The Steerable Plateau TI 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. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. 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 Steerable Plateau TI 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-6AI-4V ELI) described by 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 Steerable Plateau TI components with components from any other system or manufacturer. The Steerable Plateau TI components should never be reused under any circumstances.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter and summary for a medical device called "Steerable Plateau TI," an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study involving AI or human readers.

Therefore, many of the requested details about acceptance criteria, performance in a clinical setting, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies are not applicable or not available in this document. The document describes mechanical performance testing, but not clinical performance with human operators or AI.

However, I can extract information related to the device itself and its mechanical testing.

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

Based on the document, the acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices in mechanical testing standards. The reported performance refers to successfully meeting these standards for the tests conducted.

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance	ASTM F2077 (includes):	Demonstrate performance comparable to or exceeding predicate devices within specified limits for intervertebral body fusion devices.	Successfully tested according to ASTM F2077.
	- Static Compression		Performance data not numerically detailed, but implies successful completion.
	- Static Compression Shear		Performance data not numerically detailed, but implies successful completion.
	- Dynamic Compression		Performance data not numerically detailed, but implies successful completion.
	- Dynamic Compression Shear		Performance data not numerically detailed, but implies successful completion.
	ASTM F2267 (includes):	Demonstrate performance comparable to or exceeding predicate devices within specified limits for intervertebral body fusion devices.	Successfully tested according to ASTM F2267.
	- Static Expulsion		Performance data not numerically detailed, but implies successful completion.
	- Subsidence		Performance data not numerically detailed, but implies successful completion.
Material Equivalence	ASTM F136	Device material (Ti-6Al-4V ELI) must conform to ASTM F136.	Fabricated from Ti-6Al-4V ELI as described by ASTM F136.
Design/Function	N/A	Design and function comparable to predicate devices.	Stated to be substantially equivalent in design and function to predicate devices.
Indications for Use	N/A	Indications for Use must be substantially equivalent to predicate devices.	Stated to be substantially equivalent in indications for use to predicate devices.

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

This document describes mechanical testing of the device, not a clinical study with a "test set" of patient data in the context of AI or human reading. Therefore, this information is not applicable in the sense of a clinical study.

For mechanical testing, the "samples" would be the manufactured devices themselves. The document does not specify the number of devices tested for each mechanical test. The provenance would be the laboratory where the tests were performed; this is not specified but would typically be an in-house lab or a contracted testing facility.

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. The document does not describe a study involving expert readers or ground truth establishment for patient data. It describes mechanical performance testing of an implantable device.

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

This is not applicable. The document does not describe a study involving adjudication of clinical results.

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

This is not applicable. The document describes an intervertebral body fusion device and its mechanical testing, not an AI-assisted diagnostic tool or a study involving human readers.

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

This is not applicable. The document describes an implantable medical device, not an algorithm.

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

This is not applicable. The "ground truth" for mechanical testing is defined by the physical laws and engineering standards (ASTM F2077, ASTM F2267). The device's performance against these standards constitutes the "truth" being assessed for substantial equivalence.

8. The sample size for the training set

This is not applicable. The document does not describe an AI device with a training set.

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

This is not applicable. The document does not describe an AI device with a training set or its ground truth establishment.

Summary

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February 6, 2020

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

Re: K193521

Trade/Device Name: Steerable Plateau Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 17, 2019 Received: December 19, 2019

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

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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 (QS) 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 L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193521

Device Name Steerable Plateau TI

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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510(k) Summary Steerable Plateau TI

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:	December 17th, 2019
Trade Name:	Steerable Plateau TI
Common Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Classification:	MAX, 21 CFR 888.3080, Class II
Primary Predicate:	Life Spine Plateau (K080411)
Additional Predicate:	Life Spine Plateau-TL (K111569)Life Spine Plateau TI (K130630)Life Spine ProLift (K190488)Globus Signature Spacer System (K122097)

Device Description:

Intended Use of the Device:

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Technological Characteristics:

The Steerable Plateau TI 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 alloy (Ti-6A1-4V ELI) as described by ASTM F136. This this is the same material used in most of the predicate devices.

Performance Data:

The Steerable Plateau TI was tested according to ASTM F2077 which includes Static Compression, Static Compression Shear, Dynamic Compression and Dynamic Compression Shear. Also, the Steerable Plateau TI was tested to ASTM F2267 for Static Expulsion and Subsidence.

Substantial Equivalence:

The Steerable Plateau TI 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 Steerable Plateau TI.

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.