The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spinal stenosis. fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the indications specified above.

Device Description

NexLink OCT is the re-design and modernization of the existing OctaFix svstem. The scope of the NextLink OCT Cervical Plating System will include 1) a modular occipital plate, 2) a selection of precontoured rods, 3) hooks and 4) a refined set of instrumentation. The scope of the project is for Next ink OCT to integrate as an option to the current Nex-Link System. The NexLink OCT Occipital Cervical Plating System components are temporary implants that are used to stabilize the spine (occiput-T3) during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.

AI/ML Overview

The provided text describes the NexLink OCT Cervical Plating System. However, it does not contain information about the acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth details. The document explicitly states that "Clinical data and conclusions were not needed for this device." and relies on "Laboratory and bench testing results" to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted and the reasons why other information is unavailable:

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

Acceptance Criteria	Reported Device Performance
Not specified	Demonstrates substantial equivalence to predicate device based on laboratory and bench testing.

Reasoning: The document states, "Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device." However, it does not specify what specific acceptance criteria these tests were designed to meet (e.g., specific thresholds for strength, fatigue life, etc.), nor does it provide quantitative results of these tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. No clinical test set was used.
Data Provenance: Not applicable. The "testing" was non-clinical (laboratory and bench testing).

Reasoning: The document explicitly states, "Clinical data and conclusions were not needed for this device." The evaluation was based on non-clinical laboratory and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" for a clinical test set was established as no clinical data was required or used.

Reasoning: As no clinical data was used, there was no need for experts to establish ground truth for a clinical test set.

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

Not applicable. No clinical test set requiring adjudication was used.

Reasoning: No clinical data, no clinical test set, therefore no adjudication method applies.

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.

Reasoning: This is a medical device (cervical plating system), not an AI/software device involving human readers or interpretation of medical images. The concept of "human readers improve with AI" is not relevant to this type of device.

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

Not applicable. This is a medical device (cervical plating system), not an algorithm or AI.

Reasoning: See above.

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

Not applicable. The "ground truth" for this device's evaluation was based on engineering and material standards for mechanical testing to demonstrate substantial equivalence to a predicate device, rather than clinical outcomes or diagnostic accuracy.

Reasoning: The device's performance was evaluated through "Laboratory and bench testing results." This implies a comparison to established engineering specifications and benchmarks relevant to spinal implants, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set

Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.

Reasoning: The concept of a "training set" belongs to machine learning and AI, which are not relevant to this physical device.

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

Not applicable. No training set was used.

Reasoning: See above.

Summary

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K090060 Page 1 of 2

ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER:	Abbott Spine, Inc.
ESTABLISHMENT REGISTRATIONNUMBER:	1649384
CONTACT PERSON:	David PadgettSenior Specialist, Regulatory AffairsTelephone: (512) 533-1998Fax: (512) 258-0995
DATE:	02 June 2009
TRADE NAME:	NEXLINK OCT® Cervical Plating System
PRODUCT CODE:	KWP
CLASSIFICATION NAME:	OCCIPITAL CERVICAL PLATING SYSTEM
CLASSIFICATION REFERENCE:	21 CFR § 888.3050
PREDICATE DEVICE:	OctaFix® Occipital Cervical Fixation System, K021009Abbott Spine, cleared 18 June 2002.

Device Description:

Indications:

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K090060 Page 2 of 2

Comparison to Predicate Device:

PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL):

The subject device is the result of modifications to the existing Occipital Cervical Plating System.

The subject device has the same intended use and is substantially equivalent to the aforementioned predicate device.

Non-Clinical Performance and Conclusions:

Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized eagle emblem with three wing-like shapes. The eagle's head is facing left.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Spine, Inc. c/o Mr. David Padgett Senior Specialist, Regulatory Affairs 5301 Riata Park Ct., Bldg F Austin, Texas 78727

JUN - 2 2009

Re: K090060

Trade/Device Name: NexLink OCT Cervical Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: May 26, 2009 Received: May 27, 2009

Dear Mr. Padgett:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,
Mark M. Milliman

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 (if known): K090060

Device Name: NEX-LINK OCT® Cervical Plating System

Indications for Use:

The Nex-Link OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (Tt-T3) for additional stabilization of the cervical spine for the indications specified above.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of I

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090066

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.