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 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 Polyetheretherketone (PEEK-OPTIMA LT1) 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 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

This 510(k) summary describes a spinal implant (PLATEAU Spacer System) which is a physical device, not an AI/software as a medical device (SaMD). Therefore, the concepts of acceptance criteria for algorithm performance, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance as typically applied to SaMDs are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving performance against quantitative acceptance criteria for AI model outputs, the submission aims to show that the new device shares the same intended use, materials, basic design, and fundamental technology as previously cleared devices.

Here's an analysis based on the provided text, reinterpreting some of your questions in the context of a physical medical device submission:

A table of acceptance criteria and the reported device performance

In the context of a physical device 510(k) submission seeking substantial equivalence, acceptance criteria are generally not quantitative performance metrics for a novel algorithm. Instead, the "acceptance criteria" are demonstrating equivalence to predicate devices across key characteristics. "Reported device performance" would refer to how the device aligns with these characteristics.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance
Intended Use (same as predicate)	"The additional sizes fall within the range of sizes offered in the predicate systems. Additionally they have the same intended use..."
Material (same as predicate)	"...material..." (PEEK-OPTIMA LT1 with tantalum/titanium markers, compliant with ASTM F2026)
Basic Design (same as predicate)	"...and basic design as the predicate systems." (Intervertebral body fusion device, hollow for bone graft, with teeth)
Performance (no new worst-case scenario due to added sizes)	"Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario..."

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

Not applicable. This is not a study involving data for an AI model. The "test set" here would conceptually be a comparison to the predicate devices themselves, rather than a dataset. The document doesn't detail any specific 'test' data provenance for the physical device, beyond general material and design specifications.
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 for an AI model is not relevant here. The "ground truth" for a physical medical device's substantial equivalence is its conformity to established standards, materials, and designs, as assessed by engineering and clinical experts within the manufacturing company and subsequently by the FDA reviewers.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical device submission.
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 physical implant, not an AI system or diagnostic tool that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a physical device 510(k) submission, the "ground truth" for proving safety and effectiveness (as demonstrated through substantial equivalence) is typically based on:
- Material specifications and testing: Adherence to standards like ASTM F2026.
- Biocompatibility data: Established for the PEEK-OPTIMA LT1 material.
- Mechanical testing: To ensure the implant can withstand anticipated physiological loads and that new sizes don't introduce new worst-case scenarios. (General statement in the document: "Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario...").
- Clinical history of predicate devices: The track record of similar devices already on the market forms the basis for demonstrating safety and effectiveness without requiring new clinical trials for minor modifications.
The sample size for the training set

Not applicable. This is not an AI model.
How the ground truth for the training set was established

Not applicable. This is not an AI model.

Summary

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JUL - 6 2011

510(k) Summary PLATEAU® Spacer System

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:	June 2nd, 2011
Trade Name:	Life Spine Plateau Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, 21 CFR 888.3080, Class II
Predicate Device:	Plateau Spacer System (K080411), Medtronic Capstone (K073291),Orthofix Pillar System (K081177)

Device Description:

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Intended Use of the Device: -

Material:

The PLATEAU Spacer System implants are manufactured according to ASTM F2026 from Polyetheretherketone (PEEK-OPTIMA LT1), which is a biocompatible material manufactured and supplied by Invibio, and either 6-4 Alloy Titanium markers or unalloyed Tantalum markers. PEEK-OPTIMA is a biocompatible radiolucent material, allowing visualization of osteogenesis.

Characteristic Comparison:

The purpose of this submission is to add additional sizes to the offering of the PLATEAU Spacer System. The additional sizes fall within the range of sizes offered in the predicate systems. Additionally they have the same intended use, material, and basic design as the predicate systems.

Performance Data:

Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario and are therefore substantially equivalent to the predicate devices,

Substantial Equivalence:

The Plateau Spacer System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes extending upwards and three wave-like shapes below, representing water.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL - 6 2011

Life Spine, Inc. % Mr. Randy Lewis 2401 West Hassell Road Suite 1535 Hoffman Estates, Illinois 60169

Re: K111569

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: June 03, 2011 Received: June 06, 2011

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

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Page 2 - Mr. Randy Lewis

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
E. S. Keith

Sr Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) number (if known): ___K111569

Device Name: PLATEAU® Spacer System

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)

Division Sign Off

(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KITI 284 510(k) Number ___

Page 1 of 1

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.