The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Device Description

The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.

AI/ML Overview

The provided text describes a 510(k) submission for the Life Spine PLATEAU® Spacer System Titanium. This is an intervertebral body fusion device, and the submission primarily focuses on demonstrating its substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria for a new, unproven technology.

Therefore, many of the requested categories related to acceptance criteria and performance studies (like sample size for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of submission.

Here's a breakdown based on the information provided:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated for performance, but implied for substantial equivalence)	Reported Device Performance
Substantial Equivalence:
- Indications for Use (Match predicate)	- Equivalent indications to predicate devices.
- Design (Comparable to predicate)	- Comparable design to predicate devices.
- Function (Comparable to predicate)	- Comparable function to predicate devices.
- Materials used (Comparable to predicate)	- Titanium alloy (Ti-6Al-4V) conforming to ASTM F136, similar to material in predicate devices.
- No new worst-case performance	- Engineering analysis presented to demonstrate no new worst-case performance.

Details specifically requested about a "study":

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission relied on engineering analysis and comparison to predicate devices, not a clinical performance study with a test set of patient data.

3. 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. No ground truth was established by experts for a test set in this 510(k) submission.

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

Not Applicable. No test set or adjudication process as described was conducted.

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

Not Applicable. This is a physical intervertebral body fusion device, not an AI-assisted diagnostic 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.

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

Not Applicable. For this type of device, "ground truth" generally refers to the established safety and effectiveness of the predicate devices. The "truth" for this submission is that its design, materials, and intended use are similar enough to already cleared devices.

8. The sample size for the training set

Not Applicable. No training set for an algorithm was used.

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

Not Applicable. No training set for an algorithm was used.

Summary of the "study" for this device:

The "study" presented for the PLATEAU® Spacer System Titanium was an engineering analysis to demonstrate that the addition of titanium components "does not present a new worst case in performance and is substantially equivalent to the predicate systems." This means the company performed tests and analyses (e.g., mechanical, biocompatibility, design comparisons) to show that the titanium version behaves safely and effectively like the existing, cleared versions of their device and other predicate devices, without introducing new risks or performance issues. The FDA's determination of "substantial equivalence" is the "acceptance criteria" being met here.

Summary

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K130630 Page 1 of 2

JUN 1 3 2013

510(k) Summary PLATEAU® Spacer System Titanium

Submitted By:	Life Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	March 4th, 2013
Trade Name:	Life Spine Plateau Spacer System Titanium
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, 21 CFR 888.3080, Class II
Predicate Device:	Plateau Spacer System (K080411)Nuvasive CoRoent Titanium System (K120918)

Device Description:

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Intended Use of the Device:

Performance Data:

Engineering analysis was presented to demonstrate that the Plateau Spacer System Titanium does not present a new worst case in performance and is substantially equivalent to the predicate systems.

Substantial Equivalence:

The purpose of this submission is to add titanium components to the Plateau Spacer System. The addition of these components was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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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 the department's name in a circular arrangement around a stylized symbol. The symbol resembles an abstract human form or a bird in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

June 13, 2013

Life Spine, Incorporated % Mr. Randy Lewis Director, RA/QA 2401 West Hassell Road. Suite 1535 Hoffman Estates, Illinois 60169

Re: K130630

Trade/Device Name: PLATEAU® Spacer System Titanium Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 14, 2013 Received: May 15, 2013

Dear Mr. Lewis:

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

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Page 2 - Mr. Randy Lewis

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and

Enclosure

Radiological Health

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Indications for Use

K130630 510(k) number (if known):

Device Name: PLATEAU® Spacer System Titanium

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral 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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.