The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are 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 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) consists of a series of titanium implants that are designed to provide mechanical support to the spine while biologic fusion occurs. 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 multiple sizes to accommodate varied patient's anatomy.

AI/ML Overview

This document is focused on the regulatory clearance of a medical device, specifically a Spine Truss System, based on substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the requested information on acceptance criteria and studies proving an AI device meets those criteria, as well as details like sample sizes for test/training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable and cannot be extracted from the provided text.

The document discusses preclinical testing for mechanical performance of the spine truss system, which is different from validating an AI algorithm's performance.

Here's what can be extracted related to the device and its assessment, framed as closely as possible to your request, but highlighting the difference in context:

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

Acceptance Criteria (Performance Standards)	Reported Device Performance (Summary of Preclinical Testing)
Meet requirements of static axial compression per ASTM F2077	Performed as intended, demonstrating substantial equivalence to predicate devices.
Meet requirements of static compression shear per ASTM F2077	Performed as intended, demonstrating substantial equivalence to predicate devices.
Meet requirements of dynamic axial compression per ASTM F2077	Performed as intended, demonstrating substantial equivalence to predicate devices.
Meet requirements of dynamic compressive shear per ASTM F2077	Performed as intended, demonstrating substantial equivalence to predicate devices.
Meet subsidence requirements per ASTM F2267-04	Performed as intended, demonstrating substantial equivalence to predicate devices.
Meet expulsion testing requirements	Performed as intended, demonstrating substantial equivalence to predicate devices.

Important Note: These are mechanical performance criteria for an implantable device, not performance metrics for an AI algorithm. The reporting states the devices "performed as intended, demonstrating substantial equivalence," which is the regulatory standard for this type of device, implying the test results fell within acceptable ranges defined by the ASTM standards for equivalence. Specific numerical performance values are not provided in this summary.

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

Sample Size for Test Set: Not applicable in the context of an AI device. For the mechanical testing of the Spine Truss System, the sample size (number of devices tested) for each specific test (static axial compression, dynamic axial compression, etc.) is not explicitly stated in this summary.
Data Provenance: Not applicable in the context of an AI device. The tests are preclinical mechanical tests performed on physical devices, not clinical data sets from patients of a specific country.

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 is not applicable as the device is a spinal implant, not an AI diagnostic tool. Ground truth in this context refers to the defined parameters of the ASTM mechanical tests.

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

Not applicable as this is not an AI diagnostic study requiring expert adjudication.

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:

Not applicable. This device is a physical medical implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm.

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

For the preclinical mechanical testing, the "ground truth" is defined by the objective quantitative measurements and pass/fail criteria established by the ASTM standards (e.g., ASTM F2077, ASTM F2267-04) for intervertebral body fusion devices.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

Summary

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

April 9, 2015

4WEB, Incorporated % Richard Jansen, Pharm. D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Ft. Myers, Florida 33905

Re: K143258

Trade/Device Name: PLIF STS, TLIF STS and OLIF STS (Spine Truss System) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 6, 2015 Received: March 9, 2015

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 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

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Page 2 - Dr. Richard Jansen

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/Resourcesfor You/Industry/default.htm. 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 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 vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K143258

Device Name PLIF STS, TLIF STS and OLIF STS (Spine Truss System)

Indications for Use (Describe)

The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are 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).

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)

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FOR FDA USE ONLY

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

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K143258 510(k) Summary

Date Prepared:	April 4, 2015
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:	PLIF STS, TLIF STS and OLIF STS (Spine Truss System)
Product Class:	Class II
Classification:	21 CFR §888.3080
Common Name:	Intervertebral Body Fusion Device
Product Codes:	MAX
Panel Code:	87

Indications for Use:

The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from 12-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:

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Predicate Device(s):

The 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) is substantially equivalent to the Primary Predicate, the 4WEB ALIF STS (K112316). Additional predicates include the K2M Aleutian (K133614) and the Orthofix Forza (K103111).

Performance Standards:

Preclinical testing performed on the 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) included static axial compression, static compression shear, dynamic axial compression, and dynamic compressive shear mechanical testing per ASTM F2077. The other mechanical test included subsidence per ASTM F2267-04 as well as expulsion testing to demonstrate substantial equivalence.

Technological Characteristics

The 4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System) is exactly the same as the primary predicate device in Indications for Use, materials, manufacturing and design. It is substantially equivalent to the additional predicate devices in sizes, surgical approaches risks.

Conclusion:

4WEB, Inc. concludes that the PLIF STS, TLIF STS and OLIF STS (Spine Truss System) devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.

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.