The Hexanium® PLIF (Posterior 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 PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF 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® PLIF (Posterior Lumbar Interbody Fusion) 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 cage as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® PLIF cages are available in heights of 7-16 mm (in 1 mm increments), width of 9 mm, lengths of 22 and 25 mm, and lordosis angles of 0°, 5°, and 8°. Hexanium® PLIF cages are provided sterile and supplied with a set of non-sterile surgical instruments.

AI/ML Overview

The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is an intervertebral body fusion device. The provided text lacks the detailed "acceptance criteria" and subsequent "reported device performance" typically found in a clinical study report for AI-powered devices. The document is a 510(k) summary for a medical device (an intervertebral body fusion device, not an AI device) where equivalence to a predicate device is established through mechanical testing, not clinical performance data. Therefore, the questions related to AI device performance metrics, such as sensitivity, specificity, or human-in-the-loop performance, and associated study details are not applicable here.

However, I can extract information related to the device's performance data that was provided to demonstrate substantial equivalence:

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

The document states that the Hexanium® PLIF cages conform to the FDA guidance "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" dated June 12, 2007. The device was evaluated against predetermined functional and performance requirements and external standard requirements.

Test Type	Acceptance Criteria (Implied by adherence to standards)	Reported Device Performance (Implied by "meets the same... requirements")
Mechanical Testing	Conformity to ASTM F2077, ASTM F2267, and draft ASTM F-04.25.02.02 for intervertebral body fusion devices.	Hexanium® PLIF cages met these pre-determined functional and performance requirements.
Static Compression	Meets force/displacement, stiffness, and permanent deformation requirements as per ASTM F2077.	Performed according to ASTM F2077, implying requirements were met.
Static Compression-Shear	Meets force/displacement, stiffness, and permanent deformation requirements as per ASTM F2077.	Performed according to ASTM F2077, implying requirements were met.
Static Torsion	Meets torque/angle, stiffness, and permanent deformation requirements as per ASTM F2077.	Performed according to ASTM F2077, implying requirements were met.
Dynamic Compression	Withstands specified number of cyclic loads at defined forces without fracture or excessive deformation as per ASTM F2077.	Performed according to ASTM F2077, implying requirements were met.
Dynamic Compression-Shear	Withstands specified number of cyclic loads at defined forces without fracture or excessive deformation as per ASTM F2077.	Performed according to ASTM F2077, implying requirements were met.
Dynamic Torsion	Withstands specified number of cyclic loads at defined torques without fracture or excessive deformation as per ASTM F2077.	Performed according to ASTM F2077, implying requirements were met.
Subsidence Testing	Meets subsidence resistance requirements as per ASTM F2267.	Performed according to ASTM F2267, implying requirements were met.
Expulsion Testing	Meets expulsion resistance requirements as per draft ASTM F-04.25.02.02.	Performed according to draft ASTM F-04.25.02.02, implying requirements were met.
Biocompatibility	Meets pyrogenicity limits.	Bacterial Endotoxins Test performed in accordance with USP, implying pyrogen limit specifications were met.

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

Sample Size: Not specified in the document for mechanical testing. These tests typically involve a specific number of device samples (e.g., typically N=6 or more) for each test configuration, as defined by the ASTM standards, but the exact number is not provided.
Data Provenance: The tests are laboratory-based mechanical and biocompatibility tests, not human data. The document does not specify a country of origin for the testing itself, but the submitter is based in France.

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

This question is not applicable. The device is not an AI device requiring expert-established ground truth for a test set. The performance is assessed against engineering standards and material properties.

4. Adjudication method for the test set:

This question is not applicable. There was no clinical adjudication for an AI device. Mechanical and biocompatibility tests are assessed against predefined pass/fail criteria from international standards.

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 question is not applicable. No MRMC study was conducted as this is not an AI device. The document explicitly states: "No clinical data has been presented."

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

This question is not applicable. This is not an AI device.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is defined by the objective pass/fail criteria established within the referenced ASTM international standards for intervertebral body fusion devices (e.g., F2077, F2267, F-04.25.02.02). For biocompatibility, the ground truth is the pyrogen limit specification as per USP.

8. The sample size for the training set:

This question is not applicable. There is no training set as this is not an AI/machine learning device. The device's design and manufacturing process are based on established engineering principles for intervertebral body fusion devices.

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

This question is not applicable. There is no training set for an AI device. The device's performance is demonstrated through in-vitro mechanical and biocompatibility testing against predefined standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 16, 2022

SpineVision, S.A.S. Ms. Nancy Lincé President & CEO Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583

Re: K223251

Trade/Device Name: Hexanium® PLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 20, 2022 Received: October 21, 2022

Dear Ms. Lincé:

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

{1}------------------------------------------------

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) 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 Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K223251

Device Name Hexanium® PLIF

Indications for Use (Describe)

The Hexanium® PLIF (Posterior 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 at the involved level(s ). Patients should have received at least 6 months of non-operative treatment with Hexanium PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

Date Prepared	October 20, 2022
Submitter	SpineVision, S.A.S.10 rue de la RenaissanceBâtiment E92160 AntonyFRANCE
Submitter Contact	Quang TranDirector, Quality Assurance & Regulatory AffairsPhone: +33 1 53 33 25 25Email: q.tran@spinevision.com
CorrespondentContact	Nancy LincéLincé Consulting, LLCU.S. AgentRegulatory Affairs ConsultantPhone: (650) 759-6186Email: nlince@linceconsulting.com
Device Name	Hexanium® PLIF
Class	Class II
Product Code	MAX: Intervertebral Fusion Device with Bone Graft, Lumbar
CFR Section	21 CFR§888.3080: Intervertebral body fusion device
Device Panel	Orthopedic
Primary Predicate	K210359 SpineVision SAS Hexanium® TLIF
Additional Predicate	K153783 SpineVision SpaceVision® PLIF
Device Description	The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) is a titaniumalloy (Ti6Al4V ELI) interbody cage manufactured via an AdditiveManufacturing method. The honeycomb structure allows for bone through-growth through the structure of the cage as well as providing lateral andvertical bone graft windows in the body of the cage.Hexanium® PLIF cages are available in heights of 7-16 mm (in 1 mmincrements), width of 9 mm, lengths of 22 and 25 mm, and lordosis anglesof 0°, 5°, and 8°.Hexanium® PLIF cages are provided sterile and supplied with a set of non-sterile surgical instruments.
Indications for Use	The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is anintervertebral body fusion device indicated for use with autogenous bonegraft in skeletally mature patients with Degenerative Disc Disease (DDD) atone or two continuous levels from L2-S1. DDD is defined as discogenicback pain with degeneration of the disc confirmed by patient history andradiographic studies. These DDD patients may also have up to Grade Ispondylolisthesis or retrolisthesis at the involved level(s). Patients shouldhave received at least 6 months of non-operative treatment prior totreatment with Hexanium PLIF system. This device has to be filled withautogenous bone graft material. This device is implanted via the posteriorapproach. Hexanium PLIF system must be used in combination withsupplemental internal spinal fixation which has been cleared by the FDA foruse in the lumbar spine.
Performance Data	Hexanium® PLIF cages conform to the FDA guidance “Guidance forIndustry and FDA Staff – Class II Special Controls Guidance Document:Intervertebral Body Fusion Device" dated June 12, 2007.Mechanical testing includes static compression, static compression-shear,static torsion, dynamic compression, dynamic compression-shear, anddynamic torsion performed according to ASTM F2077, subsidence testingperformed according to ASTM F2267, and expulsion testing performedaccording to draft ASTM F-04.25.02.02.The Hexanium® PLIF cages meet the same pre-determined functional andperformance requirements and external standard requirements as thepredicate devices and do not raise any new questions of safety oreffectiveness.Bacterial Endotoxins Test was performed in accordance with USP todemonstrate that the device meets pyrogen limit specifications.
ClinicalPerformance Data	No clinical data has been presented.
SubstantialEquivalence	The Hexanium® PLIF is substantially equivalent to the predicate device interms of intended use, indications for use, design, function, technology,materials, safety, and performance as well as procedural steps, surgicalinstrumentation, and product labeling.
Conclusion	The Hexanium® PLIF is substantially equivalent to the predicate device.

{4}------------------------------------------------

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.