The Idys® LLF 3DTi system is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous level(s) 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 level(s). These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.

The Idys® LLF 3DTi system is intended to be used with bone graft composed of cancellous and/or corticocancellous bone and with cleared supplemental fixation to the integrated plate and screws.

Device Description

The Idys® LLIF 3DTi is designed for use as a lumbar intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy using an additive manufacturing method and is to be used with bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The cage has a shape which restores the intervertebral height and lordosis. The cage contains two (2) slots to receive the bone graft to promote the fusion process between the endplates. The Idys® LLIF 3DTi is a system intended to be used with a plate and two (2) bone screws, bone graft and supplemental fixation that has been authorized for surgical use in the lumbar spine. The Idys® LLF 3DTi components are made of compliant ASTM F136 Titanium alloy.

AI/ML Overview

The provided text is a 510(k) summary for the Idys® LLIF 3DTi device, which is an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness. Therefore, the information requested in the prompt, particularly regarding acceptance criteria from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details, is largely not applicable or explicitly stated in this document for the present device.

However, based on the provided text, here's what can be extracted and inferred regarding performance and "acceptance criteria" in the context of a 510(k) submission primarily relying on mechanical testing and comparison to predicates:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in a 510(k) context for a mechanical device like this relate to meeting established standards and demonstrating performance comparable to predicate devices. The document references specific ASTM standards for mechanical testing and comparisons to predicate devices' material and design characteristics.

Acceptance Criterion	Reported Device Performance
Biocompatibility	No new testing required as no changes to manufacturing or patient-contacting materials compared to primary predicate (Idys® ALIF ZP 3DTi, K200920). Confirmatory testing per ISO 10993-5 and -11 had been performed previously on the predicate.
Sterility	Validation per ISO 11737 and ISO 11137 successfully completed.
Cleaning	Validation showed acceptable limits of residues.
Mechanical Performance (Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Static Torsion)	Testing according to ASTM F2077 and ASTM F2267 demonstrated substantial equivalence with predicate devices (Idys® ALIF System, K172083; Idys® PLIF, K131178).
Expulsion Resistance	Expulsion testing demonstrated adequate resistance to expulsion, despite the absence of teeth on superior and inferior surfaces (relying on porous structure roughness).
Material Equivalence	Manufactured from medical-grade Titanium alloy (ASTM F136 / ASTM F3001) using additive manufacturing. Performance compared to PEEK (ASTM 2026) predicates, with mechanical testing showing the porous structure provides similar stiffness to PEEK, avoiding stress-shielding.
Design / Form Factor Equivalence (Lateral Approach Cages)	Similar outer shape and design to SIRION LLIF System Devices (K192006) and InFill® Interbody Fusion Devices (K152259), including bulleted nose and slots for bone graft. Overall configurations, heights, and lordotic angles are within or similar to predicate ranges.
Absence of New Safety/Effectiveness Issues	The minor technological differences do not raise any new issues of safety or effectiveness compared to the predicate devices.

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

The document does not detail specific "sample sizes" for a clinical test set in the way one might expect for an AI algorithm study or a traditional clinical trial.

Mechanical Testing: While mechanical tests were performed (e.g., static and dynamic axial compression, shear, expulsion, torsion), the sample sizes for these engineering tests (e.g., number of devices tested for each mechanical property) are not specified in the 510(k) summary. These are typically simulated or bench tests, not involving human subjects.
Data Provenance: Not applicable in the context of mechanical testing or a 510(k) premarket notification for this type of device, which does not involve clinical data collected from patients for the current submission. The "provenance" refers to the device's design, manufacturing, and R&D conducted by CLARIANCE, SAS in France.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a medical device approval based primarily on mechanical engineering testing and substantial equivalence to existing devices, not on the interpretation of medical images or patient data by human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As no human expert interpretation of a "test set" for ground truth was involved, no adjudication method was necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is relevant for diagnostic imaging AI devices, where multiple readers interpret cases with and without AI assistance. This document is for an implantable intervertebral body fusion device and does not involve such studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The Idys® LLIF 3DTi is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Engineering Standards: Adherence to recognized ASTM and ISO standards for material properties, sterility, and mechanical performance (e.g., ASTM F2077, ASTM F2267, ISO 11737, ISO 11137).
Comparison to Predicate Devices: Demonstrating that the new device's technological characteristics, mechanical performance, and safety/effectiveness profile are substantially equivalent to previously cleared devices.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in this 510(k) summary for the Idys® LLIF 3DTi itself; such data might exist for the predicate devices or in post-market surveillance.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as this is a physical medical device.

Summary

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April 1, 2021

CLARIANCE, SAS % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K202032

Trade/Device Name: Idys® LLIF 3DTi Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 9, 2021 Received: March 9, 2021

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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Brent L. Showalter, Ph.D. Assistant 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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510(k) Number (if known) K202032

Device Name ldys® LLIF 3DTi

Indications for Use

The Idys® LLF 3DTi system is intended to be used with bone graft composed of cancellous and/or corticocancellous bone and with cleared supplemental fixation to the integrated plate and screws.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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K202032

510(k) SUMMARY

CLARIANCE's Idys® LLIF 3DTi

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CLARIANCE

18 rue Robespierre

F-62217 Beaurains, France

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

Contact Person: Fadwa Bahr, Quality and Regulatory Affairs Manager

Date Prepared: March 9, 2021

Name of Device and Name/Address of Sponsor

CLARIANCE, Idys® LLIF 3DTi

Common or Usual Name

Lumbar Intervertebral Body Fusion Device with Bone Graft

Classification Name

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

Predicate Devices

Idys® ALIF ZP 3DTi, CLARIANCE SAS (K200920): primary predicate (screws, manufacturing process, cleaning, sterilization and packaging validation)

Idys® ALIF System, CLARIANCE SAS (K172083): additional predicate (system, instruments mechanical performance)

Idys® PLIF CLARIANCE SAS (K131178): additional predicate (mechanical performance)

InFill® Interbody Fusion Devices, Pinnacle Spine Group, LLC (K152259) (cage size and lateral approach reference device)

SIRION Lateral Lumbar Interbody Fusion System, Astura Medical, LLC (K192006) (cage size and lateral approach reference device)

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Intended Use / Indications for Use

The Idys® LLIF 3DTi system is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous level(s) 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 | Spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

The Idys® LLIF 3DTi system is intended to be used with bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and with cleared supplemental fixation in addition to the integrated plate and screws.

Technological Characteristics

Performance Data

Biocompatibility

As there have been no changes to the manufacturing methods or patient contacting materials as compared to the primary predicate, no new biocompatibility testing was required to establish equivalence. Confirmatory testing per ISO 10993-5 and -11 had been performed.

Sterility and Cleaning

Sterilization validation per ISO 11737 and ISO 11137 has been successfully completed. Cleaning validation has shown acceptable limits of residues.

Mechanical Testing

Mechanical testing according to ASTM F2077 and ASTM F2267 were used to support substantial equivalence with Idys® ALIF System and Idys® PLIF, (cleared respectively in K172083 and K131178). Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, expulsion testing, static torsion testing, and particle characterization, all of which demonstrated the substantial equivalence of the system to legally marketed devices.

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Substantial Equivalence

The Idys® LLIF 3DTi system and its predicates are designed for use as lumbar intervertebral body fusion devices. All devices are composed of cages or "interbody spacers" available with various configurations to accommodate patient's anatomy and are to be used with the provided plates and screws and supplemental fixation.

The Idys® LLIF 3DTi and Idys® ALIF ZP 3DTi (K200920) cages are made using the same additive manufacturing method using titanium alloy per ASTM F3001 and results in the same. porous structure. In contrast, the Idys® ALIF System (K172083), Idys® PLIF (K131178), InFill® Interbody Fusion Devices (K152259) and SIRION Lateral Lumbar Interbody Fusion cages are made of PEEK OPTIMA LT1® per ASTM 2026 (while the SIRON can also contain HA). Differences in cage material do not raise difference questions, as both devices raise the same questions regarding biocompatibility and mechanical performance. Both Titanium Alloy Ti6AI4V ELI and PEEK are well-known materials that have been used for many years, and which are standardized by ISO/ASTM as implantable grade of materials. Mechanical testing has shown that this structure does not have an adverse impact on the mechanical performance of the Idys® LLIF 3DTi system. The use of porous lattice allows the 3DTi cages to have similar stiffness than cages made of PEEK, avoiding stress-shielding and providing a scaffold for bone fusion.

The Idys® LLIF 3DTi cages, the SIRION LLIF System Devices (K192006) and the InFill® Interbody Fusion Devices (K152259) cages are inserted using a lateral approach and. accordingly, feature a similar outer shape and design. All three devices are long cages with a bulleted nose and contain slots to allow the incorporation of bone graft which is essential to promoting the fusion process. The difference in the number of slots for bone graft between the ldys® LLIF 3DTi, InFill® V2 Lateral Interbody Fusion (K152259) and SIRION Lateral Lumbar Interbody Fusion System (K192006) predicates do not raise new or different issues of safety and effectiveness since the volume available for bone graft is equivalent. Unlike the InFil® V2 Lateral Interbody Fusion (K152259) and SIRION Lateral Lumbar Interbody Fusion System (K192006) predicates, each of the superior and inferior surfaces of the Idys® LLIF 3DTi cages do not have teeth since the roughness of the porous structure is sufficient to grip the surface of the vertebral endplates and help resist expulsion. Although there are no teeth on the superior and inferior surfaces, the expulsion testing has demonstrated adequate resistance to expulsion.

In terms of configurations, the Idys® LLIF 3DTi system are similar to those of the cleared InFill® V2 Lateral Interbody Fusion predicate (K152259). Additionally, all Idys® LLIF 3DTi cage heights are within SIRION (K192006) range. The Idys® LLIF 3DTi cages are available with various footprints with different heights ranges and lordotic angles.

Conclusions

The Idys® LLIF 3DTi is substantially equivalent to Idys® ALIF ZP 3DTi (K200920). The Idys® LLIF 3DTi 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® LLIF 3DTi and its predicate device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys® LLIF 3DTi is as safe and effective

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as its predicate. Thus, the Idys® LLIF 3DTi 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.