The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. Th DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Device Description

The Cervical STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. 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 two basic "footprint" sizes, 17mm x 14mm x 11mm. These sizes are available in zero and 7 degree lordosis and each of these in 8 heights ranging from 5mm to 12mm in 1mm increments.

AI/ML Overview

The provided text describes the 510(k) summary for the Cervical Spinal Truss System (STS) Interbody Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than a clinical study evaluating human reader performance with or without AI.

Therefore, many of the requested criteria related to clinical studies, human readers, AI, and ground truth establishment are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Static Axial Compression (per ASTM F2077)	Performed, results indicate substantial equivalence
Static Compression Shear (per ASTM F2077)	Performed, results indicate substantial equivalence
Static Torsion (per ASTM F2077)	Performed, results indicate substantial equivalence
Dynamic Axial Compression (per ASTM F2077)	Performed, results indicate substantial equivalence
Dynamic Compressive Shear (per ASTM F2077)	Performed, results indicate substantial equivalence
Dynamic Torsion (per ASTM F2077)	Performed, results indicate substantial equivalence
Subsidence (per ASTM F2267-04)	Performed, results indicate substantial equivalence
Expulsion Testing (per industry accepted methodology)	Performed, results indicate substantial equivalence

Note: The document only states that testing was "performed" and that the "minor differences that do exist do not raise any new types of safety or efficacy issues" and "do not adversely impact device performance." Specific numerical acceptance values or detailed performance data are not provided in this 510(k) summary (which is typical for such summaries, as detailed data is usually in the full submission).

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

Sample size: Not explicitly stated for each test (e.g., how many devices were tested for static compression). The tests appear to be benchtop mechanical engineering tests, not tests on biological samples or patient data.
Data provenance: Not applicable in the context of clinical data. These are laboratory-based mechanical performance tests.

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

Not applicable. This device's evaluation is based on engineering performance tests against established ASTM standards and an industry-accepted methodology for expulsion testing. It does not involve human expert interpretation of data points in the way a diagnostic AI would.

4. Adjudication method for the test set

Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for mechanical performance testing against objective standards.

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

No such study was done. This document is for an interbody fusion device, not a diagnostic AI system.

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

Not applicable. This refers to diagnostic AI system performance; the device is a physical implant.

7. The type of ground truth used

Objective engineering standards and measurements: The "ground truth" for the performance testing is adherence to the specified ASTM standards and an "industry accepted methodology" for expulsion testing. This is based on physical properties and mechanical behavior.

8. The sample size for the training set

Not applicable. This evaluation does not involve machine learning or a training set.

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

Not applicable. This evaluation does not involve machine learning or a training set.

Summary

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510(k) Summary according to 807.92(c)

K121741

OCT 1 8 2012

January 17, 2011 Date prepared: Jessee Hunt, President Contact: 4-Web, Inc. 6170 Research Road, Suite #219 Frisco, TX 75033 972-841-6126

Trade Name: Product Class: Classification: Product Codes: Panel Code:

Cervical Spinal Truss System ® Interbody Fusion Device Class II 21 CFR §888.3080 Orthosis, intervertebral fusion ODP 87

Indications for Use:

Device Description:

Predicate Device(s):

The Cervical STS® Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAK/C (P980048), Phantom Plus Cage (K082801), Endoskeleton TC (K100889) and for manufacturing and materials purposes, the 4-Web ALIF STS (K083894, K112316).

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K121741 Page 2 of 2

Performance Testing:

Preclinical testing performed on the 4-Web Cervical STS® Interbody Fusion Device included static axial compression, static compression shear, static torsion, dynamic axial compression, dynamic compressive shear and dynamic torsion mechanical testing per ASTM F2077. Other mechanical tests included subsidence per ASTM F2267-04 and expulsion testing per an industry accepted methodology.

Conclusion:

4-Web, Inc concludes that the Cervical STS device is the same intended use as the predicate devices. The indications for use are the same and the materials used are also the same as the predicate devices. There are no significant differences in technological characteristics compared to the predicates, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, bench testing demonstrates that these differences do not adversely impact device performance. 4-Web concludes that the Cervical STS device is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

4-Web. Incorporated % Silver Pine Consulting, Limited Mr. Richard Jansen, Pharm. D. Consultant 13540 Guild Avenue Apple Valley, Minnesota 55124

OCT 18 2012

Re: K121741

Trade/Device Name: Cervical Spinal Truss System® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 01, 2012 Received: October 02, 2012

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Richard Jansen, Pharm. D.

device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours,

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

Enclosure

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Statement of Indications for Use

510(k) Number (if known): _KI217 41

Indications for Use:

The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Prescription Use ___ ج (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI21741 510(k) Number_

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.