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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental internal spine fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Device Description

The Plateau-V 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 either PEEK-OPTIMA LT1 or Zeniva PEEK ZA-500 with tantalum markers. The implant is hollow to permit packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone 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.

AI/ML Overview

The provided text describes a medical device, the Life Spine Plateau Spacer System, and its clearance process with the FDA. However, it does not contain any information regarding acceptance criteria or a study proving that an AI-powered device meets such criteria.

The document is a 510(k) premarket notification for an intervertebral body fusion device, which is a physical implant, not an AI device. The included "Performance Data" section solely refers to mechanical testing of the implant itself (e.g., static axial compression, expulsion, subsidence, and dynamic axial compression tests) to demonstrate its substantial equivalence to predicate devices, focusing on physical and material properties.

Therefore, I cannot fulfill your request for the following sections because the provided text does not contain this type of information:

A table of acceptance criteria and the reported device performance: No AI device is described, so no such criteria or performance data is available.
Sample size used for the test set and the data provenance: No AI device or test set for an AI device is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI device or ground truth for an AI device.
Adjudication method: Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document discusses substantial equivalence for a physical medical device (intervertebral body fusion device) based on its design, materials, indications for use, and mechanical performance relative to existing predicate devices.

Summary

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

November 26, 2018

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Life Spine Ms. Angela Batker RA/OA Specialist 13951 S Quality Drive Huntley, Illinois 60142

Re: K182470

Trade/Device Name: Plateau Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 6, 2018 Received: September 10, 2018

Dear Ms. Batker:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall -S

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

Enclosure

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

Indications for Use

510(k) Number (if known) K182470

Device Name Plateau Spacer System

Indications for Use (Describe)

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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental internal spstem (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------	-------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

K182470 510(k) Summary Life Spine Plateau Spacer System

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Angela BatkerLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	September 9, 2018
Trade Name:	Plateau Spacer System
Common Name:	Interbody Fusion Device
Classification:	MAX, CFR 888.3080, Class II
Primary Predicate:	Life Spine Plateau (K080411/K111569)
Secondary Predicate:	Life Spine Plateau Ti (K130630)Life Spine Plateau Lo (K172105)Life Spine Pro Lift (K153400)

Device Description:

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

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

Intended Use of the Device:

Technological Characteristics:

The Life Spine Plateau Spacer System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Material:

This submission seeks clearance of a device made from either PEEK-OPTIMA LT1 or Zeniva PEEK ZA-500 per ASTM F2026 or Titanium (Ti-6A1-4V ELI) per ASTM F136. This this is the same material used in the predicate devices.

Performance Data:

Testing according to ASTM F2077 & F2267 included Static axial compression, static expulsion, static subsidence, and dynamic axial compression tests was presented to demonstrate the substantial equivalency of the Life Spine Plateau (K080411/K111569).

Substantial Equivalence:

The Life Spine Plateau Spacer System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

Conclusion:

The information presented demonstrates the substantial equivalency of The Life Spine Plateau Spacer System.

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.