(125 days)
The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini Ti Spacer System is intended for use with autograft comprised of cancellous and/ or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.
The CONSTRUX Mini Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure. CONSTRUX Mini Ti spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.
The CONSTRUX Mini Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach. The CONSTRUX Mini Ti implants are provided sterile.
The information provided describes the acceptance criteria and the study for the CONSTRUX Mini Ti Spacer System, a medical device, not an AI/ML powered device. Therefore, many of the typical AI/ML study questions, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable.
Here's a summary of the available information regarding the device's acceptance criteria and the study proving it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
For the CONSTRUX Mini Ti Spacer System, the "acceptance criteria" are implied by the mechanical testing standards, and the "reported device performance" is that the device met these standards and was found substantially equivalent to predicate devices.
| Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F2077) | Met standard |
| Dynamic Axial Compression (ASTM F2077) | Met standard |
| Static Compression Shear (ASTM F2077) | Met standard |
| Dynamic Compression Shear (ASTM F2077) | Met standard |
| Static Torsion (ASTM F2077) | Met standard |
| Dynamic Torsion (ASTM F2077) | Met standard |
| Subsidence (ASTM F2267) | Met standard |
| Characterization of Particles (ASTM F1877) | Met standard |
| Overall Equivalence to Predicate Devices | Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes mechanical testing performed according to specified ASTM standards. These standards dictate the number of test specimens (samples) required for each test. However, the exact sample sizes used for each specific test (e.g., how many devices were subjected to static axial compression) are not explicitly stated in this document.
The "data provenance" is typically the results of in-vitro mechanical testing performed by the manufacturer, Orthofix Inc. This is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For mechanical testing of medical devices, "ground truth" is established by the specifications and methodologies outlined in the ASTM standards themselves, and the measurements are taken by testing equipment and qualified technicians/engineers. There is no expert consensus involved in establishing ground truth for mechanical test results in this manner.
4. Adjudication Method for the Test Set
This question is not applicable as the "test set" refers to mechanical testing, not a clinical study involving human assessment that would require 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
This question is not applicable as the device is a spinal implant, not an AI/ML-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a spinal implant, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical performance testing, the "ground truth" relies on:
- ASTM standards: The established methodologies and acceptance criteria defined within ASTM F2077, ASTM F2267, and ASTM F1877.
- Physical measurements: The quantitative results obtained from the mechanical tests (e.g., force, displacement, wear).
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical implant, not an AI/ML model that undergoes a "training" phase.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 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.