The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate. supplemental fixation must be used.

Device Description

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through 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 heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Cervical Spine Truss System - CSTS). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance testing (mechanical and material testing, and finite element analysis).

It's crucial to understand that 510(k) submissions for devices like the CSTS (intervertebral body fusion devices) typically do not involve clinical studies with human participants in the same way that software-as-a-medical-device (SaMD) or drug trials do. Therefore, the concepts of "acceptance criteria for device performance studies," "sample sizes for test sets (in a clinical context)," "expert adjudication of ground truth," "MRMC studies," "standalone algorithms," and "training sets for AI models" as described in your prompt, are not applicable to this type of regulatory submission or the information contained within this document.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing that verifies the mechanical integrity and safety of the implant.

Here's how to address your prompt based only on the provided text, while clarifying the differences:

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

The document does not explicitly state numerical "acceptance criteria" for the mechanical tests in a tabular format, nor does it provide specific numerical "reported device performance" values. Instead, it states that the tests were completed "per the following standards" (ASTM F2077, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2051, and "accepted industry standard" for Expulsion Testing) and that the results "show that the strength of the CSTS interbody and CSTS Interbody with an Integrated Plate is sufficient for its use and is substantially equivalent to legally marketed predicate devices."

Table: Non-Clinical Performance Testing and Outcomes

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Summary)
Meets ASTM F2077 for Static Axial Compression	Strength sufficient for use; substantially equivalent to predicates
Meets ASTM F2077 for Static Compression Shear	Strength sufficient for use; substantially equivalent to predicates
Meets ASTM F2077 for Static Torsion	Strength sufficient for use; substantially equivalent to predicates
Meets ASTM F2077 for Dynamic Axial Compression (With and Without Integrated Plate)	Strength sufficient for use; substantially equivalent to predicates
Meets ASTM F2077 for Dynamic Compression Shear (With and Without Integrated Plate)	Strength sufficient for use; substantially equivalent to predicates
Meets ASTM F2077 for Dynamic Torsion (With and Without Integrated Plate)	Strength sufficient for use; substantially equivalent to predicates
Meets Screw Pushout Testing (per accepted industry standard)	Strength sufficient for use; substantially equivalent to predicates
Meets Expulsion Testing (per accepted industry standard)	Strength sufficient for use; substantially equivalent to predicates
Validated Finite Element Analysis (FEA) demonstrating non-inferiority to existing devices	Worst-case CSTS device for each endplate geometry is not a new worst-case compared to previously tested CSTS devices.
Meets ASTM F2119 for MR Image Artifact	Results support substantial equivalence to predicates for MR compatibility.
Meets ASTM F2182 for MR Induced Heating	Results support substantial equivalence to predicates for MR compatibility.
Meets ASTM F2213 for MR Induced Torque	Results support substantial equivalence to predicates for MR compatibility.
Meets ASTM F2051 for MR Induced Displacement Force	Results support substantial equivalence to predicates for MR compatibility.

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

Sample Size for Test Set: Not specified in terms of number of surgical cases or patient data, as this is not a clinical study. For mechanical testing, "sample size" refers to the number of physical devices or components tested, which is not detailed in this summary.
Data Provenance: Not applicable in the context of clinical data. The "data" refers to results from laboratory mechanical and MR compatibility testing, and finite element analysis.

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

This concept is not applicable as the "ground truth" for a mechanical device like this is established by adherence to engineering standards and validated models, not by expert consensus on clinical images or outcomes.

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

This concept is not applicable in this context.

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

An MRMC study is not applicable as this is not an AI/imaging device.

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

This concept is not applicable as this is not an AI/software device.

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

The "ground truth" (or verification of performance) for this device relies on:
- Adherence to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion device mechanical testing and MR compatibility.
- Validated Finite Element Analysis (FEA), which is a computational method used to predict how a product reacts to real-world forces, heat, vibration, etc.
- Demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics (indications for use, materials, function, sizes) and performance testing.

8. The sample size for the training set

This concept is not applicable as this is not an AI/machine learning device.

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

This concept is not applicable as this is not an AI/machine learning device.

In summary: The provided document is a regulatory submission for a physical medical implant. Its "acceptance criteria" and "proof" relate to meeting established engineering and material standards, and demonstrating substantial equivalence to similar devices already on the market, rather than clinical efficacy studies involving human participants or AI performance metrics.

Summary

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September 25, 2023

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

Re: K231739

Trade/Device Name: Cervical Spine Truss System (CSTS) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: June 14, 2023 Received: August 24, 2023

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. 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

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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 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-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 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,

Brent Showalter -S

Brent Showalter, Ph.D. 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

Submission Number (if known)

K231739

Device Name

Cervical Spine Truss System (CSTS)

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:	June 14,2023
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:	Cervical Spine Truss System
Product Class:	Class II
Classification:	21 CFR §888.3060, 21 CFR §888.3080
Common Name:	Intervertebral Body Fusion Device
Product Codes:	OVE, ODP
Panel Code:	87

Indications for Use:

The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate, supplemental fixation must be used.

Device Description:

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Predicate Device(s):

The primary predicate device is the 4WEB Medical Cervical Spine Truss System (K221266). Additional reference predicates include the 4WEB Medical Cervical Spine Truss System Stand Alone (K190870), Depuy Synthes ACIS anterior cervical interbody fusion device (K120275), and the 4WEB Medical Lateral Spine Truss System Plating Solution (K203065).

Performance Standards:

Performance testing has been completed per the following standards:

ASTM F2077 Static Axial compression ●
ASTM F2077 – Static Compression Shear
ASTM F2077 Static Torsion ●
ASTM F2077 – Dynamic Axial Compression (With and Without the Integrated Plate)
ASTM F2077 – Dynamic Compression Shear (With and Without the Integrated Plate)
ASTM F2077 - Dynamic Torsion (With and Without the Integrated Plate)
Screw Pushout Testing
Expulsion Testing per accepted industry standard

Validated finite element analysis demonstrated that the worst case CSTS device for each endplate geometry is not a new worst case compared to the previously tested CSTS devices within the 4WEB portfolio.

MR Conditional Testing has been completed on the primary predicate device, the 4WEB Cervical Spine Truss System (K221266) and the reference predicate device, the Lateral Spine Truss System Plating Solution (K203065) to the following standards:

. ASTM F2119 — MR Image Artifact
ASTM F2182 – MR induced Heating
ASTM F2213 MR Induced Torque ●
. ASTM F2051 – MR Induced Displacement Force

The results of this non-clinical testing show that the strength of the CSTS interbody and CSTS Interbody with an Integrated Plate is sufficient for its 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:

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4WEB, Inc. concludes that the CSTS 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.