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 & TL 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's conditions. Spineart JULIET® Ti cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. Juliet® Ti PO, OL & TL spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. Juliet® Ti PO, OL & TL spinal implants are additively manufactured and present both solid and porous structures. The Juliet Ti cages are delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile).

AI/ML Overview

This FDA document is a 510(k) premarket notification for the "Juliet® Ti" intervertebral body fusion device. While it describes the device and its claimed substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/human reader performance study.

The document details the device's indications for use, materials, and mechanical testing performed to demonstrate substantial equivalence to predicate devices. The "Discussion of Testing" section lists various mechanical tests conducted (e.g., static and dynamic axial compression, shear compression, subsidence, material characterization, static shear strength, fatigue shear strength, static tensile strength, and abrasion resistance). These tests assess the physical and mechanical properties of the implant, not the performance of an AI system or human readers.

Therefore, I cannot provide the requested information from this document. The questions you've asked (about sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance, and acceptance criteria tables for AI performance) are typical for the evaluation of AI/machine learning medical devices, which this document does not cover.

In summary:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical performance testing of a physical implant, not AI performance.
2. Sample sized used for the test set and the data provenance: Not applicable. No AI test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for AI performance is mentioned.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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

July 15, 2016

SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20, route de Pré-Bois - CP1813 1215 Geneva. SWITZERLAND

Re: K153621

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: June 13, 2016 Received: June 15, 2016

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 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/ResourcesforYou/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

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

K153621

Page 1 of 1

510(k) Number (if known) K153621

Device Name Juliet® Ti

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Zane W. Wyatt Division of Orthopedic Devices

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."

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Traditional 510k JULIET * Ti

Image /page/3/Picture/1 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the word. The butterfly is purple, and the word "spineart" is in a dark color, with the "a" and "r" in a lighter shade of purple.

510(k) SUMMARY

Submitted by	SPINEART
	International Center Cointrin
	20 route de pré-bois
	CP1813
	1215 GENEVA 15
	SWITZERLAND
Contacts	Franck PENNESI Director of Industry & Quality
	Phone : +41 22 570 1246 Fax : +41 22 799 4026
	Mail : fpennesi@spineart.com
	Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)
	Mail : idrubaix@nordnet.fr
Date Prepared	June 13, 2016
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: Cascadia Interbody System (K150481) manufactured by K2M,
	Inc
	Additional predicates: Dynamik intervertebral body fusion device (renamed
	Juliet) (K081888) manufactured by Spineart; JULIET PO (K142277) manufactured
	by Spineart; Capstone Control Spinal System (K120368) manufactured by
	Medtronic Sofamor Danek Usa, In; Capstone Spinal System (K133650)
	manufactured by Medtronic Sofamor Danek Usa, In; LUCENT (K071724)
	manufactured by Spinal Elements, Inc
Indications for use	Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebralbody fusion procedures in skeletally mature patients with degenerative discdisease (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 confirmedby patient history and radiographic studies. These DDD patients may also have upto Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinalimplants are to be used with autogenous bone graft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbarinterbody devices are to be used with supplemental fixation that has beencleared for use in the lumbosacral spine. Patients should have at least six (6)months of non-operative treatment prior to treatment with an intervertebralcage.
Description of the device	Spineart Juliet® Ti PO, OL & TL spinal implants consist of a range of intervertebralbody spacers with various shapes and designs so as to be implanted via an openposterior or transforaminal approach and to adapt different patient's conditions.Spineart JULIET® Ti cage is offered in a variety of lengths, heights, widths andlordotic angles to adapt to a variety of patient anatomies.Juliet® Ti PO, OL & TL spinal implants are made of Titanium alloy Ti6Al4V ELIconforming to ASTM F136. Juliet® Ti PO, OL & TL spinal implants are additivelymanufactured and present both solid and porous structures.The Juliet Ti cages are delivered sterile (gamma sterilization) and supplied withsurgical instruments (reusable - provided non-sterile).
ofSummaryTechnologicalCharacteristics	The subject JULIET Ti device is identical in indications for use, surgical technique,manufacturing method and raw material to the predicate device cleared inK150481. The subject JULIET Ti device shares similar design features, comparableheights, widths, depths, lordotic angles and surgical instrumentation as thepredicate devices (K081888, K142277, K120368, K133650, K071724).
Discussion of Testing	Testing in compliance with: FDA's "Class II Special Controls Guidance Document:Intervertebral Body Fusion Device" was performed for the JULIETⓇ Ti Cages anddemonstrated substantially equivalent performance to the identified predicatedevices. The following mechanical tests were performed: Static and dynamic axialcompression (per ASTM F2077), Static and dynamic Shear compression (perASTM F2077), Subsidence (per ASTM F2267)The characterization of the chemical, physical and mechanical properties of thematerial was performed in accordance with ASTM F3001 and ASTM E8/E8M.The porous structure featured on titanium alloy implants additivelymanufactured was performed based on the FDA's Guidance for industry on thetesting of metallic plasma sprayed coatings on orthopedic implants to supportreconsideration of postmarket surveillance requirements. The following testswere performed: Static shear strength (per ASTM F1044), Fatigue shear strength(per ASTM F1160) Static tensile strength (per ASTM F1147) and abrasionresistance (per ASTM F1978).
Conclusion	Based on the design features, the use of established well known materials,feature comparisons, indications for use, and results of the mechanical testing,the JULIET Ti has demonstrated substantial equivalence to the identifiedpredicate 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.