(125 days)
The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx" IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
The StaXx® IBL System is an intervertebral body fusion device composed of wafers that are stacked into an expandable implant to adjust the implant. The implant. The implants are to be used with autogenous bone graft material. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers. The system also includes a delivery device to both implant and expand the implant.
This submission describes a medical device, specifically an intervertebral body fusion device, and does not involve AI or machine learning. Therefore, many of the requested elements for an AI/ML study (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training) are not applicable.
Below is the information that is applicable to this medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static and Dynamic Axial Compression (per ASTM F2077) | The StaXx® IBL System must demonstrate performance substantially equivalent to its predicate devices in terms of mechanical strength and fatigue resistance under axial compression according to ASTM F2077 standards. | Met: "The following mechanical tests were performed to demonstrate the substantial equivalence of the StaXx® IBL System to its predicate." The submission implies the device successfully passed these tests, demonstrating substantial equivalence. |
| Static and Dynamic Compression Shear (per ASTM F2077) | The StaXx® IBL System must demonstrate performance substantially equivalent to its predicate devices in terms of mechanical strength and fatigue resistance under compression shear according to ASTM F2077 standards. | Met: "The following mechanical tests were performed to demonstrate the substantial equivalence of the StaXx® IBL System to its predicate." The submission implies the device successfully passed these tests, demonstrating substantial equivalence. |
| Subsidence (per ASTM F2267) | The StaXx® IBL System must demonstrate performance substantially equivalent to its predicate devices in terms of resistance to subsidence into vertebral bodies according to ASTM F2267 standards. | Met: "The following mechanical tests were performed to demonstrate the substantial equivalence of the StaXx® IBL System to its predicate." The submission implies the device successfully passed these tests, demonstrating substantial equivalence. |
| Overall Conclusion | The device must be shown to be substantially equivalent to predicate devices in its indications for use, technological characteristics, materials, and performance, without presenting new issues of safety or effectiveness. | Met: "Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® IBL System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a submission for a physical medical device, not an AI/ML model evaluated on a data test set. The "tests" mentioned are mechanical bench tests on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically defined for AI/ML models is not relevant here. Device performance is established through mechanical testing against ASTM standards and comparison to predicate devices, which are objective engineering measurements.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML application requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is used to evaluate human reader performance, often with and without AI assistance, which is not relevant for this physical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here. The device itself is evaluated for its mechanical properties.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance is based on established engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate "substantial equivalence" to these benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. Since there is no training set for an AI/ML model, there is no ground truth for it to be established.
§ 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.