MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/ plate fixation of the cervical spine until the bone fusion occurs.

The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions:

· degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

· spondylolisthesis,
· trauma (i.e., fracture or dislocation),
· spinal stenosis,
· deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
· tumor,
· pseudoarthrosis,
· and failed previous fusion

This implant has to be used with an appropriate bone graft.

Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.

Device Description

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is an anterior system, which consists of a variety of cervical plate lengths and a variety of cervical bone screws.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications.

AI/ML Overview

This document, a 510(k) Premarket Notification from the FDA, focuses on the substantial equivalence of a medical device (MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System) to existing predicate devices. It does not present acceptance criteria or a study proving the device meets specific acceptance criteria in the way a performance study for a diagnostic AI device would.

Instead, the document primarily demonstrates that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, materials, mechanical safety, and performance. This is a regulatory pathway that relies on comparison to existing devices rather than new clinical outcome studies for performance.

Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

Not Applicable in the traditional sense of a performance study for a diagnostic device.
The document implies "acceptance criteria" through demonstrating substantial equivalence to predicate devices. This means the device is considered acceptable if its features, materials, and mechanical performance are comparable to devices already on the market.
Reported device performance: The "performance" reported here is mechanical testing results, comparing the device to industry standards (ASTM F1717-15) and implicitly to the predicate devices. The document states: "The components of MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F1717-15." The results are not explicitly detailed in a table beyond the statement that these tests were conducted.

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

Not Applicable. This is a mechanical device, not a diagnostic AI device. The testing involves physical prototypes of the device, not a "test set" of patient data.
The mechanical tests (static and dynamic compression, static torsion) would have been performed on a sample of the manufactured device components. The specific number of test articles is not detailed.
"Data provenance" related to patient data is not relevant here.

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. Ground truth, in the context of expert consensus, is not relevant for the mechanical testing of this type of device. Mechanical testing results are based on objective physical measurements and engineering standards.

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

Not Applicable. Adjudication methods are used to establish ground truth in studies involving subjective interpretation (like AI diagnostics). Mechanical tests do not require this.

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. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a surgical implant, not an AI diagnostic tool.

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

Not Applicable. This device is a physical surgical implant, not an algorithm or AI system.

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

For mechanical testing: The "ground truth" is defined by established engineering principles and the limits specified by the ASTM F1717-15 standard, as well as comparison to the known performance of predicate devices. There's no "expert consensus" on mechanical measurements in the way there is for medical diagnoses.
For demonstrating substantial equivalence: The ground truth is the performance and safety profiles of the legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This device is not an AI algorithm, so there is no training set.

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

Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary, this FDA 510(k) submission primarily relies on demonstrating substantial equivalence through a comparison of design, materials, intended use, and mechanical testing to predicate devices already on the market. It does not involve a performance study against specific acceptance criteria for a diagnostic AI system, and therefore, many of the requested elements are not present in this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 8, 2016

Medicrea International S.A. David Ryan VP Product Development and Marketing 14 Porte Du Grand Lyon Neyron, 01700 France

Re: K162194

Trade/Device Name: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 10, 2016 Received: November 14, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Vincent J. Devlin -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K162194

Device Name

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

Indications for Use (Describe)

MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/ plate fixation of the cervical spine until the bone fusion occurs.

· degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

· spondylolisthesis,
· trauma (i.e., fracture or dislocation),
· spinal stenosis,
· deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
· tumor,
· pseudoarthrosis,
· and failed previous fusion

This implant has to be used with an appropriate bone graft.

Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.

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)

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510(k) SUMMARY

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted for MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System:

Date Prepared: 02 August 2016

1. Submitter:

Contact Person:

MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR Phone Number : +33 4 72 01 87 87

David RYAN MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR

1. Trade name: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

Regulatory Identification/ Classification

SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Regulation Number: 21CFR 888.3060 Product Code: KWQ Class II

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

Primary predicate:

. MaxAn Anterior Cervical Plate System, (BIOMET SPINE, K133518)

Additional predicate:

Stella Cervical Plate, (SCIENT'X, K052763) ●
Synthes Spine Anterior CSLP System (SYNTHES SPINE, K030866)
o Uniplate Anterior Cervical Plate System (DEPUY SPINE, K100070)

No reference devices were used in this submission.

Description of the device: ব

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is an anterior system, which consists of a variety of cervical plate lengths and a variety of cervical bone screws.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications.

Never use stainless steel and titanium implant components in the same construct.

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To achieve best results, do not use any of the MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System components from any other systems or manufacturer unless specifically labeled to do so in this or another MEDICREA® INTERNATIONAL document.

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F136-11 & ISO 5832-3

Function: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System was developed as an implant:

· To provide immobilization and stabilization of anterior 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

MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/plate fixation of the cervical spine until the bone fusion occurs.

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis, ●
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ●
. tumor,
pseudoarthrosis,
o and failed previous fusion

This implant has to be used with an appropriate bone graft.

Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.

6. Substantial equivalence claimed to predicate devices

MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate components are technologically similar to the already cleared Stella Cervical Plate: MaxAn Anterior Cervical Plate System, Synthes Spine Anterior CSLP System, and Uniplate Anterior Cervical Plate System from Depuv Spine components in terms of intended use, materials used, mechanical safety and performances.

The table below compares the features and characteristics of MEDICRA INTERNATIONAL Anterior Cervical Locking Plate components to their predicate devices.

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Device	MEDICREAINTERNATIONALAnterior CervicalLockingPlateSystem	BIOMETSPINEMaxAnAnteriorCervicalPlateSystem	SYNTHESSPINEAnteriorCSLPSystem	DEPUYSPINEUniplateAnteriorCervical Plate	SCIENT'XSTELLACervical Plate
510(k)number	Unknown	K133518	K030866	K100070	K132012
Intendeduse
AnteriorCervical	Yes	Yes	Yes	Yes	Yes
Components
CervicalPlate	1-Level Plate2-Level Plate3-Level Plate4-Level Plate	1-Level Plate2-Level Plate3-Level Plate4-Level Plate5-Level Plate	1-Level Plate2-Level Plate3-Level Plate4-Level Plate	1-Level Plate2-Level Plate	1-Level Plate2-Level Plate3-Level Plate4-Level Plate5-Level Plate
CervicalScrews	Ø4mm &Ø4.5mmVariable andfixed anglesscrews available	Ø4mm &Ø4.5mmVariable andfixed anglesscrewsavailable	Ø4mm &Ø4.35mm &Ø4.5mmVariable andfixed anglesscrewsavailable	Ø4,6mm &Ø5.2mm	Ø4mm &Ø4.5mmVariable andfixed anglesscrewsavailable
LockingMechanism
	Part turnedtopreventscrewback out	Based ontitaniumelasticity,ringdeformation	Based onTitaniumdeformation,a lockingscrew isscrewedwithin thescrew head	Part turnedto preventscrew backout	Part turnedto preventscrew backout
Materials
	TitaniumAlloy(Ti-6Al-4V)accordingtoASTM F136&ISO 5832-3	TitaniumAlloy (Ti-6Al-4V)according toASTM F136& ISO 5832-3	TitaniumAlloy (Ti-6Al-4V)according toASTM F136& ISO 5832-3	TitaniumAlloy (Ti-6Al-4V)according toASTM F136& ISO 5832-3	TitaniumAlloy (Ti-6Al-4V)according toASTM F136& ISO 5832-3

7. Non-clinical Test Summary:

The components of MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F1717-15.

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Pyrogenicity testing was conducted in support to MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System component substantial equivalence.

8. Clinical Test Summary

No clinical data was provided

9. Conclusions Non clinical and Clinical

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is substantially equivalent to legally marketed predicate device.

Regulation Number and Section

N/A