The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, 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 disease (DDD) with up to Grade 1 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.

Device Description

The intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine Apache® Interbody Fusion System (K103034 and K153123). This submission will offer various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine lumbar interbody fusion device, which may be implanted as a single device via an Anterior or Anterolateral approach.

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

The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System implant components are made of polyetheretherketone (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® Anterior Lumbar Interbody Fusion System. It states that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your questions, noting that this is a medical device with mechanical testing, not an AI/Software as a Medical Device (SaMD), so many of your requested items pertaining to AI model validation (like sample size of test sets, ground truth establishment, MRMC studies, training set details) are not applicable to this document.

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

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for performance, as would be expected for a diagnostic device. Instead, the performance is demonstrated through biomechanical testing to show substantial equivalence to predicate devices.

Performance Attribute	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength	Substantially equivalent to predicate devices for intended use.	Static Push-out Test: Performed per ASTM Draft Standard F-04.25.02.02. Results contributed to demonstrating substantial equivalence.
Biomechanical Stability	Substantially equivalent to predicate devices for intended use.	Finite Element Analysis (FEA): Performed. Results contributed to demonstrating substantial equivalence.
Material Biocompatibility	Conformance to relevant ASTM standards.	Implant components are made of polyetheretherketone (Invibio PEEK Optima LT1) conforming to ASTM F2026. Tantalum markers conform to ASTM F560.

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

Test Set Sample Size: Not explicitly stated in terms of a "sample size" of patients or cases. The testing refers to mechanical tests (Static Push-out Test and Finite Element Analysis) which are typically performed on a set of physical devices or computational models, not patient data.
Data Provenance: Not applicable in the context of patient data. The testing is non-clinical, focusing on the mechanical properties of the device itself.

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 is not applicable to this type of device submission. Ground truth and expert consensus are relevant for diagnostic devices that interpret patient data. For a spinal implant, the "ground truth" is typically defined by engineering standards, material specifications, and biomechanical principles, which are evaluated by engineers and materials scientists.

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

This is not applicable to this type of device submission. Adjudication methods are used for resolving discrepancies in expert interpretations, primarily for diagnostic devices.

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 is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools and the impact on human reader performance. This document concerns a physical spinal implant.

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

This is not applicable. This question refers to the standalone performance of an AI algorithm. The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is a physical medical device, not an AI algorithm.

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

The "ground truth" (or basis for evaluation) for this device is its adherence to established engineering standards (e.g., ASTM F2026 for materials, ASTM Draft Standard F-04.25.02.02 for push-out testing), and its demonstrated mechanical equivalence to predicate devices through non-clinical testing (Static Push-out Test and Finite Element Analysis).

8. The sample size for the training set

This is not applicable. Training sets are used for machine learning models. This is a physical interbody fusion system.

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

This is not applicable. As above, training sets and their ground truth are concepts for machine learning, not for physical medical device submissions like this one.

Summary

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

November 8, 2016

Genesys Spine Mr. Brian Bergeron Vice President of Engineering 1250 Capital of Texas of Highway South, Building 3 Suite 600 Austin, Texas 78746

Re: K161438

Trade/Device Name: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 6, 2016 Received: October 11, 2016

Dear Mr. Bergeron:

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/Resourcesfor You/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) K161438

Device Name

GENESYS SPINE APACHE® ANTERIOR LUMBAR 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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4. 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:	Brian J. Bergeron
Date Summary wasPrepared:	October 6, 2016
Trade or Proprietary Name:	Genesys Spine Apache® Anterior Lumbar InterbodyFusion System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification:	Class II per 21 CFR §888.3080
Product Codes:	MAX
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Primary Predicate:	Genesys Spine Apache® Interbody Fusion System(K103034 / K153123)
Additional Predicates:	NuVasive® Brigade® and ACR Hyperlordotic System(K112561/K123045)DePuy Spine I/F Cage (P960025)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine Apache® Interbody Fusion System (K103034 and K153123). This submission will offer various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine lumbar interbody fusion device, which may be implanted as a single device via an Anterior or Anterolateral approach.

INDICATIONS FOR USE

The Genesys Spine Apache® Anterior Lumbar 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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TECHNICAL CHARACTERISTICS

PERFORMANCE DATA

Nonclinical testing was performed to demonstrate that the subject Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is substantially equivalent to other predicate devices. The following testing was performed:

Static Push-out Test per ASTM Draft Standard F-04.25.02.02 .
Finite Element Analysis

The results of these studies, as well as the descriptive information presented, demonstrates that the subject Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is substantially equivalent to the performance of the predicate devices, and the device was therefore found to be substantially equivalent.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is substantially equivalent to the Genesys Spine Apache® Interbody Fusion System (K103034 / K153123), NuVasive® Brigade® and ACR Hyperlordotic System (K112561 / K123045), and DePuy Spine I/F Cage (P960025).

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.