The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.

Device Description

The Idys™ ALIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys™ ALIF TiVac System is designed for use as a lumbar intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) coated with titanium on its superior and inferior surfaces and is to be used with autograft.

The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant coated with titanium are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting back out. The Idys™ ALIF TiVac System is a standalone system intended to be used with plate and four bone screws, autogenous bone graft and requires no additional supplementary fixation. The Idys™ ALIF TiVac System cages are made of ASTM F2026 compliant polyetheretherketone (PEEK) coated with compliant ASTM F1580 titanium and, markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages, plates and screws are provided sterile and are for single use only.

AI/ML Overview

This document describes the marketing clearance for a medical device implant, specifically an intervertebral body fusion device, not an AI/Software as a Medical Device (SaMD). Therefore, the typical "acceptance criteria" and study designs related to diagnostic accuracy, sensitivity, specificity, or reader performance for AI/SaMD are not directly applicable.

The performance criteria for this device, a physical implant, are primarily based on biocompatibility and mechanical testing to demonstrate its safety and effectiveness compared to a previously cleared predicate device.

However, I can extract the relevant information from the provided text regarding the closest equivalent to "acceptance criteria" and "proof of meeting these criteria" for this specific type of medical device.

Key Information regarding Device Evaluation:

Device Name: Idys™ ALIF TiVac
Product Type: Intervertebral Body Fusion Device (Implantable)
Regulatory Class: Class II
Product Code: OVD
Regulatory Mechanism: 510(k) Premarket Notification (demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring de novo clinical trials for novel devices).

Based on the provided text, here's a breakdown of the information, adapting the requested categories to fit the context of an implantable medical device undergoing 510(k) clearance:

1. Acceptance Criteria and Reported Device Performance (Adapted for an Implantable Device)

For this type of device, "acceptance criteria" are not framed as diagnostic accuracy metrics but rather as meeting established performance standards for implants to demonstrate functional equivalence and safety to a predicate device.

Acceptance Criteria Category (Equivalence to Predicate)	Specific Criteria / Performance Demonstrated
Material Biocompatibility	The modified device (with titanium coating) must be demonstrated to be biocompatible.
Mechanical Performance (Bench Testing)	The device must demonstrate equivalent mechanical integrity and performance to the predicate device under various simulated physiological loads. This includes: - Static and dynamic axial compression testing - Static and dynamic compression shear testing - Subsidence testing - Expulsion testing - Static torsion testing - Wear testing (PEEK and titanium particles)
Coating Integrity & Performance	The added plasma-sprayed titanium coating must meet established standards for adhesion, strength, and durability. This includes: - Static tensile strength - Static shear strength - Shear fatigue strength - Abrasion resistance - Coating porosity/thickness
Clinical Equivalence (Indications for Use)	The device must have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device, with any differences not raising new safety or effectiveness issues.

Reported Device Performance:

Biocompatibility: "The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1."
Mechanical Testing (Device Functionality): "The results of these studies were determined to be substantially equivalent to legally marketed devices." (Referring to functional tests such as axial compression, shear, subsidence, expulsion, torsion, and wear).
Mechanical Testing (Coating Performance): Coating tests (static tensile, static shear, shear fatigue, abrasion resistance, porosity/thickness) were performed "with satisfactory results."
Clinical Equivalence: "The Idys™ ALIF TiVac is as safe and effective as the Idys™ ALIF (K172083). The Idys™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Idys™ ALIF TiVac and its predicate device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys™ ALIF TiVac is as safe and effective as its predicate."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of human patient data for an AI test set. This device's performance was evaluated via bench testing of physical prototypes/samples. The specific number of mechanical test specimens used for each test (e.g., how many devices were subjected to axial compression) is not stated in this summary but would be detailed in the full premarket notification.
Data Provenance: The data primarily originates from laboratory bench testing performed by the manufacturer, CLARIANCE SAS, in France ("Beaurains, France"). This is not retrospective or prospective human patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not Applicable. For a physical implantable device, "ground truth" is not established by human expert interpretation of medical images or clinical outcomes in the same way as for AI/SaMD. Instead, it's based on objective, quantifiable physical and mechanical properties measured in a lab setting against established ASTM/ISO standards.
The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting the mechanical and biocompatibility tests.

4. Adjudication Method for the Test Set

None. Adjudication methods like "2+1" or "3+1" are specific to establishing ground truth from multiple human readers for diagnostic AI/SaMD. In this context, the "ground truth" for the device's performance relies on direct physical measurements and compliance with engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is specifically designed for AI systems that aid human readers in diagnostic tasks. It is not relevant for an implantable medical device.
Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This refers to the evaluation of AI algorithm performance. This product is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective, quantifiable physical and mechanical properties measured through bench testing against established industry standards (e.g., ASTM, ISO) and comparison to the mechanical properties of the predicate device.
Biocompatibility: In vitro and in vivo (animal, if applicable, though not specified here) testing against ISO 10993-1.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a "training set." The device itself is the product, evaluated based on its physical properties.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no AI training set, there is no ground truth establishment for it.

Summary

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June 6, 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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

CLARIANCE SAS

% Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K191263

Trade/Device Name: Idys™ ALIF TiVac Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: May 10, 2019 Received: May 10, 2019

Dear Ms. Hogan:

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 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 on last page

510(k) Number (if known) K191263

Device Name

ldys™ ALIF TiVac 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)

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FORM FDA 3881 (7/17)

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K191263 510(k) SUMMARY CLARIANCE's Idys™ ALIF TiVac Intervertebral Fusion Device With Integrated Fixation, Lumbar

Submitter's Name, Address, Telephone number, Contact person and Date prepared

CLARIANCE SAS 18 rue Robespierre 62217 Beaurains, France

Phone: + 33(0)3 21 16 12 15 Facsimile: + 33(0)3 21 15 50 73

Contact Person: Willy VIVANZ, Chief Technology Officer

Date Prepared: May 28, 2019

Name of Device

ldys™ ALIF TiVac

Common or Usual Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Classification Name

Class II, 21 CFR §888.3080 - Intervertebral body fusion device, OVD

Predicate Devices

Idys™ ALIF, CLARIANCE SAS (K172083): primary predicate

ldys™ TLIF TiVac, CLARIANCE SAS (K183259): additional predicate

Purpose of the Special 510(k) notice

The Idys™ ALIF TiVac is a modification to the 510(k) cleared Idys™ ALIF predicate (K172083). The modification consists of the addition of plasma-sprayed, pure titanium coating compliant with ASTM F1580 on the superior and inferior surface of the device. The same coating has been previously cleared in K183259. The cages have similar design, shape and dimensions as those already cleared under K172083 for the Idys™ ALIF predicate device.

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Device Description

Indications for Use

The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondvlolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.

Substantial Equivalence

The Idys™ ALIF TiVac and the predicate Idys™ ALIF (K172083) are designed for use as lumbar intervertebral body fusion devices are available with equivalent range and configurations to accommodate patient anatomy.

The Idys™ ALIF TiVac and the Idys™ ALIF (K172083) feature a similar outer shape and design. The design features two slots to allow the incorporation of bone graft which is essential for promoting the fusion process. The superior and inferior surfaces of the Idys™ ALIF TiVac and the Idys™ ALIF (K172083) have teeth to grip the surface of the vertebral endplates and help to resist expulsion.

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The primary difference between the cleared Idys™ ALIF (K172083) and the subject device is the addition of the plasma-sprayed titanium coating on the superior and the inferior surface of the Idys™ ALIF TiVac cages. However, the same coating has been cleared in CLARIANCE Idys™ TLIF TiVac (K183259).

Verification and Validation steps performed following the addition of the titanium coating demonstrate that the modification does not raise any new issues of safety or effectiveness compared to the cleared Idys™ ALIF (K172083).

Performance Data

Biocompatibility

The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1.

Mechanical Testing

Bench mechanical testing according to ASTM F2077 and ASTM F2267 was used to support the decision of substantial equivalence compared to the Idys™ ALIF predicate device (K172083). Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, and wear testing (PEEK and titanium particles). The results of these studies were determined to be substantially equivalent to legally marketed devices.

Mechanical bench testing of the pure titanium coating was performed according to the FDA's guidance, Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. Specifically, the following tests were performed: static tensile strength testing according to ASTM F1147, static shear strength according to ASTM F1044, shear fatigue strength according to ASTM F1160, abrasion resistance according to ASTM F1978- 99, and coating porosity/thickness per ASTM F1854 with satisfactory results.

Conclusions

The Idvs™ ALIF TiVac is as safe and effective as the Idvs™ ALIF (K172083). The Idvs™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Idys™ ALIF TiVac and its predicate device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys™ ALIF TiVac is as safe and effective as its predicate. Thus, the Idys™ ALIF TiVac is substantially equivalent.

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.