism of neoduralization and absorption, independent of the size of the induced dural defect. Demonstrated signs of resorption with infiltration of fibrovascular connective tissue and successful neoduralization.
Clinical Performance (Animal Study): Overall safety and efficacy.	Equivalent clinical performance at each time point, successfully repaired induced dural defects independent of defect size. Demonstrates equivalent safety and efficacy when compared to the predicate device.
Indications for Use: Repair of dura mater for defects up to 4.4 in² (28.3 cm²).	The subject device supports repair of dura mater for defects up to 4.4 in² (28.3 cm²), which is a larger indicated defect size than the predicate device (1.9 in² (12.5cm²)). The side-by-side animal study concluded equivalency independent of defect size, supporting this larger indication.

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

Test Set Sample Size: The "test set" was the animal study.
- Canine Bilateral Duraplasty Model: "Each time point evaluated 3 test and 3 control animals, each with 2 defects."
- This means a total of 6 animals per time point (3 for subject device, 3 for predicate device).
- Since it states "at both time points" (implying at least two), it would be a minimum of 12 animals in total (6 animals x 2 time points), generating 24 defects.
Data Provenance: The study was a "canine bilateral duraplasty model." This indicates it was a prospective animal study. The country of origin of the data is not specified.

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

Ground Truth Establishment: For the animal study, tissue samples were processed by histopathology techniques and analyzed for dural integrity/neoduralization and local tissue reactions according to ISO 10993-6.
Number and Qualifications of Experts: The document does not specify the exact number or qualifications of the individuals who performed the histopathology analysis or interpreted the results. It only mentions "tissue samples from each defect site were processed by histopathology techniques and analyzed."

4. Adjudication method for the test set

The document does not describe an adjudication method for the animal study results. The histopathology analysis would likely have been performed by a qualified pathologist, but no multi-reader review or consensus method is described.

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, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (dura substitute), not an AI algorithm. Therefore, there is no discussion of human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This is a hardware medical device, not an algorithm.

7. The type of ground truth used

For the animal study, the ground truth was established through histopathology analysis (morphological and cellular evaluation of tissue samples) and clinical observations (e.g., absence of CSF leaks, neurological evaluations). These are essentially expert observations/assessments based on established scientific methods.

8. The sample size for the training set

This device is not an AI algorithm; therefore, there is no training set in the context of machine learning. The "predicate device" study (K153613) serves as a baseline/reference, from which the current subject device draws its "equivalent" conclusions regarding mechanical and biocompatibility data.

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

Not applicable, as there is no training set for an AI algorithm. The performance of the predicate device (K153613) was established through its own set of non-clinical and potentially animal/clinical studies, which presumably used similar ground truth methods (e.g., pathology, clinical assessment).

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of the human profile in triplicate.

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

August 8, 2016

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

Re: K161278

Trade/Device Name: Cerafix Dura Substitute Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: May 5, 2016 Received: May 10, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 yours,

Michael J. Hoffmann -A

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161278

Device Name Cerafix Dura Substitute

Indications for Use (Describe)

The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 in2 (28.3 cm2) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 green triangle on the left, with a blue curved shape at the bottom. To the right of the triangle is the word "ACERA" in green, with the word "SURGICAL" below it in a smaller font.

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	August 1, 2016
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	K153613 Cerafix® Dura Substitute

Device Description

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 4.4 in (28.3cm²) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.

{4}------------------------------------------------

Technological Characteristics

The component material used in the subject device is the exact same as the component material used in the predicate device. The only difference is finished device size.

Based on test results included in this submission, a maximum allowable defect size has been prescribed for the subject device. The subject device has the same technological characteristics as the predicate device in terms of principles of operation, materials of construction, material performance, and biocompatibility. Additionally, side-by-side animal studies show the subject device is equivalent for the indicated use of a dura substitute for the repair of dura mater. The subject device has the same technological characteristics as the predicate device as follows:

Characteristic	Cerafix® Dura Substitute(subject device)	Cerafix® Dura Substitute(predicate device)	Comparison
510(k)	K161278	K153613	N/A
Principles ofOperation	Device can be cut bysurgeon and placed ondural defect withtensionless sutureapplication. Suture lineshould be 2-3 mm fromedge of implant. Implantshould be large enough tooverlap edge of theremaining dura by at leastone (1) centimeter.	Device can be cut bysurgeon and placed ondural defect withtensionless sutureapplication. Suture lineshould be 2-3 mm fromedge of implant. Implantshould be large enoughto overlap edge of theremaining dura by atleast one (1) centimeter.	Equivalent topredicate device
Material ofConstruction	Porous polymer matrix	Porous polymer matrix	Equivalent topredicate device
Indications forUse	Indicated as a durasubstitute for the repairof dura mater. This deviceis indicated for defects of4.4 in2 (28.3cm²) or lessin area. For example, 4.0in x 1.1 in (10.1 cm x 2.8cm) would be anacceptable defect size.	Indicated as a durasubstitute for the repairof dura mater. Thisdevice is indicated fordefects of 1.9 in2(12.5cm²) or less in area.For example, 1.2 in x 1.6in (3 cm x 4 cm) wouldbe an acceptable defectsize.	Equivalent topredicate device
Size	1"x1"1"x3"2"x2"3"x3"4"x5"5"x7"	1"x1"1"x3"2"x2"3"x3"	Subject device is cutinto larger finisheddevice sizes comparedto predicate device
MaterialComposition	Porous PGLA / PDO matrix	Porous PGLA / PDOmatrix	Equivalent topredicate device

{5}------------------------------------------------

SurgicalApplicationRestrictions	Device does not haverequirement for specificorientation	Device does not haverequirement for specificorientation	Equivalent topredicate device
Sterility	Sterile, SAL 10-6	Sterile, SAL 10-6	Equivalent
Packaging	Double sterile pack.Nested pouchconfiguration within achipboard envelope.	Double sterile pack.Nested pouchconfiguration within achipboard envelope.	Equivalent topredicate device
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Equivalent
Resorbable	Yes	Yes	Equivalent topredicate device
Biocompatibility	Biocompatible	Biocompatible	Equivalent

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

. Subject device and predicate device are manufactured from the exact same component material; however, the subject device will be cut into larger finished device sizes.
Despite the size differences, the subject device is equivalent in function, indication for use, device classification product code, environment of use, and principles of operation to the predicate device. The sizes of the subject device are equivalent to the reference device.

{6}------------------------------------------------

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. The subject device is cut from the same component material as the predicate device, and therefore has equivalent mechanical properties per unit area.

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. The subject device is cut from the same component material as the predicate device, and therefore has equivalent biocompatibility.

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

The subject device (test) was compared to the predicate device (control) using a canine bilateral duraplasty model with terminal assessments at 4-weeks post-operatively. Each time point evaluated 3 test and 3 control animals, each with 2 defects. Animals were observed daily and weighed weekly for signs of general clinical health. Particular attention was paid to the implant sites to assess the presence of hydrocephalus, cerebral spinal fluid (CSF) leakage, hemorrhage, infection, and any other adverse side effects. At each end-point, CSF was obtained from each animal and submitted for analysis. Tissue samples from each defect site were processed by histopathology techniques and analyzed for dural integrity / neoduralization and local tissue reactions according to ISO 10993-6.

All animals in both test and control groups appeared healthy with normal neurological evaluations at both time points. No CSF leaks were observed in either group throughout the duration of both studies. Test and control articles were shown to be similar in the mechanism of neoduralization and absorption, independent of the size of the induced dural defect at both time points. Test and control articles demonstrated signs of resorption with infiltration of fibrovascular connective tissue and successful neoduralization.

In total, both the test and control articles showed equivalent clinical performance at each time point and successfully repaired the induced dural defects independent of defect size. Therefore, the results of these studies indicate that the subject device demonstrates equivalent safety and efficacy when compared to the 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.

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).