When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and DDD (neck pain of discogeme oright my spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization to promote fusion following Hooks and rous are uiso intentiou to trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions The use of multiaxial screws are not intended to be placed in the cervical spine.

Device Description

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, connectors, and instruments for inserting and securing the implants.

The subject device, the Variable Crosslink, represents a design modifications made to the predicate device, the Nex-Link Spinal Fixation System (K031985) or others. The subject device shares the same intended use and fundamental scientific technology as the predicate.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Nex-Link Spinal Fixation System Variable Crosslink. The information provided heavily emphasizes comparison to a predicate device and bench testing. It explicitly states that clinical data and conclusions were not needed for this device. Therefore, the document does not contain the detailed information typically found in a clinical study report that would address many of your specific questions.

Here's the breakdown of what can be extracted and what cannot:

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

Since this is a 510(k) clearance based on substantial equivalence and non-clinical data, there are no "acceptance criteria" in the sense of clinical performance metrics (e.g., sensitivity, specificity) with target values. The "performance" reported is primarily that the device is substantially equivalent to a predicate device based on bench testing.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (Nex-Link Spinal Fixation System, K031985)	"Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device."
Meets the same intended use and fundamental scientific technology as the predicate device	"The subject device shares the same intended use and fundamental scientific technology as the predicate."

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 for Test Set: Not applicable. The "test set" here refers to the non-clinical (bench) tests conducted. The document does not specify the number of samples or tests conducted in the laboratory and bench testing.
Data Provenance: Not applicable. The data is from laboratory and bench testing, not clinical data about patients from a specific country or in a retrospective/prospective study design.

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. There was no clinical ground truth established by experts as clinical data was not required or provided. The "ground truth" for bench testing would be engineering specifications and standards.

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

Not applicable. This concept applies to clinical studies where expert consensus or adjudication is used to resolve discrepancies in diagnoses or outcomes. It is not relevant for bench testing.

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 MRMC study was done. This device is a physical spinal implant, not an AI-powered diagnostic tool. The concept of human readers and AI assistance does not apply.

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

Not applicable. This device is a physical spinal implant, not an algorithm.

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

Ground Truth: For the non-clinical tests, the "ground truth" would be established engineering standards, design specifications, and performance characteristics of the predicate device against which the modified device was compared. Clinical ground truth was not used or required.

8. The sample size for the training set

Not applicable. There was no training set, as no machine learning algorithm was developed or evaluated.

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

Not applicable. There was no training set.

Summary

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ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER:	Abbott Spine (formerly Spinal Concepts, Inc.)
ESTABLISHMENT REGISTRATIONNUMBER:	1649384
CONTACT PERSON:	Noah BartschSpecialist, Regulatory Affairs
	Telephone: 512.533.1840
	Fax: 512.918.2784
DATE:	August 17, 2005
TRADE NAME:	Nex-Link Spinal Fixation System VariableCrosslink
COMMON NAME:	Posterior Spinal Implant
CLASSIFICATION NAME:	KWQ: Spinal Intervertebral Body Fixation OrthosisMNI: Pedicle Screw Spinal System
CLASSIFICATION REFERENCE:	21 CFR § 888.3050, 888.3070
PREDICATE DEVICE:	Spinal Concepts, Inc. (now Abbott Spine, Inc.)Nex-Link Spinal Fixation System, K031985,cleared September 11, 2003.

DEVICE DESCRIPTION:

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the The Nox Emic Spine (C1-T3). The system consists of a series of longitudinal members, ecerviconomics (Sectors, and instruments for inserting and securing the implants.

The subject device, the Variable Crosslink, represents a design modifications made to the The subject device, the Nations or others. The subject device shares the same intended use and fundamental scientific technology as the predicate.

INDICATIONS:

INDICATIONS:
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

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DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and DDD (neck pain of discogeme origin with degeneratives et eture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction TIORS and Tods are arso intended we the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The use of maniantal betern is timended to be placed in the cervical spine.

COMPARISON TO PREDICATE DEVICE:	The subject device is the result of designmodifications to the predicate device, has the sameintended use, and is substantially equivalent to thepredicate device.
PERFORMANCE DATA (NONCLINICALAND/OR CLINICAL):	NON-CLINICAL PERFORMANCE AND CONCLUSIONS:
	Laboratory and bench testing results demonstratethat the proposed device is substantially equivalentto the predicate device.
	CLINICAL PERFORMANCE AND CONCLUSIONS:
	Clinical data and conclusions were not needed forthis device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

SEP 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K052247

Trade Name: Nex-Link™ Spinal Fixation System Variable Crosslink Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, KWP Dated: August 17, 2005 Received: August 18, 2005

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the Medical Device Amendments, or to conninered prior to ria) 2011-07-12 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmetic For (110) and the device, subject to the general controls provisions of the Act. The r ou may, dierelore, manner of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is elassified (vor a controls. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 loase oc advised that 1 Dr b resumerat your device complies with other requirements of the Act that IDA has made a acternmentations administered by other Federal agencies. You must of ally if cach statutes and regarations sincluding, but not limited to: registration and listing (21 Comply with an the Act 81 equinements, and manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Bartsch

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieting your manieting of your device to a legally premarket notification: "The PDF intentig gour device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your as (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Complanes as (est notification" (21CFR Part 807.97). You may obtain Misoraliums by releveloc to premanse robilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Car Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K052247

Device Name: Nex-Link™ Spinal Fixation System

Indications for Use:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

Hooks and rods are also intended to provide stabilization to promote fusion following Hooks and rous are uiso intentiou to trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions The use of multiaxial screws are not intended to be placed in the cervical spine.

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)

Signature

(Division Sign-Off) Division of General, Resund and Neurological Devices

Page 1 of 1

510(k) Number K052247

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.