It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.

The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

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)
spinal stenosis
pseudoarthrosis
tumor
and failed previous fusion.

Device Description

The NEXT GENERATION™ Anterior Cervical Plating System is an anterior cervical plating system intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The subject components of this submission are cervical plates, screws, and various instrumentation.

AI/ML Overview

The provided text describes a 510(k) submission for the Alphatec Spine NEXT GENERATION™ Anterior Cervical Plating System. This is a medical device, specifically a spinal implant, and not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The "study" referenced in this document is a mechanical and dynamic testing of the device to demonstrate substantial equivalence to predicate devices, not a clinical study involving patients or AI performance.

Here's a breakdown of the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (from text)
Mechanical Performance Equivalent to Predicate Devices	"Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices."
Dynamic Performance Equivalent to Predicate Devices	"Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices."
Compliance with Regulatory Requirements (e.g., QSR)	Device granted 510(k) clearance, implying compliance with general controls and manufacturing regulations.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This was mechanical and dynamic testing of the device itself, not a test set of data like in an AI/ML study.
Data Provenance: Not applicable. The "data" comes from the physical testing of the device prototypes/samples.

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

Not applicable. Ground truth as understood in AI/ML studies (e.g., expert consensus on medical images) is not relevant to mechanical device testing. The "ground truth" for mechanical testing would be engineering standards and measurement accuracy.

4. Adjudication method for the test set

Not applicable. There was no "test set" in the AI/ML sense, nor a need for expert adjudication.

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. This is a spinal implant device, not an AI/ML diagnostic or assistive tool.

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

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

7. The type of ground truth used

Ground Truth: For mechanical testing, the "ground truth" refers to established engineering standards, material properties, and biomechanical parameters. The device's performance is compared against these standards or the performance of predicate devices according to these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of the Study:

The "study" described for the Alphatec Spine NEXT GENERATION™ Anterior Cervical Plating System was a mechanical and dynamic testing regimen. This testing compared the physical performance characteristics of the new device to those of two legally marketed predicate devices: the Synthes Spine CSLP (K000536) and the Scient'x Stella (K042317). The purpose of this testing was to demonstrate substantial equivalence in mechanical performance, which is a key requirement for 510(k) clearance for medical devices. The document explicitly states that "The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices."

Summary

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Alphatec Spine NEXT GENERATION™ Cervical Plate System

510(k) Number K07068/

510(k) SUMMARY

NEXT GENERATION™ Anterior Cervical Plating System 510(k) SUMMARY March 2007

MAY - 4 2007

Company:	Alphatec Spine, Inc.2051 Palomar Airport Road#100Carlsbad, CA 92011 USATelephone: (760) 431-9286Fax: (760) 431-9132
Contact Person:	Paula Morgan, Director of Regulatory Affairs
Trade/Proprietary Name:	NEXT GENERATION™ Anterior Cervical Plating System
Common Name:	Anterior Cervical plate System
Classification Name:	Spinal Intervertebral body fixation Orthosis (888.3060)

Product Description:

Indications for Use:

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.

degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies)
트 spondvlolisthesis
. trauma (i.e., fracture or dislocation)
지 spinal stenosis
트 tumor
미 pseudoarthrosis
체 and failed previous fusion.

Confidential and Proprietary

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Substantial Equivalence:

The NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the following predicate devices:

Trade/Proprietary Name	Manufacturer	Clearance
CSLP	Synthes Spine	K000536
Stella	Scient'x	K042317

Performance Data:

Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices.

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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 features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alphatec Spine, Inc. % Ms. Paula Morgan Director of Regulatory Affairs & Compliance 2051 Palomar Airport Road, Suite 100 Carlsbad, California 92011

MAY - 4 2007

Re: K070681

Trade Name: NEXT GENERATION™ Anterior Cervical Plate System Regulation Number(s): 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 20, 2007 Received: April 25, 2007

Dear Ms. Morgan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls (1 mil) appliethe Act and the limitations described below. 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 such 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); 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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Page 2 - Ms. Paula Morgan

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

Harbaye Muehlup

Mark N. Melkerson 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):

Device Name: NEXT GENERATION™ Anterior Cervical Plating System

Indications for Use:

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.

degenerative disc disease(DDD) (defined as back pain of discogenic origin with I degeneration of the disc confirmed by history and radiographic studies)
트 spondylolisthesis
trauma (i.e., fracture or dislocation) . ■
에 spinal stenosis
pseudoarthrosis 예
트 tumor
and failed previous fusion.

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oarlare Buend

Division of General, Restorative, and Neurological Devices

Confidential and Propriatio(k) Number_

Page 42 of 45

1 of 1

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.