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).

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 0, 6, 8 and 12 degree lordosis and each of these in 9 heights ranging from 8mm to 17mm in 1mm increments.

AI/ML Overview

The provided document describes the 510(k) summary for the ALIF Spinal Truss System® Interbody Fusion Device. It details the device, its indications for use, and a comparison to predicate devices, focusing on mechanical performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Static Compression	Not explicitly stated, inferred to be comparable or better than predicates.	"The results indicate equal to or better than performance to the original design or other previously approved devices."
Static Compression Shear	Not explicitly stated, inferred to be comparable or better than predicates.	"The results indicate equal to or better than performance to the original design or other previously approved devices."
Static Torsion	Not explicitly stated, inferred to be comparable or better than predicates.	"The results indicate equal to or better than performance to the original design or other previously approved devices."
Dynamic Axial Compression	Not explicitly stated, inferred to be comparable or better than predicates.	"The results indicate equal to or better than performance to the original design or other previously approved devices."
Dynamic Compressive Shear	Not explicitly stated, inferred to be comparable or better than predicates.	"The results indicate equal to or better than performance to the original design or other previously approved devices."
Subsidence (per ASTM F2267-04)	Not explicitly stated, inferred to be comparable or better than predicates.	"The results indicate equal to or better than performance to the original design or other previously approved devices."
Expulsion Testing (per industry accepted methodology)	Not explicitly stated, inferred to be comparable or better than predicates.	"The results indicate equal to or better than performance to the original design or other previously approved devices."

Explanation of "Acceptance Criteria" based on the document:
The acceptance criteria are not quantitatively defined in the provided text. However, the regulatory submission relies on demonstrating substantial equivalence to predicate devices. Therefore, the implicit acceptance criteria for the mechanical performance tests are that the ALIF Spinal Truss System® Interbody Fusion Device performs "equal to or better than" the original design (K083894) or other previously approved predicate devices (DePuy/AcroMed Brantigan Cage and Advanced Medical Technologies Distractable Wave Cage).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the sample size (number of devices or tests performed) for the preclinical mechanical performance testing.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "Preclinical testing performed" by "4-Web Spine, Inc." It is assumed this testing was conducted in a laboratory setting for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of preclinical mechanical performance study. "Ground truth" in this context would typically refer to clinical outcomes or expert diagnoses, which are not part of a mechanical testing submission for substantial equivalence. The "truth" here is the physical performance as measured by ASTM standards and industry-accepted methodologies.

4. Adjudication Method for the Test Set

This is not applicable to preclinical mechanical performance testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or interpretive devices involving human readers, which is not the case for this interbody fusion device's mechanical performance assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is an interbody fusion implant, not an algorithm or software. Its performance is entirely standalone in a mechanical testing environment.

7. The Type of Ground Truth Used

As explained in point 3, the concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic devices is not directly applicable. For this mechanical performance study, the "ground truth" is established by adherence to and measurement against recognized industry standards (ASTM F2077, ASTM F2267-04) and industry-accepted methodologies, with the performance benchmarks being those of legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable. The ALIF Spinal Truss System® is a medical implant, not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as point 8.

Summary

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K112316 Page 10

DEC 14 2011

510(k) Summary according to 807.92(c)

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
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 4-Web

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Image /page/1/Picture/0 description: The image shows the logo for 4WEB. The logo consists of a geometric shape on the left and the word "4WEB" on the right. The geometric shape is a three-dimensional object made up of triangles. The word "4WEB" is in a bold, sans-serif font. There is a trademark symbol to the right of the word WEB.

KI12316

ge 1 of 2

Spine STS (K083894), the DePuy/AcroMed Brantigan Cage (P960025) and the Advanced Medical Technologies Distractable Wave Cage (K083626).

Performance Testing:

Preclinical testing performed on the 4-Web STS® Interbody Fusion Device included static compression, static compression shear, static torsion, dynamic axial compression, and dynamic compressive shear mechanical testing per ASTM F2077. Other mechanical tests included subsidence per ASTM F2267-04 and expulsion testing per an industry accepted methodology.

Design Changes to (K083894):

Design changes include reduced struts diameter, removal of struts, rounding the top and bottom rim, adding domed contact surfaces, rounding the posterior edge, adding thread ports, increasing the number of lordotic angles and heights available as well as adding one additional cross strut under the posterior rims. The modified design underwent the same performance testing as to the previously approved device. The results indicate equal to or better than performance to the original design or other previously approved devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 4 2011

4-Web Spine, Inc. % Silver Pine Consulting, Ltd. Rich Jansen, Pharm.D. 13450 Guild Avenue Apple Valley, Minnesota 55124

Re: K112316

Trade/Device Name: ALIF Spinal Truss System® Interbody Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: . Class II Product Code: MAX Dated: December 08, 2011 Received: December 09, 2011

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 -- Rich 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson
Director

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

Enclosure

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4-Web. Inc. 510(k)

Statement of Indications for Use

510(k) Number (if known): K112316

Indications for Use:

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) ・

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

KILZ316 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.