When used as a cervical intervertebral body fusion device, the Genesys Spine Apache™ Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. 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. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description

The Genesys Spine Apache™ Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine cervical interbody fusion device, which may be implanted as a single device via an anterior approach.

The Genesys Spine Interbody Fusion System implant components are made of polyether ether ketone (Invibio PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.

AI/ML Overview

This document is a 510(k) premarket notification for the Genesys Spine Apache™ Cervical Interbody Fusion System. It does not describe an AI/ML device or a study involving human readers. Therefore, most of the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.

However, I can extract the relevant information regarding the performance data that was provided for this medical device and what served as its "acceptance criteria" for substantial equivalence.

Here's a summary based on the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Device conforms to material standards.	The implant components are made of polyether ether ketone (Invibio PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560).
Mechanical performance, specifically expulsion resistance, is adequate.	Expulsion testing was conducted.
Structural integrity and biomechanical equivalence to predicate device.	Cross-Sectional Area calculations and FEA analysis were performed to show that a new worst-case device was not created. This Finite Element Analysis (FEA) tool was validated by the predicate system's mechanical test data.
Device dimensions fall within the scope of cleared predicate devices.	The length, width, and height of the Cervical Interbody Fusion System implants fall within the scope of predicate devices already cleared.
Overall technological characteristics are equivalent to predicate.	The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line. The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ Cervical Interbody Fusion System is substantially equivalent to the legally marketed predicate devices.

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

This information is not provided in the document. The submission relies on mechanical testing and analysis, not a clinical study with patients.

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)

This information is not applicable as the document describes a physical medical device submission based on mechanical testing and material properties, not an AI/ML product requiring expert-established ground truth from images or clinical data.

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

This information is not applicable. See point 3.

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

This information is not applicable. This submission is for a physical orthopedic implant, not an AI/ML diagnostic or assistive device.

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

This information is not applicable. This is not an algorithm or AI device.

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

For the mechanical performance, the "ground truth" (or reference) used was the mechanical test data of the predicate system for validation of the FEA tool, and general ASTM material standards. For design dimensions, the "ground truth" was the dimensions of already cleared predicate devices.

8. The sample size for the training set

This information is not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable. There is no training set mentioned.

Summary

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

September 3, 2015

Genesys Spine Mr. Dave Lamb Vice President of Compliance 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746

Re: K150812

Trade/Device Name: Genesys Spine Apache™ Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 28, 2015 Received: July 30, 2015

Dear Mr. Lamb:

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

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Page 2 - Mr. Dave Lamb

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" (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 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) K150812

Device Name

Genesys Spine Apache™ Cervical Interbody Fusion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subnart D)	Over-The-Counter Use (21 CFR 801 Subnart 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:	512-381-7070
Submitter's Fax:	800-817-4938
Contact Name:	Dave Lamb
Date Summary wasPrepared:	August 31, 2015
Trade or Proprietary Name:	Genesys Spine Apache™ Cervical Interbody FusionSystem
Common or Usual Name:	Intervertebral Fusion Device, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Codes:	ODP
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Primary Predicate	Genesys Spine Apache™ Interbody Fusion System(K103034)
Additional predicate	Eminent Spine Copperhead (K090064)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

When used as a cervical intervertebral body fusion device, the Genesys Spine Apache™ Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. 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. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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TECHNICAL CHARACTERISTICS

The Genesys Spine Apache™ Cervical Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

PERFORMANCE DATA

Expulsion testing was conducted. Cross-Sectional Area calculations, FEA analysis, and projected area calculations show that a new worst-case device was not created. This Finite Element analysis tool was validated by the predicate system's mechanical test data and is sufficient to allow for a substantial equivalence designation for the subject device. In addition, the length, width, and height of the Cervical Interbody Fusion System implants fall within the scope of predicate devices already cleared.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ Cervical Interbody Fusion System is substantially equivalent to the legally marketed predicate devices.

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.