(154 days)
When used as a cervical intervertebral fusion device, the IMSE Cervical Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior screw systems) cleared for use in the cervical spine.
The IMSE Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The IMSE Cervical Cage of intervertebral body fusion devices are made from the PEEK (Solvay Zeniva ZA-500) radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
The provided document is a 510(k) premarket notification for a medical device called the "IMSE Cervical Cage." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies like those for novel technologies or AI/ML-based devices.
Therefore, the information requested for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not applicable to this submission.
This submission focuses on nonclinical testing (mechanical tests) to demonstrate that the device performs comparably to a predicate device and is safe and effective for its intended use.
Here's a summary of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The results of these [nonclinical] studies showed that the IMSE Cervical Cage met the acceptance criteria." However, specific numerical acceptance criteria and precise performance values are not detailed in this summary. The tests performed are listed as per ASTM standards, implying that the acceptance criteria are defined by those standards.
| Acceptance Criteria Category | Reported Device Performance (as stated) |
|---|---|
| Mechanical Performance | |
| Static Compression (ASTM F2077) | Met acceptance criteria |
| Dynamic Compression (ASTM F2077) | Met acceptance criteria |
| Static Compression Shear (ASTM F2077) | Met acceptance criteria |
| Dynamic Compression Shear (ASTM F2077) | Met acceptance criteria |
| Static Torsion (ASTM F2077) | Met acceptance criteria |
| Dynamic Torsion (ASTM F2077) | Met acceptance criteria |
| Subsidence (ASTM F2267) | Met acceptance criteria |
| Wear Debris (ASTM F1877) | Met acceptance criteria |
| Static Expulsion Test | Met acceptance criteria |
| Sterilization | |
| Autoclave Validation (ISO 17665) | Achieved Sterility Assurance Level (SAL) of 10^-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a mechanical device. The "test set" refers to physical units of the IMSE Cervical Cage that underwent nonclinical (mechanical) testing. The document does not specify the number of devices or "samples" used for each mechanical test, nor is data provenance in terms of country of origin or retrospective/prospective relevant for this type of 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 in the context of expert review is relevant for diagnostic or AI/ML devices. For a mechanical device, the "ground truth" is established by adherence to performance standards (like ASTM) measured through engineering tests, not expert consensus on interpretations.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods are typically used for expert review of data, which is not part of this device's nonclinical performance evaluation.
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. MRMC studies are for evaluating diagnostic performance, particularly with AI/ML systems where human readers interpret results. This is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering standards and specifications (e.g., ASTM standards) for mechanical strength, durability, and material properties, as opposed to medical diagnostic "ground truth."
8. The sample size for the training set
- Not Applicable. This is a mechanical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
§ 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.