The Idys™ TLIF 3DTi cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

The Idys™ TLIF 3DTi cages, which have various widths and heights, are designed for use as a lumbar intervertebral body fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains a slot to receive the autologous bone graft to promote the fusion process between the endblates. The Idvs™ TLIF 3DTi cages are made of compliant ASTM F136 Titanium alloy. The device is manufactured using an additive manufacturing process to result in a porous material with tightly defined structure. It is essential to insert implants with instrumentation specifically designed for this purpose.

AI/ML Overview

The provided text describes CLARIANCE's Idys™ TLIF 3DTi, an intervertebral body fusion device. Here's an analysis of the acceptance criteria and study proving the device meets them:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it refers to industry standards (ASTM F2077 and ASTM F2267) and states that the device's performance was found to be "substantially equivalent" to legally marketed predicate devices.

Here's a summary based on the provided text:

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Static Axial Compression	Performance was deemed "substantially equivalent" to legally marketed devices based on testing according to ASTM F2077.
Dynamic Axial Compression	Performance was deemed "substantially equivalent" to legally marketed devices based on testing according to ASTM F2077.
Static Compression Shear	Performance was deemed "substantially equivalent" to legally marketed devices based on testing according to ASTM F2077.
Dynamic Compression Shear	Performance was deemed "substantially equivalent" to legally marketed devices based on testing according to ASTM F2077.
Subsidence	Performance was deemed "substantially equivalent" to legally marketed devices based on testing according to ASTM F2267.
Expulsion	Demonstrated adequate resistance to expulsion despite the absence of teeth on the superior and inferior surfaces (unlike the predicate device). This performance was deemed "substantially equivalent" to legally marketed devices.
Static Torsion	Performance was deemed "substantially equivalent" to legally marketed devices based on testing.
Wear	Performance was deemed "substantially equivalent" to legally marketed devices based on testing.
Biocompatibility	The device is made of compliant ASTM F136 Titanium alloy, which is a common and accepted material for implantable devices. The porous structure formed by additive manufacturing is mentioned, with mechanical testing showing it does not adversely impact mechanical performance. (Implicitly, the material choice and manufacturing process align with established biocompatibility expectations for titanium implants, though no specific biocompatibility study details are provided).
Equivalency	The Idys™ TLIF 3DTi is as safe and effective as the predicate devices (Idys™ TLIF K131178 and CASCADIA™ TL K150481), sharing the same intended use, similar indications, principles of operation, and technological characteristics.

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

The document mentions "Performance testing was conducted according to ASTM F2077 and ASTM F2267." It does not specify the exact sample size for each test performed (e.g., number of devices tested for axial compression, expulsion, etc.).

Sample Size: Not explicitly stated as a number (e.g., "n=5" for each test). The ASTM standards themselves would specify minimum sample sizes for such tests.
Data Provenance: The testing was conducted by CLARIANCE, SAS, located in France. The provenance of the test data is, therefore, from their internal testing. It's a prospective set of tests designed specifically for this regulatory submission.

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 information is not applicable to this type of device and study. The "ground truth" for a mechanical device like an intervertebral fusion cage is established through physical and mechanical testing against predefined standards or comparison to a predicate device's performance, not by expert consensus on clinical findings or images.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving interpretative tasks (e.g., image reading) where multiple experts assess cases to reach a consensus for ground truth. For mechanical performance testing, the results are objectively measured against established criteria or predicate device performance.

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 information is not applicable. The device is an orthopedic implant (an intervertebral body fusion device), not an imaging analysis or AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable. The device is a physical implant, not an algorithm. Standalone performance for an algorithm would assess its accuracy in tasks like disease detection or measurement without human intervention.

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

The "ground truth" for this device's performance evaluation is based on:

Compliance with recognized testing standards: ASTM F2077 (for static and dynamic compression, shear, and torsion) and ASTM F2267 (for subsidence). These standards define the methodologies and acceptable performance envelope.
Mechanical equivalence to predicate devices: The device's performance was compared directly to that of legally marketed predicate devices, meaning the established mechanical characteristics of those predicates served as the benchmark for "ground truth" in terms of what constitutes safe and effective mechanical performance for this type of implant.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The "training" for such devices typically refers to the iterative design and development process, which doesn't involve a quantifiable "training set" of data in the same way.

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

This information is not applicable for the same reason as point 8; there is no "training set" in the sense of machine learning for this physical device. The "ground truth" for the design and development process would be established through engineering specifications, material science principles, clinical needs, and regulatory requirements that guide the creation of the device.

Summary

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Image /page/0/Picture/0 description: The image contains 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 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.

December 15, 2017

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

Re: K172465

Trade/Device Name: Idys™ TLIF 3DTi cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 17, 2017 Received: November 17, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Ms. Janice Hogan

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

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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510(k) Number (if known)

K172465

Device Name

ldys™ TLIF 3DTi

Indications for Use (Describe)

The Idys™ TLIF 3DTi cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via a posterior and/or transforminal approach. These devices are intended to be used with supplementation, which has been cleared for use in the lumbar spine.

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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K172465 Page 1 of 3

510(k) SUMMARY

CLARIANCE's Idys™ TLIF 3DTi

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

CLARIANCE, SAS 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: Pascal Rokegem, Chief Technology Officer

Date: December 6, 2017

Name of Device and Name

ldys™ TLIF 3DTi

Common or Usual Name

Lumbar Intervertebral Body Fusion Device

Classification Name

888.3080 - Intervertebral body fusion

Product Code

MAX

Predicate Devices

CLARIANCE, Idys TLIF Cage, K131178 (primary)

K2M, CASCADIA TL, K150481 (additional)

Intended Use / Indications for Use

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transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

Comparison of Technological Characteristics

The Idys™ TLIF 3DTi cages and the predicate Idys™ TLIF (K131178) 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.

The Idys™ TLIF 3DTi and the Idys™ TLIF (K131178) cages feature a similar outer shape and design. Both devices are banana-shaped with a convex design and a bulleted nose. The shape is also similar to the CASCADIA™ TL (K150481). The design features slots to allow the incorporation of bone graft which is essential to promoting the fusion process. The difference in the number of slots for autograft between the Idys™ TLIF 3DTi and Idys™ TLIF predicate (K131178) do not raise new or different issues of safety and effectiveness since the volume available for autograft is equivalent. Unlike the Idys™ TLIF cages (K131178), each of the superior and inferior surfaces of the Idys™ TLIF 3DTi cages devices 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™ TLIF 3DTi cages are similar to those of the cleared ldys™ predicate (K131178). The Idys™ TLIF 3DTi cages are available with two footprints with different heights ranges and no lordotic angles.

The structure of both Idys™ TLIF 3DTi and CASCADIA™ TL (K150481) is made of porous titanium with rough surfaces in order to achieve biological fixation. Mechanical testing has shown that this structure does not have an adverse impact on the mechanical performance of the the Idys™ TLIF 3DTi cages.

Performance Data

Performance testing was conducted according to ASTM F2077 and ASTM F2267. 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. The results of these studies were determined to be substantially equivalent to legally marketed devices.

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Conclusion

The Idys™ TLIF 3DTi is as safe and effective as the Idys™ TLIF (K131178) and CASCADIA™ TL (K150481). The Idys™ TLIF 3DTi has the same intended use, similar indications, principles of operation, and technological characteristics as the Idys™ TLIF (K131178) and the CASCADIA™ TL (K150481). Bench testing has shown equivalent performance. Thus, the Idys™ TLIF 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.