(283 days)
MONET™ 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. MONET™ Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. MONET™ 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 with an intervertebral cage.
The MONET™ 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. 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 with tantalum markers or titanium allov.
This document does not contain information about an AI/ML powered device, thus the standard acceptance criteria and study information typically requested for such devices are not applicable.
The MONET™ Anterior Cervical Interbody Fusion Cage System is a medical device for spinal fusion, and its acceptance criteria and study data are based on mechanical and material equivalence rather than AI performance.
Therefore, many of the requested fields (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not relevant to this medical device filing.
Here's the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Results) |
|---|---|
| ASTM F2077 (2014) | Results demonstrated that the performance of the subject device was equivalent to the predicate devices for: |
| a. Static and Dynamic Axial Compression | |
| b. Static and Dynamic Compression-Shear | |
| c. Static and Dynamic Torsion | |
| ASTM F2267 (2013) | Results demonstrated that the performance of the subject device was equivalent to the predicate devices for: |
| Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | |
| Static Push-out Test | Results demonstrated that the performance of the subject device was equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical testing. The testing was conducted on samples of the MONET™ Anterior Cervical Interbody Fusion Cage System itself, not patient data. The provenance is the device manufacturer's testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not expert medical consensus.
4. Adjudication method for the test set: Not applicable. Mechanical test results are measured values, not subject to medical adjudication.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used: For mechanical tests, the "ground truth" is defined by the physical properties and performance characteristics as measured against established engineering standards (ASTM F2077, ASTM F2267). The comparison is against the performance of a predicate device.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
Study Proving Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria is a series of mechanical and material performance tests. These tests were conducted according to established ASTM (American Society for Testing and Materials) standards.
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Tests Performed:
- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices. This standard includes:
- Static and Dynamic Axial Compression
- Static and Dynamic Compression-Shear
- Static and Dynamic Torsion
- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
- Static Push-out Test
- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices. This standard includes:
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Conclusion of the Study: The results from these tests "demonstrated that the performance of the subject device was equivalent to the predicate devices." This equivalence, along with similar intended uses, indications, technological characteristics, and principles of operation, led to the determination of Substantial Equivalence to the predicate devices (MATISSE™ Anterior Cervical Interbody Fusion Cage System, K162682 and K121569). The minor technological differences did not raise new issues of safety or effectiveness.
§ 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.