The Lumbar Spine Truss System Plation (LSTS-PS) without integrated fixation is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The LSTS-PS with integrated fixation is intended to be attached to the Lateral Spine Truss System (LSTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS with integrated fixation is intended to be used with supplemental fixation (e.g. posterior fixation).

Device Description

The Lumbar Spine Truss System Plating Solution (LSTS-PS) is comprised of lumbar plates and screws. The lumbar plates have a rotating locking tab for each screw position to prevent back-out of the screw. The plates are available in 1-hole, and 4-hole integrated configurations and 2-hole and 4-hole non-integrated configurations. Each plate is available in multiple lengths for single level fusion. The screws are available in two diameters and various lengths to accommodate the patient's anatomy. All LSTS-PS plates and screws are made from Ti6Al4V alloy.

AI/ML Overview

This is a medical device application for the Lumbar Spine Truss System Plating Solution (LSTS-PS). The provided text describes the device, its indications for use, and a summary of performance testing. However, it does not contain the kind of information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria and a study proving those criteria were met for an AI algorithm.

The document discusses a physical medical device (plates and screws for spinal fixation), not an AI algorithm. Therefore, many of your requested points, such as sample size for test sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to the content provided.

Here's an attempt to answer your questions based on the provided document, highlighting where the information is absent or not applicable:

Acceptance Criteria and Study Proving Device Meets Criteria for Lumbar Spine Truss System Plating Solution (LSTS-PS)

As per the provided 510(k) summary, the device under review is a physical medical implant (spinal plates and screws), not an AI/SaMD algorithm. Therefore, the "acceptance criteria" and "study" described in the document refer to the mechanical and material performance of the hardware, tested against established engineering standards, rather than diagnostic performance of an AI.

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

The document states that the device has been tested per various ASTM standards (F1717, F543, F2077). The acceptance criterion, implicitly, is that the device meets or surpasses the requirements of these standards to be considered "sufficient for its intended use and substantially equivalent to legally marketed predicate devices."

The document provides a general statement about the performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Meet mechanical performance requirements per specified standards (ASTM F1717, F543, F2077) for:	"The results of this non-clinical testing show that the strength of the LSTS-PS is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
- Static axial compression bending	Sufficient strength
- Static torsion	Sufficient strength
- Dynamic axial compression bending fatigue	Sufficient strength
- Axial screw pushout	Sufficient strength
- Static axial compression	Sufficient strength
- Static compression shear	Sufficient strength
- Dynamic axial compression fatigue	Sufficient strength
- Dynamic compression shear fatigue	Sufficient strength

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

This information is not provided in the document. For mechanical testing, the sample size would refer to the number of physical devices or components tested. The term "data provenance" (country/retrospective/prospective) is typically for clinical data or imaging, which is not the focus of this particular submission.

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

This information is not applicable/provided. Since this is a physical device, the "ground truth" is established by the mechanical properties of the materials and the structural integrity of the design, measured by engineering tests, not by expert medical interpretation.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers for diagnostic studies, which is not relevant here.

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 information is not applicable/provided. This type of study applies to AI-assisted diagnostic devices. The LSTS-PS is a surgical implant.

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

This information is not applicable/provided. This question pertains to AI algorithm performance.

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

The "ground truth" for this device is based on engineering benchmarks and material specifications derived from the ASTM standards mentioned. This includes material properties, mechanical strength under various loads (static, dynamic, compression, torsion, shear), and resistance to fatigue.

8. The sample size for the training set

This information is not applicable/provided. "Training set" refers to data used to train an AI algorithm. In this context, there is no AI algorithm being developed or cleared. If interpreted very broadly, "training" for mechanical design might refer to iterative design processes, but typical sample sizes for training sets are not relevant here.

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

This information is not applicable/provided. As above, there is no "training set" in the context of an AI algorithm. The design and manufacturing of the physical device would follow engineering principles and material science, where performance targets are established based on industry standards and predicate device characteristics.

Summary

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March 10, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

Re: K203065

Trade/Device Name: Lumbar Spine Truss System Plating Solution (LSTS-PS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ, OVD Dated: February 6, 2021 Received: February 8, 2021

Dear Rich 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. 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 Actinclude 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 (QS) 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203065

Device Name

Lumbar Spine Truss System Plating Solution (LSTS-PS)

Indications for Use (Describe)

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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510(k) Summary

Date Prepared:	February 3, 2021
Contact:	Jessee Hunt, President
	4WEB, Inc.
	2801 Network Blvd., Suite 620
	Frisco, TX 75034
	Phone: (800) 285-7090
	Fax: 972-488-1816
Regulatory Contact:	Rich Jansen, Pharm. D.
	Silver Pine Consulting, LLC
	richj@s-pineconsulting.com
Trade Name:	Lumbar Spine Truss System Plating Solution (LSTS-PS)
Product Class:	Class II
Classification:	21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis
Common Name:	Intervertebral Body Fusion Device with Integrated Fixation
Product Codes:	KWQ, OVD
Panel Code:	87

Indications for Use:

The Lumbar Spine Truss System Plating Solution (LSTS-PS) without integrated fixation is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (11-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The LSTS-PS with integrated fixation is intended to be attached and remain attached to the Lateral Spine Truss System (LSTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS with integrated fixation is intended to be used with supplemental fixation (e.g. posterior fixation).

Device Description:

The Lumbar Spine Truss System Plating Solution (LSTS-PS) is comprised of lumbar plates and screws. The lumbar plates have a rotating locking tab for each screw position to prevent back-out of the

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screw. The plates are available in 1-hole, and 4-hole integrated configurations and 2-hole and 4-hole non-integrated configurations. Each plate is available in multiple lengths for single level fusion. The screws are available in two diameters and various lengths to accommodate the patient's anatomy. All LSTS-PS plates and screws are made from Ti6Al4V alloy.

Predicate Device(s):

The primary predicate device is the CoreLink Lateral Plate System (K190016). Reference predicates include the 4WEB Lateral Spine Truss System (K172392), 4WEB Anterior Spine Truss System – Stand Alone (K200002) and Nuvasive Modulus XLIF Interbody System (K192760).

Performance Standards:

The Lumbar Spine Truss System Plating Solution (LSTS-PS) has been tested per the following:

Static axial compression bending per ASTM F1717
Static torsion per ASTM F1717
Dynamic axial compression bending fatigue per ASTM F1717
Axial screw pushout per ASTM F543
Static axial compression per ASTM F2077
Static compression shear per ASTM F2077
Dynamic axial compression fatigue per ASTM F2077
Dynamic compression shear fatigue per ASTM F2077

The results of this non-clinical testing show that the strength of the LSTS-PS is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

Technological Characteristics:

4WEB, Inc. has compared these devices to the previously cleared predicate devices in regard to indications for use, materials, function, sizes and simulated testing. These comparisons demonstrate substantial equivalence to the predicate devices.

Conclusion:

4WEB, Inc. concludes that the LSTS-PS devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.