(248 days)
MATISSE Anterior Cervical Interbody Fusion Cage system 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 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 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 prior to treatment with an intervertebral cage.
The MATISSE Anterior Cervical Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation systems that have been cleared for use in the cervical spine.
The MATISSE Anterior Cervical Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation systems that have been cleared for use in the cervical spine. 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 or Evonik VESTAKEEP i4R, with Tantalum marker pins, or titanium alloy.
The provided text describes a medical device, the MATISSE Anterior Cervical Interbody Fusion Cage System, and its clearance under a 510(k) premarket notification. This type of clearance focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria related to typical AI/software performance metrics (e.g., sensitivity, specificity, accuracy).
Therefore, many of the requested details, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "number of experts used to establish ground truth," and "ground truth for training set," are not applicable to this document. This document describes a physical medical implant, not an AI or software-based diagnostic or assistive device.
However, I can extract information related to the performance data presented within the context of a physical device's mechanical and functional equivalence.
Here's a breakdown of the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific numerical acceptance criteria (e.g., minimum load bearing, maximum displacement) nor the explicit numerical results for the device's performance against those criteria. Instead, it makes a general statement:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Finite Element Analysis (FEA) | Not explicitly stated (implied to ensure structural integrity and functional performance) | Implied to meet criteria |
| Static and Dynamic Axial Compression Testing (according to ASTM F2077) | Not explicitly stated (implied to meet relevant ASTM standards for spinal implants) | "The results met all acceptance criteria" |
| Expulsion Testing | Not explicitly stated (implied to ensure the cage remains in place) | "The results met all acceptance criteria" |
| Subsidence Testing (according to ASTM F2267) | Not explicitly stated (implied to meet relevant ASTM standards to prevent sinking) | "The results met all acceptance criteria" |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the number of devices or iterations used for each test (e.g., how many cages were tested for axial compression). It refers to "the MATISSE Anterior Cervical Interbody Fusion Cage System device" undergoing tests, implying multiple units would have been used for mechanical testing, but no specific number is given.
- Data Provenance: Not applicable. These are lab-based physical performance tests of a device, not data collected from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/software for diagnostic purposes is not relevant here. The "ground truth" for these tests would be the established engineering standards (ASTM F2077, ASTM F2267) and the physical measurements themselves.
4. Adjudication method for the test set
- Not Applicable. As these are physical performance tests against engineering standards, an adjudication method for human interpretation of data is not relevant. The results are quantitative measurements against predefined engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device (interbody fusion cage), not an AI-assisted diagnostic tool. No human reader study was performed or required.
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 an algorithm.
7. The type of ground truth used
- The "ground truth" here refers to established engineering standards (ASTM F2077, ASTM F2267) and the physical properties and performance requirements for similar medical devices. The comparison is made against the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This document describes a physical medical device, not an AI model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2017
CTL Medical Corporation % Mr. Paul Speidel Senior Regulatory/Quality Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K162682
Trade/Device Name: MATISSE Anterior Cervical Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 26, 2017 Received: May 30, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 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/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 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,
Mark N. Melkerson -S
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) K162682
Device Name
MATISSE Anterior Cervical Interbody Fusion Cage System
Indications for Use (Describe)
MATISSE Anterior Cervical Interbody Fusion Cage system 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 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 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 prior to treatment with an intervertebral cage.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------- |
|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
| Submitter | CTL Medical CorporationTosan Onosode4550 Excel Parkway Suite 300Addison, TX 75001 |
|---|---|
| Phone: 214-545-5820Fax: 888-831-4892 | |
| Contact Person: | Paul SpeidelRQMIS, Inc.110 Haverhill Road, Suite 526Amesbury, MA 01913Phone: 978-358-7307 |
Date Prepared: May 26, 2017
| Name of Device | MATISSE Anterior CervicalInterbody Fusion Cage System |
|---|---|
| Name/Address of Sponsor: | CTL Medical CorporationToson Onosode4550 Excel Parkway Suite 300Addison, TX 75001 |
Common or Usual Name
Intervertebral Body Fusion Device
Classification Name
Intervertebral Body Fusion Device, Cervical (Product Code ODP)
Class
Class II
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Classification Number
21 CFR 888.3080
Predicate Device
K121569, MATISSE Anterior Cervical Interbody Fusion Cage System
Device Description
Indications for Use:
MATISSE Anterior Cervical Interbody Fusion Cage system 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 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 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 prior to treatment with an intervertebral cage.
Intended Use:
The MATISSE Anterior Cervical Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation systems that have been cleared for use in the cervical spine. 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 or Evonik VESTAKEEP i4R, with Tantalum marker pins, or titanium alloy.
Technological Characteristics
The MATISSE Anterior Cervical Interbody Fusion Cage System consists of PEEK with marker pins made of Tantalum as well as Titanium, both of which are identical to its predicate device. All of the heights, lengths, and widths are within range covered by its predicate device.
Performance Data
The MATISSE Anterior Cervical Interbody Fusion Cage System device underwent Finite Element Analysis ("FEA"), static and dynamic axial compression testing and confirmatory static axial compression testing according to ASTM F2077, expulsion testing, and subsidence testing according to ASTM F2267. The
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results met all acceptance criteria and demonstrate that the MATISSE Anterior Cervical Interbody Fusion Cage System does not raise concerns regarding safety and effectiveness.
Conclusion
The MATISSE Anterior Cervical Interbody Fusion Cage System is as safe and effective as the predicate MATISSE Anterior Cervical Interbody Fusion Cage System (K121569). The MATISSE Anterior Cervical Interbody Fusion Cage System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the MATISSE Anterior Cervical Interbody Fusion Cage System and its predicate device raise no new issues of safety or effectiveness. Thus, the MATISSE Anterior Cervical Interbody Fusion Cage System is substantially equivalent.
§ 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.