The Genesys Spine Apache® Anchored Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

Device Description

The Genesys Spine Apache® Anchored Cervical Interbody Fusion System includes a PEEK interbody that is implanted with two (2) titanium bone nails. The Apache® Anchored Cervical Interbody Fusion System was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.

The Genesys Spine Apache® Anchored Cervical Interbody Fusion System implants are comprised of two components; 1) PEEK interbodies with tantalum markers and 2) titanium alloy cervical bone nails. Both the interbodies and the cervical bone nails are offered in various sizes. The bone nails are inserted through the channels in the PEEK interbody and into the adjacent cervical vertebrae. The device is inserted after a discectomy and the integrated fixation provides additional stabilization to the spine during fusion.

The interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disc space. The bone nail components are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F-136.

AI/ML Overview

The provided document describes a medical device, the Genesys Spine Apache® Anchored Cervical Interbody Fusion System, and its substantial equivalence to predicate devices, rather than a study proving an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not applicable to this document.

However, I can extract information related to the non-clinical performance data and the conclusion of the tests which serves as the "acceptance criteria" for this specific medical device.

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

Acceptance Criteria Category	Specific Test	Predetermined Pass-Fail Criterion	Reported Device Performance
Mechanical Performance	Static Axial Compression	Equivalent to (or greater than) previously cleared interbody fusion systems	Met, as concluded to be substantially equivalent to predicate devices.
	Dynamic Axial Compression	Equivalent to (or greater than) previously cleared interbody fusion systems	Met, as concluded to be substantially equivalent to predicate devices.
	Static Torsion	Equivalent to (or greater than) previously cleared interbody fusion systems	Met, as concluded to be substantially equivalent to predicate devices.
	Dynamic Torsion	Equivalent to (or greater than) previously cleared interbody fusion systems	Met, as concluded to be substantially equivalent to predicate devices.
	Static Subsidence	Equivalent to (or greater than) previously cleared interbody fusion systems	Met, as concluded to be substantially equivalent to predicate devices.
	Expulsion Testing	Equivalent to (or greater than) previously cleared interbody fusion systems	Met, as concluded to be substantially equivalent to predicate devices.
	Bone Nail Back-Out Force	Determined to meet acceptable force for bone nail back-out under worst-case conditions	Met, as concluded to be substantially equivalent to predicate devices.
Material Conformance	PEEK Interbodies	Conformance to ASTM F2026	Conforms to ASTM F2026.
	Tantalum Markers	Conformance to ASTM F560	Conforms to ASTM F560.
	Titanium Alloy	Conformance to ASTM F-136	Conforms to ASTM F-136.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "a cadaveric validation study" but does not specify the sample size for this study or its provenance. It is a non-clinical, pre-market submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical implant, not an AI or diagnostic device that requires expert ground truth establishment for its performance metrics in the context of this submission. The "ground truth" here is the performance of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a diagnostic or AI device study involving human interpretation.

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 document is for a physical medical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for proving substantial equivalence was the mechanical performance and material characteristics of legally marketed predicate devices. The mechanical tests were performed against established standards (ASTM F2077-11, ASTM F2267-04, and an ASTM draft standard for expulsion testing, plus a test for bone nail back-out force).

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

9. 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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.

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

July 28, 2016

Genesys Spine Mr. Benjamin V. Keller Product Development Engineer 1250 Capital of Texas Highway South Building Three. Suite 600 Austin, Texas 78746

Re: K152099

Trade/Device Name: Genesys Spine Apache® Anchored Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 19, 2016 Received: July 21, 2016

Dear Mr. Keller:

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,

Vincent J. 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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Indications for Use

510(k) Number (if known) K152099

Device Name

Genesys Spine Apache® Anchored Cervical Interbody Fusion System

Indications for Use (Describe)

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

Submitter's Name:	Genesys Spine
Submitter's Address:	1250 Capital of Texas Highway SouthBuilding Three, Suite 600Austin, Texas 78746
Submitter's Telephone:	512-381-7093
Submitter's Fax:	512-381-7076
Submitter's E-mail:	Ben.Keller@genesysspine.com
Contact Name:	Ben Keller
Date Summary wasPrepared:	07/25/16
Trade or Proprietary Name:	Genesys Spine Apache® Anchored Cervical InterbodyFusion System
Common or Usual Name:	Intervertebral Fusion Device With Integrated Fixation,Cervical
Classification:	Class II per 21 CFR §888.3080
Product Codes:	OVE
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate (unmodified)devices to Which SubstantialEquivalence is Claimed:	LDR Spine Cervical Interbody Fusion System – ROI-C(K091088, K113559) [Primary Predicate], ExactechAcapella One Cervical Spacer System (K132582)

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Question	YES	NO
Is the device intended for prescription use (21 CFR 801 SubpartD)?	X
Is the device intended for over-the-counter use (21 CFR 807Subpart C)?		X
Does the device contain components derived for a tissue or otherbiologic source?		X
Is the device provided sterile?		X
Is the device intended for single use?	X
Is the device a reprocessed single use device?		X
Does the device contain a drug?		X
Does the device contain a biologic?		X
Does the device use software?		X
Does the submission include clinical information?		X
Is the device implanted?	X

Genesys Spine regards information provided in support of this premarket notification to be confidential and proprietary and afforded such protection under 21CFR 807.95 and other applicable statutes. In accordance with the Safe Medical Devices Act of 1990, a 510(k) Summary of Safety and Effectiveness is included in this notification.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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INDICATIONS FOR USE:

TECHNICAL CHARACTERISTICS:

NON-CLINICAL PERFORMANCE DATA:

The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine Apache® Anchored Cervical Interbody Fusion System be equivalent to (or greater than) previously cleared interbody fusion systems. Prior to performing mechanical testing, all possible configurations of the Apache® Anchored Cervical Interbody Fusion System constructs were analyzed in order to determine the worst case to be used for testing.

The Genesys Spine Apache® Anchored Cervical Interbody Fusion System was tested in static and dynamic axial compression and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, and expulsion testing per ASTM draft standard F-04.25.02.02. The system was also tested to determine the force for bone nail back-out under worst-case conditions.

The Genesys Spine Apache® Anchored Cervical Interbody Fusion System was evaluated in a cadaveric validation study.

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CONCLUSION OF NON-CLINICAL TESTS:

The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine Apache® Anchored Cervical Interbody Fusion System is substantially equivalent to the LDR Spine Cervical Interbody Fusion System – ROI-C (K091088, K113559) and the Exactech Acapella One Cervical Spacer System (K132582).

Bez. V. Kella

Ben Keller Genesys Spine 07/25/16

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.