When used as a cervical intervertebral body fusion device, the Genesys Spine 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 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.

When used as a lumbar intervertebral body fusion device, the Genesys Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the Genesys Spine System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.

Device Description

The Genesvs Spine Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

1. Genesys Spine cervical interbody fusion device(s), which may be implanted as a single device via an anterior approach.
1. Genesys Spine lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach:
- as a single device via a transforaminal (TLIF) approach; or ،
- as as a single device via an anterior/anterolateral (ALIF) approach. ﺑ
Genesys Spine vertebral body replacement device(s), which may be implanted in the thoracic 3) and/or thoracolumbar spine (T1-L5).

The Genesys Spine Interbody Fusion System implant components are made of polyether ether ketone (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 Genesys Spine Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device, the Genesys Spine Interbody Fusion System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance thresholds for the Genesys Spine Interbody Fusion System. Instead, the "acceptance criteria" are implied to be demonstrating substantial equivalence to predicate devices by achieving comparable performance in non-clinical mechanical tests. The reported device performance is that the Genesys Spine Interbody Fusion System met these equivalence standards.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices in mechanical testing.	Conclusion: "The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Genesys Spine Interbody Fusion System is substantially equivalent to the predicate device."
Specific Tests for Equivalence:
- Static and dynamic compression testing (per ASTM F2077-03)	Conducted in accordance with ASTM F2077-03. Results implicitly deemed comparable to predicates for substantial equivalence.
- Static and dynamic torsion testing (per ASTM F2077-03)	Conducted in accordance with ASTM F2077-03. Results implicitly deemed comparable to predicates for substantial equivalence.
- Subsidence testing (per ASTM F2267-04)	Conducted in accordance with ASTM F2267-04. Results implicitly deemed comparable to predicates for substantial equivalence.
- Expulsion testing (per ASTM Draft Standard F-04.25.02.02)	Conducted in accordance with ASTM Draft Standard F-04.25.02.02. Results implicitly deemed comparable to predicates for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical mechanical testing. For such tests, the "sample size" refers to the number of devices or components tested, not human subjects. The document does not specify the exact number of devices tested for each mechanical test (e.g., how many devices underwent static compression).

Data Provenance: The tests conducted are laboratory-based mechanical tests. Therefore, there is no "country of origin for data" or "retrospective/prospective" distinction in the way it applies to clinical studies involving human subjects. The tests were performed in a controlled laboratory environment to ASTM standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This question is not applicable to the provided document. The "tests" conducted are non-clinical mechanical tests, not diagnostic or interpretative studies requiring expert ground truth establishment. The performance is measured against engineering standards (ASTM).

4. Adjudication Method for the Test Set

This question is not applicable. There is no "adjudication method" in the context of mechanical engineering tests. The results are quantitative measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes non-clinical mechanical tests to demonstrate substantial equivalence for a physical implantable device. It does not involve any human readers or AI in a diagnostic or interpretative capacity, thus no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question is relevant for AI/algorithm-based devices. The Genesys Spine Interbody Fusion System is a physical interbody fusion device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical mechanical tests, the "ground truth" or reference performance is derived from the established performance characteristics of the predicate devices as demonstrated by their own testing and regulatory clearance, and the requirements outlined in the ASTM standards (e.g., F2077-03, F2267-04, and the draft F-04.25.02.02). The goal is to show the new device performs comparably to these established benchmarks.

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The device design is based on engineering principles and material science, not data-driven algorithm training.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated in point 8.

Summary

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DEC 1 0 2010

Genesys Spine Interbody Fusion System

Premarket Notification

SUBMITTED BY	Genesys Spine1250 Capital of Texas Highway SouthBuilding Three, Suite 600Austin, TX 78746
ESTABLISHMENTREGISTRATION NUMBER	Pending
OWNER/OPERATORNUMBER	Pending
CONTACT PERSON	Josh KaufmannPrincipalGenesys SpinePhone: 512-560-3446Fax: 800-817-4938
SUBMISSION PREPARED BY	Lisa PetersonQA Consulting, Inc.Phone: 512-507-0746
DATE PREPARED	October 11, 2010
CLASSIFICATION NAME	Intervertebral Fusion Device with Bone Graft, LumbarIntervertebral Fusion Device with Bone Graft, CervicalSpinal Intervertebral Body Fixation Orthosis
DEVICE CLASS	Class II
REGULATION NUMBER	888.3080 (Product Code: MAX)888.3080 (Product Code: ODP)888.3060 (Product Code: MQP)
COMMON NAME	Intervertebral Body Fusion Device (MAX, ODP)Spinal Vertebral Body Replacement Device (MQP)
PROPRIETARY NAME	Genesys Spine Interbody Fusion System
IDENTIFICATION OF PREDICATEDEVICE(S)	Predicate devices include various cleared interbody fusionand VBR systems:RAY® Threaded Fusion Cage (P950019)Lumbar I/F Cage (P960025)InterFix (P970015)BAK/C (P980048)Affinity Cage System (P000028)MC+ (K043479, K091088)

MC+ (K043479, K091088)
Eminent Spine System (K090064) -

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DEVICE DESCRIPTION

The Genesvs Spine Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

1. Genesys Spine cervical interbody fusion device(s), which may be implanted as a single device via an anterior approach.
1. Genesys Spine lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach:
- as a single device via a transforaminal (TLIF) approach; or ،
- as as a single device via an anterior/anterolateral (ALIF) approach. ﺑ
Genesys Spine vertebral body replacement device(s), which may be implanted in the thoracic 3) and/or thoracolumbar spine (T1-L5).

The Genesys Spine Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

INDICATIONS

When used as a lumbar intervertebral body fusion device, the Genesys Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Genesys Spine Interbody Fusion System. The Genesys Spine Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

Intended for use at one level from the C2-C3 disc to the C7-TI disc for the treatment । degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at the involved level.
-Intended for use at either one level or two contiquous levels from L2-S1 for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
-When used as a VBR, the implants are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column (T1-L5) even in the absence of fusion for a prolonged period.
Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 -
Static and dynamic torsion testing, conducted in accordance with ASTM F2077-03 ﺘ
Subsidence testing, conducted in accordance with ASTM F2267-04 ﻬﺎ ﻓﻬﻮ: ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 -

CONCLUSIONS

The subiect and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Genesys Spine Interbody Fusion System is substantially equivalent to the predicate device.

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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 with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Genesys Spine % Mr. Josh Kaufmann 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746

DEC 1 0 2010

Re: K103034

Trade/Device Name: Genesys Spine Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: October 11, 2010 Received: October 13, 2010

Dear Mr. Kaufmann:

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

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Page 2 – Mr. Josh Kaufmann

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 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/CDRH/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Arj. P. h. ta

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Genesys Spine Interbody Fusion System Device Name:

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Genesys Spine

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

	510(k) Number	K 103034------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746

Phone: 512-560-3446 Fax: 800-817-4938

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.