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). The JULIET® Ti LL Lumbar Interbody Device are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Implants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

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 subject Product Line Extension consists of an extended range of titanium alloy spacers with integrated fixation. Juliet® Ti LL Product Line Extension also introduces a range of hyperlordotic intervertebral spacers of various sizes, heights, footprints and lordosis with the integrated fixation. The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

AI/ML Overview

The provided text describes a medical device, the JULIET® Ti LL Lumbar Interbody Device, and its 510(k) summary, which includes information regarding its substantial equivalence to predicate devices based on non-clinical testing. However, the document does not contain information about the acceptance criteria and study details as typically defined for AI/ML-based devices (e.g., performance metrics like sensitivity, specificity, or AUC, and aspects like human reader studies, ground truth establishment, or training/test set sample sizes).

The document is for a traditional medical device (an intervertebral body fusion device) and therefore does not include the typical elements of an AI/ML device approval.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based on the information available in the text:

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

The document does not explicitly state "acceptance criteria" in the context of performance metrics that would be applicable to an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, it discusses the device meeting mechanical and material performance standards for traditional orthopedic implants.

Acceptance Criteria (Implicit from testing)	Reported Device Performance
Static and dynamic axial compression (per ASTM F2077)	Demonstrated comparable mechanical properties to predicate device.
Static and dynamic shear compression (per ASTM F2077)	Demonstrated comparable mechanical properties to predicate device.
Static and dynamic torsion (per ASTM F2077)	Demonstrated comparable mechanical properties to predicate device.
Expulsion	Tested (results imply satisfactory, but specific numbers not provided).
Subsidence (per ASTM F2267)	Tested (results imply satisfactory, but specific numbers not provided).
Mass loss determination after dynamic testing (5 million cycles)	Tested (results imply satisfactory, but specific numbers not provided).
Axial push out on fixation screws through the plate	Tested (results imply satisfactory, but specific numbers not provided).
Bacterial endotoxin limit of 20 EU/device (USP standard for pyrogenicity)	Compliance based on endotoxin testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable or provided for this type of medical device which undergoes mechanical and material testing, not data-driven performance evaluation. The "test set" here refers to physical samples of the device and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the evaluation involves mechanical and material testing against established ASTM standards, not a clinical assessment requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for mechanical and material testing.

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 is not applicable as the device is not an AI/ML-based diagnostic or assistive tool.

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

This is not applicable as the device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is defined by established engineering and material standards (e.g., ASTM F2077, ASTM F2267, USP standards for endotoxin). The device's performance is compared against these objective standards and against the performance of legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as the device is developed through engineering design and manufacturing processes, not machine learning.

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

This is not applicable as there is no "training set" in the context of an AI/ML device. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements for intervertebral body fusion devices.

Summary

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May 29, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spineart Mr. Franck Pennesi Chief Technical Officer 3 chemin du pre Fleuri Plan Ouates, 1228 Ch

Re: K190877

Trade/Device Name: Juliet® Ti LL Lumbar Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: April 2, 2019 Received: April 4, 2019

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. 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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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,

for

CAPT Raquel Peat, PhD, MPH, USPHS Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190877

Device Name

JULIET® Ti LL Lumbar Interbody Device

Indications for Use (Describe)

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

[ ] Over-The-Counter Use (21 CFR 801 Subpart C) > Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) SUMMARY

510k	TRADITIONAL
Basis for submission	NEW DEVICES -LINE EXTENSION
Submitted by	SPINEART3 Chemin du Pré Fleuri 1228 PLAN LES OUATESGENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical OfficerPhone: +41 22 570 1200 Fax: +41 22 594 8306Mail: fpennesi@spineart.comRegulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr
Date Prepared	March 26, 2019
Common Name	Intervertebral body fusion device
Trade Name	JULIET® Ti LL Lumbar Interbody Device
Classification Name	Intervertebral Fusion Device with Integrated Fixation Lumbar / Intervertebral Fusion Device Lumbar
Class	II
Product Code	OVD / MAX
CFR section	888.3080
Device panel	ORTHOPEDIC
Legally marketed predicate devices	Primary predicate: Scarlet® AL-T (K181818) manufactured by SpineartAdditional predicates: Juliet® Ti LL (K173702) manufactured by Spineart and Timberline® MPF (K163543) manufactured by Zimmer Biomet
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). The JULIET® Ti LL Lumbar Interbody Device are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Implants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine
Description of the device	Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebralbody spacers, implanted via a lateral approach, with various sizes and footprints soas to adapt different patient's conditions. The Juliet® Ti LL spinal implants are madeof Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The Juliet® Ti LL spinalimplants are additively manufactured and present both solid and porous structures.The subject Product Line Extension consists of an extended range of titanium alloyspacers with integrated fixation. Juliet® Ti LL Product Line Extension also introducesa range of hyperlordotic intervertebral spacers of various sizes, heights, footprintsand lordosis with the integrated fixation.The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) andsupplied with dedicated surgical instruments (reusable - provided non-sterile).Bacterial endotoxin testing as specified in USP standard is used for pyrogenicitytesting to achieve the Endotoxin limit of 20 EU / device.
Technologicalcharacteristicscompared topredicate devices	The added Juliet® Ti LL implants present similar design features, solid, lattice andporous structures, the same manufacturing technology, i.e. additive manufacturing(SLM) and the same material, i.e. titanium alloy conforming to ASTM F136 identicallyto Juliet® Ti LL (K173702).The previously cleared Juliet® Ti LL (K173702) and added hyperlordotic interbodyspacers can be implanted in a configuration with integrated fixation provided by themean of titanium alloy plate that come in various shapes, and heights and fixationscrews that come in various diameters and lengths so as to better fulfil surgeon'sneeds and to accommodate varying patient anatomy. The bone screws are securedby the mean of a cover-plate that prevent backing out.Juliet® Ti LL implants conform to the Guidance for Industry and Food and DrugAdministration Staff issued on December 5, 2017 "Technical Considerations forAdditive Manufactured Devices".As was established in this submission added Scarlet® AC-T fixation screws aresubstantially equivalent and has the same technological and mechanicalcharacteristics to predicate devices.
Discussion of Testing	The following non-clinical tests were conducted on the Juliet® Ti LL: static anddynamic axial compression (per ASTM F2077), static and dynamic shearcompression (per ASTM F2077), static and dynamic torsion (per ASTM F2077),expulsion, subsidence (per ASTM F2267) and mass loss determinationafter dynamic testing on assemblies (spacer + plate + fixation screws) that passed 5million cycles. Results demonstrate comparable mechanical properties to theprimary predicate device Scarlet® AL-T (K181818) manufactured by Spineart.Additionally, axial push out on the fixation screws through the plate hasbeen conducted.
Conclusion	Based on the design features, technological characteristics, feature comparisons,indications for use, and non-clinical performance testing, the added Juliet® Ti LLdevices have demonstrated substantial equivalence to the identified predicatedevices

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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.