The Idys® ALIF 3DTi (Anterior Lumbar Integrated Fusion) 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 level. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF System should be used with the integrated fixation screws provided.

The Idys® ALIF 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

Device Description

The Idys® ALIF 3DTi 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 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion process between the endplates.

The device has to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft.

The Idys® ALIF 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with bone graft. The insert for fixation of the plate is made of ASTM F2026 compliant polyetheretherketone (PEEK). The screws and plates are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idys® ALIF 3DTi cages are positioned using a set of surgical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the Idys® ALIF 3DTi device, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy.

Therefore, the following information cannot be fully extracted from the provided text:

A table of acceptance criteria and the reported device performance (in a clinical context for diagnostic/prognostic devices)
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study existence or effect size
Standalone algorithm performance
Type of ground truth used (for clinical outcomes)
Sample size for the training set (for an AI/ML device)
How ground truth for the training set was established

The document primarily describes bench mechanical testing and biocompatibility to demonstrate that the new device (Idys® ALIF 3DTi) is as safe and effective as its predicate devices, despite changes in material and manufacturing processes. It does not refer to a clinical study establishing performance against specific acceptance criteria in the manner typically seen for diagnostic AI/ML devices.

Here's an attempt to structure the available information relevant to the prompt, highlighting what is present and what is not:

Acceptance Criteria and Study for Idys® ALIF 3DTi Device

This 510(k) summary for the Idys® ALIF 3DTi focuses on demonstrating substantial equivalence to predicate devices (Idys® ALIF (K172083) and Idys® ALIF ZP 3DTi (K192168)) through performance data derived primarily from bench mechanical testing and biocompatibility assessments. The goal is to show that material and manufacturing changes do not raise new safety or effectiveness concerns compared to the already cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied / Demonstrated Equivalence)	Reported Device Performance (Idys® ALIF 3DTi)
Mechanical Performance	Demonstrated substantial equivalence to predicate devices (Idys® ALIF (K172083) and Idys® ALIF ZP 3DTi (K192168)) per ASTM F2077 and ASTM F2267 standards.	Successfully completed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, and wear testing (titanium particles). All tests demonstrated substantial equivalence to legally marketed predicate devices.
Biocompatibility	Demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1.	Demonstrated to be biocompatible. (Specific findings are not detailed in the summary, but the conclusion is positive).
Sterility & Cleaning	Sterilization validation per ISO 11737 and ISO 11137. Acceptable limits of residues after cleaning validation.	Repeated sterilization validation successfully completed. Cleaning validation showed acceptable limits of residues. (Specific limits and results are not detailed).
Clinical Performance	Safety and effectiveness profile similar to the predicate device, as documented in a pivotal clinical study (mentioned in predicate documentation, implied for this device).	"Based on the clinical performance as documented in the pivotal clinical study, the Idys® ALIF 3DTi has a safety and effectiveness profile that is similar to the predicate device." (This statement refers to prior clinical data on the predicate device, extrapolating to the subject device due to demonstrated equivalence in mechanical and biological properties, rather than presenting a new clinical study for the subject device).

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

Test Set Sample Size: Not applicable for a clinical test set from this document. For mechanical testing, the sample sizes would be defined by the ASTM standards (F2077, F2267) but are not explicitly stated in this summary.
Data Provenance: The mechanical and biocompatibility testing was performed by CLARIANCE, the manufacturer. The document does not specify a country of origin for a clinical test set, as no new clinical test set appears to have been generated for this 510(k). The clinical performance reference points to a "pivotal clinical study" previously conducted for the predicate device. The information is retrospective to the predicate's clearance regarding clinical data.

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

This information is not applicable as the summary does not detail a clinical study with human readers to establish ground truth for a diagnostic or prognostic device. Ground truth for mechanical testing would be the measured physical properties against established standard requirements.

4. Adjudication Method for the Test Set

Not applicable as no clinical images or diagnostic assessments requiring adjudication are part of this 510(k) summary for the Idys® ALIF 3DTi.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance

Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

Mechanical Testing: Ground truth is based on the requirements and pass/fail criteria defined by the relevant ASTM standards (F2077, F2267) for various mechanical properties.
Biocompatibility: Ground truth is based on the risk assessments and testing requirements of ISO 10993-1.
Clinical Performance (reference to predicate): The "pivotal clinical study" for the predicate device would have established clinical outcomes data relevant to fusion, pain relief, and adverse events. The specific type of ground truth for that original study (e.g., radiographic fusion assessment, patient-reported outcomes) is not detailed here.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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April 12, 2021

Clariance % Janice Hogan, Esq. Partner Hogan Lovells US LLP 1735 Market Street. Suite 2300 Philadelphia, Pennsylvania 19103

Re: K200919

Trade/Device Name: Idys® ALIF 3DTi Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: February 16, 2021 Received: February 16, 2021

Dear Janice 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,

Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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)

K200919

Device Name Idys® ALIF 3DTi

Indications for Use

The Idys® ALIF 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

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 (7/17)

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K200919 510(k) SUMMARY CLARIANCE's Idys® ALIF 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: February 16, 2021

Name of Device

Idys® ALIF 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

Idvs® ALIF. CLARIANCE SAS (K172083): primary predicate ldys® ALIF ZP 3DTi, CLARIANCE SAS (K192168): reference device

Device Description

The Idvs® ALIF 3DTi 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 device has to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft.

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plates are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idvs® ALIF 3DTi cages are positioned using a set of surgical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

Intended Use/Indications for Use

The Idvs® ALIF 3DTi (Anterior Lumbar Integrated Fusion) 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 level. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF System should be used with the integrated fixation screws provided.

The Idys® ALIF 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

Substantial Equivalence

The Idys® ALIF 3DTi and the predicate Idys® ALIF (K172083) are designed for use as lumbar intervertebral body fusion devices Both devices are available with equivalent range and configurations to accommodate patient anatomy.

The Idys® ALIF 3DTi and the Idys® ALIF (K172083) feature a similar outer shape and design. The design features two slots to allow the incorporation of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. Each of the superior and inferior surfaces of the Idys® ALIF 3DTi and the Idys® ALIF (K172083) have teeth to grip the surface of the vertebral endplates and help to resist expulsion.

The primary difference between the cleared Idys® ALIF (K172083) and the subject device is the change of the raw material and the manufacturing process of the cage. Idvs® ALIF 3DTi caqe are made of ASTM F3001 titanium alloy components and ASTM F136 Ti-6AI-4V ELI, while the predicate cage (K172083) is made of F2026 compliant polyetheretherketone (PEEK). Moreover, the Idys® ALIF 3DTi has a porous structure that integrates to the bone while the predicate Idys® ALIF cages use teeth. Idys® ALIF 3DTi has the same insert of its predicate device, made of F2026 compliant polyetheretherketone (PEEK), in order to attach to the plate.

Performance Data

Biocompatibility

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

Sterility and Cleaning

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

Mechanical Testing

Bench mechanical testing according to ASTM F2077 and ASTM F2267 were used to support the decision of substantial equivalence with Idys® ALIF cages and Idys® ALIF ZP 3DTi

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predicate devices (K172083 and K192168, respectively). 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 (titanium particles), all of which demonstrated the substantial equivalence of the system to legally marketed devices.

Based on the clinical performance as documented in the pivotal clinical study, the Idys® ALIF 3DTi has a safety and effectiveness profile that is similar to the predicate device.

Conclusions

The Idys® ALIF 3DTi is as safe and effective as the Idys® ALIF (K172083) and Idys® ALIF ZP 3DTi (K192168). The Idys® ALIF 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® ALIF 3DTi and its predicate devices do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys® ALIF 3DTi is as safe and effective as its predicates. Thus, the Idys® ALIF 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.