The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Device Description

The purpose of this submission is the introduction of a new device for intervertebral body fusion and vertebral body replacement. The Zyston Straight Spacer System is constructed of medical grade Polyetheretherketone (PEEK-OPTIMA LT1, a registered trademark of Invibio Limited) and tantalum radiographic markers for spinal applications.

AI/ML Overview

The provided text describes a medical device submission (K112014) for the "Zyston Straight Spacer System," a non-cervical spinal spacer and vertebral body replacement device. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria in the way a clinical trial for an AI/software device would.

Therefore, the information requested in the prompt related to the acceptance criteria and study for an AI/software device, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, cannot be found in this document.

This document describes a mechanical device, and the "study" it refers to is primarily mechanical testing to demonstrate the device's physical performance characteristics and substantial equivalence to existing devices, not clinical studies in the typical sense used for AI/software.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied by Special Controls Guidance)	Reported Device Performance
Static Axial Compression (ASTM F-2077)	Sufficient mechanical strength for intended use
Dynamic Axial Compression (ASTM F-2077)	Sufficient mechanical strength for intended use
Static Compression-Shear (ASTM F-2077)	Sufficient mechanical strength for intended use
Dynamic Compression-Shear (ASTM F-2077)	Sufficient mechanical strength for intended use
Subsidence (ASTM F-2267 and ASTM F-2077)	Sufficient mechanical strength for intended use
Static Torsion (ASTM F-2077)	Sufficient mechanical strength for intended use
Dynamic Torsion (ASTM F-2077)	Sufficient mechanical strength for intended use
Expulsion (ASTM Draft F-04.25.02.02)	Sufficient mechanical strength for intended use

Study Description:

The study conducted was a series of mechanical tests on the Zyston Straight Spacer System. These tests were performed in accordance with "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and "Guidance for Industry and FDA Staff: Spinal System 510(k)s." The specific ASTM standards followed were:

ASTM F-2077 for Static Axial Compression, Dynamic Axial Compression, Static Compression-Shear, Dynamic Compression-Shear, Static Torsion, and Dynamic Torsion.
ASTM F-2267 and ASTM F-2077 for Subsidence.
ASTM Draft F-04.25.02.02 for Expulsion.

The overall reported performance is that the "Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use."

Information NOT available in the provided text (as it pertains to AI/software device studies):

Sample size used for the test set and the data provenance: Not applicable to this mechanical device testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For mechanical devices, the "ground truth" is typically defined by engineering specifications and direct physical measurement against established standards (e.g., strength, durability).
The sample size for the training set: Not applicable (this is not an AI/ML device).
How the ground truth for the training set was established: Not applicable.

Summary

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

Page 1/3 KII 2014

OCT 1 7 2011

Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

510(k) Summary

Preparation Date:	September 8, 2011
Applicant/Sponsor:	Biomet Spine (aka EBI, LLC)100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Julie A. RyanPhone: 973-299-9300, ext. 3310Fax: 973-257-0232
Trade name:	Zyston Straight Spacer System
Common Name:	Non-cervical spinal spacerVertebral body replacement
Classification Name:	Intervertebral body fusion device, 21 CFR §888.3080Spinal intervertebral body fixation orthosis, 21 CFR §888.3060
Device Panel /ProductCode:	Orthopedic MAXOrthopedic MQP

Device Description:

Indications for Use:

The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

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

Image /page/1/Picture/1 description: The image shows the logo for Biomet Spine. The logo is in black and white and features the word "BIOMET" in large, bold letters. Below the word "BIOMET" is the word "SPINE" in smaller letters. The logo is simple and modern.

spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Summary of Technologies:

The technological characteristics (material, design and sizing) of the Zyston Straight Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include:

Ibex Spinal Spacer System (K091381, K050861) .
Expandable PEEK Implant (K082406, K040928) .
ESL Spacer (K092574, K040482) .
Novel LCC Spacer System (K080699)
AVS PL PEEK Spacer System (K050624, K073470, K082014) .

Performance Data

Mechanical testing recommended in the special controls guidance document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was conducted. The testing conducted, along with the ASTM standard, are listed below:

1. Static Axial Compression (ASTM F-2077)
1. Dynamic Axial Compression (ASTM F-2077)
1. Static Compression-Shear (ASTM F-2077)
1. Dynamic Compression-Shear (ASTM F-2077)
1. Subsidence (ASTM F-2267 and ASTM F-2077)

Additional mechanical testing recommended in the special controls guidance document entitled "Guidance for Industry and FDA Staff: Spinal System 510(k)s" was conducted. The testing conducted, along with the ASTM standard, are listed below:

1. Static Torsion (ASTM F-2077)
1. Dynamic Torsion (ASTM F-2077)
1. Expulsion (ASTM Draft F-04.25.02.02)

Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use.

Substantial Equivalence:

The Zyston Straight Spacer System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and

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

Image /page/2/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with each letter outlined in black. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font, also outlined in black. The logo is simple and modern, and the use of black and white gives it a clean and professional look.

principles of operation and do not present any new issues of safety or effectiveness. principles of operation above are distributed for similar indications, and have similar design features.

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

OCT 1 7 2011

Biomet Spine % Ms. Julie A. Ryan 100 Interpace Parkway Parsippany, New Jersey 07054

"平

Re: K112014

Trade/Device Name: Zyston Straight Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: September 08, 2011 Received: September 09, 2011

Dear Ms. Ryan:

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

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

Page 2 – Ms. Julie A. Ryan

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric Keith

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Zyston Straight Spacer System

Indications for Use:

The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

・・ ਸ਼

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, Orthopedic, and Restorative Devices

ジ

)( (1) 2014510(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.