The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Device Description

The Ardis® Interbody System is an implant device for interbody fusion of the anterior column of the spine. It is available in various height, width and length options. The device has a textured "tooth" pattern on both the cranial and caudal sides of the device and teardrop holes on the medial and lateral sides of the device. The implant incorporates an internal cavity that allows for the placement of bone graft material.

The system includes the single-use spacer implant, as well as the associated reusable instruments used for site preparation, trialing, and placement/extraction of the device, such as rasps, tamps, shavers, bone funnel, bone tamp, slap-hammer, T-handle and trials.

AI/ML Overview

The provided document pertains to the 510(k) summary for the Ardis® Interbody System, an implantable medical device, not an AI/ML powered device. As such, it does not contain information typically found in studies for AI/ML devices, such as acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test sets in an AI/ML context, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone performance, or training set details.

The "Summary of Performance Testing" section describes a simulated surgical evaluation using a cadaver specimen. This type of test is for the physical and functional aspects of the surgical device and instruments, not for an AI/ML algorithm's performance.

Here's the relevant information that can be extracted, interpreted in the context of a non-AI medical device:

Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Meet documented user needs and intended use (of the Ardis Interbody System and associated instruments)	"All responses met the established acceptance criteria."
Function (of the associated instruments)	Evaluated and met criteria.
Performance (of the associated instruments)	Evaluated and met criteria.
Conformance to user needs and intended use (of the associated instruments)	Validated and met criteria.

Sample size used for the test set and the data provenance:
- Sample Size: A "cadaver specimen" was used. The document does not specify the number of cadaver specimens.
- Data Provenance: The cadaver specimen provides biological/anatomical data. The study involved "participating healthcare professionals" suggesting a U.S. or similar clinical setting for the evaluation. Prospectiveness is implied as it's a simulated surgical evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Participating healthcare professionals" were involved. The exact number is not specified.
- Qualifications of Experts: Not explicitly stated, but "healthcare professionals" implies medical doctors or other qualified clinical staff who would typically perform or assist in spinal surgeries.
Adjudication method for the test set:
- Not applicable in the context of this type of performance testing for a physical device. The "function, performance, and conformance to user needs and intended use" were "validated based on responses received from the participating healthcare professionals," indicating an expert review or feedback process. It doesn't describe a formal adjudication method as understood for diagnostic accuracy studies.
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, an MRMC study was not done. This study is for a physical surgical implant system, not an AI tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI/ML algorithm. The performance testing was for the physical device and instruments, involving human interaction (healthcare professionals performing a simulated surgery).
The type of ground truth used:
- For this type of device, "ground truth" relates to the physical and functional suitability of the device and instruments during a simulated surgical procedure. The "ground truth" was established by the feedback and validation from participating healthcare professionals on whether the device and instruments met their needs and intended use in a cadaver model.
The sample size for the training set:
- Not applicable. This is not an AI/ML device; therefore, there is no "training set." Device development would involve design, engineering, and iterative testing, but not in the sense of training a machine learning model.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.

Summary

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	510(k) SUMMARY	JAN 30 2014
P. BROKERSspine	Ardis® Interbody System
Date of Summary Preparation:	October 08, 2013
Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, MN 55439
Establishment Registration Number:	2184052 (Minneapolis)
Company Contact:	Michelle LenzRegulatory Affairs SpecialistEmail: Michelle Lenz@Zimmer.comOffice 952.830.6243Fax 952.837.6843
Secondary Contact:	Jonathan GilbertRegulatory Affairs DirectorEmail: Jonathan. Gilbert@Zimmer.comOffice: 952.830.6385Fax: 952.837.6985
Trade Name:	Ardis® Interbody System
Device Name (Common Name):	Interbody Fusion Device
Device Classification:	Class II
Product Code(s):	MAX
Regulation Number:	21 CFR § 888.3080
Regulation Description:	Intervertebral Body Fusion Device
Predicate Device:	Ardis Spacer (K073202)

General Device Description:

Indications for Use:

The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the

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treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Summary of Technological Characteristics:

Implant Design: The Ardis Interbody System implant is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths and heights.

Implant Placement: Ardis Interbody System implants are designed to be placed through a posterior or transforaminal approach and to address vertebrae in the lumbosacral region of the spine. The system contains implants of various sizes to accommodate different patient anatomy, and instruments for site preparation, trialing, and placement/extraction.

Materials, Implants and Instruments: Ardis Interbody System implants are made from (polyetheretherketone) PEEK-OPTIMA® (ASTM F2026). As PEEK-OPTIMA is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires and beads (ASTM F560) that are press-fit into small holes in the implant.

Patient-contacting, reusable instruments for use with the Ardis implants are manufactured from stainless steel and may include an aluminum titanium nitride (AITiN) PVD and/or titanium nitride (TiN) PVD coating.

Sterility, Implants and Instruments: Ardis implants are gamma sterilized and provided to the end user in sterile packaging.

The associated instruments and perforated instrument cases for use with the Ardis implants are supplied non-sterile and must be sterilized by the healthcare facility prior to use.

Summary of Performance Testing:

A simulated surgical evaluation was conducted using a cadaver specimen to verify that the design of the Ardis Interbody System and associated instruments meet documented user needs and intended use. All instruments in the system were evaluated during the course of the procedure. The function, performance, and conformance to user needs and intended use were validated based on responses received from the participating healthcare professionals. All responses met the established acceptance criteria.

Substantial Equivalence:

Zimmer Spine considers the subject Ardis Interbody System product performance to be substantially equivalent to its predicate device, Ardis Spacer (K073202) because there are no changes to the intended use, design, materials or function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with its wings spread, symbolizing protection and care. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the organization's name and national affiliation. The overall design is simple yet recognizable, representing the department's role in promoting the health and well-being of the nation.

Public Health Service

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

January 30, 2014

Zimmer Spine, Incorporated Ms. Michelle Lenz Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K133184

Trade/Device Name: Ardis® Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 8, 2013 Received: October 17, 2013

Dear Ms. Lenz:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Michelle Lenz

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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.

Vincen Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133184

Device Name Ardis® Interbody System

Indications for Use (Describe)

The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (1.2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be reated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The Artis Interbody System is implanted using a posterior or transforminal approach and is intended to be used singly or in pairs with supplemental fixation.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

,一个 100 000 000 000 FOR FOR FOR FOR FOR FOR FOR FOR FOR F :

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

on E. Dmitrie

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

PSC Poblishing Scrvices (301) 443-6740

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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.