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510(k) Data Aggregation
(125 days)
4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
The ALIF Spinal Truss 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 devices. 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 0, 6, 8 and 12 degree lordosis and each of these in 9 heights ranging from 8mm to 17mm in 1mm increments.
The provided document describes the 510(k) summary for the ALIF Spinal Truss System® Interbody Fusion Device. It details the device, its indications for use, and a comparison to predicate devices, focusing on mechanical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Static Compression Shear | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Static Torsion | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Dynamic Axial Compression | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Dynamic Compressive Shear | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Subsidence (per ASTM F2267-04) | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
| Expulsion Testing (per industry accepted methodology) | Not explicitly stated, inferred to be comparable or better than predicates. | "The results indicate equal to or better than performance to the original design or other previously approved devices." |
Explanation of "Acceptance Criteria" based on the document:
The acceptance criteria are not quantitatively defined in the provided text. However, the regulatory submission relies on demonstrating substantial equivalence to predicate devices. Therefore, the implicit acceptance criteria for the mechanical performance tests are that the ALIF Spinal Truss System® Interbody Fusion Device performs "equal to or better than" the original design (K083894) or other previously approved predicate devices (DePuy/AcroMed Brantigan Cage and Advanced Medical Technologies Distractable Wave Cage).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size (number of devices or tests performed) for the preclinical mechanical performance testing.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "Preclinical testing performed" by "4-Web Spine, Inc." It is assumed this testing was conducted in a laboratory setting for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of preclinical mechanical performance study. "Ground truth" in this context would typically refer to clinical outcomes or expert diagnoses, which are not part of a mechanical testing submission for substantial equivalence. The "truth" here is the physical performance as measured by ASTM standards and industry-accepted methodologies.
4. Adjudication Method for the Test Set
This is not applicable to preclinical mechanical performance testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or interpretive devices involving human readers, which is not the case for this interbody fusion device's mechanical performance assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is an interbody fusion implant, not an algorithm or software. Its performance is entirely standalone in a mechanical testing environment.
7. The Type of Ground Truth Used
As explained in point 3, the concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic devices is not directly applicable. For this mechanical performance study, the "ground truth" is established by adherence to and measurement against recognized industry standards (ASTM F2077, ASTM F2267-04) and industry-accepted methodologies, with the performance benchmarks being those of legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. The ALIF Spinal Truss System® is a medical implant, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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