The PLATEAU-A Ti Anterior Lumbar Spacer 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 nonoperative 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 a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-X Ti Lateral Lumbar Spacer 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 spondylolistthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative 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 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-A Ti Anterior Lumbar Spacer implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6A1-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.

The Plateau-X Ti Lateral Lumbar Spacer 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 ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

AI/ML Overview

The provided document is a 510(k) summary for the Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a new device with novel performance claims.

Therefore, the information typically requested regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance as understood in the context of AI/ML or diagnostic devices is not directly applicable or available in this document.

However, I can extract information related to the device's substantial equivalence demonstration for mechanical performance.

Here's an analysis based on the provided text, addressing the points where possible:

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

Acceptance Criteria: The document does not specify quantified acceptance criteria (e.g., specific load values or displacement limits) for the mechanical tests. Instead, it relies on demonstrating that the new device performs acceptably compared to its predicate devices. The implicit acceptance criterion is that the new device's mechanical performance is equivalent to or better than the predicate devices, as demonstrated by meeting relevant ASTM standards.
Reported Device Performance: The document states: "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)." It does not provide numerical results of these tests, only that the tests were performed and were sufficient to demonstrate substantial equivalency to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Meet ASTM F2077 & F2267 standards for intervertebral body fusion devices, demonstrating mechanical performance substantially equivalent to predicate devices (K080411/K111569).	Testing included Static axial compression, static expulsion, static subsidence, and dynamic axial compression tests according to ASTM F2077 & F2267. This testing "was presented to demonstrate the substantial equivalency" to the predicate devices. (Specific numerical results are not provided in this summary).

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

This information is not explicitly provided. For mechanical testing, the "sample size" would refer to the number of device units tested. The document does not specify the number of units or the specific test specimens.
Data provenance (country of origin, retrospective/prospective) is not relevant to this type of mechanical testing. The testing would be conducted in a laboratory setting.

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. This device is an implanted medical device (spinal spacer), and its evaluation for 510(k) clearance primarily involves mechanical and material testing, not subjective assessment by medical experts for ground truth establishment.

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

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to establish ground truth or resolve discrepancies. This document describes mechanical testing.

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 not an AI/ML device or a diagnostic device that would involve human readers or AI assistance.

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

Not applicable. This is an implanted medical device, not an algorithm.

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

For mechanical testing, the "ground truth" is defined by the objective measurements obtained from standardized tests (e.g., load-displacement curves, failure loads). Compliance with relevant ASTM standards (F2077 & F2267) serves as the benchmark against which performance is measured.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for an orthopedic implant through mechanical testing. It does not contain information typically found in submissions for diagnostic or AI/ML devices regarding clinical study design, expert ground truth, or performance metrics against specific acceptance thresholds in a clinical context. The "study" mentioned is the series of mechanical tests to ASTM standards, and the "acceptance criteria" are implicitly met by demonstrating equivalency to the predicate devices through these tests.

Summary

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 4, 2020

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

Re: K201500

Trade/Device Name: Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 1, 2020 Received: June 5, 2020

Dear Angela 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201500

Device Name

Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer

Indications for Use (Describe)

The Plateau-X Ti Lateral Lumbar Spacer 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 nonoperative 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 a supplemental internal spinal fixation system (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)

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510(k) Summary Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer

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:	May 29, 2020
Trade Name:	Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X TiLateral Lumbar Spacer
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-X Spacer System (K121116)AlphaTec Holdings Indenti TI Porous Ti Interbody System (K183705)Alpha Tec Holdings Lateral Interbody System (K191311)

Device Description:

All implants are intended for single use only and should not be reused under any circumstances. Do

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not use any of the PLATEAU-A Ti Anterior Lumbar Spacer components with components from any other system or manufacturer. The components should never be reused under any circumstances.

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

Intended Use of the Device:

The PLATEAU-A Ti Anterior Lumbar Spacer 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 a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-X Ti Lateral Lumbar Spacer 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 nonoperative 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 a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Technological Characteristics:

The Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer 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 Titanium (Ti-6AI-4V ELI) per ASTM F136. This this is the same material used in the predicate devices.

Performance Data:

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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®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer 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 Plateaux®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer.

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.