Axis Spine Technologies ALIF by Axis Spine Technologies Ltd

The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The ALIF System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Description

The Axis Spine Technologies ALIF is an inter-fixated interbody system consisting of a modular interbody spacer manufactured from Ti6Al4V. The system is designed to be assembled in vivo. The spacer comprises of two endplates and a central core. Each component is available in a variety of shapes and sizes to allow the assembled device to suit the individual pathology and anatomical conditions of the patient.

The Axis Spine Technologies ALIF System intervertebral fusion device is designed to address lumbar pathologies utilizing placement through an anterior approach. The device's hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft to help promote a solid fusion. A rough surface on the device endplates serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The subject device is indicated for use with supplemental internal spinal fixation (i.e., posterior pedicle screw and rodsystem).

The Axis Spine Technologies ALIF implant is composed of:

one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.
one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-4V ELI) ● conforming to ASTM F136 and ISO 5832-3.
one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to . ASTM F136 and ISO 5832-3.
three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) ● conforming to ASTM F136 and ISO 5832-3.
one (1) cover plate manufactured from PEEK-Optima HA Enhanced. ●

AI/ML Overview

This document is a 510(k) summary for the Axis Spine Technologies ALIF system, an intervertebral body fusion device. It details the device's characteristics, intended use, and comparative testing against predicate devices to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided PDF:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, etc., and "reported device performance" are typical for diagnostic or AI-driven devices where a quantitative measure of performance against a ground truth is established.

However, this document describes a spinal implant (intervertebral body fusion device). For such devices, acceptance criteria primarily revolve around mechanical performance, biocompatibility, and substantial equivalence to existing devices, rather than diagnostic accuracy. The "study" proving acceptance criteria is primarily non-clinical (bench) testing and comparison to predicate devices.

Therefore, the table format for typical medical device AI/diagnostic performance metrics (sensitivity, specificity, etc.) is not directly applicable here. Instead, the acceptance criteria are based on biocompatibility and mechanical performance tests to ensure the device is safe and effective and performs comparably to or better than predicate devices.

Table of Acceptance Criteria (for a spinal implant) and Reported Device Performance:

Acceptance Criterion Type	Specific Test/Standard	Acceptance Goal (Implicit)	Reported Device Performance (Summary)
Mechanical Performance	Static Compression per ASTM F2077	Meets or exceeds predicate device performance; within design specifications	The Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device.
	Dynamic Compression per ASTM F2077	Meets or exceeds predicate device performance; within design specifications	The Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device.
	Static Compression Shear per ASTM F2077	Meets or exceeds predicate device performance; within design specifications	The Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device.
	Dynamic Compression Shear per ASTM F2077	Meets or exceeds predicate device performance; within design specifications	The Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device.
	Subsidence per ASTM F2267	Resistance to subsidence comparable to or better than predicate device	The Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device.
	Expulsion and Axial Pushout of Retention Device Testing	Secure fixation and resistance to expulsion	The Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device.
Material/Biocompatibility	Ti6Al4V ELI conforming to ASTM F136 and ISO 5832-3; PEEK-Optima HA Enhanced	Biocompatible and safe for implantation; materials meet established standards	Materials used conform to specified ASTM and ISO standards for implantable devices.

The study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical (bench-top) performance testing program and a comparison against legally marketed predicate devices.

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set (Non-Clinical): For mechanical testing, the "sample size" refers to the number of physical devices or components tested. While not explicitly stated with a specific number (e.g., n=X devices), the tests were conducted per relevant ASTM standards (ASTM F2077, ASTM F2267). These standards specify the number of samples required for each test (e.g., 6 samples for static compression, 3 for dynamic, etc.).
- Data Provenance: The device is manufactured by Axis Spine Technologies Ltd, located in the United Kingdom. The testing would have been conducted in a laboratory setting, typically in the country of manufacture or a qualified testing facility. The data is retrospective in the sense that it's generated from manufactured devices for the purpose of regulatory submission, not from a patient population study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For an implantable medical device undergoing non-clinical mechanical testing, "ground truth" is established by engineering standards and specifications (e.g., ASTM standards) and the objective physical measurements of the devices' performance.
- There isn't a concept of a "human expert" establishing ground truth in the way a radiologist establishes ground truth for an AI diagnostic algorithm. The "experts" involved would be engineers and technicians conducting the tests in accordance with validated protocols and interpreting the results against the specified standards and predicate device performance. Their qualifications would be in biomedical engineering, mechanical engineering, or materials science.
Adjudication method for the test set:
- Not applicable in the context of non-clinical mechanical testing. Adjudication is relevant for subjective assessments (like image interpretation) where multiple readers' opinions need to be reconciled. Here, the results are quantitative physical measurements.
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 study is a clinical study typically used to evaluate the performance of diagnostic devices or AI algorithms when used by human readers. This submission is for an implantable spinal fusion device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm-driven device. It is a physical implant.
The type of ground truth used:
- For this device, the "ground truth" is defined by established engineering performance standards (ASTM) and the demonstrated performance characteristics of the legally marketed predicate devices. The goal is to show comparable or superior mechanical performance and material properties.
The sample size for the training set:
- Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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May 20, 2020

Axis Spine Technologies Ltd Mr. Edwin Lindsay QA/RA Consultant Suite 204, 54-56 Victoria Street St. Albans, AL1 3HZ United Kingdom

Re: K200352

Trade/Device Name: Axis Spine Technologies ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 3, 2020 Received: March 11, 2020

Dear Mr. Lindsay:

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

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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 (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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Enclosure

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Indications for Use

510(k) Number (if known) K200352

Device Name Axis Spine Technologies ALIF

Indications for Use (Describe)

The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1.

The ALIF System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

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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For Axis Spine Technologies ALIF

510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name:

Axis Spine Technologies Ltd

Submitter's Address:

Axis Spine Technologies Ltd Suite 204, 54-56 Victoria Street, St. Albans, AL1 3HZ United Kingdom

Telephone: +44 (0) 330 123 0535

Contact Person:

Edwin Lindsay Telephone +44 (0) 7917134922

Date Prepared:

19th May 2020

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For Axis Spine Technologies ALIF

Below summaries the Device Classification Information regarding the Axis Spine Technologies ALIF:

Primary Product Code:

RegulationNumber	Device	DeviceClass	ProductCode	ClassificationPanel
883.3080	Axis Spine ALIF	2	OVD	Orthopedic

Device Trade Name:

Axis Spine Technologies ALIF

Device Common Name:

Intervertebral Body Fusion Device

Intended/ Indications Use:

The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The ALIF System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Summary of Substantial Equivalence:

The following predicate devices have been chosen that the Axis Spine Technologies ALIF can claim equivalence with, and these are detailed below:

● Primary Predicate:

K132596 - Custom Spine Optimus ALIF System

● Additional Predicate:

K170592 - NuVasive BASE Interfixated Titanium System

Any technical differences have been justified, both scientifically and using performance testing, These do not affect the safety or effectiveness of the proposed device.

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For Axis Spine Technologies ALIF

Device Description:

The Axis Spine Technologies ALIF implant is composed of:

one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.
one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-4V ELI) ● conforming to ASTM F136 and ISO 5832-3.
one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to . ASTM F136 and ISO 5832-3.
three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) ● conforming to ASTM F136 and ISO 5832-3.
one (1) cover plate manufactured from PEEK-Optima HA Enhanced. ●

Technological Characteristics:

As was established in this submission, the subject Axis Spine Technologies ALIF is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States.

The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

Non-Clinical Tests (Performance/Physical Data):

Nonclinical testing was performed to demonstrate that the subject BASE Interfixated Titanium System is substantially equivalent to other predicate devices. The following testing was performed:

Static and dynamic compression testing per ASTM F2077
Static and dynamic compression shear testing per ASTM F2077 ●
Subsidence testing per ASTM F2267
Expulsion and Axial Pushout of Retention Device testing

The results of these studies show that the Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.

Animal Studies

No animal studies were conducted as part of submission to prove substantial equivalence.

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For Axis Spine Technologies ALIF

Clinical Studies

No clinical studies were conducted as part of submission to prove substantial equivalence.

Safety and Effectiveness/Conclusion:

Based on the information presented in these 510(k) premarket notifications the Axis Spine Technologies ALIF is considered substantially equivalent. The Axis Spine Technologies ALIF is as safe and effective as the currently marketed predicate devices.

Based on testing and comparison with the predicate devices, the Axis Spine Technologies ALIF indicated no adverse indications or results. It is our determination that the Axis Spine Technologies ALIF is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.

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.