The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Device Description

The Anova Containment Device is a flexible, synthetic composite implantable mesh. It includes a polyester mesh component connected by a mono-filament suture to a porous expanded polytetrafluoroethylene or "ePTFE" component. This ePTFE component is placed between the polyester mesh and the overlying soft tissues. The ePTFE component is not anchored to the disc. The Anova Containment Device is attached to the spine with four suture anchors (two fastened to the vertebra above and two fastened to the vertebra below the disc). The sutures from the anchors overlay the mesh and hold it against the vertebral body and to reinforce the mesh against pressure from the graft material.

AI/ML Overview

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details for the Anova Containment Device:

It's important to note that the provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to predicate devices, rather than a detailed scientific study report with specific performance metrics and acceptance criteria. Therefore, many of the requested points, especially those related to specific performance metrics, sample sizes for training/test sets, ground truth establishment, and expert involvement, are not explicitly stated in this type of document.

Acceptance Criteria and Device Performance

Based on the nature of a 510(k) submission, the primary "acceptance criteria" is demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is essentially that it functions similarly and addresses the same intended use.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: Same intended use as predicate devices.	The Anova Containment Device has the "same intended use."
Technological Characteristics Equivalence: Similar technological characteristics to predicate devices.	The Anova Containment Device has "similar technological characteristics."
Safety and Effectiveness Equivalence: Differences in design/performance from predicates do not affect safety and/or effectiveness.	"Differences... do not affect either the safety and/or effectiveness."
Substantial Equivalence: Device is as safe and effective as legally marketed predicate devices.	Evaluations demonstrate the device is "substantially equivalent to the cited predicate devices." and "as safe and effective as legally marketed devices."

Study Details

The provided document describes a regulatory submission (510(k)), not a clinical study in the typical sense with explicit test sets, training sets, and human reader performance measurements.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "evaluations based on data provided in this 510(k)," but does not detail a specific test set size or methodology for evaluating performance.
- Data Provenance: Not specified. Given it's a premarket notification, it likely involved bench testing and potentially some animal or cadaveric studies (though not mentioned explicitly as "data provenance"). There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document does not describe a process for establishing "ground truth" by experts for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not specified. This type of regulatory submission does not typically involve adjudication of a test set by multiple readers.
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:
- MRMC Study: No. This device is a physical implant (surgical mesh), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with AI assistance is not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly defined in terms of a clinical "ground truth." For a device like this, the "ground truth" would likely be established through biomechanical testing, material characterization, and potentially animal model compatibility, demonstrating the device's ability to "maintain the relative position of weak bony tissue" and its physical properties. It's not a diagnostic device with pathology or outcomes as direct ground truth for a discrete "test set."
The sample size for the training set:
- Sample Size: Not applicable/Not specified. This is a physical device, and the concept of a "training set" as understood in machine learning/AI does not apply. If "training set" refers to data used during the device's development and optimization, it is not detailed in this submission.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable/Not specified, as the concept of a "training set" with ground truth in the AI context does not apply here. Development involved engineering principles, material science, and possibly pre-clinical testing, but not "ground truth" as typically defined for AI/diagnostic studies.

Summary of what the document does provide:

Device Description: A flexible, synthetic composite implantable mesh with polyester and ePTFE components, designed to be attached to the spine with suture anchors.
Intended Use: To maintain the relative position of weak bony tissue (allografts/autografts) in spinal fusion procedures, in conjunction with rigid fixation, and not for load-bearing.
Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence to predicate devices (K041105, K014200, K070148).
Conclusion: The device is considered "as safe and effective" as legally marketed devices and "substantially equivalent" to the cited predicates based on the provided evaluation data.

Summary

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K063461...

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Anova Corporation Page 6

2.0 510(K) SUMMARY FOR THE ANOVA CONTAINMENT DEVICE

Submission Date: November 15, 2006

Submitter Information:

Company:	Anova Corporation25 DeForest AvenueSummit, NJ 07901	AUG 13 200.
Contact Person:	Bret Ferree, M.D.President and CEOTel: 513-817-7327Fax: 513-871-3131

Correspondent Information:

Campbell Tuskey, M.S.P.H. 2001 Pennsylvania Avenue, NW Suite 575 Washington, DC 20006 Tel: 202-822-1850 Fax: 202-822-1859

Device Information:

Trade Name:	Anova Containment Device
Common Name:	Surgical meshSpinal intervertebral body fixation orthosis
Classification:	21 CFR §878.3300 EZX21 CFR §888.3060 KWQ
Device Class:	Class II
Trade Name:	MYSTIQUE™ Resorbable Graft Containment PlatingSystem
Manufacturer:	MacroPore Biosurgery, Inc.
K Number:	K041105
Product Code:	K WQ
Trade Name:	OptiMesh™ 1500
Manufacturer:	Spineology, Inc.
K Number:	K014200
Product Code:	EZX
Trade Name:	Graft Containment Device
Manufacturer:	NuVasive, Incorporated
K Number:	K070148
Product Code:	KWQ
Intended Use:	The Anova Containment Device, in conjunction withtraditional rigid fixation, is intended for use in spinal fusionprocedures as a means to maintain the relative position ofweak bony tissue such as allografts or autografts. Thedevice is not intended for load bearing indications.
Device Description:	The Anova Containment Device is a flexible, syntheticcomposite implantable mesh. It includes a polyester meshcomponent connected by a mono-filament suture to aporous expanded polytetrafluoroethylene or "ePTFE"component. This ePTFE component is placed between thepolyester mesh and the overlying soft tissues. The ePTFEcomponent is not anchored to the disc.
	The Anova Containment Device is attached to the spinewith four suture anchors (two fastened to the vertebraabove and two fastened to the vertebra below the disc).The sutures from the anchors overlay the mesh and hold itagainst the vertebral body and to reinforce the mesh againstpressure from the graft material.

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Predicate Devices:

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510(k) Premarket Notification Anova Containment Device

Anova Corporation Page 8 100

Comparison to Predicate Devices: The Anova Containment Device has the same intended use and similar technological characteristics as the predicate devices. Differences in the design and performance from the cited predicates do not affect either the safety and/or effectiveness of the Anova Containment Device for its intended use. The safety and effectiveness evaluations based on data provided in this 510(k) demonstrate that the Anova Containment Device is substantially equivalent to the cited predicate devices. Conclusion: The results of our evaluation of the Anova Containment Device support the conclusion that it is as safe and effective as legally marketed devices for its intended use and that because it has the same intended use and similar technology, it is substantially equivalent to the cited predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wings, representing the department's mission to protect the health of all Americans and provide essential human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Anova Corporation % Becker & Associates Consulting, Inc. Ms. Campbell T. Hutton, MSPH 2001 Pennsylvania Avenue, SW Washington, District of Columbia 20006

Re: K063461

Trade/Device Name: Anova Containment Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: EZX, KWO Dated: July 8, 2009 Received: July 8, 2009

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

AUG 18 2009

Dear Ms. Hutton:

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.

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 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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Page 2 - Ms. Campbell T. Hutton, MSPH

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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Barbara Buchr

Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.0 STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K

Device Name:

Anova Containment Device

Indications for Use:

The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.

Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K063461

Page 1 of 1

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.