The TiBow™ Expandable 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 nonoperative 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 TiBow™ Expandable 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 titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. 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.

AI/ML Overview

This document describes a spinal implant device, the TiBow™ Expandable Spacer System, and its clearance process with the FDA. It is a 510(k) premarket notification, which means the device is being cleared based on its substantial equivalence to a legally marketed predicate device, rather than a full premarket approval (PMA) which would typically require extensive clinical trials.

Therefore, the "study that proves the device meets acceptance criteria" refers to non-clinical performance testing to demonstrate this substantial equivalence to predicate devices, specifically regarding mechanical performance.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance that are directly compared to "reported device performance" in a table format as might be found in a clinical study for diagnostic accuracy. Instead, the performance data section refers to standard tests and compares the device's performance to that of predicate devices, implicitly implying that meeting these standards and being comparable to the predicates constitutes acceptable performance.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Performance: - Static compression strength - Dynamic compression strength - Shear strength (In accordance with ASTM F2077 standards)	"Static compression, dynamic compression and shear testing in accordance with ASTM F2077, in addition to Finite Element Analysis and engineering rationale, was presented to demonstrate the substantial equivalency of The TiBow™ Expandable Spacer System." Conclusion: "The TiBow™ Expandable Spacer System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." Note: Specific numerical performance values are not provided in this summary.
Material Composition	Fabricated from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
Design and Functionality	Expands in situ, hollow for bone graft, superior and inferior teeth for stability. Claimed to be substantially equivalent to predicate systems in terms of design and function.
Indications for Use	Intended for spinal fusion in skeletally mature patients with DDD at L2-S1, up to Grade 1 spondylolisthesis, after 6 months nonoperative treatment, with autogenous bone graft and supplemental fixation. Claimed to be substantially equivalent to predicate systems in indications for use.

2. Sample Size Used for the Test Set and the Data Provenance

Given this is a 510(k) filing for a spinal implant, the "test set" refers to the mechanical testing performed on the physical device itself or simulations (Finite Element Analysis).

Sample Size: The document does not specify the exact number of devices or simulations used for the mechanical testing (e.g., number of units tested for static compression).
Data Provenance: The data is derived from non-clinical bench testing and Finite Element Analysis of The TiBow™ Expandable Spacer System. There is no mention of human clinical data (retrospective or prospective) in this regulatory summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this 510(k) submission. "Ground truth" established by experts typically pertains to diagnostic device performance or clinical outcomes. For this device (an intervertebral body fusion device), the "truth" is established by adhering to recognized engineering standards (ASTM F2077, ASTM F136) and demonstrating substantial equivalence through mechanical testing and engineering rationale. The FDA's review division (Office of Device Evaluation, Division of Orthopedic Devices) comprises experts who review the submitted data to determine regulatory compliance.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) refer to how discrepancies in expert opinions on clinical cases are resolved to establish a "ground truth." Since this submission relies on engineering standards and mechanical testing, such a method is irrelevant.

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 question is not applicable. MRMC studies, AI assistance, and human reader improvement are relevant to diagnostic software or AI-enabled tools, not for an implantable spinal fusion device like The TiBow™ Expandable Spacer System.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This question is not applicable. This refers to the standalone performance of an algorithm or AI system, which is not relevant to an intervertebral body fusion device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on:

Engineering Standards: Compliance with recognized ASTM standards for intervertebral body fusion devices (ASTM F2077 for mechanical testing, ASTM F136 for material composition).
Substantial Equivalence: Comparison of the device's design, materials, indications for use, and mechanical performance to legally marketed predicate devices (The Longbow Spacer System K133717 and The Plateau Spacer System K130630). The "truth" is that its performance is equivalent to these already-cleared devices.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train machine learning models. This device is not an AI/ML-based product.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for an AI/ML model for this device.

Summary

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

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

August 3, 2017

Re: K170919

Trade/Device Name: The TiBow™ Expandable Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 5, 2017 Received: May 8, 2017

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 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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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) K170919

Device Name

The TiBow™ Expandable 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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510(k) Summary The TiBow™ Expandable 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 18th, 2017
Trade Name:	The TiBow™ Expandable Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, 21 CFR 888.3080, Class II
Primary Predicate :	The Longbow Spacer System (K133717)
Additional Predicate:	The Plateau Spacer System (K130630)

Device Description:

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Intended Use of the Device:

Technological Characteristics:

The TiBow™ Expandable Spacer System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Performance Data:

Static compression, dynamic compression and shear testing in accordance with ASTM F2077, in addition to Finite Element Analysis and engineering rationale, was presented to demonstrate the substantial equivalency of The TiBow™ Expandable Spacer System.

Conclusions:

The TiBow™ Expandable 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.