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510(k) Data Aggregation
(27 days)
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Sniper® Spine System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® Spine System implants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The Sniper® Spine System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the Sniper® Spine System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the Sniper® Spine System. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance data presented refers to specific tests conducted.
| Acceptance Criteria (Implicit) | Reported Device Performance (as stated in document) |
|---|---|
| Substantial equivalence to predicate device in terms of safety and effectiveness for its intended use and indications. | Engineering analyses, dynamic axial compression bending testing according to ASTM F1717, as well as cadaveric validation was performed to demonstrate that the modified Sniper Spine System is substantially equivalent to the predicate device. The document explicitly states: "Based on the indications for use, technological characteristics, performance testing and comparison to the predicate, the subject Sniper® Spine System has been shown to be substantially equivalent to the predicate device identified in this submission." This implies that the results of the mentioned tests supported this conclusion of substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document mentions "cadaveric validation" but does not specify the sample size (number of cadavers) used. It also does not provide information about the provenance of this data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document refers to engineering analyses and cadaveric validation, which are typically evaluated by engineers and potentially surgeons, but the specific number or qualifications are not mentioned for establishing "ground truth" in the context of expert review.
4. Adjudication method for the test set
This information is not provided in the document.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance in this document. The device in question is a physical spinal implant system, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical pedicle screw spinal system, not an algorithm.
7. The type of ground truth used
For the engineering and cadaveric testing mentioned, the "ground truth" would be established through:
- Engineering analyses: Based on established biomechanical principles, material properties, and design specifications.
- Dynamic axial compression bending testing (ASTM F1717): The ground truth is defined by the standardized test parameters and the observed mechanical performance (e.g., strength, durability, deformation) under these conditions.
- Cadaveric validation: The ground truth would likely be established through direct observation of the device's performance, stability, and fit within the cadaveric spine, possibly evaluated against anatomical landmarks or surgical expectations.
8. The sample size for the training set
This is not applicable as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable as this is not a machine learning or AI-based device.
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