(169 days)
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.
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.
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.
§ 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.