The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.

Device Description

The SurgTech Interbody System is a system of intervertebral body fusion devices. The Posterior Lumbar device is a structural column in a generally rectangular shape having a rounded nose. Teeth are integral to the inferior and superior surfaces and there is a central cavity to be filled with autograft. The implants are available in an assortment of footprint, height and angulation combinations to accommodate a variety of anatomic requirements.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "SurgTech Interbody System." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific clinical acceptance criteria through a study with performance metrics.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, and MRMC studies are not applicable or available within this type of regulatory submission.

However, I can extract information regarding the performance testing that was conducted:

Table of acceptance criteria and reported device performance:
The document does not specify quantitative acceptance criteria. Instead, it states that the device's performance was compared to predicate devices.

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not specified (Qualitative: Substantially equivalent to predicate)	Not specified (Qualitative: Demonstrated substantial equivalence to predicate)

Performance Testing Details Provided:

Mechanical Testing: Performed on the "worst case" SurgTech Interbody System device according to ASTM F2077. This included static and dynamic compression.
Subsidence Testing: Performed on the "worst case" SIS PL device according to ASTM F2267.
Conclusion: "The mechanical test results demonstrate that the SurgTech Interbody System performance is substantially equivalent to the predicate devices."

Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing, not a clinical study on a patient test set. The provenance is internal testing by SurgTech Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was mechanical engineering testing, not clinical evaluation requiring expert ground truth.
Adjudication method for the test set: Not applicable.
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-enabled device and no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-enabled device.
The type of ground truth used: For the mechanical tests, the "ground truth" was established by adherence to and successful completion of specified ASTM standards (ASTM F2077 for static/dynamic compression and ASTM F2267 for subsidence). The "substantial equivalence" claim is relative to the performance of predicate devices under similar testing.
The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device. The testing was physical mechanical testing.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

March 25, 2016

SurgTech Incorporated % Karen E. Warden, Ph.D. BackRoads Consulting Incorporated P.O. Box 566 Chesterland, Ohio 44026

Re: K152200

Trade/Device Name: SurgTech Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 11, 2016 Received: March 14, 2016

Dear Dr. Warden:

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 yours,

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) K152200

Device Name SurgTech Interbody System

Indications for Use (Describe)

The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date:	5 August 2015
Sponsor:	SurgTech Inc.24600 Center Ridge Road, Suite 195Westlake, OH 44145Phone (216) 421-2613
Sponsor Contact:	Xuegong Yu, General Manager
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Trade Name:	SurgTech Interbody System
Common Name:	Interbody fusion device
Device Classification	Class II
Classification Name:	Intervertebral body fusion device
Regulation:	888.3080
Device ProductCode:	MAX
Device Description:	The SurgTech Interbody System is a system of intervertebral body fusiondevices. The Posterior Lumbar device is a structural column in a generallyrectangular shape having a rounded nose. Teeth are integral to the inferiorand superior surfaces and there is a central cavity to be filled with autograft.The implants are available in an assortment of footprint, height andangulation combinations to accommodate a variety of anatomicrequirements.
Indications for Use:	The SurgTech Interbody System is indicated for use with autogenous bonegraft in skeletally mature patients with degenerative disc disease (DDD) atone or two contiguous levels from L2 to S1. DDD is defined as discogenicback pain with degeneration of the disc confirmed by history andradiographic studies. These patients should have had six months of non-operative treatment. These patients may have had a previous non-fusionspinal surgery and may also have up to Grade 1 spondylolisthesis orretrolisthesis at the involved spinal level(s). These devices are intended tobe used with supplemental fixation which has been cleared for use in thelumbar spine.
Materials:	The SurgTech Interbody System cages are manufactured from PEEKOptima® LT1 (polyetheretherketone) per ASTM F2026 and contain tantalumradiopaque markers per ASTM F560.
Primary Predicate:	PLIF Cage (Eisertech LLC, K113478)
Additional Predicate:	AVS® PL PEEK Spacers (Stryker Spine – K073470, K082014 & K093704)
Performance Data:	Mechanical testing of the worst case SurgTech Interbody System devicewas performed according to ASTM F2077 and included static and dynamiccompression. Subsidence testing according to ASTM F2267 was performedon the worst case SIS PL device.The mechanical test results demonstrate that the SurgTech InterbodySystem performance is substantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The SurgTech Interbody System implants possess similar technologicalcharacteristics as one or more of the predicate devices. These include:
	performance (as described above), basic design (hollow structural column), implant grade materials (PEEK polymer and tantalum), and sizes (widths, lengths, heights and angulation are within the range(s) offered by the predicates).
	Therefore the fundamental scientific technology of the SurgTech Interbody System is similar to previously cleared devices.
Conclusion:	The SurgTech Interbody System possesses similar intended use andtechnological characteristics as the predicate devices. Therefore SurgTechInterbody System is substantially equivalent to legally marketed predicates.

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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.