The Avenue T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Description

The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous or allogenic bone graft for fusion.

After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral locking pin.

The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and ASTM F2063 wrought nickel-titanium shape memory alloy anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.

The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.

AI/ML Overview

This looks like a 510(k) submission for a medical device, specifically an intervertebral body fusion device (Avenue T TLIF Cage). The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, much of the information you've requested regarding AI algorithm performance, ground truth, expert consensus, and reader studies is not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily refers to general performance criteria through mandated ASTM standards and other non-clinical tests. It doesn't present precise numerical acceptance criteria with corresponding performance values in a direct table format as might be seen for an AI algorithm. Instead, it states that the device "is sufficient for its intended use" and "conformance to endotoxin limits."

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Mechanical Strength	Dynamic compressive shear testing per ASTM F2077-11	Sufficient for intended use
Stability/Fixation	Static anchoring plate expulsion testing	Sufficient for intended use
Durability	Wear testing & debris analysis	Not explicitly detailed, but implied as sufficient
Biocompatibility	Corrosion testing	Not explicitly detailed, but implied as sufficient
Sterility/Endotoxin	Limulus Ameebocyte Lysate (LAL) endotoxin testing	Conformance to endotoxin limits
Design Integrity	Finite Element Analysis	Not explicitly detailed, but implied as sufficient

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

This question is not applicable as there is no "test set" in the context of an AI algorithm or clinical study with human patients used for demonstrating performance in this 510(k) submission. The non-clinical tests would have their own sample sizes (e.g., number of devices tested for mechanical properties), but these are not specified in the summary.

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

This question is not applicable. There is no "ground truth" establishment in the context of medical image interpretation or diagnosis by experts as this submission is for a physical implant device, not a diagnostic AI tool.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as (3).

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 question is not applicable. This submission is for a physical medical device (spinal cage), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This question is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

This question is not applicable. For an intervertebral body fusion device, "ground truth" would relate to successful fusion or clinical outcomes, which are not assessed in this non-clinical submission. The "truth" for the bench tests is adherence to engineering specifications and performance standards.

8. The Sample Size for the Training Set:

This question is not applicable. This is not an AI algorithm.

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

This question is not applicable. This is not an AI algorithm.

Summary of Relevant Information from the Document:

Device Type: Avenue® T TLIF Cage (Intervertebral body fusion device with integrated fixation, lumbar).
Purpose of Submission: To demonstrate substantial equivalence to a predicate device via non-clinical performance data.
Performance Data Provided: Non-clinical bench testing, including:
- Finite Element Analysis
- Dynamic compressive shear testing per ASTM F2077-11
- Static anchoring plate expulsion testing
- Wear testing & debris analysis
- Corrosion testing
- Limulus Ameebocyte Lysate (LAL) endotoxin testing
Conclusion: The non-clinical testing demonstrated that the Avenue T TLIF Cage is sufficient for its intended use, conforms to endotoxin limits, and is substantially equivalent to legally marketed predicate devices.
Clinical Data: "Clinical testing was not required to demonstrate substantial equivalence." (Page 5)

This document is a typical 510(k) clearance letter and summary for a Class II medical device, relying heavily on engineering and material performance tests rather than clinical trials or AI performance evaluations.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other.

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

September 28, 2016

LDR Spine USA, Inc. Mr. Brad Strasser Manager, U.S. Regulatory Affairs 13785 Research Blvd, Suite 200 Austin, Texas 78750

Re: K161173

Trade/Device Name: Avenue® T TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 1, 2016 Received: September 2, 2016

Dear Mr. Strasser:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K161173

Device Name Avenue® T TLIF Cage

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Research Use (Part 21 CFR 312 Subject to Review)
☐ Care That Is Subject to Health Insurance Portability and Accountability Act (HIPAA)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image is a logo for LDR. The logo features a stylized eye-shaped graphic in light blue on the left, followed by the letters "LDR" in bold, dark blue font. Below the letters, there is a tagline that reads "a passion for innovation" in a smaller, lighter font.

	510(k) Summary
Owner's Name & Address:	LDR Spine USA13785 Research Blvd. Suite 200Austin, TX 78750
Contact Person:	Brad Strasser, RACManager, U.S. Regulatory AffairsPhone: (512) 344-3395Fax: (512) 795-8306Email: brad.strasser@zimmerbiomet.com
Date:	September 27, 2016
Trade Name:	Avenue® T TLIF Cage
Common Name:	Intervertebral body fusion device with integrated fixationlumbar
Panel:	Orthopedic
Product Code:	OVD
Classification:	Class II, 21 CFR 888.3080
Primary Predicate Device:	K142645 Avenue T TLIF Cage
Additional Predicates:	K153495 Avenue T TLIF Cage

Device Description:

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inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral locking pin.

The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.

Indications for Use:

Non-Clinical Performance Data:

Non-clinical performance bench testing considered to support substantial equivalence for the Avenue T TLIF Cage included:

Finite Element Analysis ●
. Dynamic compressive shear testing per ASTM F2077-11
Static anchoring plate expulsion testing ●
. Wear testing & debris analysis
. Corrosion testing
. Limulus Amebocyte Lysate (LAL) endotoxin testing

The results of this non-clinical testing demonstrate that the Avenue T TLIF Cage is sufficient for its intended use in terms of strength and conformance to endotoxin limits and is therefore substantially equivalent to legally marketed predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for LDR. The logo consists of a stylized eye shape in light blue, with a figure inside the eye. To the right of the eye is the text "LDR" in dark blue, with the letters stacked on top of each other. Below the logo is the text "a passion for innovation" in a smaller font size.

Clinical Performance Data:

Clinical testing was not required to demonstrate substantial equivalence.

Comparison of Technological Characteristics:

The Avenue T TLIF Cage system is substantially equivalent to the predicate devices based on intended use and indications for use. There are no differences in fundamental scientific technology from the predicate device. Minor differences in technological characteristics were assessed via a risk analysis and verification and validation activities. These activities demonstrated that the technological differences between the subject and predicate devices do not raise any new questions of safety and effectiveness, and the Avenue T TLIF Cage is substantially equivalent to the predicate.

Conclusion:

In conclusion, non-clinical testing has demonstrated the subject Avenue T TLIF Cage is equivalent to the predicate device in terms of bench performance and conformance with endotoxin limits. Verification and validation activities performed in conjunction with risk analysis demonstrate the device does not raise any issues of safety and effectiveness. Therefore, the Avenue T TLIF Cage overall is substantially equivalent to the predicate device.

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.