(750 days)
The ALIF Spinal Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.
The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in zero degree lordosis and 8 degree lordosis and each of these in 8 heights ranging from 10mm to 17mm in 1mm increments.
The provided 510(k) summary describes an interbody fusion device, the ALIF Spinal Truss System (STS) Interbody Fusion Device, not an AI/ML powered device. Therefore, many of the requested criteria, such as those related to AI models, training sets, ground truth establishment for AI, human reader studies, and adjudication methods, are not applicable to this submission.
The document focuses on the mechanical and biological performance of the implant itself through pre-clinical testing, rather than the performance of an algorithm or diagnostic tool.
ALIF Spinal Truss System (STS) Interbody Fusion Device Performance Summary
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Mechanical Testing (per ASTM F2077): | |
| Static Compression Shear | Preclinical testing performed; outcome indicates substantial equivalence to predicate devices. |
| Static Torsion | Preclinical testing performed; outcome indicates substantial equivalence to predicate devices. |
| Dynamic Axial Compression | Preclinical testing performed; outcome indicates substantial equivalence to predicate devices. |
| Dynamic Compressive Shear | Preclinical testing performed; outcome indicates substantial equivalence to predicate devices. |
| Other Mechanical Tests: | |
| Subsidence (per ASTM F2267-04) | Testing performed; outcome indicates substantial equivalence to predicate devices. |
| Expulsion Testing (industry accepted methodology) | Testing performed; outcome indicates substantial equivalence to predicate devices. |
| Finite Element Analysis (FEA): | |
| Mechanical Stiffness | Analysis completed. |
| Stress Quantification | Analysis completed. |
| Intra-cage Pressure Quantification | Analysis completed. |
| Porosity Quantification | Analysis completed. |
| Biological Performance: | |
| Fusion in vivo (Animal Study) | Animal study in sheep performed, demonstrating fusion. |
2. Sample size used for the test set and the data provenance
- Test Set (Preclinical Testing): The document does not specify the exact sample sizes (e.g., number of devices tested) for each mechanical test. It generally states that "Preclinical testing performed" and an "animal study in sheep" were conducted.
- Data Provenance: The preclinical mechanical tests (ASTM F2077, F2267-04, expulsion testing) and Finite Element Analysis were internal studies conducted by the manufacturer or their chosen testing facilities. The animal study was conducted in sheep. No country of origin is explicitly stated for the animal study, but given the 510(k) submission to the FDA, it is presumed to be compliant with US regulatory standards or equivalent. These are prospective studies and tests conducted specifically for this device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is Not Applicable as the submission is for a physical interbody fusion device, not a diagnostic or AI-powered device requiring expert-established ground truth for its performance assessment. Performance is based on objective mechanical tests and a biological animal study.
4. Adjudication method for the test set
- This question is Not Applicable as there is no diagnostic outcome or subjective assessment requiring adjudication in the context of this device's performance claims.
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 submission is for a physical interbody fusion device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is Not Applicable as the submission is for a physical interbody fusion device, not an algorithm.
7. The type of ground truth used
- For Mechanical Performance: The "ground truth" is defined by the objective results of standardized ASTM tests and industry-accepted methodologies. The device's performance is compared against the performance of predicate devices or established engineering benchmarks for substantial equivalence.
- For Biological Performance: The "ground truth" for fusion was evidence observed in the animal study (sheep). This would typically involve histological analysis, radiographs, or other methods to confirm bone growth and fusion in the animal model.
8. The sample size for the training set
- This question is Not Applicable as the submission is for a physical interbody fusion device and does not involve AI model training data.
9. How the ground truth for the training set was established
- This question is Not Applicable as the submission is for a physical interbody fusion device and does not involve AI model training data or ground truth establishment for a training set.
§ 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.