The CoreLink Lateral Plate System (LPS) is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Device Description

The CoreLink Lateral Plate System (LPS) is comprised of a lumbar plate and screws. The lumbar plate has a sliding, spring loaded lock tab for each screw position to prevent back-out of the screw. The plate is available in a 2-screw or 4-screw version and in multiple lengths for single level fixation. The screws are available in various lengths and 2 diameters.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically a Spinal Intervertebral Body Fixation Orthosis. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against a set of acceptance criteria for diagnostic or AI-driven systems.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these relate to AI/diagnostic device validation, are not applicable or extractable from this document.

The document discusses mechanical performance testing to demonstrate that the device is sufficient for its intended use and substantially equivalent to legally marketed predicate devices. However, this is not the type of performance data typically associated with the "device performance" and "acceptance criteria" structure you are asking about for AI/diagnostic devices.

Here's an attempt to fill in relevant sections based on the provided text, while explicitly noting where the requested information is not applicable due to the nature of the device (a spinal fixation system, not a diagnostic AI):

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

Acceptance Criteria Category	Specific Test Mode	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Static axial compression bending per ASTM F1717	Not explicitly stated as numerical acceptance criteria, but implicitly to demonstrate "sufficient strength for its intended use" and "substantially equivalent to legally marketed predicate devices."	"The strength of the Lateral Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
Mechanical Performance	Static torsion per ASTM F1717	(Same as above)	(Same as above)
Mechanical Performance	Dynamic axial compression bending fatigue per ASTM F1717	(Same as above)	(Same as above)
Mechanical Performance	Static pull apart testing	(Same as above)	(Same as above)
Biocompatibility	Material Compliance	Materials made from Ti-6Al-4V ELI in accordance with ASTM F136 and Nitinol per ASTM F2063.	"Lateral Plate System plates are made from Ti-6Al-4V ELI in accordance with ASTM F136, and the lock springs are manufactured from Nitinol per ASTM F2063."

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

This information is not applicable as the document describes mechanical testing of a physical implant rather than a study involving human or animal subjects that generate data in the context of AI/diagnostic device validation. The "tests" refer to laboratory mechanical assessments of the device components.

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)

This information is not applicable. Ground truth, in the context of diagnostic or AI systems, is not relevant for the mechanical testing of a spinal fixation device.

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

This information is not applicable. Adjudication methods are typically used for expert review and consensus in diagnostic or AI studies and are not relevant for mechanical device 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

There was no MRMC comparative effectiveness study done. This device is a passive spinal implant, not an AI-assisted diagnostic or treatment system involving human readers.

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

There was no standalone algorithm performance study done. This device is a passive spinal implant, not an algorithm.

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

This information is not applicable. "Ground truth" in the diagnostic/AI sense is not established for the mechanical properties of a spinal implant. The "truth" for this device lies in its adherence to established ASTM standards for mechanical strength and material composition.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this device is a physical implant, not an AI model requiring machine learning.

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

This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Summary

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June 12, 2019

CoreLink, LLC % Meredith L. May, MS, RAC Vice President Empirical Consulting LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K190016

Trade/Device Name: Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: May 7, 2019 Received: May 8, 2019

Dear Ms. May:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K190016 Device Name Lateral Plate System

Indications for Use (Describe)

The CoreLink Lateral Plate System (LPS) is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L 1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

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)

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5.510(K) SUMMARY

Submitter's Name:	CoreLink
Submitter's Address:	2072 Fenton Logistics Park Blvd.St. Louis, Missouri 63026
Submitter's Telephone:	888-349-7808
Contact Person:	Meredith Lee May MS, RACEmpirical Consulting719.337.7579Mmay@EmpiricalConsulting.com
Date Summary was Prepared:	8 Jan 19
Trade or Proprietary Name:	Lateral Plate System
Common or Usual Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification:	Class II per 21 CFR §888.3060 Spinal Intervertebral BodyFixation Orthosis
Product Code:	KWQ
Classification Panel:	Orthopedic Review Panel

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The CoreLink Lateral Plate System (LPS) is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

TECHNOLOGICAL CHARACTERISTICS

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Lateral Plate System plates are made from Ti-6A1-4V ELI in accordance with ASTM F136, and the lock springs are manufactured from Nitinol per ASTM F2063. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

Indications for Use
. Intended Use
Implant sizes ●
Manufacturing ●

510kNumber	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K120092	Plymouth Plate System	Globus	Primary
K131533	CAYMAN	K2M	Additional
K150449	LITe	Stryker	Additional
K091044	Accufit ALP System	Spinal USA (Precision Spine)	Additional
K082187	Valiant Anterior LumbarPlate System	Biomet Spine	Additional
K111866	Halo II Anterior LumbarPlate System	NuVasive	Additional
K163104	Terrace™ AnteriorCervical Plate System	CoreLink, LLC	Additional

Table 5-1 Predicate Devices

Performance Data

The Lateral Plate System has been tested in the following test modes:

. Static axial compression bending per ASTM F1717
. Static torsion per ASTM F1717
Dynamic axial compression bending fatigue per ASTM F1717
. Static pull apart testing

The results of this non-clinical testing show that the strength of the Lateral Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Lateral Plate System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.