Avenue P 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). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The device is implanted via a transforaminal or posterior approach and intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Avenue P is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation cleared for use as an adjunct to fusion in the lumbar spine.

Device Description

The Avenue® P Cage System consists of various sized, titanium coated, PEEK intervertebral body fusion cages, titanium anchoring plates for integrated fixation, and associated instrumentation. The system is intended to be used to stabilize lumbosacral spinal segments, promote spinal fusion in combination with bone graft and to restrict motion at the implanted vertebral level.

The Avenue® P cages have been designed for use with optional VerteBRIDGE® integrated fixation anchoring plates. Upon insertion, the VerteBRIDGE® anchoring plate provides and maintains additional stability and expulsion resistance by direct purchase into the bony vertebral endplates.

The base material of the Avenue® P Cage System implant is polyetheretherketone (PEEK-OPTIMA LT1) which conforms to ASTM F2026-12. This PEEK base is coated on the superior and inferior surfaces with a plasma sprayed, commercially pure titanium (SPONDYCOAT-T 371A) conforming to ASTM F1580-12.

AI/ML Overview

The provided text describes the Zimmer Biomet Spine, Inc. Avenue® P Cage System (K181096), an intervertebral body fusion device. The submission is a 510(k) premarket notification, which aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, rather than proving its effectiveness through a de novo study with specific clinical performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, and ground truth establishment for AI/algorithm-based devices is not directly applicable in this context.

Here's a breakdown of what is available in the document, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is typically found in submissions for novel devices or those undergoing a de novo classification, where a specific performance threshold needs to be met to demonstrate safety and effectiveness. For a 510(k) submission like K181096, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through various tests.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary of Performance Data)
Mechanical integrity according to ASTM standards (ASTM F2077)	Intervertebral body fusion device assessed and tested appropriately in accordance with ASTM standards. Functioned as intended and demonstrated substantial equivalence to predicate devices.
MR Safety according to ASTM standards (ASTM F2052, F2213, F2119, F2182)	MR Safety testing conducted. In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate devices.
Intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles are same as or similar to predicates.	Identified as same as, or similar to, the primary predicate CONCORDE® Bullet (K151773), and additional predicates Lucent Ti-Bond Systems (K150061), Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645), and ROI-C Titanium-Coated Implant System (K151934).
No new issues of safety or effectiveness compared to predicate devices.	"The subject Avenue® P components do not raise any new issues of safety or effectiveness when compared to the cited predicates. Performance data presented also demonstrated comparable properties to the previously cleared devices."

2. Sample size used for the test set and the data provenance: Not applicable. This submission is for a medical device (intervertebral cage) and primarily relies on mechanical and safety testing against established standards and comparisons to predicate devices, not on a test set of data like an AI algorithm would use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is relevant for clinical studies or AI algorithm validation, not for the mechanical and material testing described here.

4. Adjudication method for the test set: Not applicable for the reasons stated above.

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: Not applicable. This is not an AI-assisted diagnostic or treatment planning device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implantable medical device.

7. The type of ground truth used: For this type of device, the "ground truth" aligns with established engineering principles, material science, and biocompatibility standards. The various ASTM standards (F2077 for mechanical testing, F2052, F2213, F2119, F2182 for MR safety) represent the accepted criteria and methodologies for evaluating the performance and safety of such implants.

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for an intervertebral body fusion device. Its focus is on demonstrating "substantial equivalence" to existing, legally marketed predicate devices through engineering and material testing, rather than presenting clinical study data with acceptance criteria for a novel therapeutic or diagnostic outcome. Therefore, many of your specific questions related to AI/algorithm validation or clinical efficacy studies are not addressed in this type of regulatory submission.

Summary

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January 15, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer Biomet Spine, Inc. Mr. Alex Pawlowski Regulatory Affairs Specialist 10225 Westmoor Drive Westminster, Colorado 80021

Re: K181096

Trade/Device Name: Avenue® P Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: December 14, 2018 Received: December 18, 2018

Dear Mr. Pawlowski:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall -S

For 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) K181096

Device Name Avenue® P Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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/1 description: The image shows the logo for Zimmer Biomet, a medical device company. The logo consists of a stylized letter Z in blue, followed by the company name in gray. Above the logo, the text "K181096 Page 1 of 3" is visible, likely indicating a document identifier and page number.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date	April 25, 2018
Applicant/Sponsor	Zimmer Biomet Spine, Inc.10225 Westmoor Dr.Westminster, CO 80021
Contact Person	Alex PawlowskiRegulatory Affairs SpecialistPhone: 303-533-1062Fax: 303-465-5522
Trade Name	Avenue® P Cage System
Common Name	Intervertebral body fusion device
Device Class	Class II
Classification Name	OVD - Intervertebral Body Fusion Device With Integrated Fixation, Lumbar(21 CFR 888.3080)MAX – Intervertebral Body Fusion Device With Bone Graft, Lumbar(21 CFR 888.3080)
Device Panel	Orthopedic

Device Description & Technological Characteristics:

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Image /page/4/Picture/1 description: The image shows the logo of Zimmer Biomet, a medical device company. The logo consists of a stylized blue "Z" followed by the text "ZIMMER BIOMET" in a sans-serif font. Above the logo, the text "K181096 Page 2 of 3" is visible, likely indicating a document number and page number.

Intended Use / Indications for Use:

Summary of Technological Characteristics:

The technological characteristics of the subject Avenue® P cage system components remain the same as, or similar to, the primary predicate, CONCORDE® Bullet (K151773), and the additional predicates, Lucent Ti-Bond Systems (K150061), Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles. The purpose of this submission is to seek clearance for the Avenue® P Cage System.

Summary of Performance Data:

To support substantial equivalence, mechanical testing of the intervertebral body fusion implants of the subject Avenue P Cage System were assessed and tested appropriately in accordance with ASTM standards. The assessment concluded that intervertebral body fusion device are substantially equivalent to the identified predicates for use with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing included assessments per ASTM F2077 (axial compression shear, and torsion). MR Safety testing was conducted per ASTM F2052 (Displacement Force), ASTM F2213 (Torque), ASTM F2119 (Image Artifact), and ASTM F2182 (RF heating). In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the Zimmer Biomet logo, which consists of a blue stylized "Z" and the text "ZIMMER BIOMET" in a sans-serif font. Above the logo, there is the text "K181096" and "Page 3 of 3". The logo and text are likely part of a document or presentation.

Substantial Equivalence:

The subject Avenue® P Cage System implants have intended use, indications, technological characteristics, and principles of operation as the previously cleared CONCORDE® Bullet (K151773), Lucent® Ti-Bond Systems (K150061), Biomet Spine Fusion System (K153695), Avenue T TLF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934). Additionally, the subject Avenue® P Cage System and it's predicates are regulated under 21 CFR 888.3080. The subject Avenue® P components do not raise any new issues of safety or effectiveness when compared to the cited predicates. Performance data presented also demonstrated comparable properties to the previously cleared devices.

Conclusion:

The Avenue® P Cage System is substantially equivalent to the predicate system as a spinal fixation device in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the CONCORDE® Bullet, Lucent Ti-Bond, Biomet Spine Fusion, Avenue T TLIF Cage and ROI-C Titanium-Coated Implant Systems which have been cleared for intervertebral body fusion. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.

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.