The ALIF Spinal Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Device Description

The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.

The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in zero degree lordosis and 8 degree lordosis and each of these in 8 heights ranging from 10mm to 17mm in 1mm increments.

AI/ML Overview

The provided 510(k) summary describes an interbody fusion device, the ALIF Spinal Truss System (STS) Interbody Fusion Device, not an AI/ML powered device. Therefore, many of the requested criteria, such as those related to AI models, training sets, ground truth establishment for AI, human reader studies, and adjudication methods, are not applicable to this submission.

The document focuses on the mechanical and biological performance of the implant itself through pre-clinical testing, rather than the performance of an algorithm or diagnostic tool.

ALIF Spinal Truss System (STS) Interbody Fusion Device Performance Summary

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Mechanical Testing (per ASTM F2077):
Static Compression Shear	Preclinical testing performed; outcome indicates substantial equivalence to predicate devices.
Static Torsion	Preclinical testing performed; outcome indicates substantial equivalence to predicate devices.
Dynamic Axial Compression	Preclinical testing performed; outcome indicates substantial equivalence to predicate devices.
Dynamic Compressive Shear	Preclinical testing performed; outcome indicates substantial equivalence to predicate devices.
Other Mechanical Tests:
Subsidence (per ASTM F2267-04)	Testing performed; outcome indicates substantial equivalence to predicate devices.
Expulsion Testing (industry accepted methodology)	Testing performed; outcome indicates substantial equivalence to predicate devices.
Finite Element Analysis (FEA):
Mechanical Stiffness	Analysis completed.
Stress Quantification	Analysis completed.
Intra-cage Pressure Quantification	Analysis completed.
Porosity Quantification	Analysis completed.
Biological Performance:
Fusion in vivo (Animal Study)	Animal study in sheep performed, demonstrating fusion.

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

Test Set (Preclinical Testing): The document does not specify the exact sample sizes (e.g., number of devices tested) for each mechanical test. It generally states that "Preclinical testing performed" and an "animal study in sheep" were conducted.
Data Provenance: The preclinical mechanical tests (ASTM F2077, F2267-04, expulsion testing) and Finite Element Analysis were internal studies conducted by the manufacturer or their chosen testing facilities. The animal study was conducted in sheep. No country of origin is explicitly stated for the animal study, but given the 510(k) submission to the FDA, it is presumed to be compliant with US regulatory standards or equivalent. These are prospective studies and tests conducted specifically for this device submission.

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

This question is Not Applicable as the submission is for a physical interbody fusion device, not a diagnostic or AI-powered device requiring expert-established ground truth for its performance assessment. Performance is based on objective mechanical tests and a biological animal study.

4. Adjudication method for the test set

This question is Not Applicable as there is no diagnostic outcome or subjective assessment requiring adjudication in the context of this device's performance claims.

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

This question is Not Applicable as the submission is for a physical interbody fusion device, not an AI-assisted diagnostic tool.

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

This question is Not Applicable as the submission is for a physical interbody fusion device, not an algorithm.

7. The type of ground truth used

For Mechanical Performance: The "ground truth" is defined by the objective results of standardized ASTM tests and industry-accepted methodologies. The device's performance is compared against the performance of predicate devices or established engineering benchmarks for substantial equivalence.
For Biological Performance: The "ground truth" for fusion was evidence observed in the animal study (sheep). This would typically involve histological analysis, radiographs, or other methods to confirm bone growth and fusion in the animal model.

8. The sample size for the training set

This question is Not Applicable as the submission is for a physical interbody fusion device and does not involve AI model training data.

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

This question is Not Applicable as the submission is for a physical interbody fusion device and does not involve AI model training data or ground truth establishment for a training set.

Summary

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510(k) Summary according to 807.92(c)

JAN 18 201

Date prepared:	January 17, 2011
Contact:	Jessee Hunt, President
	4-Web Spine, Inc.
	6629 Whispering Woods Ct.
	Plano, TX 75024
	972-841-6126
Trade Name:	ALIF Spinal Truss System ® Interbody Fusion Device
Product Class:	Class II
Classification:	21 CFR §888.3080 Orthosis, intervertebral fusion
Product Codes:	MAX
Panel Code:	87

Indications for Use:

Device Description:

Predicate Device(s):

The ALIF STS® Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Infix System from Spinal Concepts (K031672) and the Brantigan Lumbar I/F Cage (AcroMed, P960025). (Add Titan Spine?)

Performance Testing:

Preclinical testing performed on the 4-Web STS® Interbody Fusion Device included static r receimedi compression shear, static torsion, dynamic axial compression, and dynamic

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K083894 page 2 of 2

compressive shear mechanical testing per ASTM F2077. Other mechanical tests included subsidence per ASTM F2267-04 and expulsion testing per an industry accepted methodology. Finite Element Analysis to assess mechanical stiffness, quantify stresses and intra-cage pressure and to quantify porosity was also completed. Finally, an animal study in sheep which demonstrated fusion was performed. The outcome of pre-clinical testing performed indicates that the ALIF STS® Interbody Fusion Device is substantially equivalent to the predicate devices..

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

4-Web Spine. Inc. % Richard Jansen, Pharm.D. Silver Pine Consulting 13540 Guild Avenue Apple Valley, Minnesota 55124

JAN 1 8 2011

Re: K083894

Trade/Device Name: ALIF Spinal Truss System® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2010 Received: December 27, 2010

Dear Dr. Jansen:

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. 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

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Page 2 - Richard Jansen, Pharm.D.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of

K083894

Statement of Indications for Use

510(k) Number (if known): K083894

Indications for Use:

The ALIF Spinal Truss Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K083894 510(k) Number_

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.