The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.

Device Description

The NexGen Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The NexGen Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping configurations), and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

AI/ML Overview

The provided document is a 510(k) summary for the NexGen Anterior Cervical Plate System. It describes the device and its equivalence to predicate devices, but it does not contain information about acceptance criteria for a device performance study or the results of such a study in terms of metrics like sensitivity, specificity, or AUC.

Instead, the document details a non-clinical test summary focused on mechanical properties to demonstrate substantial equivalence to predicate devices. It explicitly states: "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used for performance evaluation, as this information is not present in the provided text.

The closest relevant information is the Non-clinical Test Summary, which describes the testing performed for the device's mechanical integrity.

Here's what can be extracted from the document regarding the non-clinical testing:

Device Meeting Acceptance Criteria (Non-Clinical Mechanical Testing):

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical strength and durability to be "as strong or stronger than the predicate devices" in static and dynamic conditions.	The results of evaluations for • Static and dynamic compression and torsion per ASTM F1717 showed that the NexGen Anterior Cervical Plate System is as strong or stronger than the predicate devices.

Missing Information (Not provided in the document):

Sample size used for the test set and the data provenance: Not applicable as no clinical study or test set for performance was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) 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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

Non-clinical Test Summary: Static and dynamic compression and torsion testing per ASTM F1717.
Conclusion: The device is "as strong or stronger than the predicate devices."
Clinical Test Summary: "No clinical studies were performed."

This device's clearance is based on substantial equivalence to predicate devices primarily through mechanical performance testing and similarity in design, materials, and intended use, rather than a clinical performance study with human subjects or AI algorithm evaluations.

Summary

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October 29, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Precision Spine % Mr. J.D. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401

Re: K192494

Trade/Device Name: NexGen Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 10, 2019 Received: September 11, 2019

Dear Mr. Webb:

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 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

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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 medical devices and radiation-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

(Ronald Jean) Vacant Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192494

Device Name NexGen Anterior Cervical Plate System

Indications for Use (Describe)

The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.

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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510(k) Summary:

Date Prepared	September 10, 2019
Submitted By	Precision Spine2050 Executive DrivePearl, MS 39208
Primary Contact	J.D. Webb4313 W. 3800 SWest Haven, UT 84401512-590-5810e-mail: jdwebb@orthomedix.net
Secondary Contact	Michael C. DawsonPrecision Spine2050 Executive DrivePearl, MS 39208973-455-7150 ext. 128
Trade Name	NexGen Anterior Cervical Plate System
Common Name	Anterior Cervical Plate System
Classification Name	Spinal intervertebral body fixation orthosis
Class	II
Product Code	KWQ
CFR Section	21 CFR section 888.3060
Device Panel	Orthopedic
Primary PredicateDevice	Zion Anterior Cervical Plating System, Astura Medical (K160702)
Secondary PredicateDevices	C-Tek® MaxAn™Anterior Cervical Plate System, Biomet (K080646)CSLP Cervical Plate, Synthes (K000536)UNIPLATE, DePuy (K042544 / K082273 / K100070)
Reference Device	AccuFit™ Lateral Plate System, Precision Spine (K162211)
Device Description	The NexGen Anterior Cervical Plate System components are temporary implants that areintended for anterior interbody screw fixation of the cervical spine during the developmentof a cervical spinal fusion. The NexGen Anterior Cervical Plate System consists of a varietyof shapes and sizes of bone plates, screws (available in self-drilling or self-tappingconfigurations), and associated instruments. Fixation is provided by bone screws insertedinto the vertebral body of the cervical spine using an anterior approach.
Materials	Implants are made from Ti-6Al-4V ELI conforming to ASTM F136.
Intended Use	The NexGen Anterior Cervical Plate System is intended for anterior interbody screwfixation of the cervical spine during the development of a cervical spinal fusion.
SubstantialEquivalence Claimedto Predicate Devices	The NexGen Anterior Cervical Plate System is substantially equivalent to thepredicate devices in terms ofintended use, design, materials used, andmechanical performance.
Indications for Use	The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilizationof the anterior spine from C2 to T1 during the development of cervical spinal fusions in
	patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenicorigin with degeneration of disc confirmed by patient history and radiographic studies);spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity(defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failedprevious fusions.
Summary of thetechnologicalcharacteristicscompared topredicate	When compared to the predicate devices, NexGen Anterior Cervical Plate System has thesame intended use and similar technological characteristics, including:• Design• Function/Performance• Principle of Operation• Materials of Construction• Fundamental Scientific Technology
Non-clinical TestSummary	The following analyses were conducted:• Static and dynamic compression and torsion per ASTM F1717The results of these evaluations show that the NexGen Anterior Cervical Plate System isas strong or stronger than the predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Precision Spine considers the NexGen Anterior Cervical Plate System to be equivalent tothe predicate devices listed above. This conclusion is based upon the devices' similaritiesin principles of operation, technology, materials and indications for use

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.