The Life Spine 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 fusion in patients with (1) degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) trauma (including fractures or dislocations), (4) spinal cord stenosis, (5) deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis), (6) tumors, (7) pseudarthrosis, (8) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

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

Device Description

The Life Spine Anterior Cervical Plate consists of various sizes of anterior cervical bone plates and screws. 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 Life Spine Anterior Cervical Plate components will be supplied clean and "NON-STERILE'.

AI/ML Overview

The provided 510(k) summary for the Life Spine Anterior Cervical Plate System does not include acceptance criteria or a study demonstrating the device meets performance criteria in the way typically expected for an AI/CADe device. This document is for a physical medical implant (a spinal fixation system), and as such, the performance evaluation focuses on biomechanical properties and material compatibility rather than diagnostic accuracy metrics.

Therefore, many of the requested categories for AI/CADe device studies are not applicable to this 510(k) submission. Below, I've filled in the relevant information based on the provided text, and noted when information is not applicable or not present.

Acceptance Criteria and Device Performance for Life Spine Anterior Cervical Plate System

Information Category	Acceptance Criteria (Specified in Document)	Reported Device Performance (Specified in Document)
Primary Performance Metric	Not explicitly stated as acceptance criteria, but substantial equivalence in biomechanical testing is the goal.	Biomechanical testing in accordance with ASTM F1717 was conducted. Substantial equivalence to predicate devices (Life Spine NEO™ Cervical Plating System K040844, Life Spine KINETIC® Anterior Cervical Plate K062643) in indications for use, design, function, and materials used was demonstrated.
Material Compatibility	Use of implant grade titanium alloy 6A1-4V ELI per ASTM F-136.	Components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136.
Sterility	Supplied clean and "NON-STERILE".	Supplied clean and "NON-STERILE".
Indications for Use (Equivalence)	Equivalent indications for use to predicate devices.	The device's intended use mirrors that of the predicate devices.
Design and Function (Equivalence)	Equivalent design and function to predicate devices.	Substantial equivalence in design and function was demonstrated.

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. Biomechanical testing (ASTM F1717) uses physical test specimens of the device, not a "test set" of patient data as would be used for AI/CADe. The number of physical units tested is not specified.
- Data Provenance: Not applicable. The testing is laboratory-based biomechanical testing of the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth, in the context of AI/CADe devices, refers to an agreed-upon clinical diagnosis or finding. For a physical implant, "ground truth" relates to material properties and mechanical performance measured against standards, not expert medical consensus on a dataset.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to adjudication of clinical findings by experts, which is not relevant for biomechanical testing of a physical implant.
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 is not an AI/CADe device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/CADe device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: For this type of device, the "ground truth" for performance is defined by established engineering standards and material specifications. Specifically, ASTM F1717 provides the methods and criteria for testing spinal implant constructs, and ASTM F136 specifies the standard for the titanium alloy material. The device's performance is compared against the expected behavior for devices meeting these standards and the performance of the chosen predicate devices.
The sample size for the training set:
- Not applicable. This is not an AI/CADe device.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/CADe device.

Summary of the Device Evaluation:

The Life Spine Anterior Cervical Plate System's acceptance criteria and proof of performance are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through:

Material Specification: Using an implant grade titanium alloy (Ti 6A1-4V-ELI) that conforms to ASTM F-136, a recognized standard for surgical implant materials.
Biomechanical Testing: Conducting biomechanical tests in accordance with ASTM F1717, a standard specifically for spinal implant constructs. These tests evaluate the mechanical properties and stability of the device. The results from these tests would have been compared to the performance of the predicate devices to show that the new device performs at least as safely and effectively.
Comparison of Indications for Use, Design, and Function: The submission explicitly states that the device was shown to be substantially equivalent to predicate devices in these aspects. This means clinical indications, physical design, and how the device is intended to perform its function were determined to be similar enough that no new safety or effectiveness concerns are raised.

In essence, for this physical medical device, "acceptance criteria" are implied by the requirements for substantial equivalence, which primarily involve adherence to recognized material standards and performance comparable to existing, legally marketed devices as demonstrated through established biomechanical testing protocols.

Summary

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070285

MAR 1 3 2007

510(k) Summary

510(k) Summary - Life Spine Anterior Cervical Plate System

Submitted By:	Life Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Rebecca M. BrooksLife Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60195Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	January 26, 2007
Trade Name:	Life Spine Anterior Cervical Plate System
Common Name:	Spinal Fixation System
Classification:	KWQ 888.3060 - Spinal Intervertebral Body FixationOrthosis21 CFR 888.3060Class II
Device Product Code:	KWQ
Predicate Device:	Life Spine NEO ™ Cervical Plating System K040844Life Spine KINETIC ® Anterior Cervical Plate K062643

Device Description:

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070285 Page 2 of 2

Intended Use of the Device:

The Life Spine Anterior Cervical Plate System is interior 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 fusion in patients with:

1. Degenerative disease, DDD (as defined by neck pain of discogenic origin with degeneration of dise confirmed by patient history and radiographic studies);
1. Spondvlolisthesis
1. Trauma (including fractures or dislocations);
1. Spinal cord stenosis;
1. Deformity or curvatures (i.e. kyphosis, lordosis and/or scollosis);
1. Tumors:
1. Pseudarthrosis:
1. Failed previous fusions.

Nota Benet This device system is intended for anterior cervical interverterbral body fusions only.

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

Muterial:

The Life Spine Anterior Cervical Plate System is manufactured from medical grade itlanium alloy described by ASTM F136 (Ti 6A1-4V-ELI).

Performance Data:

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

Substantial Equivalence:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Life Spine LLC % Ms. Rebecca Brooks Project Coordinator 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195

MAR 1 3 2007

Re: K070285

Trade/Device Name: Life Spine Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 26, 2007 Received: January 29, 2007

Dear Ms. Brooks:

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.

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Page 2 - Ms. Rebecca Brooks

This letter will allow you to begin marketing your device as described in your Section 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 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 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). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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): _K070285

Device Name: Life Spine Anterior Cervical Plate System

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

WARNING: This device is not approved for screw attachment 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)

Salvare Bonetur

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

510(k) Number K070285

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.