The Hexanium® TLIF (Transformational Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous 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 6 months of non-operative treatment prior to treatment with Hexanium® TLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via transforaminal approach. Hexanium® TLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

Device Description

The Hexanium® TLIF device is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® TLIF is available in heights of 7mm to 16mm in 1mm increments in a Small footprint (28mm X 9mm) or a Medium footprint (32mm X 10.5mm). Hexanium® TLIF has a 5° Lordosis angle. Hexanium® TLIF devices are provided sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hexanium® TLIF device:

This document is a 510(k) Premarket Notification from the FDA for the Hexanium® TLIF device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report in the way a clinical trial or algorithm validation study would.

Based on the provided text, the "acceptance criteria" and "study" are described in terms of mechanical and biological performance, aiming for equivalence to a predicate device, as typically required for a 510(k) submission for an intervertebral body fusion device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category/Test	Acceptance Criteria (Implicit from Device Guidance & Predicate Comparison)	Reported Device Performance
Mechanical Performance
Static Compression	Conforms to ASTM F2077-14; Comparable to predicate device.	Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device.
Dynamic Compression	Conforms to ASTM F2077-14; Comparable to predicate device.	Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device.
Static Compression Shear	Conforms to ASTM F2077-14; Comparable to predicate device.	Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device.
Dynamic Compression Shear	Conforms to ASTM F2077-14; Comparable to predicate device.	Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device.
Subsidence	Conforms to ASTM F2267-04; Comparable to predicate device.	Performed according to ASTM F2267-04; Results demonstrate comparable mechanical properties to the predicate device.
Expulsion Testing	Comparable to predicate device.	Performed; Results demonstrate comparable mechanical properties to the predicate device.
Biological Performance
Bacterial Endotoxins Test	Meets pyrogen limit specifications (in accordance with USP).	Performed in accordance with USP; Device meets pyrogen limit specifications.
General Conformance	Conforms to "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Document issued on June 12, 2007."	Device conforms to the specified guidance document.

Explanation of the "Study":

The "study" described here is a series of benchtop mechanical and biological tests designed to demonstrate that the Hexanium® TLIF device performs equivalently to its predicate device (SpaceVision® Interbody Fusion Cages, K153783) and meets relevant industry standards and FDA guidance for intervertebral body fusion devices.

Missing Information (based on the provided text):

The provided text is a 510(k) summary, which is a regulatory document and not a detailed study report. Therefore, several of the requested points are not applicable (N/A) or not explicitly stated in this type of document, especially those related to AI algorithm validation, human-reader studies, or clinical trials.

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

Sample Size for Test Set: Not specified in terms of number of devices/units tested for each mechanical test. Typically, these benchtop tests involve a small, statistically valid number of samples (e.g., 5-10 per test condition), but the exact number is not provided.
Data Provenance: The tests are described as being performed to ASTM standards and USP. This implies laboratory testing. The manufacturing entity, SpineVision SAS, is based in France, so the testing could have been conducted in France or at a qualified testing facility elsewhere. The document doesn't specify a "country of origin for data" in the context of patient data, as this is a benchtop study. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission, not retrospectively analyzing existing data.

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

N/A. This is a mechanical/biological benchtop study, not a study involving interpretation of medical images or clinical outcomes by human experts to establish ground truth. The "ground truth" for these tests is defined by the ASTM standards and USP specifications.

4. Adjudication Method for the Test Set:

N/A. As it's a benchtop physical and biological test comparing to standards and a predicate, there's no "adjudication method" in the sense of expert consensus for interpretations. The results are quantitative measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study is typically performed for diagnostic devices, especially those involving image interpretation or AI algorithms, to assess inter-reader variability and the impact of the device on human performance. This is a spinal implant for fusion, and no such study is mentioned or required for this type of device in a 510(k) context.

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

No. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

For mechanical testing: Industry Standards (ASTM F2077-14, ASTM F2267-04) and Predicate Device Performance (side-by-side comparison).
For biological testing: Pharmacopoeial Standards (USP for Bacterial Endotoxins Test).

8. The Sample Size for the Training Set:

N/A. This study does not involve a "training set" as it is not an AI/machine learning model.

9. How the Ground Truth for the Training Set was Established:

N/A. This study does not involve a "training set" or "ground truth for a training set."

In summary, the provided document details the regulatory pathway for a conventional medical device (spinal implant) through a 510(k) submission. The "acceptance criteria" and "study" revolve around demonstrating mechanical and biological equivalence to a previously cleared predicate device and compliance with established industry standards through benchtop testing, rather than complex clinical or AI-based performance studies.

Summary

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May 4, 2018

SpineVision, SAS % Mr. Donald Guthner Regulatory Consultant Orgenix LLC 111 Hill Road Douglassville, Pennsylvania 19518

Re: K180437

Trade/Device Name: Hexanium® TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 6, 2018 Received: April 9, 2018

Dear Mr. Guthner:

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 Part 801); medical device 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K180437

Device Name Hexanium® TLIF

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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Submitter	SpineVision SAS10 rue de la RenaissanceBatiment E92160 Antony - FRANCE
Submitter Contact	Anaëlla GallegoQA and RA ManagerTel: +33 1 53 33 25 25Fax: +33 1 72 69 00 30EMAIL: a.gallego@spinevision.com
CorrespondentContact	Donald W. GuthnerORGENIX LLC111 Hill RoadDouglassville, PA 19518USATel. +1 646-460-2984Fax. +1 484-363-5879Email: dg@orgenix.com
Device Name	Hexanium® TLIF
Class	Class II
Product Code	MAX: Intervertebral Fusion Device with Bone Graft, Lumbar
Classification	888.3080: Intervertebral body fusion device
Device Panel	Orthopedic
Primary Predicatedevice	K153783 – SpaceVision® Interbody Fusion Cages, SpineVision SAS
Device Description	The Hexanium® TLIF device is a titanium alloy (Ti6Al4V ELI)interbody cage manufactured via an Additive Manufacturing method.The honeycomb structure allows for bone through-growth throughthe structure of the device as well as providing lateral and verticalbone graft windows in the body of the cage.Hexanium® TLIF is available in heights of 7mm to 16mm in 1mmincrements in a Small footprint (28mm X 9mm) or a Medium footprint(32mm X 10.5mm). Hexanium® TLIF has a 5° Lordosis angle.Hexanium® TLIF devices are provided sterile.
Indications for Use	The Hexanium® TLIF (Transforaminal Lumbar Interbody Fusion)system is an intervertebral body fusion device indicated for use withautogenous bone graft in skeletally mature patients with DegenerativeDisc Disease (DDD) at one or two continuous levels from L2-S1.DDD is defined as discogenic back pain with degeneration of the discconfirmed by patient history and radiographic studies. These DDDpatients may also have up to Grade I spondylolisthesis or retrolisthesisat the involved level(s). Patients should have received at least 6 monthsof non-operative treatment prior to treatment with Hexanium® TLIFsystem. This device has to be filled with autogenous bone graftmaterial. This device is implanted via transforaminal approach.Hexanium® TLIF system must be used in combination withsupplemental internal spinal fixation which has been cleared by theFDA for use in the lumbar spine.
Performance Data	The Hexanium® TLIF device conforms to the Class II SpecialControls Guidance Document: Intervertebral Body FusionDevice Document issued on June 12, 2007.
	Mechanical testing includes static compression, dynamic compression,static compression shear and dynamic compression shear performedaccording to ASTM F2077-14, subsidence testing performed accordingto ASTM 2267-04 and expulsion testing.
	Mechanical testing was performed in a side-by-side comparison to thepredicate device.
	Results demonstrate comparable mechanical properties to the predicatedevice.
	Bacterial Endotoxins Test was performed in accordance to USP todemonstrate that the device meets pyrogen limit specifications.
ClinicalPerformance Data	No clinical data has been presented.
SubstantialEquivalence	The Hexanium® TLIF is substantially equivalent to the primarypredicate device SpaceVision Interbody Fusion Cages in terms ofintended use, design, mechanical properties and function.
Conclusion	The Hexanium® TLIF is substantially equivalent to thepredicate device.
Date	2018-05-03

510K SUMMARY

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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.