When used as an interbody fusion device, the ProLift® 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 ProLift 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) as described by ASTM F136. The implant allows packing 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.

AI/ML Overview

The provided text is an FDA 510(k) summary for the ProLift® Expandable System, which is an intervertebral body fusion device. Upon reviewing the text, it is clear that this document describes the submission and clearance of a medical device based on showing substantial equivalence to predicate devices, rather than an AI/ML medical device that requires a study proving its performance against acceptance criteria.

The document discusses:

Device Name: ProLift® Expandable System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral body fusion device
Regulatory Class: Class II
Product Code: MAX
Indications for Use: Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), to be used with autograft/allogeneic bone graft and supplemental internal spinal fixation system.
Technological Characteristics: Substantially equivalent to predicate systems in terms of design, materials, indications for use, and sizing.
Material: Titanium alloy (Ti-6Al-4V ELI)
Performance Data: Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, and subsidence according to ASTM F2267. These are mechanical tests, not AI/ML performance studies.
Conclusion: Demonstrates substantial equivalency.

Therefore, the information required to specifically answer your questions regarding acceptance criteria and a study proving an AI/ML device's performance (like sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in this document. The provided text describes the regulatory clearance process for a physical medical implant, not a software-as-a-medical-device (SaMD) or an AI/ML-driven diagnostic tool.

However, if we interpret "acceptance criteria" and "study" in the context of this specific device (ProLift® Expandable System) as outlined in the document, it refers to the mechanical and material performance needed to demonstrate substantial equivalence.

Here's an attempt to answer your questions based on the closest relevant information provided, interpreting "study" as the mechanical performance testing conducted for this physical device:

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

The document does not provide a specific table with numerical acceptance criteria and performance results (e.g., minimum compression strength, actual measured strength) but mentions the types of tests conducted to demonstrate substantial equivalency to predicate devices. The "acceptance criteria" in this context would be that the device performs at least as well as, or comparably to, the predicate devices in these mechanical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Meets or exceeds mechanical properties of predicate devices	Static compression, dynamic compression, static and dynamic shear testing demonstrated substantial equivalency.
Demonstrates acceptable subsidence characteristics	Subsidence testing according to ASTM F2077 and ASTM F2267 was presented to demonstrate substantial equivalency.
Fabricated from specified material with acceptable strength	Fabricated from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, same material as predicate devices.
Conforms to "Indications for Use" and "Intended Use"	The device's design, materials, and mechanical performance support its intended use for spinal fusion in DDD patients with specific conditions and adjunctive therapies.

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

This information is not provided in the document. For mechanical testing of a physical device, "sample size" would refer to the number of devices or components tested. The data provenance (country, retrospective/prospective) is typically relevant for clinical or observational studies, not mechanical bench testing of an implant.

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)

This question is geared towards AI/ML diagnostic devices. For a physical implant, "ground truth" would be established by validated test methods (e.g., ASTM standards) and objective measurements using calibrated equipment, not expert consensus or clinical expert review. Therefore, this information is not applicable/provided.

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

This question refers to the process of resolving discrepancies in expert labeling or diagnoses, common in AI/ML validation. This is not applicable to the mechanical testing described for this physical 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

No such study was conducted or is applicable for this physical medical implant. MRMC studies are specific to evaluating AI/ML diagnostic tools in a clinical setting with human readers.

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

This refers to the performance of an AI algorithm on its own. This is not applicable to a physical intervertebral fusion device.

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

For this physical device, the "ground truth" (or basis for evaluation) for performance is established through standardized mechanical testing (e.g., ASTM F2077, ASTM F2267) and material specifications (ASTM F136). It is not based on expert consensus, pathology, or clinical outcomes data presented in this particular 510(k) summary, which focuses on bench testing for substantial equivalence.

8. The sample size for the training set

This question is related to AI/ML model development. It is not applicable to this physical device. The device itself is not "trained."

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

This question is related to AI/ML model development. It is not applicable to this physical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

July 23, 2019

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

Re: K190488

Trade/Device Name: ProLift® Expandable System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 21, 2019 Received: June 25, 2019

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/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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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 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 Melissa Hall, M.S. 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

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

510(k) Number (if known) K190488

Device Name ProLift® Expandable System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K190488 510(k) Summary ProLift® Expandable 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:	February 18th, 2019
Trade Name:	ProLift® Expandable System
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, 21 CFR 888.3080, Class II
Primary Predicate :	ProLift Expandable Cage System (K173182)
Additional Predicate:	ProLift Expandable Cage System (K153400)Globus Caliber Spacer (K123231)Globus Rise Spacer (K113447)Life Spine Plateau (K080411)

Device Description:

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

Intended Use of the Device:

When used as an interbody fusion device, the ProLift® 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 nonfusion 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 Pro-Lift Expandable System 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 implant grade (Ti-6AL-4V) Titanium alloy according to F136. This this is the same material used in the predicate devices.

Performance Data:

Static compression, dynamic compression, static and dynamic shear testing and subsidence according to ASTM F2077, as well as subsidence according to ASTM F2267, was presented to demonstrate the substantial equivalency of the Pro-Lift Expandable System.

Substantial Equivalence:

The Pro-Lift Expandable 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 Life Spine Pro-Lift Expandable 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.