When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar 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.

Device Description

The NeoFuse™ HA Enhanced PLIF/TLIF devices are intervertebral body fusion devices made from PEEK-OPTIMA HA Enhanced (HA PEEK). Each device may include an optional Titanium Insert containing through holes to increase graft volume. The implants are available in various heights to accommodate patients' anatomy. The implants are provided non-sterile with surgical instruments to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), or titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.

AI/ML Overview

This is a notification of intent to market a medical device, specifically an intervertebral body fusion device called NeoFuse™ HA Enhanced PLIF/TLIF. The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a standalone study with acceptance criteria, human expert validation, or clinical efficacy data on the device's performance in a diagnostic or interpretive task.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.

Here's why and what information is provided:

Acceptance Criteria and Reported Device Performance:
- This document does not specify "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic or interpretive task.
- The "performance" reported is related to bench testing for mechanical properties.
- Table of Acceptance Criteria and Reported Device Performance: This cannot be created as such. The document states:
  - "Test results demonstrated that the devices are substantially equivalent to the predicate devices."
  - "Performance bench testing and comparisons have demonstrated NeoFuse is substantially equivalent to the predicate devices in regards to Indications for Use, Dimensions, Function, Materials, Mechanical Testing, and Technology Characteristics."
- The criteria for "substantial equivalence" are based on comparing the mechanical test results of the NeoFuse to those of the predicate devices, ensuring they perform similarly under test conditions. Specific numerical values for these criteria are not provided in this summary.
Sample Size used for the test set and the data provenance:
This information is not applicable and not provided. The "test set" here refers to the physical devices undergoing mechanical bench testing, not a dataset of patient images or clinical outcomes. The provenance would refer to the testing lab and standards (ASTM F2077 and ASTM F2267).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. "Ground truth" in this context would refer to the true mechanical properties, which are measured directly through standardized testing, not established by human experts.
Adjudication method for the test set:
This information is not applicable and not provided. Mechanical testing results are objective measurements, not subject to human adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This device is not an AI-powered diagnostic or interpretive tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this device is a physical intervertebral body fusion device, not an algorithm.
The type of ground truth used:
The "ground truth" for the mechanical testing would be the actual physical measurements obtained from the standardized ASTM tests. This is not "expert consensus, pathology, or outcomes data."
The sample size for the training set:
This information is not applicable and not provided. There is no AI algorithm being trained for this device.
How the ground truth for the training set was established:
This information is not applicable and not provided.

In summary, this document is a 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence through comparisons of materials, design, and mechanical bench testing to legally marketed predicate devices, rather than through clinical studies involving human performance or AI algorithms.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized representation of three faces in profile, stacked one above the other.

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

May 6, 2016

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

Re: K153615

Trade/Device Name: NeoFuse™ HA Enhanced PLIF/TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 16, 2016 Received: April 18, 2016

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 Part 807); labeling (21 CFR Parts 801); medical device 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 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) K153615

Device Name NeoFuse™ HA Enhanced PLIF/TLIF

Indications for Use (Describe)

The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

HT Medical LLC's

NeoFuse™ HA Enhanced PLIF/TLIF

Intervertebral Body Fusion System

Trade Name:	NeoFuse™ HA Enhanced PLIF/TLIF
Common Name:	Intervertebral Body Fusion Device
Product Class:	Class II
Classification:	888.3080
Product Code:	MAX (Lumbar)
Panel Code:	87 Orthopedic
Date Prepared:	May 5, 2016

Sponsor / Manufacture Information:

HT Medical, LLC Attn: Robert Compton 6316 E 102nd Street Tulsa, OK 74137 Phone: 417-309-9457 Registration Number: PENDING

Contact Information:

Additive Innovations, LLC Attn: Nicholas Cordaro 533 2nd Street, Suite A Encinitas, CA 92024 Phone: 760-525-9900

Device Description

Predicate Device

The interbody fusion system is substantially equivalent to legally marketed predicate devices. The primary predicate devices is Depuy/AcroMed Lumbar I/F Cage per P960025, with additional predicates including Meditech Spine Talos-C per K142345, SpineFrontier, Inc., Arena-C HA PEEK Cervical Interbody Fusion Device per K142026, and Cutting Edge Spine, LLC's EVOS Lumbar Interbody System per K150321.

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Intended Use / Indications for Use

When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar 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 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.

Technology Characteristics

The technological characteristics of the NeoFuse are equivalent or similar to the predicate devices, including the materials. Identical to K142345, K142026, and K150321 the hydroxyapatite filled polyetheretherketone (HA PEEK ) contains HA which is a naturally occurring mineral in bone and is widely used in the orthopedic field. Similar to K142026, the devices are supplied non-sterile for steam sterilization. NeoFuse has the same technology characteristics and intended use as the intervertebral body fusion predicate devices P960025, K142345, K142026, and K150321.

Summary of Non-clinical Testing

The interbody fusion system was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear, static torsion, subsidence, and expulsion.

Test results demonstrated that the devices are substantially equivalent to the predicate devices.

Conclusion

Performance bench testing and comparisons have demonstrated NeoFuse is substantially equivalent to the predicate devices in regards to Indications for Use, Dimensions, Function, Materials, Mechanical Testing, and Technology Characteristics. The NeoFuse does not raise new questions of safety and effectiveness; and NeoFuse demonstrates substantial equivalence to 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.