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

Device Description

The PROLIFT® 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. 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.

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 PROLIFT® Expandable Spacer System components with components from any other system or manufacturer. The PROLIFT® Expandable Spacer System components should never be reused under any circumstances.

AI/ML Overview

The provided FDA 510(k) clearance letter for the ProLift Expandable Spacer System does not describe the specific acceptance criteria and study proving the device meets those criteria in the level of detail requested. This document primarily focuses on the regulatory aspects of substantial equivalence for a medical device (an intervertebral body fusion device), not a software or AI-based diagnostic tool, which typically entails the type of performance evaluation outlined in your request.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission for a physical implant.

However, I can extract the information that is present and explain why other information is not available in this document.

Analysis of the Provided Document for Acceptance Criteria and Study Details

The provided document is an FDA 510(k) clearance letter for a medical device, specifically an intervertebral body fusion device (ProLift Expandable Spacer System). This type of clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than a de novo approval that often requires extensive clinical performance data with specific acceptance criteria as you've requested for an AI/software device.

For a physical device like this, performance data typically refers to mechanical testing, biocompatibility, and sterilization validation, not diagnostic accuracy metrics.

Here's what can be gathered from the document, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). For this physical device, "performance" refers to mechanical properties and material characteristics.

What is present regarding "performance":

Performance Data Section (Page 6): "Through the Comparison Analysis it is determined that the mechanical performance has not change as the worst case is still the same and therefore is substantially equivalent to the Life Spine ProLift Expandable Spacer System (K190488) and ProLift Micro Expandable Spacer System (K223430 & K212520)."

This indicates that the key "acceptance criterion" related to performance for this 510(k) submission was demonstrating that the mechanical performance of the new device is substantially equivalent to its predicate devices, meaning it performs similarly in relevant mechanical tests (e.g., strength, durability under load). No specific numerical acceptance values for mechanical performance are provided in this regulatory letter itself, as they would typically be detailed in the full 510(k) submission document.

2. Sample sizes used for the test set and the data provenance

Not applicable/Not provided in this document. For a physical mechanical device, "test set" in the context of AI/software performance is not relevant. Mechanical testing would involve a certain number of device samples, but this is not typically referred to as a "test set" in the same way. The document does not specify the number of devices or test conditions used for mechanical performance comparison. Data provenance (country of origin, retrospective/prospective) is also not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided in this document. "Ground truth" established by experts (like radiologists for imaging devices) is for diagnostic devices where human interpretation is being evaluated or augmented. For an intervertebral body fusion device, the "ground truth" of its mechanical properties would be established through engineering tests following industry standards, not expert consensus on interpretations.

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

Not applicable/Not provided in this document. Adjudication methods are relevant for resolving discrepancies in human expert interpretations, which is not the type of evaluation described for this device.

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/Not provided in this document. MRMC studies are specific to evaluating diagnostic accuracy, especially for AI-assisted image interpretation. This device is a physical implant, not a diagnostic tool.

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

Not applicable/Not provided in this document. This applies to algorithms. The device is a physical implant.

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

For this device, the "ground truth" for its performance would implicitly be based on engineering standards, material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and biomechanical testing standards to ensure it meets safety and functional requirements equivalent to established devices. The document explicitly mentions "mechanical performance" and "material."

8. The sample size for the training set

Not applicable/Not provided in this document. "Training set" is a concept for machine learning models.

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

Not applicable/Not provided in this document.

In summary, the provided FDA 510(k) clearance letter for the ProLift Expandable Spacer System is for a physical medical implant, not an AI or software-based diagnostic device. Therefore, the detailed performance study information typically associated with AI/software (acceptance criteria tables, expert adjudication, MRMC studies, ground truth establishment for training/test sets) is not present and generally not part of a 510(k) submission for this class of device.

The "study" that proves the device meets the (unspecified but implied mechanical) acceptance criteria is the "Comparison Analysis" mentioned on Page 6, which determined that the mechanical performance of the new device is substantially equivalent to the predicate devices. The specifics of this comparison (e.g., number of tests, exact parameters) would be in the full 510(k) submission, not typically in the public clearance letter itself.

Summary

FDA 510(k) Clearance Letter - ProLift Expandable Spacer System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 9, 2025

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

Re: K250373
Trade/Device Name: ProLift Expandable Spacer System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral body fusion device
Regulatory Class: Class II
Product Code: MAX
Dated: January 23, 2025
Received: February 10, 2025

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 (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.

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K250373 – Ms. Angela Batker
Page 2

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).

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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250373 – Ms. Angela Batker
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assistance/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

Enclosure

Page 4

K250373

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250373

Device Name
ProLift 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."

Page 5

K250373 - 510(k) Summary

ProLift Expandable Spacer System

Submitted By:
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118

510(k) Contact:
Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118

Date Prepared: March 25th, 2025

Trade Name: ProLift Expandable Spacer System

Common Name: Intervertebral Body Fusion Device

Classification: MAX, CFR 888.3080, Class II

Primary Predicate: Life Spine ProLift Expandable Spacer System (K190488)

Additional Predicate: Life Spine ProLift Micro (K212520, K223430)

Device Description:

Intended Use of the Device:

K250373 - 510(k) Summary
Page 1 of 2

Page 6

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

Material:

This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136). This is the same material used in the predicate devices.

Performance Data:

Through the Comparison Analysis it is determined that the mechanical performance has not change as the worst case is still the same and therefore is substantially equivalent to the Life Spine ProLift Expandable Spacer System (K190488) and ProLift Micro Expandable Spacer System (K223430 & K212520).

Substantial Equivalence:

The ProLift 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 The ProLift Expandable Spacer System.

K250373 - 510(k) Summary
Page 2 of 2

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.