The Anterior Spine 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 and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

Device Description

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Anterior Spine Truss System (STS) Interbody Fusion Device." This device is an intervertebral body fusion device made from Ti6Al4V alloy, designed with an open architecture truss to support bone growth and fusion. It's intended for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, and must be used with supplemental fixation and bone graft.

Based on the provided text, the document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance testing (mechanical, MR compatibility). It does NOT describe a clinical study involving human patients, nor a study on an Artificial Intelligence (AI) device.

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/Machine Learning device's performance against human readers or standalone performance, expert ground truth establishment, or sample sizes for training/test sets in the context of an AI study.

The acceptance criteria and "study" described in this document are related to the physical properties and mechanical performance of the implied medical device itself, not an AI component.

Here's what can be inferred about the "acceptance criteria" and "study" from the provided text, related to the physical device:

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

The document doesn't provide a direct table of specific acceptance limits alongside the exact numerical results for each test. Instead, it lists the performance standards that the device was tested against. The "reported device performance" is implicitly that the device met these standards, allowing for a finding of substantial equivalence.

Acceptance Criteria Category	Specific Standard/Test	Implied Performance Statement
Mechanical Performance	ASTM F2077	Met (Static & dynamic axial compression, static & dynamic compression shear, static torsion)
	ASTM F2267-04	Met (Subsidence Testing)
MR Compatibility	ASTM F2119	Met (MR Image Artifact)
	ASTM F2052	Met (MR Induced Displacement Force)
	ASTM F2213	Met (MR Induced Torque)
	ASTM F2182	Met (MR Induced Heating)
Other	Expulsion testing	Met (per accepted industry standard)

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

Sample size: Not applicable in the context of a clinical study or AI model test set. For mechanical and MR testing, "samples" would refer to the number of physical devices tested to statistically demonstrate compliance with the standards. This specific number is not provided in the document, but it's typically a small number of devices (e.g., 5-10 per test) as per the individual ASTM standards.
Data provenance: Not applicable. These are engineering tests performed on the device itself, not on patient data.

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

This is not applicable as there is no "ground truth" in the context of a clinical or AI study. The "ground truth" for the device's performance is established by the engineering standards themselves and the results of the physical tests.

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

This is not applicable as there are no expert readers or interpretations to adjudicate in these engineering and MR compatibility tests.

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 is not applicable. This document describes an interbody fusion device, not an AI or imaging diagnostic device that would involve human readers.

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

This is not applicable. This document describes a physical medical implant, not an algorithm.

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

The "ground truth" for this device's performance is compliance with established engineering and material standards (ASTM standards), demonstrated through physical testing of the device.

8. The sample size for the training set:

This is not applicable as there is no training set mentioned for an AI model.

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

This is not applicable as there is no training set mentioned for an AI model.

In summary, this document is a 510(k) submission for a physical medical device (an interbody fusion device) and does not involve AI or machine learning technology, nor does it describe a clinical study with human patients in the typical sense of evaluating diagnostic or treatment effectiveness through patient outcomes. The "study" refers to the engineering performance testing to demonstrate the device meets predefined physical and material requirements.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 7, 2017

Image /page/0/Picture/4 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

4Web. Inc. % Rich Jansen Consultant Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers, Florida 33905

Re: K170851

Trade/Device Name: Anterior Spine Truss System (STS) Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 6, 2017 Received: July 10, 2017

Dear Mr. 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 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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170851

Device Name

Anterior Spine Truss System (STS) Interbody Fusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Date Prepared:	August 7, 2017
Contact:	Jessee Hunt, President4WEB, Inc.6170 Research Rd. Suite 219Frisco, TX 75033Phone: (800) 285-7090Fax: 972-488-1816
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consulting, LLCrichj@s-pineconsulting.com
Trade Name:Product Class:	Anterior Spine Truss System (STS) Interbody Fusion DeviceClass II
Classification:	21 CFR §888.3080
Common Name:	Intervertebral Body Fusion Device
Product Codes:	MAX
Panel Code:	87

Purpose:

The purpose of this submission is to update the system with design changes to implants and instruments, update sterile packaging, add new EBM machining, revise the Indications for Use, and add MR Conditional labeling.

Indications for Use:

The Anterior Spine 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 devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Device Description:

{4}------------------------------------------------

made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

Predicate Device(s):

The primary predicate device is the 4WEB ALIF STS (K112316). Additional predicates include K142112, K150135 and K160924.

Performance Standards:

Performance testing has been completed per the following standards: ASTMF2077 - Static and dynamic axial compression, static and dynamic compression shear, and static torsion ASTM F2267-04 - Subsidence Testing ASTM F2119 - MR Image Artifact ASTM F2052 - MR Induced Displacement Force ASTM F2213 – MR Induced Torque ASTM F2182 - MR Induces Heating Expulsion testing per accepted industry standard.

Technological Characteristics:

4Web, Inc. has compared these changes to the previously cleared predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.

Conclusion:

4WEB, Inc. concludes that the Anterior Spine Truss System (STS) devices are substantially equivalent to the predicate devices.

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.