The ProLift® Lateral HELO 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 discogence 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 HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous bone. The ProLift® Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift® Lateral HELO Fixated may optionally be used with two bone screws.

Device Description

The ProLift® Lateral HELO 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-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. 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.

All implants are provided and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Lateral HELO Fixated with components from any other System or manufacturer. The ProLifi® Lateral HELO Fixated components should never be reused under any circumstances.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "ProLift Lateral HELO Fixated," which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with acceptance criteria and device performance results in the context of an AI-powered diagnostic device or a study involving human readers.

Therefore, many of the requested fields are not applicable to the information contained in this FDA 510(k) submission.

Here's an analysis based on the provided text, indicating where information is not applicable:

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

The document does not explicitly state acceptance criteria in a table format with corresponding reported device performance values as would be expected for a diagnostic AI study. Instead, it refers to performance data from mechanical testing.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document as specific performance metrics and targets for each test. The overall acceptance criterion is to demonstrate that the device is "safe, effective and substantially equivalent" to the predicate.	"Static axial compression, dynamic axial compressive shear and dynamic compressive shear testing according to ASTM F2077, was presented to demonstrated that the ProLifi® Lateral HELO Fixated is safe, effective and substantially equivalent to the Pro-Lift Expandable System (K173182)." Specific numerical results are not provided in this summary.

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

Sample size for test set: Not applicable. This is a mechanical testing study, not a clinical study with patient data. The "test set" would refer to the number of devices or constructs tested. The specific number of devices tested for each mechanical test is not provided in this summary.
Data provenance: Not applicable. The data is from mechanical testing, not patient data.

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)

Not applicable. This is a mechanical testing study, not a study requiring expert clinical review or diagnosis to establish ground truth.

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

Not applicable. This is a mechanical testing study. Adjudication methods are relevant for clinical studies or studies using human readers.

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. This document describes a submission for a physical medical device (intervertebral body fusion device), not an AI-powered diagnostic system. No MRMC study was conducted or is relevant.

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

Not applicable. This document is for a physical medical device, not an algorithm.

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

The "ground truth" for the mechanical testing would be defined by the standardized testing protocols (ASTM F2077) and the physical properties of the materials and device design. The "acceptance" is based on meeting or exceeding the performance of the predicate device under these standardized conditions.

8. The sample size for the training set

Not applicable. This is a medical device clearance based on substantial equivalence and mechanical testing, not an AI model that requires a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study referenced is based on mechanical performance testing to demonstrate the safety, effectiveness, and substantial equivalence of the ProLift® Lateral HELO Fixated device to its predicate devices.

Study Type: Mechanical Performance Testing

Tests Conducted:

Static axial compression
Dynamic axial compressive shear
Dynamic compressive shear

Standard Used: ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices)

Comparison: The performance of the ProLift® Lateral HELO Fixated was compared to the Pro-Lift Expandable System (K173182) to demonstrate substantial equivalence.

Conclusion: The information presented, including the mechanical testing, demonstrated the substantial equivalency of The ProLift Lateral HELO Fixated in terms of indications for use, design, function, materials used, and mechanical performance to its predicate devices. The implicit "acceptance criteria" were met by demonstrating that the device performed comparably to, or better than, the predicate device under the established ASTM F2077 standards. Specific numerical results of these tests are not included in this summary.

Summary

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April 30, 2021

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

Re: K210061

Trade/Device Name: ProLift® Lateral HELO Fixated Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: January 28, 2021 Received: February 1, 2021

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/cdrb/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 vou. 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 (OS) 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(@;tda.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

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Indications for Use

510(k) Number (if known) K210061

Device Name ProLift Lateral HELO Fixated

Indications for Use (Describe)

The The ProLift® Lateral HELO 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 discogence 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 HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous bone. The ProLift® Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift® Lateral HELO Fixated may optionally be used with two bone screws.

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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K210061 510(k) Summary ProLift Lateral HELO 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 5th, 2021
Trade Name:	ProLift Lateral HELO Fixated
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, CFR 888.3080, Class IIOVD, CFR 888.3080, Class II
Primary Predicate:	Life Spine ProLift Lateral Fixated (K200338)
Additional Predicate:	Life Spine TruLift Expandable Cage (K201721)Life Spine ProLift Expandable System (K173182)Globus Elsa Spacer (K161379)Life Spine Plateau Spacer System (K080411)

Device Description:

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Indications for Use:

The ProLift® Lateral HELO 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 HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The ProLift® Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift® Lateral HELO Fixated may optionally be used with two bone screws.

Technological Characteristics:

The ProLifi® Lateral HELO Fixated has the same technological charrateristics as the predicates devices including design, intended use, material composition, function and range of sizes.

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 axial compression, dynamic axial compressive shear and dynamic compressive shear testing according to ASTM F2077, was presented to demonstrated that the ProLifi® Lateral HELO Fixated is safe, effective and substantially equivalent to the Pro-Lift Expandable System (K173182).

Substantial Equivalence:

The ProLift Lateral HELO 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 HELO 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.