The NEO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusions in patients with degenerative disc disease (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 cord stenosis; deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); tumors: pseudarthrosis; and / or failed previous fusions.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The NEO™ Anterior Cervical Plate consists of various sizes of anterior cervical bone plates, screws and screw locking tabs. Components are available in a variety of sizes to fit popient. anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V EIJ per ASTM F-136. The NEO™ Anterior Cervical Plate components will be supplied clean and "NON-STERILE".

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NEO™ Anterior Cervical Plate:

This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the NEO™ Anterior Cervical Plate. In the context of 510(k) submissions, the “acceptance criteria” and "study that proves the device meets the acceptance criteria" are generally framed in terms of demonstrating substantial equivalence to a predicate device, rather than detailed performance metrics against specific, quantitative acceptance criteria common in software or diagnostic device evaluations.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biomechanical Performance (Strength, Durability, Stability)	Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Material Compatibility/Safety	Manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI).
Indications for Use Equivalence	Shown to be substantially equivalent to previously cleared devices in indications for use.
Design Equivalence	Shown to be substantially equivalent to previously cleared devices in design.
Function Equivalence	Shown to be substantially equivalent to previously cleared devices in function.

Note: For a 510(k) submission of this type of orthopedic implant, "acceptance criteria" are generally demonstrated through equivalence to a predicate device in terms of safety and effectiveness, which is supported by material testing and biomechanical testing aligning with recognized standards. Specific quantitative performance targets are less frequently disclosed in the summary documents, especially for devices establishing substantial equivalence to prior-generation predicate devices.

Study Information:

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Biomechanical testing in accordance with ASTM F1717." ASTM F1717 is a standard for "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This standard typically outlines how tests should be performed and what parameters to measure (e.g., stiffness, displacement, fatigue life), but it does not specify a "sample size" in the clinical sense (e.g., number of patients).
For biomechanical testing, the "sample size" would refer to the number of test specimens (e.g., number of device constructs tested). This specific number is not provided in the document.
The data provenance is laboratory testing, not human or patient data. Therefore, the concepts of "country of origin of the data" and "retrospective or prospective" do not apply.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to this type of device and study. The "ground truth" for biomechanical testing is typically established by the adherence to and results of a recognized international standard (ASTM F1717) and engineering principles, not through expert consensus on clinical cases. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the standard and predicate device data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving human readers or evaluators, not for direct biomechanical engineering tests.

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 hardware orthopedic implant (anterior cervical plate). An MRMC study is relevant for diagnostic devices, particularly AI-powered ones. There is no AI component mentioned or implied.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a hardware orthopedic implant. This question pertains to AI/software.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for this device is based on engineering standards and direct physical measurements derived from biomechanical testing, compared to the known performance of a predicate device. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set."

In summary:

The provided document describes a 510(k) submission for a physical medical implant. The primary "study" mentioned is biomechanical testing in accordance with ASTM F1717. This testing serves to demonstrate that the device performs mechanically in a manner substantially equivalent to its predicate device(s), thereby establishing its safety and effectiveness for its intended use and material composition. The questions regarding AI, expert consensus, clinical sample sizes, and adjudication methods are not relevant to this type of regulatory submission or device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for "Life Spine". The word "Life" is in bold, and the word "Spine" is in a thinner font. There is a curved line under the word "Spine", and a registered trademark symbol to the right of the word "Spine".

K062831/

0C1 1 9 2006

	Special 510(k) Summary of Safety and Effectiveness
	Special 510(k) Summary - NEO™ Anterior Cervical Plate
Submitted By:	Life Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Erin MalloyLife Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60169
Date Prepared:	September 19, 2006
Trade Name:	NEO™ Anterior Cervical Plate
Common Name:	Spinal Fixation System
Classification:	Spinal Invertertebral Body Fixation OrthosisCFR 888.3060Class II
Device Product Code:	KWQ
Predicate Device:	NEO™ Anterior Cervical Plate System K040844 and otherpredicate devices

Device Description:

Intended Use of the Device:

The NEO™ Anterior Cervical Plate 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);

1. Spondylolisthesis
1. Trauma (including fractures or dislocations);

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line appears beneath the word "Spine", and a registered trademark symbol is located to the right of the word "Spine".

1. Spinal cord stenosis;
1. Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis);
1. Tumors;
1. Pseudarthrosis;
1. Failed previous fusions.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Material:

The NEO™ Anterior Cervical Plate is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI).

Performance Data:

Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.

Substantial Equivalence:

The NEO™ Anterior Cervical Plate was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2006

Life Spine LLC % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195

Re: K062831

Trade/Device Name: NEO™ Anterior Cervical Plate Regulation Number: 21 CFR 878.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 19, 2006 Received: September 20, 2006

Dear Ms. Malloy:

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.

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.

{3}------------------------------------------------

Page 2 - Ms. Erin Malloy

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organ mailing of substantial equivalence of your device to a legally premits to the are device results in a classification for your 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 Jour ac 11-07-20120. Also, please note the regulation entitled, Connact the Orities of Complanes as (21CFR Part 807.97). You may obtain 101501411118 by reference to presence to presensibilities under the Act from the Division of Small other general mionmation on your Corpumer 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 your

Y.C.
Mark N. Melkerson

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) number (if known):

Device Name: NEOTM Anterior Cervical Plate System

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar 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)

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

510(k) Number_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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.