The ProLift® Lateral Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral Fixated is to be filled with autograft and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.

Device Description

The ProLift® Lateral Fixated 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) 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. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

AI/ML Overview

This document (K200338) is a 510(k) premarket notification for a medical device called ProLift® Lateral Fixated, which is an intervertebral body fusion device. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is at least as safe and effective.

The provided document does not contain information about software, artificial intelligence (AI),
or a study involving human readers and AI assistance. This submission focuses on the mechanical and material performance of an implantable intervertebral fusion device, not on diagnostic or AI-powered image analysis.

Therefore, I cannot fulfill the request for information regarding AI acceptance criteria, human reader studies, or ground truth establishment in the context of an AI device, as the content is irrelevant to those topics.

The document describes the following acceptance criteria and the study that proves the device meets them for this specific type of medical device (intervertebral fusion device):

Here's the relevant information from the document regarding the device's performance validation:

A table of acceptance criteria and the reported device performance:
- The document primarily refers to standard ASTM testing for intervertebral body fusion devices. It implies that the acceptance criteria are adherence to these standards.
- Acceptance Criteria (Implied by standard testing): Meets the performance requirements for static compression, dynamic compression, static shear, and dynamic shear as specified by ASTM F2077.
- Reported Device Performance: "Static compression, dynamic 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)." (This suggests the ProLift® Lateral Fixated met these criteria as it's being compared to a predicate that already demonstrated this).
- The document states: "The ProLift® Lateral Fixated was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance."
Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for mechanical testing. This information would typically be in a detailed test report, which is not included in this summary.
- Data provenance is not applicable here as it's lab-based mechanical testing of the physical device, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is mechanical engineering testing, not expert interpretation of diagnostic data. The "ground truth" is established by the physical properties and performance measured against ASTM standards.
Adjudication method for the test set:
- Not applicable. This is not a study involving human adjudication of data; it's mechanical testing.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an implantable medical device, not an AI or diagnostic software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not relevant to an implantable device.
The type of ground truth used:
- The "ground truth" for the mechanical performance of this device is established by compliance with recognized consensus standards (ASTM F2077) for intervertebral body fusion devices and direct measurement of mechanical properties (e.g., strength, durability) under load.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for an implantable device, as there is no machine learning or AI involved.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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April 17, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K200338

Trade/Device Name: ProLift® Lateral Fixated Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: February 7, 2020 Received: February 11, 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 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

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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 medical devices and radiation-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,

for

Brent Showalter, Ph.D. 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) K200338

Device Name ProLift® Lateral Fixated

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 ProLift® Lateral Fixated

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:	April 13th, 2020
Trade Name:	ProLift® Lateral Fixated
Common Name:	Intervertebral Fusion Device With Integrated Fixation, Lumbar
Classification:	OVD, CFR 888.3080, Class IIMAX, CFR 888.3080, Class II
Primary Predicate:	Life Spine ProLift Expandable System (K191005)
Additional Predicate:	Life Spine ProLift Expandable System (K173182)Globus Elsa (K161379)Life Spine Sentry (K180166)

Device Description:

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Intended Use of the Device:

The ProLift® Lateral Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift Lateral Fixated System is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.

Technological Characteristics:

The ProLift® Lateral Fixated 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-6Al-4V ELI) as described by ASTM F136. This this is the same material used in the predicate devices.

Performance Data:

Static compression, dynamic 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 ProLift® Lateral Fixated 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® Lateral Fixated.

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.