UNiD 3D printed interbody system device 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 3D printed interbody system device 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

The UNiD 3D printed cage is an intervertebral lumbar device, which consists of various implant sizes to adapt the implant to the patient anatomy. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.

AI/ML Overview

This document is a 510(k) premarket notification for the UNiD Patient Specific 3D printed cage. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance against those criteria as would be found for a novel device requiring extensive clinical trials.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" for performance in a clinical sense. Instead, it describes mechanical tests performed following established ASTM standards to ensure the device's physical and mechanical properties are comparable to legally marketed predicate devices. The performance reported is that these tests were "conducted" and presumably met the requirements of these standards for substantial equivalence.

Acceptance Criteria (Implied by ASTM Standards)	Reported Device Performance
Static Compression-shear	Tests were conducted.
Dynamic Compression	Tests were conducted.
Dynamic Compression-shear	Tests were conducted.
Subsidence (under Static Axial Compression)	Tests were conducted.

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

Sample Size: The document does not specify the sample size for the non-clinical mechanical tests. Typically, these tests would involve a small number of device samples (e.g., 3-6 per test condition).
Data Provenance: The tests were non-clinical (mechanical). There is no patient data or country of origin mentioned.

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. This device is an intervertebral fusion cage, and the testing described is mechanical, not involving human interpretation or clinical ground truth establishment by medical experts.

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

Not applicable. There was no clinical test set requiring adjudication.

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 not an AI/imaging device. No MRMC study was conducted.

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

Not applicable. This is not an algorithmic device.

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

For the non-clinical mechanical tests, the "ground truth" would be the established performance requirements and thresholds defined within the ASTM standards (F2077 and F2267). The device's performance is compared against these industry-accepted mechanical benchmarks.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

Summary

{0}------------------------------------------------

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 the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

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

April 25, 2018

Re: K173782

Trade/Device Name: UNiD Patient Specific 3D printed cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 26, 2018 Received: March 29, 2018

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. 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);

{1}------------------------------------------------

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,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K173782

Device Name UNiD Patient Specific 3D printed cage

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

MEDICREA INTERNATIONAL's UNiD Patient Specific 3D printed cage

In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted for the UNiD 3D printed interbody system.

1. Submitter:

MEDICREA® INTERNATIONAL S.A. 5389 route de Strasbourg - Vancia 69140 RILLIEUX-LA-PAPE- France

Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88

Contact Person: David RYAN Chief Operating Officer dryan@medicrea.com

Date Prepared: 23 Apr 2018

2. Trade name: UNiD Patient Specific 3D printed cage

Common Name: UNiD 3D cage

Classification Name:

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

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

Primary predicate:

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

4. Description of the device

{4}------------------------------------------------

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

Function: The 3D printed Lumbar cage was designed to provide immobilization and stabilization of spinal segments. This stability is intended to facilitate fusion at the treated level(s).

Major dimensions which can be adapted:

Anterior and posterior heights .
Lordosis -
-Length
-Width

5. Indication for Use

UNiD 3D printed interbody system device 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 or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD 3D printed interbody system device 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 Lumbar Interbody Device are technologically similar to the already cleared Lumbar Interbody Device in terms of intended use, materials used, mechanical safety and performances

. MEDICREA INTERNATIONAL IMPIX 3D printed interbody system (K163595)
The table below compares the features and characteristics of 3D printed Lumbar cages to their predicate devices.

Device	UNiD 3D cage	IMPIX 3D PLIF
510(k) number	K173782	K163595
Intended use
Lumbar spine (L2-S1)	Yes	Yes
Approach	Posterior	Posterior
Design
Shape	Rectangular anatomical shape	Rectangular anatomical shape
Dimensions	Lengths: 15 to 40 mmHeights: 6 to 20 mmWidth:8 to 12 mmLordosis angles:0° to 22°	Lengths : 15 to 40 mmHeights : 6 to 20 mmWidth:8 to 12 mmLordosis angles :0° to 22°
Cage	Titanium Alloy (Ti-6Al-4V) according to theASTM F3001	Titanium Alloy (Ti-6Al-4V)according to the ASTM F3001
	Provided Sterile (Gammasterilized) or non-sterile(steam sterilization) -Single use only	Provided Sterile (Gammasterilized) - Single use only

{5}------------------------------------------------

7. Non-clinical Test Summary

Testing was performed on the system 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

8. Clinical Test Summary

No clinical studies were performed.

9. Conclusions Non-clinical and Clinical

MEDICREA® INTERNATIONAL UNiD 3D printed Lumbar Interbody Device are substantially equivalent to its predicate device in terms of indications for use, design, materials and function.

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.