The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

Device Description

The Mecta-C Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C intervertebral body fusion devices consist of a PEEK (Polyetheretherketone) body and tantalum markers. The markers are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Mecta-C Intervertebral Body Fusion Device. This type of submission relies on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical studies with human participants or AI performance metrics. Therefore, many of the requested criteria related to studies involving AI, human readers, ground truth establishment for clinical data, and specific sample sizes for training/test sets are not applicable to this document.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The Mecta-C device aims to demonstrate "similar" or "substantially equivalent" mechanical performance according to specific ASTM standards.

Acceptance Criteria (Predicate Performance)	Reported Device Performance (Mecta-C)
Similar Static Axial Compression (ASTM F2077)	Similar Static Axial Compression (ASTM F2077)
Similar Dynamic Axial Compression (ASTM F2077)	Similar Dynamic Axial Compression (ASTM F2077)
Similar Static Compression/Shear (ASTM F2077)	Similar Static Compression/Shear (ASTM F2077)
Similar Dynamic Compression/Shear (ASTM F2077)	Similar Dynamic Compression/Shear (ASTM F2077)
Similar Static Torsion (ASTM F2077)	Similar Static Torsion (ASTM F2077)
Similar Dynamic Torsion (ASTM F2077)	Similar Dynamic Torsion (ASTM F2077)
Similar Subsidence (ASTM F2267)	Similar Subsidence (ASTM F2267)

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of mechanical performance tests conducted according to established ASTM standards. These tests compare the Mecta-C Intervertebral Body Fusion Device to identified predicate devices (Vu cPOD and Bengal Cage).

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size for Test Set: The document does not specify the exact number of Mecta-C devices or predicate devices used in each mechanical test. Mechanical testing typically involves multiple samples (e.g., 5-10 per test condition) to ensure statistical significance, but these details are not provided in this 510(k) summary.
Data Provenance: The data provenance is from mechanical laboratory testing, not human or clinical data. The tests were performed to ASTM standards, which are international standards. The country where the testing took place is not explicitly stated, but Medacta International SA is based in Switzerland and Medacta USA is in California.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not Applicable. For mechanical testing of medical devices, "ground truth" is established by the physical properties and performance characteristics of the predicate devices and the specifications of the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when there's ambiguity in human interpretation of data. For mechanical tests, the results are quantitative measurements against predefined criteria in the ASTM standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is a mechanical device submission, not an AI or imaging diagnostic device. MRMC studies analyze human reader performance, often in conjunction with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This refers to AI algorithm performance. This submission is for a physical implantable device.

7. The Type of Ground Truth Used:

Objective Mechanical Performance Data: The "ground truth" in this context is the quantitative mechanical performance data obtained from testing both the Mecta-C device and the predicate devices according to established ASTM standards (ASTM F2077 for various compression/shear/torsion tests and ASTM F2267 for subsidence). The FDA's acceptance of "substantial equivalence" relies on the Mecta-C device's performance falling within acceptable limits relative to these predicate devices.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence. This concept applies to machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. See point 8.

Summary

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K112862 Page // z

DEC 1 9 2011

Image /page/0/Picture/2 description: The image shows the logo for Medacta International. The logo consists of two triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is the word "International" in a smaller font, and to the right of the word "International" is a small square with a plus sign inside.

510(k) Summary

Medacta International SA Manufacturer: Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66

Mr. Adam Gross Contact Person: Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com
Date Prepared: September 30. 2011

DEVICE INFORMATION

Trade/Proprietary Name: Mecta-C Common Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Body Fusion Device, Cervical

21 CFR 888.3080 Class II Device Product Codes: ODP

Predicate Devices: K101363 Theken Spine Vu cPOD P980048 Centerpulse Spine-Tech BAK-C K081917 Depuy Spine Bengal Cage K110927 Medacta MectaLIF K083311 Aesculap CeSpace K073177 Pioneer Intervertebral Body Fusion System K100889 - Titan Spine Endoskeleton TC

Section 5 - Page 2 of 4

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Product Description

Indications for Use

Comparison to Predicate Devices

The Mecta-C Intervertebral Body Fusion Device is substantially equivalent to K101363 Theken Spine Vu cPOD. P980048 Centerpulse Spine-Tech BAK-C. K083311 Aesculap CeSpace, K073177 Pioneer Intervertebral Body Fusion System, K100889 Titan Spine Endoskeleton TC, and K081917 Depuy Spine Bengal Cage in terms of indications for use, design, and function. Mecta-C is also substantially equivalent to K110927 Medacta MectaLIF, Vu crPOD and Bengal Cage in terms of materials. Mecta-C is substantially equivalent to MectaLIF in the manufacturing process. Performance testing has demonstrated that the Mecta-C Intervertebral Body Fusion Device is substantially equivalent in mechanical performance to the Vu cPOD and the Bengal Cage in Static and Dynamic Compression, Compression/Shear, Torsion, and Subsidence performance.

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Performance Testing

Similar Static Axial Compression - ASTM F2077 Similar Dynamic Axial Compression - ASTM F2077 Similar Static Compression/Shear - ASTM F2077 Similar Dynamic Compression/Shear - ASTM F2077 Similar Static Torsion - ASTM F2077 Similar Dynamic Torsion - ASTM F2077 Similar Subsidence - ASTM F2267

Conclusion:

Based on the above information, the Mecta-C Intervertebral Body Fusion Device can be considered as substantially equivalent to its predicate devices in regards to indications, intended use, and technological features.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

Medacta International SA % Medacta USA Mr. Adam Gross Director of Regulatory and Quality 4725 Calle Quetzal, Unit B Camarillo, California 93012

DEC 1 9 2011

Re: K112862

Trade Name: Mecta-C Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 17, 2011 Received: November 18, 2011

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

For D.D. Moore

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

Enclosure

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Indications for Use

510(k) Number (if known): K112862

Device Name: Mecta-C

Indications for Use:

Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Divisio

(Diysion Sign-Off) Diffision of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K 112862

Mecta-C 510(k) November 14, 2011

Section 4 - Page 2 of 2

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.