The Plateau-LO 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-LO 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 PEEK (Polyetheretherketone) with tantalum markers. 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-LO Spacer System components with components from any other system or manufacturer. The Plateau-LO Spacer System components should never be reused under any circumstances.

AI/ML Overview

This document describes the regulatory approval of "The Plateau-LO Spacer System," an intervertebral body fusion device. The information provided is for a 510(k) premarket notification and focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than a detailed clinical study demonstrating device performance against specific acceptance criteria in the way one might expect for a diagnostic AI device.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission and the information available. The document is primarily concerned with proving the new device is as safe and effective as existing, legally marketed devices.

Here's an attempt to address your request based on the provided text, highlighting what is (and isn't) present:

1. A table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or reported device performance in the way a diagnostic AI device study would. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and mechanical performance.

Criterion Type	Acceptance Criteria (Not explicitly stated as numerical targets)	Reported Device Performance (Summary of evidence presented)
Design Equivalence	The Plateau-LO Spacer System's design should be comparable to the predicate devices.	The document states: "The Plateau-LO Spacer System is substantially equivalent to the predicate systems in terms of design..." It is fabricated from PEEK with tantalum markers and is hollow for bone graft. Similar to common intervertebral fusion devices.
Material Equivalence	Materials used should be comparable and possess similar biocompatibility and mechanical properties to the predicate devices.	The document states: "...materials used..." are substantially equivalent to the predicate systems. Specifically, it's made from PEEK (Polyetheretherketone) with tantalum markers, which are standard materials for such implants.
Indications for Use	The intended use should be the same as or very similar to the predicate devices.	The document states: "...indications for use..." are substantially equivalent to the predicate systems. The intended use is for spinal fusion in skeletally mature patients with degenerative disc disease (DDD) at L2-S1, possibly with Grade 1 spondylolisthesis, after 6 months of non-operative treatment, used with autogenous bone graft and a supplemental internal spinal fixation system. This matches typical indications for such devices.
Mechanical Performance	The mechanical strength and stability (e.g., resistance to expulsion) should be equivalent to or better than the predicate devices, ensuring safety and efficacy in vivo.	Data presented included "Engineering rationale, finite element analysis and expulsion testing." These studies aimed to "demonstrate the substantial equivalency of The Plateau-LO Spacer System" in terms of mechanical performance compared to the predicate devices. Specific numerical results are not provided in this summary.
Functional Equivalence	The device should perform its intended function (facilitating intervertebral fusion) similarly to the predicate devices.	The document states: "...function..." is substantially equivalent to the predicate systems. Its design (hollow for bone graft, teeth on surfaces) supports its function to promote fusion and prevent migration, consistent with predicate devices.
Sizing Equivalence	The range of available sizes should be comparable to the predicate devices to accommodate various patient anatomies.	The document states: "...sizing" is substantially equivalent to the predicate systems. It's noted that the implant is "available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient."
Biocompatibility (Implicit)	Materials should be biocompatible for implantation in the human body.	Though not explicitly stated as a criterion, using PEEK, a common and well-established biocompatible material for implants, implies that biocompatibility was confirmed or established through a history of safe use of similar materials in predicate devices.

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

This document is a 510(k) summary, which typically relies on non-clinical performance data (bench testing, engineering analysis) and comparison to predicate devices, rather than a clinical "test set" from patient data.

Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" (if we consider it as the subject of the performance data) would be the physical devices used in the engineering rationale, finite element analysis, and expulsion testing. The specific number of devices tested is not mentioned.
Data Provenance: The studies mentioned (engineering rationale, finite element analysis, expulsion testing) are typically conducted in a laboratory setting by the manufacturer (Life Spine Inc.). No "country of origin of data" for clinical patient data is relevant here. The studies would be considered prospective in terms of how the tests were designed and executed on the device prototypes/samples.

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)

This is not applicable. "Ground truth" in the sense of expert consensus on clinical findings is not established for this type of submission. The ground truth here is derived from engineering principles, material science, and established acceptable performance limits for intervertebral fusion devices, as demonstrated through bench testing.

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

Not applicable. There's no clinical "test set" requiring adjudication by clinical experts as this is not a diagnostic device and no clinical data review is described.

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 device is a surgical implant, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this submission is established by:

Engineering principles and material science: For the design, materials, and mechanical properties.
Regulatory standards and guidance: For what constitutes "substantial equivalence" for intervertebral body fusion devices.
Performance of predicate devices: The established safety and effectiveness of the legally marketed predicate devices serve as the benchmark.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 2, 2018

Life Spine Inc. Randy Lewis General Manager 13951 S Quality Drive Huntley, Illinois 60142

Re: K172105

Trade/Device Name: The Plateau-LO Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 22, 2018 Received: January 24, 2018

Dear Randy 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about medical devices and radiation-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,

Katherine D. Kavlock -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K172105

Device Name The Plateau-LO Spacer System

Indications for Use (Describe)

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)

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K172105 Page 1 of 2

510(k) Summary The Plateau-LO Spacer System

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	July 12th, 2017
Trade Name:	The Plateau-LO Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, 21 CFR 888.3080, Class II
Primary Predicate :	The Plateau Spacer System (K080411)
Additional Predicate:	The Plateau-X Spacer System (K151116)The ProLift Expandable System (K153400)The Globus Sustain System (K151665)The Medtronic CAPSTONE CONTROL System (K120368)

Device Description:

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau-LO Spacer System components with

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components from any other system or manufacturer. The Plateau-LO Spacer System components should never be reused under any circumstances.

Intended Use of the Device:

Technological Characteristics:

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

Performance Data:

Engineering rationale, finite element analysis and expulsion testing was presented to demonstrate the substantial equivalency of The Plateau-LO Spacer System.

Substantial Equivalence:

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

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.