When used as an interbody fusion device, the TruLift® Micro Expandable 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. 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.

When used as an interbody fusion device, the TruLift® Expandable 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. 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 TruLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136and ASTM F1537. 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. All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Micro Expandable System components with components from any other system or manufacturer. The TruLift® Micro Expandable System components should never be reused under any circumstances.

The TRULIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient.
· The 8mm-9mm width implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 & ASTM F1537
· The 10mm-12mm width implants are 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.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TRULIFT® Expandable Spacer System components with components from any other system or manufacturer. The TRULIFT® Expandable Spacer System components should never be reused under any circumstances.

AI/ML Overview

This FDA 510(k) summary describes the TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as this pertains to a physical orthopedic implant, not an AI/ML algorithm or software.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of medical device generally revolve around demonstrating mechanical performance equivalence to legally marketed predicate devices. The reported performance refers to the results of these mechanical tests.

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Mechanical Performance	Static Axial Compression performance equivalent to predicate devices.	Static Axial Compression testing according to ASTM F2077 was presented to demonstrate the substantial equivalency. (Specific numerical reported performance is not detailed in this summary, but the conclusion states "substantial equivalency" was shown.)
	Dynamic Axial Compression performance equivalent to predicate devices.	Dynamic Axial Compression testing according to ASTM F2077 was presented to demonstrate the substantial equivalency.
	Static Shear performance equivalent to predicate devices.	Static Shear testing according to ASTM F2077 was presented to demonstrate the substantial equivalency.
	Dynamic Shear performance equivalent to predicate devices.	Dynamic Shear testing according to ASTM F2077 was presented to demonstrate the substantial equivalency.
Biocompatibility	Materials used are biocompatible and equivalent to predicate devices.	The device is fabricated from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (Co-26Cr-6Mo) per ASTM F136 and ASTM F1537, which are "the same material used in the predicate devices." Implied acceptance is that these materials are already established as biocompatible for this application.
Design and Function	Design and function are substantially equivalent to predicate devices.	The device is available in a range of sizes and footprints, expands to desired height (8mm to 16mm), allows packing of bone graft, and has superior/inferior teeth – all described as substantially equivalent to predicate systems in terms of design, materials, indications for use, and sizing.
Sterility	Provided sterile and intended for single use.	"All implants are provided sterile and intended for SINGLE USE ONLY." (This is a design and labeling requirement, not a performance metric in the same sense as mechanical testing, but crucial for safety).
Indications for Use	Indications for Use are equivalent to predicate devices.	The stated Indications for Use (spinal fusion for DDD at one or two contiguous levels L2-S1, up to Grade 1 spondylolisthesis, after 6 months non-operative treatment, with autograft/allograft and supplemental fixation) are stated to be substantially equivalent to predicate devices.

The study that proves the device meets the acceptance criteria is the demonstration of substantial equivalence through mechanical performance testing (Static Axial Compression, Dynamic Axial Compression, Static Shear, and Dynamic Shear according to ASTM F2077), and comparison of materials, design, and indications for use to legally marketed predicate devices.

Information Not Applicable to This Device (AI/ML Specifics)

Sample size used for the test set and the data provenance: Not applicable. This is a physical implant, not an AI/ML algorithm evaluated on a data set. The "test set" here refers to physical specimens subject to mechanical testing. The provenance isn't described in terms of "country of origin of data" but rather the standards (ASTM F2077) governing the testing.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for an orthopedic implant's mechanical performance is established by standardized material and mechanical tests (e.g., ASTM standards), not expert interpretation of images or clinical data.
Adjudication method: Not applicable for a physical implant's mechanical testing.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a physical medical device, not an AI assistance tool for human readers.
Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable. This is a physical implant.
The type of ground truth used: For mechanical properties, the "ground truth" is defined by the physical properties measured under standardized testing conditions and compared against performance of predicate devices. For biocompatibility, it's the established safety profile of the materials. For indications for use, it's alignment with predicate devices.
The sample size for the training set: Not applicable. This is not an AI/ML model that undergoes "training."
How the ground truth for the training set was established: Not applicable.

In summary, for K232611, the "study" demonstrating device acceptance is the suite of mechanical tests and comparative analysis against predicate devices, which collectively establish substantial equivalence as required for 510(k) clearance by the FDA. The specifics of these mechanical tests (e.g., number of samples per test type, detailed results) are typically found in the full 510(k) submission, not in the public summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

November 30, 2023

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

Re: K232611

Trade/Device Name: TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 3, 2023 Received: November 3, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K232611

Device Name

TruLift Micro Expandable Spacer System & TruLift 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)
----------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

510(k) Summary TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System

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:	August 18th, 2023
Trade Name:	TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, CFR 888.3080, Class II
Primary Predicate:	Life Spine TruLift Expandable Cage System (K190488)
Additional Predicate:	Life Spine ProLift Micro Expandable Cage System (K223430, K212520)Globus Rise Spacer System (K113447)Globus Altera Spacer System (K140411)

Device Description:

System components should never be reused under any circumstances.

{4}------------------------------------------------

· The 8mm-9mm width implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 & ASTM F1537 · The 10mm-12mm width implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.

Intended Use of the Device:

When used as an interbody fusion device, the TRULIFT® 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 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.

Technological Characteristics:

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

{5}------------------------------------------------

Material:

This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and Co-26Cr-6Mo UNS R31537) Cobalt Chrome per ASTM F1537. This is the same material used in the predicate devices.

Performance Data:

Static Axial Compression, Dynamic Axial Compression, Static Shear and Dynamic Shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the Pro-Lift Expandable System (K191005).

Substantial Equivalence:

The TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System 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 TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System.

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.