The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

Device Description

MectaLIF TiPEEK is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants with a Titanium coating and Tantalum Markers. MectaLIF TiPEEK consists of the Oblique Interbody Fusion Device and Posterior Interbody Fusion Device. The Oblique and Posterior Interbody Fusion Devices are used to replace a degenerative disc in order to restore the height of the spinal column structure. MectaLIF TIPEEK can be applied with common surgical techniques such as PLIF (Posterior Lumbar Intervertebral Fusion) and TLIF (Transforaminal Lumbar Intervertebral Fusion). The devices are intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The materials of MectaLIF TiPEEK are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) with commercially pure titanium (CPTi, ASTM F 1580) coating and Marker: Tantalum (ISO 13782 / ASTM F 560).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MectaLIF TiPEEK device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the MectaLIF TiPEEK "passed all requirements" for the performance tests. The specific quantitative acceptance criteria or threshold values are not provided in the text. However, the tests performed indicate the areas where the device's performance was evaluated against industry standards.

Test Category	Specific Test (ASTM Standard)	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance
Mechanical Strength	Static axial compression	(Implied by standard conformance)	Passed all requirements
	Dynamic axial compression	(Implied by standard conformance)	Passed all requirements
	Static shear compression	(Implied by standard conformance)	Passed all requirements
	Dynamic shear compression	(Implied by standard conformance)	Passed all requirements
	Static Tensile strength	(Implied by standard conformance)	Passed all requirements
	Static Shear strength	(Implied by standard conformance)	Passed all requirements
	Shear fatigue strength	(Implied by standard conformance)	Passed all requirements
Stability	Subsidence	(Implied by standard conformance)	Passed all requirements
Coating Performance	Abrasion resistance	(Implied by standard conformance)	Passed all requirements
Material Analysis	Micrographical Analysis	(Implied by standard conformance)	Passed all requirements
Wear	Wear Analysis	(Implied by standard conformance, explicitly mentioned)	Passed all requirements
	Wear analysis for particulates	(Implied by standard conformance, explicitly mentioned)	Passed all requirements

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

The document states: "MectaLIF TiPEEK was tested using the worst-case device for each of the following tests".

Sample Size: For each specified mechanical and material test, the sample size was "the worst-case device." This implies a very limited sample size, likely one or a few devices representing the highest stresses or risks, common in medical device mechanical testing for substantial equivalence.
Data Provenance: The study was conducted as part of Medacta International's premarket notification (510(k)) to the FDA. The testing was performed in accordance with FDA Guidance documents. The location of the testing facility is not explicitly stated, but it's likely a laboratory, either internal or third-party, that adheres to relevant international standards (e.g., ISO, ASTM). This is a prospective study in the sense that the testing was performed before market clearance.

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

This information is not applicable to this type of performance testing. The "ground truth" for mechanical and material performance is established by the specified ASTM standards and FDA guidance, which define the test methods, conditions, and expected outcomes (e.g., fracture loads, wear rates, material properties). Expert consensus is typically used for clinical endpoints or diagnostic accuracy, not mechanical device performance.

4. Adjudication Method for the Test Set

This is not applicable. As this is mechanical and material performance testing, there is no "adjudication" in the traditional sense of human interpretation of results. The results are quantitative measurements against predefined criteria within the ASTM standards.

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

No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is relevant for evaluating the clinical effectiveness or diagnostic accuracy of a device when interpreted by humans, typically in imaging or diagnostic applications. MectaLIF TiPEEK is an implantable intervertebral fusion device, and its performance is assessed through mechanical and material testing, not human interpretation.

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

No, a standalone performance study in the context of an algorithm or AI without human-in-the-loop was not conducted or mentioned. The device itself is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this performance testing is based on established industry standards and regulatory guidance. Specifically:

ASTM Standards: F2077, F2267, F1877, F1978, F1147, F1044, F1160, F1854. These standards define the scientific methods and expected results for evaluating intervertebral body fusion devices and metallic coatings.
FDA Guidance Documents: "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and "Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." These guidances provide regulatory expectations and testing protocols.

8. Sample Size for the Training Set

This is not applicable. The MectaLIF TiPEEK is a physical medical device. It does not involve a "training set" in the context of machine learning or artificial intelligence. Its design and manufacturing processes are informed by engineering principles, material science, and previous predicate device designs, but not a data-driven training set.

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

This is not applicable as there is no "training set" for this device. The design and validation are based on engineering principles and compliance with established standards, not a data-driven training process.

Summary

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JAN 30 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: Mr. 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

January 20, 2014 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name: MectaLIF TiPEEK Common Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar 21 CFR 888.3080 Class II Device Product Codes: MAX

Predicate Devices:

510(k)	Product	510(k) Holder	ClearanceDate
K110927	MectaLIF	Medacta International	6/13/2011
K131671	MectaLIF Extension	Medacta International	7/05/2013
K112036	Calix PC Spinal Implant System	X-spine Systems, Inc	11/8/2011

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Product Description

Indications for Use

Comparison to Predicate Devices

MectaLIF TiPEEK is identical to the implants cleared under K110927 and K131671 except for the addition of the commercially pure titanium (CPT). ASTM F 1580) coating. which is the same coating used with K112036 Calix PC. The indications for use of MectaLIF TiPEEK are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The substantial equivalence of the MectaLIF TiPEEK implants are supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.

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Performance Testing

Performance testing was conducted in accordance with FDA Guidance - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device as well as in accordance with FDA Guidance - Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. Additional wear analysis for particulates was conducted and it was determined that MectaLIF TiPEEK passed all requirements.

MectaLIF TiPEEK was tested using the worst-case device for each of the following tests:

Static and dynamic axial compression - ASTM F2077 Static and dynamic shear compression - ASTM F2077 Subsidence - ASTM F 2267 Wear Analysis - ASTM F2077, ASTM F1877 Abrasion resistance - ASTM F1978 Static Tensile strength - ASTM F1147 Static Shear strength - ASTM F1044 Shear fatigue strength - ASTM F1160 Micrographical Analysis - ASTM F1854

Conclusion:

Based on the above information, the MectaLIF TIPEEK 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

January 30, 2014

Medacta International Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 West Carroll Avenue Chicago, Illinois 60607

Re: K133192

Trade/Device Name: MectaLIF TiPEEK Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 18, 2013 Received: November 14, 2013

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

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Page 2 - Mr. Adam Gross

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Vincen EDDevlin -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

510(k) Number (if known) K133192

Device Name

MectaLIF TiPEEK

Indications for Use (Describe)

The Mecal.[F implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with desc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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・・・・・ : . . . . . . FOR FDA USE ONLY . . . . . . . . . .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

EDmitrie

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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.