The Cervical Spine Truss System Plating Solution (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Cervical Spine Truss System Plating Solution (CSTS-PS) is comprised of cervical plates and screws. The cervical plates have a rotating locking tab for each double screw position to prevent back-out of the screw. The plates are available in 1-level, 3-level, 4-level, and 5-level configurations. Each plate is available in multiple lengths to accommodate varying patient anatomy. The screws are available in two diameters and various lengths. All CSTS-PS plates and screws are made from Ti6Al4V alloy.

AI/ML Overview

The provided text describes the Cervical Spine Truss System Plating Solution (CSTS-PS), a medical device intended for anterior interbody screw fixation of the cervical spine. It focuses on demonstrating the device's substantial equivalence to predicate devices, particularly regarding its mechanical performance.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Set by FDA Guidance Document)	Reported Device Performance
Performance criteria for safety and performance based pathway for Spinal Plating Systems (December 11, 2020), specifically for: - Static compression bending - Dynamic compression bending - Static torsion - Screw push out testing	"All performance testing has met the acceptance criteria established in FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway., December 11, 2020." (This statement confirms that the device did meet all specified criteria for these tests, without providing numerical results in this document.)
MR Conditional (per ASTM F2503)	"The CSTS-PS implants are MR Conditional per ASTM F2503."

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

The study described is focused on the mechanical performance of the device, not a clinical study involving patients or human data.

Sample Size for Test Set: The text does not explicitly state the number of devices or components tested for each mechanical test (static compression bending, dynamic compression bending, static torsion, screw push out). It only indicates that "4WEB has conducted" these tests. For these types of biomechanical tests, sample sizes are typically determined by established standards like ASTM F1717 and ASTM F543, which would specify the number of samples required.
Data Provenance: The data is generated from in-vitro (benchtop) testing in a laboratory setting by the manufacturer, 4WEB Medical, Inc. It is not patient data, and therefore, concepts like "country of origin" or "retrospective/prospective" do not apply in the typical sense for clinical trials.

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

This question is not applicable in the context of this submission. The "ground truth" for mechanical performance tests is established by the specified ASTM standards (F1717, F543, F2503) and the FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway. These standards and guidelines dictate the testing methodologies and acceptance thresholds, which are developed through a consensus process involving engineers, scientists, and regulatory bodies. The compliance is against these pre-defined, objective criteria, not based on expert consensus on individual test outcomes in the same way clinical ground truth is established.

4. Adjudication Method for the Test Set:

Not applicable. Mechanical testing results are objectively measured against pre-defined numerical or qualitative criteria specified in the ASTM standards and FDA guidance. There is no human adjudication process involved in interpreting these mechanical test results beyond verifying that the measurements fall within the acceptable ranges.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation AI devices where human readers' performance is being evaluated with and without AI assistance. The CSTS-PS is a physical medical implant, and its evaluation revolves around its mechanical and material properties, not its interpretive capabilities.

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

Not applicable. The CSTS-PS is a surgical implant, not an algorithm or AI system. Its "performance" is assessed through its physical and mechanical properties in a standalone, benchtop testing environment.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is derived from established engineering standards and regulatory guidance. Specifically:

ASTM F1717: Standard Test Methods for Static and Fatigue Testing of Spinal Implant Constructs in a Corpectomy Model.
ASTM F543: Standard Specification for Metallic Medical Bone Screws.
ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway (December 11, 2020): This document provides the specific acceptance criteria for the various mechanical tests.

These documents establish the objective performance benchmarks against which the device's mechanical integrity and MR compatibility are evaluated.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its development and testing are based on engineering principles and materials science, not machine learning.

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

Not applicable, as there is no "training set" for this device.

Summary

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

May 18, 2022

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

4WEB Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, Florida 33905

Re: K212527

Trade/Device Name: Cervical Spine Truss System Plating Solution (CSTS-PS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ

Dear Richard Jansen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 17, 2022. Specifically, FDA is updating the device name in the Indications for Use as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Colin O'Neill, OHT6: Office of Orthopedic Devices, colin.oneill@fda.hhs.gov.

Sincerely,

Colin O'neill -S

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

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

May 17, 2022

Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

4WEB Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossv Oak Drive Fort Myers, Florida 33905

Re: K212527

Dear Richard 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 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

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

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 (OS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

Colin O'neill -S

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

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

Indications for Use

510(k) Number (if known) K212527

Device Name

Cervical Spine Truss System Plating Solution (CSTS-PS)

Indications for Use (Describe)

The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1.

The Cervical Spine Truss System Plation (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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

510(k) Summary

Date Prepared:	April 12, 2022
Contact:	Jessee Hunt, President4WEB, Inc.2801 Network Blvd., Suite 620Frisco, TX 75034Phone: (800) 285-7090Fax: 972-488-1816
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consulting, LLCrichj@s-pineconsulting.com
Trade Name:	Cervical Spine Truss System Plating Solution (CSTS-PS)
Product Class:	Class II
Classification:	21 CFR §888.3060
Common Name:	Spinal intervertebral body fixation orthosis
Product Codes:	KWQ

Indications for Use:

The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1.

The Cervical Spine Truss System Plating Solution (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description:

{5}------------------------------------------------

Predicate Device(s):

The primary predicate device is the Nuvasive Archon Anterior Cervical Plate System (K131025). Additional predicates include the 4WEB Lumbar Spine Truss System Plating Solution (K203065), 4WEB Cervical Spine Truss System (K173159), and 4WEB Cervical Spine Truss System-Stand Alone (K190870).

Performance Standards:

4WEB has conducted static compression bending, dynamic compression bending, static torsion, and screw push out testing per ASTM F1717 and ASTM F543 on the subject device. All performance testing has met the acceptance criteria established in FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway., December 11, 2020. The CSTS-PS implants are MR Conditional per ASTM F2503.

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 CSTS-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.