Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine 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 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

Spineart Juliet® Ti PO & OL spinal implants consist of a range of intervertebral body spacers with various shapes and designs so as to be implanted via an open posterior or transforaminal approach and to adapt different patient anatomy. The devices have a central cavity that can receive autogenous bone graft intended to promote intervertebral fusion. Juliet® Ti PO & OL spinal implants are all made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The subject Juliet® Ti PO & OL spinal implants are additively manufactured and present both solid and porous structures. The subject implants Juliet® Ti OL Insert/Rotate will extend the previously cleared Juliet® Ti (PO, OL & TL) range of implants (K153621) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM). The Juliet® Ti PO & OL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a medical device called "Juliet® Ti," an intervertebral body fusion device. This document is a regulatory submission to the FDA, asserting substantial equivalence to a legally marketed predicate device.

Crucially, this document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device submission. The text focuses on the device's design, manufacturing process (additive manufacturing), material (Titanium alloy), and non-clinical mechanical testing (e.g., static and dynamic compression, shear compression, subsidence) which were performed on the predicate device.

The key statement regarding testing for the subject device (the new Juliet® Ti OL Insert/Rotate) is: "No additional testing has been performed for the subject Spineart Juliet® Ti OL Insert/Rotate spinal implants."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI/ML, as the provided document does not contain this information. The document itself states that "No additional testing has been performed for the subject Spineart Juliet® Ti OL Insert/Rotate spinal implants," relying instead on the substantial equivalence to a predicate device and testing performed on that predicate device.

Summary

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June 28, 2018

Spineart Frank Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri Plan Les Quates. 1228 Ch Geneva

Re: K181203

Trade/Device Name: Juliet® Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 25, 2018 Received: May 29, 2018

Dear Mr. Pennesi:

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 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,

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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) K181203

Device Name Juliet® Ti

Indications for Use (Describe)

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)

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Special 510k Juliet® Ti

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510(k) SUMMARY

510k	SPECIAL
Basis for submission	Extension of the range of Juliet® Ti devices
Submitted by	SPINEART
	3 Chemin du Pré Fleuri
	1228 PLAN LES OUATES
	GENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical Officer
	Phone: +41 22 570 1200 Fax: +41 22 594 8306
	Mail: fpennesi@spineart.com
	Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr
Date Prepared	May 3, 2018
Common Name	Intervertebral body fusion device
Trade Name	Juliet® Ti
Classification Name	Intervertebral Fusion Device with Bone Graft, Lumbar
Class	II
Product Code	MAX
CFR section	888.3080
Device panel	ORTHOPEDIC
Legally marketed predicate devices	Primary predicate: Juliet® Ti (K153621) manufactured by Spineart
Indications for use	Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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Descriptionofthedevice	Spineart Juliet® Ti PO & OL spinal implants consist of a range of intervertebral body spacers with various shapes and designs so as to be implanted via an open posterior or transforaminal approach and to adapt different patient anatomy. The devices have a central cavity that can receive autogenous bone graft intended to promote intervertebral fusion. Juliet® Ti PO & OL spinal implants are all made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The subject Juliet® Ti PO & OL spinal implants are additively manufactured and present both solid and porous structures.The subject implants Juliet® Ti OL Insert/Rotate will extend the previously cleared Juliet® Ti (PO, OL & TL) range of implants (K153621) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM).The Juliet® Ti PO & OL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).
Technologicalcharacteristicscompared tothepredicate devices	The Juliet® Ti OL Insert/Rotate spinal implants are manufactured using the same manufacturing technology, i.e. additive manufacturing (SLM) as predicate device Juliet® Ti (PO, OL & TL). The characterization of the chemical, physical and mechanical properties of the material was performed in accordance with ASTM F3001 and ASTM E8/E8M. The porous structure featured on titanium alloy implants additively manufactured was validated based on the FDA's Guidance for industry on the testing of metallic plasma sprayed coatings on orthopedic implants to support reconsideration of postmarket surveillance requirements.The Juliet® Ti PO & OL spinal implants present a similar design feature and range of devices as the previously cleared Juliet® Ti devices.The following non-clinical tests were conducted on predicate devices: Static and dynamic axial compression (per ASTM F2077), Static and dynamic Shear compression (per ASTM F2077) and subsidence (per ASTM F2267). A Finite Element Analysis has been submitted to support substantial equivalence.Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Discussion of Testing	No additional testing has been performed for the subject Spineart Juliet® Ti OL Insert/Rotate spinal implants.
Conclusion	Based on the design features, technological characteristics, feature comparisons and indications for use, the subject Juliet® Ti OL Insert/Rotate has demonstrated substantial equivalence to the identified 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.