The Genesys Spine 3DP Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3DP Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.

When used without the internal fixation:

The Genesys Spine 3DP 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 3DP Cervical Interbody System includes 3D-Printed (3DP) titanium interbodies. The 3DP Cervical Interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The version that utilizes integrated fixation may be used as a stand-alone cervical device that is implanted with two (2) titanium alloy anchors. All interbodies are made from Ti-6Al-4V ELI titanium alloy. The standalone version includes an integrated locking mechanism and various sizes of anchors which are all manufactured from Ti-6Al-4V ELI titanium alloy.

The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine 3DP Cervical Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance evaluations, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text, as this type of information is typically part of clinical trials or specific performance studies, which are not detailed in a 510(k) summary focused on non-clinical equivalence.

Here's an assessment based on the available information:

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

The document describes performance evaluations conducted on constructs against mechanical testing standards. It does not list quantitative acceptance criteria or specific reported numerical performance values in a table format. Instead, it makes a general statement of equivalency.

Acceptance Criteria (Not explicitly stated with values in the document)	Reported Device Performance (General Conclusion)
Static compression (In accordance with ASTM F2077)	Substantially the same as predicate devices
Static torsion (In accordance with ASTM F2077)	Substantially the same as predicate devices
Static compression shear (In accordance with ASTM F2077)	Substantially the same as predicate devices
Dynamic compression (In accordance with ASTM F2077)	Substantially the same as predicate devices
Dynamic torsion (In accordance with ASTM F2077)	Substantially the same as predicate devices
Dynamic compression shear (In accordance with ASTM F2077)	Substantially the same as predicate devices
Subsidence (In accordance with ASTM F2267)	Substantially the same as predicate devices
Expulsion testing	Substantially the same as predicate devices
Force to overcome locking mechanism	Demonstrated equivalence
Cadaver testing	Demonstrated equivalence

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document mentions "constructs representing the worst-case components" for the non-clinical tests. Medical device mechanical testing typically uses a certain number of samples, but the exact count is not provided here.
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. No country of origin for clinical retrospective or prospective data is applicable or mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. For mechanical and cadaveric testing of medical implants, "ground truth" as typically defined for AI/diagnostic studies (e.g., expert consensus on clinical images) does not apply. The "ground truth" in this context would be the objective measurements obtained during the mechanical tests themselves, compared against established industry standards (e.g., ASTM).

4. Adjudication method for the test set:

Not applicable. An adjudication method, common in clinical studies involving human interpretation or subjective assessments, is not relevant for the described non-clinical mechanical performance evaluations.

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:

No. The provided document details a 510(k) submission for an interbody fusion device, which is a physical implant, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed or mentioned.

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

Not applicable. This question pertains to AI algorithms. The device is a physical cervical interbody fusion system.

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

For the non-clinical performance evaluation, the "ground truth" is implied to be adherence to scientifically established mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and engineering principles. The document states "The Genesys Spine 3DP Cervical Interbody System was found to be substantially the same as predicate devices" based on these evaluations.

8. The sample size for the training set:

Not applicable. There is no "training set" mentioned or implied, as this document describes the evaluation of a physical medical device, not an AI algorithm.

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

Not applicable. As there is no training set mentioned, the establishment of its ground truth is also not applicable.

Summary

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January 8, 2020

Genesys Spine Mr. Benjamin Keller Product Development Engineer 1250 South Capital of Texas Highway, Building 3 Suite 600 Austin, Texas 78746

Re: K191489

Trade/Device Name: Genesys Spine 3DP Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: December 11, 2019 Received: December 13, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191489

Device Name

Genesys Spine 3DP Cervical Interbody Fusion System

Indications for Use (Describe)

When used with the internal fixation and as a stand-alone system:

When used without the internal fixation:

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

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Image /page/3/Picture/1 description: The image shows the logo for Genesys Spine. The word "Genesys" is in gray, with the "G" in brown and a brown arrow pointing to the right. Below the word "Genesys" is the word "spine" in brown with the registered trademark symbol.

4. 510(K) SUMMARY

Submitter's Name:	Genesys Spine
Submitter's Address:	1250 Capital of Texas Highway SouthBuilding Three, Suite 600Austin, Texas 78746
Contact Name:	Benjamin V. Keller (Primary)	William W. Sowers (Secondary)
Submitter'sTelephone:	512-381-7093	512-381-7080
Submitter's Fax:	800-817-4938	800-817-4938
Date Summary wasPrepared:	December 31st, 2019
Trade or ProprietaryName:	Genesys Spine 3DP Cervical Interbody System
Common or UsualName:	Intervertebral Body Fusion Device, Cervical
Classification Name:	Intervertebral Fusion Device With Integrated Fixation, Cervical
Classification:	Class II per 21 CFR §888.3080
Regulation Number:	21 CFR 888.3080
Product Codes:	OVE, ODP
Classification Panel:	Orthopedic Devices Panel
Legally Marketed(unmodified) devicesto Which SubstantialEquivalence isClaimed:	Primary Predicate:Genesys Spine AIS-C Cervical Stand-Alone System (Genesys Spine - K181295)Additional Predicate Devices:3DP Lumbar Interbody System (Genesys Spine – K182987)EIT Cellular Titanium® Cervical & Lumbar Cages (Emerging ImplantTechnologies – K170503)Apache® Interbody Fusion System (Genesys Spine - K103034)Apache® Cervical Interbody Fusion System (Genesys Spine - K150812)LDR Spine Cervical Interbody Fusion System (LDR Spine - K091088)

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DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

When used with the integrated fixation and as a stand-alone system:

When used without the integrated fixation:

TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The Genesys Spine 3DP Cervical Interbody System was compared to the predicate systems and the designs, materials, features, functions, and intended uses were found to be substantially the same.

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NON-CLINICAL PERFORMANCE EVALUATION

Performance evaluations were conducted on constructs representing the worst-case components (including static compression, static torsion, static compression shear, dynamic compression, dynamic torsion, dynamic compression shear [in accordance with ASTM F2077], subsidence [in accordance with ASTM F2267], expulsion testing, and cadaver testing. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions. The Genesys Spine 3DP Cervical Interbody System was found to be substantially the same as predicate devices.

CONCLUSION OF NON-CLINICAL TESTS:

The overall technological characteristics and mechanical performance data demonstrate that the Genesys Spine 3DP Cervical Interbody System is substantially equivalent to the Genesys Spine AIS-C Anchored Cervical Stand-Alone System (K181295), the EIT Cellular Titanium® Cervical Cages (K170503), the Genesys Spine Apache® Cervical Interbody Fusion System (K150812), and the Genesys Spine Apache® IBFD System (K103034).

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.