The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

Device Description

VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Polyetheretherketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-rav. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment (B) is installed. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. InterFuse T device will be available in two anterior - posterior (AP) lengths of 20 mm and 24 mm. The middle segment (B) comes in two widths (9 mm or 10 mm).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the InterFuse® T - Intervertebral Body Fusion Device, which is a spinal implant. This submission is for a modification to an already cleared device, and the primary focus of the document is to demonstrate substantial equivalence to the predicate device through non-clinical testing.

Therefore, the requested information about acceptance criteria and device performance as it pertains to AI/algorithm performance metrics (like sensitivity, specificity, MRMC studies, standalone performance, and ground truth establishment with experts) is not applicable to this submission. This document details a physical medical device, not an AI or software device.

However, I can extract the information relevant to the non-clinical performance claims and the study conducted to demonstrate the modified device's equivalence to its predicate.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of a clinical trial or AI evaluation. Instead, it states that the modified device was tested to ensure it met performance standards for intervertebral body fusion devices, and the results supported substantial equivalence to the predicate. The "acceptance criteria" implicitly are that the modified device's performance is comparable to or better than the predicate device in the specified tests, conforming to relevant ASTM standards.

Acceptance Criteria (Implied)	Reported Device Performance
Performance comparable to predicate device per ASTM standards.	Modified device passed all tested parameters.
Meet standards for:
- Static and Dynamic Compression (per ASTM F2077)	Demonstrated sufficient static and dynamic compression.
- Static and Dynamic Compression Shear (per ASTM F2077)	Demonstrated sufficient static and dynamic compression shear.
- Subsidence (per ASTM F2267)	Demonstrated acceptable subsidence characteristics.
- Expulsion testing	Demonstrated acceptable expulsion resistance.

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

Sample Size: Not explicitly stated in terms of a number of devices or iterations for each test. The document refers to "bench testing" and "performance data" but does not quantify the number of units tested.
Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Thus, there is no country of origin of data or retrospective/prospective nature to describe in this context.

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

This is not applicable to the non-clinical bench testing described. "Ground truth" in this context would refer to the validated measurement methods and standards (e.g., ASTM F2077, F2267) used in the mechanical testing. There were no human experts establishing a subjective ground truth.

4. Adjudication Method for the Test Set

Not applicable. This refers to the process of resolving discrepancies in expert opinions, which did not occur in this bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for evaluating human interpretation of medical images or data, often with AI assistance, which is not the subject of this 510(k) submission.

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For this mechanical device, the "ground truth" for the non-clinical tests is based on established engineering standards and validated test methodologies as outlined by organizations like ASTM (e.g., ASTM F2077, ASTM F2267). The performance is measured against these objective, quantitative standards.

8. The Sample Size for the Training Set

Not applicable. This refers to training data for algorithms, which is not relevant for this physical device.

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

Not applicable for the same reason as above.

Summary

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

K110226

3. 510(k) SUMMARY

MAY 2 7 2011

510(k) SUMMARY [as required by section 807.92(c)]

510(k) Owner's Name:	Vertebral Technologies, Inc.
Address:	5909 Baker Road, Suite 550Minnetonka, MN 55345
Phone/Fax/Email:	Office - Direct: (952) 979-9357Company Main Tel: (952) 912-5400Fax: (952) 912-5410email: sghai@vti-spine.com
Name of Contact Person:	Suresh Ghai, Ph.D.VP, Quality and Regulatory Affairs
Date prepared:	25th January, 2011
Trade or Proprietary Name:	InterFuse®T - Intervertebral Body Fusion Device
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device with Bone Graft, Lumba21 CFR § 888.3080Product code: MAXDevice Class: II

3.1 LEGALLY MARKETED DEVICE TO WHICH YOUR FIRM IS CLAIMING EQUIVALENCE The modified InterFuse® T - Intervertebral Body Fusion Device is substantially equivalent in performance, indication, design and material to VTI's own InterFuse® T Intervertebral Body Fusion Device cleared under Premarket notification # K102277.

3.2 DEVICE DESCRIPTION

Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

Pg 1 of 2

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

3.3 INTENDED USE OF THE DEVICE

3.4 TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

The modified InterFuse® T - Intervertebral Body Fusion Device (current submission) is substantially equivalent in performance, indication, design and materials to InterFuse® T Intervertebral Body Fusion Device from Vertebral Technologies, Inc., cleared under 510(k) premarket notification # K102277.

3.5 SUMMARY AND CONCLUSIONS FROM THE NONCLINICAL TESTS SUBMITTED

The substantial equivalence is supported by bench testing comparing the modified InterFuse® T Intervertebral Body Fusion Device to the predicate un-modified device (K102277).

The basic design of the device has not changed from the 510(k) cleared device (K102277). Devices with a new AP length (i.e. 20 mm) are being added in this submission.

There is no change to the materials of construction of the device, manufacturing process, packaging materials, packaging configuration, sealing parameters (and sealing equipment), sterilization process and sterility assurance level. The shelf-life of the modified device has also not changed.

The performance of the modified device (InterFuse T) was tested, post gamma irradiation sterilization as detailed below:

Static and Dynamic Compression; Static and Dynamic Compression Shear per ASTM F2077 .
Subsidence per ASTM F2267 .
Expulsion testing .

Substantial equivalence comparison between the modified InterFuse T and the predicate device is given in section 10.

The detailed performance results are given in section 11.

On the basis of performance data it is concluded that the modified device (InterFuse T -Intervertebral Body Fusion Device) is substantially equivalent to the unmodified InterFuse T device (K102277).

Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

Pg 2 of 2

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circular shape.

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

Vertebral Technologies, Inc. % Suresh Ghai, Ph.D. VP, Quality & Regulatory Affairs 5909 Baker Road, Suite 550 Minnetonka, Minnesota 55345

MAY 2 7 2011

Re: K110226

Trade/Device Name: InterFuse T Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 03, 2011 Received: May 05, 2011

Dear Dr. Ghai:

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

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

Page 2 - Suresh Ghai, Ph.D.

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 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 yours,

Eric S. Keith

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

Enclosure

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

2. STATEMENT OF INDICATION FOR USE

Indication for Use

KIIO226 510(k) Number (if known): Device Name: InterFuse® T - Intervertebral Body Fusion Device

Indications for Use:

The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

Prescription Use(Part 21 CFR 801 Subpart D)	X
-------------------------------------------------	---

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Or

vision of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K110226

Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

17 of 117

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.