The Mecta-C plate system is intended for anterior Interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) psuedarthrosis, and/or 6) failed previous fusion. This device system is intended for anterior cervical intervertebral body fusions only.

Device Description

The Mecta-C Cervical Plate consists of single and multilevel plates up to four levels used to stabilize the cervical spine in order to promote fusion. The cervical plates are offered with lengths between 20 and 92mm and are made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136). The plate is fixed on the vertebral body either by means of fixed angle or variable angle screws. Screws are available in 4mm and 4.5mm diameters with a length between 12mm and 22mm. The screws consist of an inner locking screw and the outer main screw shaft and are available with a self-tapping or a self-drilling tip. The main screw shaft is made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136) and the locking screw is made of Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The cervical plates and screws are available both in sterile and unsterile packaging.

AI/ML Overview

This document describes the Mecta-C Cervical Plate, a medical device for stabilizing the cervical spine. The acceptance criteria and the study proving it meets these criteria are based on biomechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance
Static Compression Yield Strength (ASTM F1717)	Not worst-case compared to predicate devices	Mecta-C Cervical Plate was tested using the worst-case device. Results determined not to be worst case compared to predicate devices.
Static Compression Stiffness (ASTM F1717)	Not worst-case compared to predicate devices	Mecta-C Cervical Plate was tested using the worst-case device. Results determined not to be worst case compared to predicate devices.
Dynamic Compression (ASTM F1717)	Not worst-case compared to predicate devices	Mecta-C Cervical Plate was tested using the worst-case device. Results determined not to be worst case compared to predicate devices.
Static Torsion Yield Torque (ASTM F1717)	Not worst-case compared to predicate devices	Mecta-C Cervical Plate was tested using the worst-case device. Results determined not to be worst case compared to predicate devices.
Static Torsion Stiffness (ASTM F1717)	Not worst-case compared to predicate devices	Mecta-C Cervical Plate was tested using the worst-case device. Results determined not to be worst case compared to predicate devices.
Screw Plate Interface Strength: Push-out	Substantial equivalence to predicate devices	Tests performed to prove substantial equivalence of the screw plate interface.

Study Description:

The study conducted was a series of biomechanical tests designed to demonstrate the "substantial equivalence" of the Mecta-C Cervical Plate to existing predicate devices.

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not specify the exact number of samples (implants) tested for each biomechanical test. However, it indicates that "tests were performed on a two level construct as suggested in the ASTM F1717 standard," and "the Mecta-C Cervical Plate was tested using the worst-case device for each of the following tests." This implies that multiple constructs were tested to determine the "worst-case" and then that configuration was used for the formal tests.
Data Provenance: The study was conducted as part of a 510(k) premarket notification for regulatory clearance. The country of origin of the data is not explicitly stated, but the applicant/sponsor is Medacta International SA from Switzerland, with a contact in the USA. The tests follow international standards (ASTM F1717) and FDA guidance, suggesting a globally recognized testing methodology. The data is retrospective in the sense that the performance of the device was evaluated after its design and manufacturing, but within a controlled, laboratory setting.

3. Number of Experts and Qualifications for Ground Truth Establishment

This section is not applicable to this type of device and study. The "ground truth" for a mechanical device like a cervical plate is based on objective, quantifiable physical and mechanical properties, not expert clinical interpretation of data (like images). The "ground truth" here is the established performance characteristics of the predicate devices and the performance standards outlined in ASTM F1717.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication involves human reviewers reconciling differences, which is not relevant for biomechanical testing where results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic or interpretive devices where human performance with and without AI assistance is evaluated. This device is a surgical implant undergoing mechanical performance assessment.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This section is not applicable as the Mecta-C Cervical Plate is a physical implant, not an algorithm or AI system. Its performance is inherent to its mechanical design and material properties, tested directly in a laboratory setting.

7. Type of Ground Truth Used

The "ground truth" used for this study was primarily:

Biomechanical Standards: Specifically, the ASTM F1717 standard for spinal implant constructs.
Predicate Device Performance Data: The performance of the Mecta-C Cervical Plate was compared against the known performance of legally marketed predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set

This section is not applicable. This study does not involve a "training set" in the context of machine learning or AI models. The design and manufacturing process of the Mecta-C Cervical Plate are based on engineering principles and material science, not statistical learning from a dataset.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of a stylized letter "M" formed by two triangles, followed by the text "edacta" in a sans-serif font. Below the word "edacta" is a horizontal line, and below that is the word "International" followed by a plus sign.

JUN 1 2 2014

510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805) 322-3289 Fax: (805) 437-7553 Email: AGross@medacta.us.com

Date Prepared: February 5, 2014

DEVICE INFORMATION

Trade/Proprietary Name: Mecta-C Cervical Plate Common Name: Anterior Cervical Plate Classification Name: appliance, fixation, spinal intervertebral body 21 CFR 888.3060 Class II Product Code(s): KWQ

Predicate Devices: )

510(k)	Product	510(k) Holder	Clearance Date
K000742	CSLP	Synthes	3/29/2000
K001794	Anterior Cervical Plate	EBI	7/12/2000
K974706	ABC Plate	Aesculap	3/13/1998
K050451	Vectra	Synthes	3/24/2005
K081038	Atlantis	Medtronic	8/15/2008

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Product Description

Indications for Use

Comparison to Predicate Devices

The indications for use, design features and materials of the Mecta-C Cervical Plate are substantially equivalent to those of the predicate devices. The substantial equivalence of the Mecta-C Cervical Plate implants are supported by the performance testing. materials information, and data analysis provided within this Premarket Notification.

Performance Testing

The Mecta-C Cervical Plate biomechanical tests are defined according to the Guidance for Industry and FDA Staff - Spinal System 510(k)s, issued on May 3, 2004. The quidance suqqests performing static and dynamic compression tests as well as static torsion tests. Tests were performed on a two level construct as suggested in the ASTM F1717 standard. In addition to the recommended tests, screw push-out tests were performed in order to prove the substantial equivalence of the screw plate interface. The biomechanical test results of the Mecta-C Cervical Plate constructs were compared with results of the predicate devices and were determined not to be worst case. The Mecta-C Cervical Plate was tested using the worst-case device for each of the following tests:

Static Compression vield strength - ASTM F1717

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Static Compression Stiffness - ASTM F1717 Dynamic Compression - ASTM F1717 Static Torsion yield torque - ASTM F1717 Static Torsion Stiffness - ASTM F1717 Screw plate interface strength: Push-out

Conclusion:

Based on the above information, the Mecta-C Cervical Plate can be considered as substantially equivalent to its predicate devices.

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Public Health Service

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

June 12, 2014

Medacta International SA % Mr. Adam Gross Medacta USA 1556 West Caroll Avenue Chicago, Illinois 60607

Re: K140361

Trade/Device Name: Mecta-C Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: May 14, 2014 Received: May 15, 2014

Dear Mr. Gross:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/ReportalProblem/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 yours,

Ronald P. Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Explration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140361

Device Name Mecta-C Cervical Plate

Indications for Use (Describe)

The Mecta-C plate system is intended for anterior Interbody scrow/plate fixation from C2 to T1.

The system is indicated for use in the temporary spine during the development of cervical spine fusions in patients with: 1) degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including frectures), 3) lumors, 4) defined as kyphosis, lordosis, or scoliosis, a 5) paudarthrosis, and/or of failed previous fusion. This device system is intended for anterior cervical intervetebral body fusions only.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

1 1 1 135 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FOR FOR FOR FOR USE ONLY 11 11 11 11 13 1 1 1850 - 1 1 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

FORM FDA 3881 (1/14)

Page 1 of 2

PSC Published Berniers (TDU 441 6743

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Regulation Number and Section

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