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 with degencrative 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 System consists of various sizes of anterior cervical bone plates. screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The NEO ACPS components will be supplied clean and "NON-STERILE".

AI/ML Overview

Here's an analysis of the provided text regarding the Life Spine, LLC NEOTM Cervical Plating System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal clinical study with strict acceptance criteria for a novel device. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly detailed in this type of document. The study described is mechanical testing, not a clinical study.

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily discusses mechanical testing to demonstrate substantial equivalence, not clinical performance metrics or specific acceptance criteria for diagnostic accuracy (which would be relevant for devices that process medical images or data).

Acceptance Criteria (Implied)	Reported Device Performance
Static Strength (comparable)	Comparable to predicate devices
Fatigue Strength (comparable)	Comparable to predicate devices

Study Details (Based on provided text):

Since this is a 510(k) summary for a spinal implant, the "study" referred to is mechanical bench testing, not a clinical trial evaluating human performance or AI accuracy. Therefore, many of your requested fields are not applicable or cannot be extracted from this document.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the mechanical testing.
- Data Provenance: Not applicable in the context of mechanical testing of physical implants. The materials are specified as implant grade titanium alloy 6A1-4V ELI per ASTM F-136.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is defined by established engineering standards and measurements, not by expert medical consensus.
Adjudication method for the test set: Not applicable for mechanical testing.
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. This document is for a spinal implant, not an AI-powered diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a spinal implant.
The type of ground truth used: For the mechanical testing, the ground truth is established physical properties and performance benchmarks derived from standardized testing methods (e.g., ASTM standards) and comparison to the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/ML device, and no training set is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary of Device and Approval:

The Life Spine, LLC NEOTM Anterior Cervical Plate System is a medical device for temporary stabilization of the anterior spine from C2 to T1 during cervical spinal fusions. It is indicated for various conditions including degenerative disc disease, trauma, and tumors. The device consists of titanium alloy plates, screws, and locking tabs.

The 510(k) submission (K040844) demonstrated substantial equivalence to two predicate devices: Interpore Cross International Anterior Cervical Plate System (K002592) and Howmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702). The primary evidence for this equivalence was mechanical testing (static and fatigue strength) which showed comparable properties to the predicate devices. The FDA reviewed the submission and determined that the device was substantially equivalent, allowing it to be marketed.

Summary

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Life Spine, LLC NEOTM Cervical Plating System 510(k) Summary of Safety and Effectiveness

KO<40844/
page 1 of 1

1. General Information

Submitter Information:	Life Spine, LLC11925 East 65th Street, Suite 4Indianapolis, IN 46236Phone: 317-826-7006 Fax: 317-826-7007
Company Registration Number:	3004499989
Date Summary Prepared:	March 31, 2004
Classification Name:	KWQ 888.3060 - Spinal Interverterbal Body FixationOrthosis. Class II
Common or Usual Name:	Spinal Fixation System
Device Trade Name:	NEOTM Anterior Cervical Plate System

2. Predicate Devices

Interpore Cross International Anterior Cervical Plate System (K002592) and the Howmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702).

3. Intended Use

The NEO 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);

1. Spondylolisthesis
1. Trauma (including fractures or dislocations);
1. Spinal cord stenosis:
1. Deformity or curvatures (i.e. kyphosis, lordosis or scollosis);
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.

4. Device Description

5. Mechanical Testing

The results of the static and fatigue strength testing for the NEO Anterior Cervical Plate System demonstrate comparable mechanical properties to the predicate devices listed.

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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with three wing-like shapes extending from its body. The image is in black and white.

Public Health Service

JUL 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael S. Butler President Life Spine, LLC. 11965 East 65th Street, Suite 4 Indianapolis, Indiana 46236

Re: K040844

R0400++
Trade/Device Name: NEO™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 29, 2004 Received: June 30, 2004

Dear Mr. Butler:

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 for about of to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of Prizer to Frid) 2011-07-12 11:12 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic . Ior , 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.

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Page 2 – Michael S. Butler

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse FDA finding of substantial equivalence of your device to a legally premated notification " 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 11 you desire specific arrivally 3 at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal micronational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,
Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. 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 STATEMENT

Page 1 of 1

K040844 510(k) Number (if known):

Device Name: NEOTM Anterior Cervical Plate System

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X
(Per 21 CFR 801.109)

Mark A Millman

Division of General, Restorative, and Neurological Devices

510(k) Number K040844

Over-the-Counter Use: (Optional Format 1-2-96)

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.