MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description

The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of either PEEK-OPTIMA LT1 (Invibio) or VESTAKEEP i-Grade (Evoniks) PEEK with titanium alloy and titanium alloy marker pins.

AI/ML Overview

Based on the provided text, the document describes the substantial equivalence determination for a medical implant (intervertebral fusion cage system), not an AI/software medical device. Therefore, many of the requested criteria (like ground truth establishment, MRMC studies, training/test sets for AI, expert qualifications for reading, etc.) are not applicable to this type of medical device submission.

The "study" referenced in the document is a mechanical performance testing of the implant, not a clinical study involving human patients or a study of an AI algorithm's performance.

Here's an analysis based on the information provided in the document:

The device in question is the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™. This is a physical implant used in cervical spinal fusion surgery.

1. Table of Acceptance Criteria and Reported Device Performance

Device Type: Intervertebral Body Fusion Device (Physical Implant)

Acceptance Criteria Category	Specific Test Standard	Acceptance Criteria (Implicit from predicate)	Reported Device Performance
Mechanical Performance	ASTM F2077	Must meet or exceed the performance of the predicate devices for static and dynamic axial compression.	"The results met all acceptance criteria established previously for the predicate devices"
Mechanical Performance	ASTM F2267	Must perform comparably to the predicate devices in subsidence testing.	"The results met all acceptance criteria established previously for the predicate devices"

Note: The document explicitly states that the new device's material composition (specifically the titanium alloy marker pins) is the main difference from the predicate. The performance testing was to demonstrate that this material change does not negatively impact the mechanical integrity and safety of the device.

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

Sample Size for Test Set: The document does not specify an exact numerical sample size for the mechanical tests (e.g., number of devices tested). This testing typically involves a set number of physical units, but the specific quantity is not disclosed in this summary.
Data Provenance: The tests are implied to have been conducted in a laboratory setting as part of the device manufacturing and validation process for regulatory submission. There is no indication of clinical data from patients or data related to country of origin in the context of mechanical testing. This is retrospective in the sense that the testing was performed on manufactured devices for regulatory submission.

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

Not Applicable. For a mechanical implant, "ground truth" is established by adherence to engineering specifications and performance standards (like ASTM standards) through physical testing, not by expert interpretation of data like in AI or clinical studies. The results are objective, measurable physical properties.

4. Adjudication Method for the Test Set

Not Applicable. This is a mechanical performance test, not a subjective interpretation requiring adjudication among experts. The results are quantitative and pass/fail against established engineering criteria.

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

No. This type of study is specifically relevant for diagnostic devices, particularly those involving human interpretation of imaging, and often for AI-assisted diagnostic tools. It is not relevant for a physical implant like an intervertebral fusion cage.

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

Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

Engineering/Performance Standards. The "ground truth" for this device's safety and effectiveness is its ability to meet established mechanical performance specifications (e.g., static and dynamic axial compression, subsidence) as defined by ASTM standards and comparison to its predicate devices.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

Not Applicable. As there is no training set.

Summary of the "Study" Proving Acceptance:

The "study" in this context refers to pre-clinical bench testing (mechanical performance testing) of the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™. The purpose of this testing was to demonstrate that the device is substantially equivalent to its predicate devices (K121569 and K162682) despite minor material differences (specifically, the use of titanium alloy marker pins within the PEEK material).

The performance data section clearly states: "The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ device underwent testing according to ASTM F2077, specifically static and dynamic axial compression testing; and subsidence testing according to ASTM F2267. The results met all acceptance criteria established previously for the predicate devices and demonstrate that the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ does not raise concerns regarding safety and effectiveness."

This means the acceptance criteria were based on the performance of the legally marketed predicate devices, and the new device successfully replicated or exceeded that performance in the specific mechanical tests deemed relevant by the FDA for this device type.

Summary

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CTL Medical Corporation % Paul Speidel Senior Regulatory/Quality Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

January 9, 2018

Re: K172212

Trade/Device Name: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 6, 2017 Received: December 12, 2017

Dear Mr. Speidel:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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) K172212

Device Name

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKTM

Indications for Use (Describe)

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

CTL Medical Corporation's MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™

Submitter	CTL Medical CorporationAndrea Wilcox4550 Excel Parkway Suite 300Addison, TX 75001Phone: 214-545-5820Fax: 888-831-4892
Contact Person:	Barry SandsRQMIS, Inc.110 Haverhill Road, Suite 526Amesbury, MA 01913Phone: 978-358-7307

Date Prepared: December 6, 2017

Name of Device	MATISSE Anterior CervicalInterbody Fusion Cage System,Ti-PEEK™
Name/Address of Sponsor:	CTL Medical CorporationAndrea Wilcox4550 Excel Parkway Suite 300Addison, TX 75001

Common or Usual Name

Intervertebral Body Fusion Device

Classification Name

Intervertebral Body Fusion Device, Cervical (Product Code ODP)

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Class

Class II

Classification Number

21 CFR 888.3080

Predicate Devices

Primary Predicate: K121569, MATISSE Anterior Cervical Interbody Fusion Cage System; and

Additional Predicate: K162682 MATISSE Anterior Cervical Interbody Fusion Cage System.

Device Description

Indications for Use:

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description:

Technological Characteristics

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The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ consists of OPTIMA LT1 (Invibio) or VESTAKEEP i-Grade (Evoniks) PEEK with titanium alloy and marker pins made of titanium alloy, both of which are identical to its predicate device with the exception of titanium alloy marker pins. All of the heights, lengths, and widths are within the range covered by its predicate device.

Performance Data

The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ device underwent testing according to ASTM F2077, specifically static and dynamic axial compression testing; and subsidence testing according to ASTM F2267. The results met all acceptance criteria established previously for the predicate devices and demonstrate that the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ does not raise concerns regarding safety and effectiveness.

Conclusion

The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is as safe and effective as the predicate MATISSE Anterior Cervical Interbody Fusion Cage System, Titanium and PEEK (K162682 and K121569). The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ and its predicate devices raise no new issues of safety or effectiveness. Thus, the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is substantially equivalent.

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.