When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.

Device Description

The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).

The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled · implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

AI/ML Overview

The provided text describes a medical device, the Zavation IBF System, and its acceptance criteria as demonstrated through performance data. However, it does not describe a study involving an AI/algorithmic device or its performance against ground truth established by experts.

The "Performance Data" section specifically states: "Mechanical test results demonstrated that the Zavation IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed."

This indicates that the study performed was a mechanical test of the physical implant device, not a study evaluating an AI algorithm's diagnostic or predictive performance. Therefore, most of the requested information regarding AI device performance (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) cannot be extracted from this document because it is not relevant to the described studies.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance (Mechanical Testing)

Acceptance Criteria (What was tested)	Reported Device Performance (How it met the criteria)
Static Axial Compression	Met criteria demonstrating substantial equivalence to predicate devices.
Dynamic Axial Compression	Met criteria demonstrating substantial equivalence to predicate devices.
Subsidence	Met criteria demonstrating substantial equivalence to predicate devices.
Expulsion	Met criteria demonstrating substantial equivalence to predicate devices.
Compliance with ASTM F2077	Testing performed in accordance with this standard.
Compliance with ASTM F2267	Testing performed in accordance with this standard.

Explanation of Missing Information for AI/Algorithmic Devices:

Sample size used for the test set and the data provenance: Not applicable. The study was mechanical testing of a physical implant.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods.
Adjudication method 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 document is not about an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical properties and performance standards (like ASTM F2077 and F2267) which the device must meet or exceed, or demonstrate equivalence to predicate devices.
The sample size for the training set: Not applicable. (No AI training set.)
How the ground truth for the training set was established: Not applicable. (No AI training set.)

Summary

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KII2664

DEC 2 3 2011

510K Summary

Date:	September 12, 2011
Submitter:	Zavation LLC501 Avalon WayBrandon, MS 39047Phone: 601-919-1119Fax: 800-447-1302
Contact person:	John Walker
Type of 510(k) submission:	Traditional
Trade name:	Zavation IBF System
Common name:	Intervertebral Body Fusion Device
Classification regulation:	888.3080 (MAX, ODP)
Device classification:	Class II
Classification Panel:	Orthopedic
Product code:	MAX, ODP
Basis for submission:	New device

Device Description:

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Intended Use:

Materials:

The devices are manufactured from medical grade PEEK Zeniva ZA-500(ASTM F2026) with Tantalum alloy position markers (ASTM F560).

Predicate Device:

Lumbar I/F Cage, Depuy Spine (P960025) Aleutian IBF System, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K073351) Synthes Spine, Oracle, OPAL Spacer (K072791) Synthes Spine, T-PAL Spacer (K100089) Globus Medical, Patriot Spacers (K072970)

Technological Characteristics:

The Zavation IBF System possesses the same technological characteristics as the predicates. These include similar heights, widths, lengths, and intended use.

Performance Data:

Mechanical test results demonstrated that the Zavation IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

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

DEC 2 3 2011

Zavation LLC % Mr. John Walker 501 Avalon Way Brandon, Mississippi 39047

Re: K112664

Trade/Device Name: Zavation IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: December 13, 2011 Received: December 13, 2011

Dear Mr. Walker:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Mr. John Walker

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 11 you desire specific advice tor your avrites offices/CDRH/CDRHOffices/ucm115809.htm for go to mtd.io.it www.ida.gover.item.ith's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionanding by reference to premarket notification" (21CFR Part note the regulations 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 I ou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Peter

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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Indications for Use

510(k) Number: K112664

Device Name: Zavation IBF System

Indications For Use:

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

Prescription Use _ X _________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Page 1 of __ 1

ivision of Surgical, Orthopedic, and Restorative Devices

K112664 510(k) Number ___

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.