JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, implanted via a lateral approach, with various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The Juliet® Ti LL spinal implants are additively manufactured and present both solid and porous structures. the The subject implants Juliet® Ti LL 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) and will join the previously cleared Juliet® LL range of implants (K161888; K141135) which presents similar design features and addresses the same surgical approach and utilize the same instrumentation designed purposely. The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).

AI/ML Overview

This is a 510(k) premarket notification for a medical device called Juliet® Ti LL, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting a study proving performance against acceptance criteria for a new AI/CAD device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, MRMC studies, effect size, standalone performance, ground truth establishment) are not applicable to this type of submission. This document describes a medical implant, not an AI software.

Here's the information that can be extracted from the provided text, primarily focusing on the device's characteristics and the testing mentioned for ensuring its safety and effectiveness (as part of establishing substantial equivalence to predicates):

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an implant and not an AI/CAD software, there isn't a direct "acceptance criteria" table in the sense of performance metrics for an algorithm. Instead, the document describes the device and then lists the non-clinical tests performed to demonstrate its safety and effectiveness, primarily by showing it meets established standards comparable to its predicate devices. These standards effectively serve as the "acceptance criteria" for this type of device.

Acceptance Criteria (Relevant Standards/Tests)	Reported Device Performance (Summary)
Material Properties:	Conforms to ASTM F136 (Titanium alloy Ti6Al4V ELI)
ASTM F136	Conforms to ASTM F3001 and ASTM E8/E8M
ASTM F3001, ASTM E8/E8M
Biocompatibility/Safety:
Pyrogenicity (Bacterial Endotoxin testing)	Achieves Endotoxin limit of 20 EU / device (USP standard)
Mechanical Performance:
Static axial compression (ASTM F2077)	Performed on predicate devices (demonstrates similar design characteristics of subject device)
Dynamic axial compression (ASTM F2077)	Performed on predicate devices
Static shear compression (ASTM F2077)	Performed on predicate devices
Dynamic shear compression (ASTM F2077)	Performed on predicate devices
Subsidence testing (ASTM F2267)	Performed on predicate devices
Porous structure validation	Validated based on FDA Guidance for industry on metallic plasma sprayed coatings on orthopedic implants
Design/Manufacturing:
Similar design features	"presents similar design features and the same manufacturing technology" as predicates
Additive manufacturing (SLM)	Same manufacturing technology as predicate Juliet® Ti
Sterile (gamma sterilization)	Delivered sterile

Additional Requested Information:

Sample size used for the test set and the data provenance:
- N/A. This is not an AI/CAD device, so there is no "test set" of patient data in this context. The testing mentioned refers to physical, mechanical, and material testing of the device itself.
- For the physical device testing, the sample sizes would typically be small, determined by engineering statistical methods for material and mechanical verification (e.g., n=3 or n=5 for specific physical tests), but these are not explicitly stated in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No expert ground truth establishment for a patient data test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method for a patient data test set.
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:
- N/A. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this device, "ground truth" relates to compliance with established material standards (e.g., ASTM standards for titanium alloy properties) and biomechanical test methods (e.g., ASTM F2077 for intervertebral body fusion device mechanical testing). The ground truth is engineering and materials science-based, not patient-data based in the context of diagnostic accuracy.
The sample size for the training set:
- N/A. No training set as this is not an AI/ML device.
How the ground truth for the training set was established:
- N/A. No training set.

Summary

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January 3, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

SPINEART Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 PLAN LES OUATES GENEVA SWITZERLAND

Re: K173702

Trade/Device Name: Juliet® Ti LL Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 1, 2017 Received: December 4, 2017

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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, Katherine D. Kavlock -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Indications for Use

510(k) Number (if known)

K173702

Device Name Juliet® Ti LL

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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510(k) SUMMARY

Special 510k Juliet® Ti LL

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	January 03, 2018
Common Name	Intervertebral body fusion device
Trade Name	Juliet® Ti LL
Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Class	II
Product Code	MAX
CFR section	888.3080
Device panel	ORTHOPEDIC
Legally marketed	Primary predicate: Juliet® Ti (K153621) manufactured by Spineart
predicate devices	Additional predicates: Juliet® LL (K161888, K141135) manufactured by Spineart
Indications for use	JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body
	fusion procedures in skeletally mature patients with degenerative disc disease
	(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 1
	spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants
	are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody
	Device is to be used with supplemental fixation. Patients should have at least
	six (6) months of non-operative treatment prior to treatment with an
intervertebral cage.
	Spineart Juliet® Ti LL spinal implants consist of a range of titanium
Description of thedevice	intervertebral body spacers, implanted via a lateral approach, with various sizes
	and footprints so as to adapt different patient's conditions. The Juliet® Ti LL
	spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM
	F136. The Juliet® Ti LL spinal implants are additively manufactured and present
	both solid and porous structures.
	the The subject implants Juliet® Ti LL 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) and will join the previously cleared Juliet® LL range of implants (K161888;K141135) which presents similar design features and addresses the same
	surgical approach and utilize the same instrumentation designed purposely.
	The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) and
	supplied with dedicated surgical instruments (reusable - provided non-sterile).
	The Juliet® Ti LL 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
Technological	orthopedic implants to support reconsideration of postmarket surveillance
characteristics	requirements.
compared to the	The Juliet® Ti LL spinal implants present a similar design feature and range of
predicate devices	devices as the previously cleared Juliet® LL spinal implants. Both Juliet® Ti LL and
	Juliet® LL are designed for a lateral approach.
	The following non-clinical tests were conducted on the predicate devices: Static
	and dynamic axial compression, static and dynamic shear compression
	according to ASTM F2077 and subsidence testing according to 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 Spineart Juliet® Ti LL spinal
	implants.
Conclusion	Based on the design features, technological characteristics, feature
	comparisons, and indications for use, Juliet® Ti LL has demonstrated substantial
	equivalence to the identified predicate devices.

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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.