UNiD Patient specific 3D printed TLIF cage 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 I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

MEDICREA® INTERNATIONAL UNiD Patient specific 3D Printed TLIF cage consists of one single implant with specific heights, length and lordosis angle to the patient. It is intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

Function:
The UNiD Patient specific 3D printed TLIF cage was developed as an implant:

To provide immobilization and stabilization of posterior spinal segments ●
to augment the development of a solid spinal fusion
to provide stability to ease fusion ●
to be mechanically resistant to allow the fusion of the operated level

AI/ML Overview

The given text describes a 510(k) summary for the UNiD Patient specific 3D printed TLIF cage, which is an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about studies involving acceptance criteria related to device performance in an AI/algorithm context, nor does it detail a study that proves the device meets such criteria through clinical trials or performance metrics typically associated with AI-driven devices.

Therefore, many of the requested categories of information cannot be extracted from the provided text as they pertain to AI/algorithm performance and clinical study designs which are not present in this regulatory submission for a physical medical device.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria for the device performance that would typically be seen for an AI or algorithm-driven device. Instead, it relies on demonstrating substantial equivalence through material properties and mechanical testing comparisons to predicate devices. The "reported device performance" is essentially that it meets the same mechanical and biocompatibility standards as its predicates.

Acceptance Criteria (Not explicitly stated for AI/Algorithm performance)	Reported Device Performance (as per non-clinical testing)
Biocompatibility standards aligned with predicate devices	Made from the same materials as predicates; manufacturing processes similar.
Mechanical performance aligned with predicate devices, using worst-case device evaluation	Evaluated following ASTM F2077 and ASTM F2267 standards: Static Compression-shear, Dynamic Compression, Dynamic Compression-shear, and Subsidence tests conducted. No new worst-case device introduced by the submitted product.

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

Not applicable. The "test set" and "data provenance" refer to data used in evaluating AI/algorithm performance. This document describes mechanical and biocompatibility testing of a physical implant. The mechanical testing involved evaluating a "worst-case device," but the sample size for these specific tests is not provided.

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):

Not applicable, as this relates to expert-labeled data for AI/algorithm performance.

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

Not applicable, as this relates to expert adjudication for AI/algorithm ground truth.

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:

Not applicable. This is a physical medical device (intervertebral cage), not an AI/algorithm.

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

Not applicable. This is a physical medical device.

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

For the mechanical testing, the "ground truth" would be the established engineering standards (ASTM F2077, ASTM F2267) which define acceptable mechanical properties and behaviors of intervertebral body fusion devices. For biocompatibility, the ground truth would be established international standards for the biocompatibility of medical device materials.

8. The sample size for the training set:

Not applicable. There is no AI/algorithm training set.

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

Not applicable. There is no AI/algorithm training set.

Summary

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May 8, 2019

Medicrea International S.A. Mr. David Ryan Chief Operating Officer 5389 route de Strasbourg Vancia Rillieux-La-Pape 69140 France

Re: K190092

Trade/Device Name: UNiD Patient specific 3D printed TLIF cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 3, 2019 Received: May 6, 2019

Dear Mr. Ryan:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190092

Device Name UNiD Patient specific 3D printed TLIF cage

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY MEDICREA INTERNATIONAL's UNiD Patient specific 3D printed TLIF cage

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the UNiD Patient Specific 3D printed TLIF cage:

Date Prepared: January, 14, 2019

1. Submitter:
  MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR

Contact Person:

David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR

1. Trade name: UNiD Patient specific 3D printed TLIF cage

Regulatory Identification/ Classification

Intervertebral Body Fusion Device with Bone Graft, lumbar Regulation Number: 21CFR 888.3080 Product Code: MAX Class II

1. Predicate or legally marketed devices which are substantially equivalent:

Primary predicate device:

IMPIX 3D printed cage, (MEDICREA INTERNATIONAL, K163595) .

Additional Predicate:

. UNiD Patient specific 3D printed cage (MEDICREA INTERNATIONAL, K173782)

4. Description of the device:

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

Function:

The UNiD Patient specific 3D printed TLIF cage was developed as an implant:

To provide immobilization and stabilization of posterior spinal segments ●
to augment the development of a solid spinal fusion
to provide stability to ease fusion ●
to be mechanically resistant to allow the fusion of the operated level

5. Indication for Use

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and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

6. Substantial equivalence claimed to predicate devices

The UNiD Patient specific 3D printed TLIF cage are technologically similar to the already cleared IMPIX 3D printed cages (K163595) in terms of intended use, material used, mechanical safety and performances.

The table below compares the features and characteristics of the submitted UNiD Patient specific 3D printed TLIF cage to their predicate devices.

Device	MEDICREAINTERNATIONALUNiD Patientspecific 3D printedTLIF cage	PREDICATEMEDICREAINTERNATIONALIMPIX 3D Printed cage	ADDITIONALPREDICATEUNiD Patient specific3D printed cage
510(k) number	To be determined	K163595	K173782
Intended use
Lumbar	Yes	Yes	Yes
Components
Shape	Rectangularanatomical shape	Rectangular anatomicalshape	Rectangular anatomicalshape
Dimensions	Lenghts: 15 to 40mmHeights: 6 to 20mmWidth: 8 to 12mmLordosis angle: 0 to22°	Lenghts: 15 to 40mmHeights: 6 to 20mmWidth: 8 to 12mmLordosis angle: 0 to 22°	Lenghts: 15 to 40mmHeights: 6 to 20mmWidth: 8 to 12mmLordosis angle: 0 to 22°
Cage	Titanium Alloy (Ti-6Al-4V) according tothe ASTM F3001	Titanium Alloy (Ti-6Al-4V) according to theASTM F3001	Titanium Alloy (Ti-6Al-4V) according to theASTM F3001
	Provided Sterile ornon sterile - Singleuse only	Provided Sterile - Singleuse only	Provided Sterile or nonsterile - Single use only

Non-clinical Test Summary: 7.

The following performance data was provided in support of the substantial equivalence determination.

Biocompatibility Testing

The UNiD Patient specific 3D printed TLIF cage are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.

Mechanical testing

The UNiD Patient specific 3D printed TLIF cage did not introduce a new worst-case device. The previously identified worst-case device was evaluated following the protocols outlined in ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and in the ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".

The following tests were conducted: Static Compression-shear, Dynamic Compression, Dynamic Compression-shear and Subsidence test

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8. Conclusions

UNiD Patient Specific 3D printed TLIF cages are substantially equivalent to legally marketed predicate devices.

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.