(35 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 1 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 height of 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 is a medical device submission (510(k)) for the StaXx® IBL System, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device.
Therefore, many of the requested categories for a study proving acceptance criteria are not directly addressed in this document because it's not a study report. The submission leverages an "engineering rationale" and comparison to previously tested constructs rather than a new clinical or performance study with acceptance criteria.
Here's an attempt to extract the relevant information and indicate where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static Axial Compression (ASTM F2077)
- Dynamic Axial Compression (ASTM F2077)
- Static Compression Shear (ASTM F2077)
- Dynamic Compression Shear (ASTM F2077)
- Subsidence (ASTM F2267) | "The modified implants were compared to constructs previously tested in static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), and subsidence (ASTM F2267). An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to be substantially equivalent to the predicate devices." |
| Material Composition: - PEEK-OPTIMA with 6% Barium Sulfate
- Tantalum markers | The device is composed of PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers, consistent with the predicate. |
| Intended Use & Indications: - Intervertebral body fusion in skeletally mature patients with DDD of the lumbar spine (L2-L5)
- Up to Grade 1 spondylolisthesis or retrolisthesis
- Used with autogenous bone graft and supplemental fixation
- Patients should have >= 6 months non-operative treatment | The device is intended for the same indications as the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for new testing. The submission states that modified implants were compared to constructs previously tested. This implies that new physical samples of the modified implants were likely tested, but the number of samples is not stated. The evaluation relies on an "engineering rationale" based on these comparisons.
- Data Provenance: Not explicitly stated as retrospective or prospective, but likely laboratory/bench-top testing performed in a controlled environment. Country of origin for data is not mentioned but assumed to be relevant to the submitting entity (USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a pre-market submission based on mechanical testing and substantial equivalence, not a clinical study involving expert interpretation of patient data.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions. The "adjudication" here is the engineering rationale and comparison by the manufacturer's technical staff.
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 device is an implant for spinal fusion, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established ASTM standards for mechanical testing of spinal implants and the physical characteristics (material, dimensions) of the device itself. The ground truth for safety and effectiveness is based on the previously cleared predicate device and the assumption that the modified implants do not introduce new safety or effectiveness concerns.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
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.