(152 days)
The Lumbar Spine Truss System Plation (LSTS-PS) without integrated fixation is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The LSTS-PS with integrated fixation is intended to be attached to the Lateral Spine Truss System (LSTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS with integrated fixation is intended to be used with supplemental fixation (e.g. posterior fixation).
The Lumbar Spine Truss System Plating Solution (LSTS-PS) is comprised of lumbar plates and screws. The lumbar plates have a rotating locking tab for each screw position to prevent back-out of the screw. The plates are available in 1-hole, and 4-hole integrated configurations and 2-hole and 4-hole non-integrated configurations. Each plate is available in multiple lengths for single level fusion. The screws are available in two diameters and various lengths to accommodate the patient's anatomy. All LSTS-PS plates and screws are made from Ti6Al4V alloy.
This is a medical device application for the Lumbar Spine Truss System Plating Solution (LSTS-PS). The provided text describes the device, its indications for use, and a summary of performance testing. However, it does not contain the kind of information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria and a study proving those criteria were met for an AI algorithm.
The document discusses a physical medical device (plates and screws for spinal fixation), not an AI algorithm. Therefore, many of your requested points, such as sample size for test sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to the content provided.
Here's an attempt to answer your questions based on the provided document, highlighting where the information is absent or not applicable:
Acceptance Criteria and Study Proving Device Meets Criteria for Lumbar Spine Truss System Plating Solution (LSTS-PS)
As per the provided 510(k) summary, the device under review is a physical medical implant (spinal plates and screws), not an AI/SaMD algorithm. Therefore, the "acceptance criteria" and "study" described in the document refer to the mechanical and material performance of the hardware, tested against established engineering standards, rather than diagnostic performance of an AI.
1. A table of acceptance criteria and the reported device performance
The document states that the device has been tested per various ASTM standards (F1717, F543, F2077). The acceptance criterion, implicitly, is that the device meets or surpasses the requirements of these standards to be considered "sufficient for its intended use and substantially equivalent to legally marketed predicate devices."
The document provides a general statement about the performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Meet mechanical performance requirements per specified standards (ASTM F1717, F543, F2077) for: | "The results of this non-clinical testing show that the strength of the LSTS-PS is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| - Static axial compression bending | Sufficient strength |
| - Static torsion | Sufficient strength |
| - Dynamic axial compression bending fatigue | Sufficient strength |
| - Axial screw pushout | Sufficient strength |
| - Static axial compression | Sufficient strength |
| - Static compression shear | Sufficient strength |
| - Dynamic axial compression fatigue | Sufficient strength |
| - Dynamic compression shear fatigue | Sufficient strength |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For mechanical testing, the sample size would refer to the number of physical devices or components tested. The term "data provenance" (country/retrospective/prospective) is typically for clinical data or imaging, which is not the focus of this particular submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/provided. Since this is a physical device, the "ground truth" is established by the mechanical properties of the materials and the structural integrity of the design, measured by engineering tests, not by expert medical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers for diagnostic studies, which is not relevant here.
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 information is not applicable/provided. This type of study applies to AI-assisted diagnostic devices. The LSTS-PS is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. This question pertains to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering benchmarks and material specifications derived from the ASTM standards mentioned. This includes material properties, mechanical strength under various loads (static, dynamic, compression, torsion, shear), and resistance to fatigue.
8. The sample size for the training set
This information is not applicable/provided. "Training set" refers to data used to train an AI algorithm. In this context, there is no AI algorithm being developed or cleared. If interpreted very broadly, "training" for mechanical design might refer to iterative design processes, but typical sample sizes for training sets are not relevant here.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no "training set" in the context of an AI algorithm. The design and manufacturing of the physical device would follow engineering principles and material science, where performance targets are established based on industry standards and predicate device characteristics.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.