The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.

MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.

AI/ML Overview

The provided text describes information about the MCI-Neuro Fixation System, a cranial fixation device. However, it does not contain the kind of detailed information about acceptance criteria, clinical study design, sample sizes, expert qualifications, or comparative effectiveness studies that your request asks for, especially concerning an AI/ML-driven device.

The document discusses:

Regulatory Clearance (K212391): It's a 510(k) premarket notification for a Class II medical device.
Device Description: The system consists of plates, screws, and meshes made from titanium.
Predicate Device: K141911 - OPTIMUS NEURO SYSTEM.
Performance Data: This section focuses on bench testing for physical and material properties (metallographic tests, cyclic polarization, cycle bend testing of plates, screw torsion yield test, pull-out testing, driving torque testing).
Biocompatibility: Stated as supported by a reference device (K182758).
Lack of Clinical Data: Explicitly states, "No clinical data were included in this submission."

Since this device is a physical fixation system and not an AI/ML driven diagnostic or prognostic tool, the concepts of human readers, AI assistance, ground truth establishment (beyond material specifications), training sets, and test sets in the context of diagnostic accuracy are not applicable to this document.

Therefore, I cannot provide a table of acceptance criteria and device performance, or details about clinical study design, sample sizes, expert qualifications, or adjudication methods as requested, because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence through material and mechanical bench testing.

Summary

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October 21, 2022

MCI Medical Concept Innovation Inc. % Graziela Brum Regulatory Affairs Specialist Passarini Regulatory Affairs/ PR Servicos Regulatorios Administrativos Ltda ME Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096-570 Brazil

Re: K212391

Trade/Device Name: MCI-Neuro Fixation System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: September 20, 2022 Received: September 21, 2022

Dear Graziela Brum:

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.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212391

Device Name MCI - Neuro Fixation System

Indications for Use (Describe)

MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

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

ADMINISTRATIVE INFORMATION
Sponsor/Manufacturer Name	MCI Medical Concept Innovation Inc.4592 North Hiatus RoadSunrise, Florida, USA 33351Telephone +01 (954) 306-2521
Contact Person and Preparer	Graziela Brum and Ana Carolina CarvalhoRegulatory Affairs SpecialistPassarini Regulatory AffairsPR Serviços Regulatórios Administrativos LtdaE-Mail: graziela@passarini.com.brTelephone +55 (16) 3421-8488
Date Prepared	20/September/2022
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary NameCommon Name	MCI - Neuro Fixation SystemPlate, Cranioplasty, Preformed, Alterable; Cover, BurHole; Fastener, Plate, Cranioplasty
Classification Regulation	21 CFR 882.5320
Product Code	GWO, GXR, HBW
Classification PanelReviewing Branch	NeurologyNeurology
PREDICATE DEVICE INFORMATION
Predicate Device	K141911 - OPTIMUS NEURO SYSTEM
	SUBJECT DEVICE	PREDICATE DEVICE
Device Name	MCI - Neuro Fixation System	Neuro Plating System
510(K) #	K212391	K141911
Manufacturer	MCI Medical Concept Innovation Inc.	OPTIMUS NEURO SYSTEM
Indications foruse	MCI - Neuro Fixation System isindicated for use in selective traumaof the cranial skeleton, cranialsurgery, and reconstructiveprocedure.	Optimus Neuro System is intended for usein selective trauma of the cranial skeleton,cranial surgery, and reconstructiveprocedure.
Class	2	2
Product Code	GWO, GRX, HBW	GWO, GRX, HBW
Material(Chemicalcomposition)	•Plate- Pure Titanium ASTM F67(Anodized)•Screw- Titanium Alloy ASTM F136(Anodized)	•Plate- Pure Titanium ASTM F67 (Anodized)•Screw- Titanium Alloy ASTM F136(Anodized)
Device typesandDimension	Straight, Square, Rectangular, Y-shape,X-shape, Z -shape, clover, triangular,mesh, burr hole withvarious lengths and thickness (03 to06.mm). The screws range in 1.5 mm diameter to 1.7 mm and in lengths from	Straight, angle, Y-shape, X-shape, burr hole,square, matrix and mesh with variouslengths and thickness Plate has variouslength and thickness (0.1 to 0.6mm). Thescrews range in diameters of 0.8 to 1.8mm and lengths from 3.0 to 6.0mm.

Reference Devices

K971297 - CENTRE-DRIVE DRILL-FREE SCREW K161821- Stryker Universal Mesh K141452 - Leforte Neuro System Bone Plate and Screw K121624 - Biomet Microfixation Neuro Plating System K182758 - MCI -CMF System K944565- KLS-MARTIN Micro Osteosynthesis System (1.5mm)

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INDICATIONS FOR USE

MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery, and reconstructive procedure.

DEVICE DESCRIPTION

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.

Comparison of Technological Characteristics with the Predicate Device

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	3.0mm to 6.0 mm.
Single Use	Yes	Yes
Sterilization	Nonsterile, steamsterilization before use	Nonsterile, steamsterilization before use

The subject device is substantially equivalent in indications and design principles to the following predicate device: K141911 - OPTIMUS NEURO SYSTEM

Any difference in the technological characteristics do not raise new issues of safety or efficacy.

Performance Data

Test	Test Method Summary	Results
MetallographicTest	Applied Standard ASTM F67-13.Perform metallography on implantthrough an Olympus BX41M-LEDmicroscope, with Kroll attack -immersion.	The material complied with thespecifications set forth in the appliedstandard.
MetallographicTest	Applied Standard ASTM F136 -13.Perform metallography on implantthrough an Olympus BX41M-LEDmicroscope, with Kroll attack -immersion.	The material complied with thespecifications set forth in the appliedstandard.
Cyclicpolarizationtests	Applied Standard ASTM F2129-19 a.A scan rate of 1,0 mV /s was usedincreasing from the corrosionpotential, after 1 h of open-circuit ora potential variation less than 3 mVin 60 seconds. The scan was reversedto cathodic direction at 800 mVECSor when the current density reachestwo orders of magnitude greaterthan the passivation threshold.	The devices have high resistance toinitiation and to the propagation oflocalized corrosion.
Cycle BendTesting ofMetallic BonePlates	Applied Standard ASTM F382-17 AnnexA.1.Testing machine: Universal TestingMachine.The test was performed in ambientconditions (ambient air at roomtemperature.OBJECTIVE: To determine the followingfour-point bending properties (static) ofmetallic bone plate:	The Structural Stiffness (Ele) of a boneplate, is the bone plate normalizedeffective bending stiffness. The testreports showed a Structural Stiffness of0.003 Nm² for the subject andreference devices.The Bending Stiffness (K) of a boneplate, is the maximum slope of thelinear elastic portion of the load versusload-point displacement curve. Thetest reports show that the referencedevice plate Bending Stiffness was 70.4
	- Structural Stiffness- Stiffness- Bending Strength- Proof Load	N/mm and to the subject device plate75.7 N/mm.
		The Bending Strength (R) of a boneplate, is the bending momentnecessary to produce a 0.2 % offsetdisplacement in the bone plate whentested as the standard prescription.The test reports showed a BendingStrength of 0.04 Nm for the subjectand reference devices.
		The proof load (P) is the applied load atthe intersection point of line. BC withthe load versus load-pointdisplacement curve. The test reportsshow a reference device plate ProofLoad of16.08 N and to the subject device plateof 15.74 N.
		The above results allow the conclusionthat the subject device worst case plateproved to be slightly stiffer andmechanically resistant than thereference device K944565 andtherefore, can be consideredequivalents for the performancestandpoint.
Screw Torsionyield Test	Applied Standard ASTM F543-17 AnnexA.1.	The table A5.5 of the standard ASTMF543-17 - Standard Specification andTest Methods for Metallic Medical BoneScrews establish that the Screw type 1.5should presents minimum TorsionalStrength of 0.2 Nm. The worst case ofthe device in question and the referencedevice K944565 met the requirement ofthe applied standard.
	Testing machine: Torsion Equipment.The test was performed in ambientconditions (ambient air at roomtemperature.
	OBJECTIVE: To determine the followingtorsional properties of bone screw:Torsional Yield StrengthMaximum Torque	The Torsion test reports show thereference device screws presented amaximum torque 0.28 Nm, while thesubject screws presented a maximumtorque of 0.29 Nm. Both tested screws(subject and reference device)accomplish the standard requirementsand therefore can be consideredequivalents.
	According to the ASTM F543-17Standard, the specimen needs to beplaced in the holding device so that fivethreads, below the head of the screw,are exposed outside the holding device.The screws that were evaluated do notattend this condition because they aretoo small. So, the "Breaking Angle"

	request is not applicable in this case.
Pull out testing	Applied Standard ASTM F543-17 Annex A.3.OBJECTIVE: Determine axial pullout strength of bone screw	The test reports show for the reference device screw a maximum force of 46.71 N, and for the subject device screw of 45.54 N. A maximum force variation of less than 2.5% was observed between reference and subject device and therefore they were considered equivalent.
Driving torque testing	Applied Standard ASTM F543-17 Annex A.2.OBJECTIVE: To determine the driving torque of bone screwTesting machine: Torsion Equipment.The test was performed in ambient conditions (ambient air at room temperature.	The driving torque testing shows for the subject device an insertion torque of 0.05 Nm and a removal torque of 0.02 Nm. The reference device has presented an insertion and removal torque of 0.09 Nm and 0.03 Nm, respectively. For both cases, subject and reference, the insertion and removal torque are below than the Torsional Yield Strength. Therefore, considering the overall results of mechanical performance, the behavior of the subject and reference device can be deemed equivalent.

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Biocompatibility of the subject devices are supported by the reference device K182758.

No clinical data were included in this submission.

The subject devices are provided non-sterile and have no expiration date defined.

CONCLUSION

The documentation submitted in this premarket notification demonstrates that the subject devices have equivalent features and performance and, therefore, are substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).