The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Description

The NuVasive Archon Anterior Cervical Plate System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, with a nickel-cobalt-chrome-molybdenum (MP35N) lock screw option conforming to ASTM F562.

AI/ML Overview

The information provided describes a medical device, the NuVasive Archon Anterior Cervical Plate System, which is an anterior cervical plating system. The 510(k) summary and associated FDA correspondence confirm its substantial equivalence to existing predicate devices.

Here's an analysis of the provided text with respect to your questions regarding acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence to predicate devices in design	The subject device was shown to be substantially equivalent in design to its predicate devices.
Substantial equivalence to predicate devices in intended use	The subject device was shown to be substantially equivalent in intended use to its predicate devices. The intended use is for anterior screw fixation of the cervical spine, providing stabilization as an adjunct to cervical fusion for indications such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
Substantial equivalence to predicate devices in material composition	The subject device was shown to be substantially equivalent in material composition to its predicate devices. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, with a nickel-cobalt-chrome-molybdenum (MP35N) lock screw option conforming to ASTM F562.
Substantial equivalence to predicate devices in function	The subject device was shown to be substantially equivalent in function to its predicate devices.
Substantial equivalence to predicate devices in range of sizes	The subject device was shown to be substantially equivalent in range of sizes to its predicate devices.
Meets or exceeds performance of predicate device (mechanical)	The results of static and dynamic compression testing per ASTM F1717 and static torsion testing per ASTM F1717 showed that the subject Archon Anterior Cervical Plate System "meets or exceeds the performance of the predicate device."
Safety and effectiveness for intended use	Based on the overall comparison and performance testing, the device was found to be "safe and effective for its intended use."

Sample size used for the test set and the data provenance

The document describes nonclinical testing (mechanical testing) rather than clinical studies using patient data. Therefore, questions regarding "test set," "data provenance," and "country of origin" are not directly applicable in the context of clinical data. For the mechanical tests, the "samples" would refer to the physical specimens of the Archon Anterior Cervical Plate System that underwent testing. The exact number of samples tested for each mechanical test (static/dynamic compression, static torsion) is not specified in the provided text.

Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for nonclinical mechanical testing is typically established by the physical testing and measurements according to standardized protocols (e.g., ASTM F1717), not by expert consensus or interpretations of patient data.

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

This question is not applicable as the studies were nonclinical mechanical tests, not studies involving human interpretation or adjudication of patient data for establishing ground truth.

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 such study was conducted or described. This device is a mechanical implant, not an AI-assisted diagnostic tool.

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

This question is not applicable. This device is a mechanical implant, not an algorithm or AI system.

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

The "ground truth" for the nonclinical mechanical testing was based on the objective measurements derived from standardized mechanical test methods (ASTM F1717). The performance of the test samples was compared directly against the performance of predicate devices under these conditions.

The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.

How the ground truth for the training set was established

This question is not applicable. There is no training set involved for this type of mechanical device submission.

Summary of the Study:

The study was a series of nonclinical mechanical tests designed to demonstrate the physical performance and substantial equivalence of the NuVasive Archon Anterior Cervical Plate System to predicate devices.

Tests Performed:

Static and dynamic compression testing per ASTM F1717
Static torsion testing per ASTM F1717

Purpose of the Study:

To demonstrate that the subject device "meets or exceeds the performance of the predicate device" under these mechanical loads, thereby supporting the claim of substantial equivalence in its technological characteristics, function, and safety for its intended use.

Conclusion:

Based on these tests, the device was found to be "substantially equivalent" to legally marketed predicate devices and "safe and effective for its intended use."

Summary

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OCT 1 1 2012

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Cynthia Adams Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 909-1800

Date Prepared: October 9, 2012

B. Device Name

Trade or Proprietary Name:	NuVasive® Archon Anterior Cervical Plate System
Common or Usual Name:	Cervical Plate and Screw System
Classification Name:	Spinal Intervertebral Body Fixation Orthosis

Device Class:	Class II
Classification:	21 CFR §888.3060
Product Code:	KWQ

Predicate Devices C.

The subject NuVasive Archon Anterior Cervical Plate System is substantially equivalent to the following devices:

. K053581 - NuVasive, Inc. SmartPlate Gradient Plus System
K071329 - NuVasive, Inc. Helix Anterior Cervical Plating System
K000486 Aesculap ABC Cervical Plating System .

D. Device Description

E. Intended Use

Page 1 of 2

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KI22910

Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in a simple sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller, italicized font. The logo is black and white.

WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

F. Technological Characteristics

As was established in this submission, the subject Archon Anterior Cervical Plate System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Archon Anterior Cervical Plate System is substantially equivalent to other predicate devices. The following testing was performed:

Static and dynamic compression testing per ASTM F1717
Static torsion testing per ASTM F1717 ●

The results of these studies show that the subject Archon Anterior Cervical Plate System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Archon Anterior Cervical Plate System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OCT 11 2012

Nu Vasive, Incorporated % Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

Re: K122910

Trade/Device Name: NuVasive® Archon 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 20, 2012 Received: September 21, 2012

Dear Ms. Adams:

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

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Page 2 - Ms. Cynthia Adams

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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 Division 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,

Evin I. Keith

o 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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K122910

Indications for Use

510(k) Number (if known):

Device Name: NuVasive® Archon Anterior Cervical Plate System

Indications For Use:

WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use (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)

Col-bal

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122910

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.