When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device. The devices must be used with supplemental fixation and must be used with autograft/autologous bone graft to facilitate fusion for each spinal region.

When used as a Cervical Interbody Fusion device. NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment with the device. The devices must be used with supplemental fixation and must be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Device Description

The NeoFuse Ti3D PLIF/TLIF/Cervical devices are intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F136. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.

AI/ML Overview

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody. This document focuses on demonstrating substantial equivalence to predicate devices rather than the performance of a novel AI/software medical device.

Therefore, the document does not contain any information regarding:

Acceptance criteria for an AI/software device's performance.
A study proving a device meets AI/software performance acceptance criteria.
Sample sizes for test sets in an AI/software context.
Data provenance for AI/software data.
Number of experts for ground truth establishment.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI assistance.
Standalone (algorithm-only) performance studies for AI.
Type of ground truth used for AI studies.
Sample size for training sets for AI.
Ground truth establishment for training sets for AI.

The information provided describes non-clinical testing performed on a physical intervertebral body fusion device to demonstrate its safety and effectiveness, specifically:

Acceptance Criteria (for the physical device's mechanical properties): The document states that "FDA performance standards have been established" for the device, and the listed tests (Static/dynamic axial compression, torsion, shear, subsidence, expulsion) were performed to demonstrate safety based on "current industry standards." The conclusion is that the device "does not raise new issues of safety or efficacy compared to the predicates," implying it meets these established industry and FDA mechanical performance standards.
Reported Device Performance: The document only states that "The results of these tests indicated that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is substantially equivalent to the predicate devices." Specific numerical performance values (e.g., maximum force withstood, specific subsidence depth) are not reported in this summary.
Sample sizes: Not specified for the mechanical tests, but implied to be sufficient for demonstrating substantial equivalence.
Data provenance: Not applicable in the context of device mechanical testing.
Experts/Ground Truth/Adjudication/MRMC/Standalone: These concepts are not applicable as this is a review of a physical medical implant, not an AI/software device.
Training Set/Ground Truth for training: Not applicable for a physical device.

In summary, the provided text is about a 510(k) submission for a physical intervertebral body fusion device and does not contain the information required to answer the prompt regarding AI/software device acceptance criteria and study details.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected, and they form a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.

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

July, 12, 2017

HT Medical, LLC % Mr. Nicholas Cordaro President Additive Innovations. LLC 533 2nd Street. Suite A Encinitas. California 92024

Re: K170318

Trade/Device Name: NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: June 12, 2017 Received: June 14, 2017

Dear Mr. Cordaro:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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.

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)

K170318

Device Name

NeoFuse™Ti3D PLIF/TLIF/Cervical Interbody

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

DATE PREPARED

January 26, 2017

MANUFACTURER AND 510(k) OWNER

HT Medical, LLC 6316 E 102nd Street, Tulsa, OK 74137, USA (918) 995-2090 Telephone: (800) 878-0772 Fax: Official Contact: Robert Compton, Chief Executive Officer

REPRESENTATIVE/CONSULTANT

Nicholas M. Cordaro Additive Innovations, LLC Telephone: Email: nick.cordaro@additiveinnovations.net

PROPRIETARY NAME OF SUBJECT DEVICE

NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody

COMMON NAME Intervertebral body fusion device

DEVICE CLASSIFICATION

Intervertebral body fusion device (21 CFR 888.3080, Product Codes ODP and MAX, Class II)

PREMARKET REVIEW

ODE/DOD/ASDB Orthopedic Panel

INDICATIONS FOR USE

When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft/autologous bone graft to facilitate fusion for each spinal region.

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When used as a Cervical Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

The NeoFuse Ti3D PLIF/TLIF/Cervical Interbody will be shown to be substantially equivalent to the following predicates:

510(k)Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K160125	Cascadia Interbody System	✓
K153615	NeoFuse HA Enhanced PLIF/TLIF
P960025	Lumbar I/F Cage
K120275	DePuy Synthes ACIS

SUMMARY OF NON-CLINICAL TESTING

FDA performance standards have been established for the NeoFuse Ti3D PLIF/TLIF/Cervical Intervertebral Body Fusion Device. The following tests were independently performed on the lumbar and cervical devices to demonstrate safety based on current industry standards:

. Static and dynamic axial compression (per ASTM F2077)
. Static torsion (per ASTM F2077)
Static compression shear (per ASTM F2077)
. Subsidence (per ASTM F2267)
Static Expulsion (per ASTM draft standard F04.25.02.02)

The cervical devices were additionally tested per:

Dynamic torsion (per ASTM F2077)
The lumbar devices were additionally tested per:
Dynamic compression shear (per ASTM F2077) ●

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The effectiveness of the gamma irradiation as a means of sterilization for the cervical and lumbar devices was validated using AAMI/ANSI/ISO 11137-2 – method VDm%55. This included:

Bioburden recovery factor testing
Bacteriostasis and fungistasis
. Bioburden
. Verification dose
. Sterility testing of the verification dose sample

The effectiveness of the final ultrasonic cleaning procedure for gamma sterilization included the following process qualifications:

Visual verification ●
. Bioburden testing
Cytotoxicity testing
UV/Vis testing
Total organic carbon (TOC)
Bacterial Endotoxin (LAL)

The effectiveness of the packaging and shipping of sterile product included the following process qualifications:

Shipping testing
. Peel strength testing
. Bubble emission testing
. Integrity inspections

The results of these tests indicated that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is substantially equivalent to the predicate devices.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

HT Medical believes that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody has been shown to be substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions, intended use and similar technology characteristics as the devices cleared in K160125, K153615, and P960025. The subject device has an identical manufacturing method as the device cleared in K160125. The device has shown to have equivalent strength characteristics as the cleared predicate devices.

CONCLUSION

The NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicates.

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.