(259 days)
The Apollo Spine Venus Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 4.5mm and 5.5 mm screws. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Apollo Venus Facet System is indicated for treatment of any or all of the following:
- Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
- Spondylolisthesis
- Spondylolysis
- Degenerative disk disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
- Degeneration of the facets with instability
- Trauma including spinal fractures and/or dislocations
The Venus Facet Screw System consists of two separate diameter screws and is provided in variable lengths for cervical and lumbar use. The screws have small fenestration in the threaded portion. The system includes a cervical and lumbar facet screws. The system screws provide fixation and are designed to connect vertebral facets, resulting from such causes as degenerative disease and/or trauma. These screw kits are considered a 'family' product line with sizes based on the anatomical variations of the patient's facets. The materials contained in the device include implant grade titanium alloy, Ti-6AI-4V (ELI) per ASTM F-136. The device is sold non-sterile and is to be sterilized at the end use facility by steam sterilization. The Venus Facet Screw System is a single use device.
The provided text is a 510(k) Premarket Notification for the Apollo Spine Venus Facet Screw System. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of a software or AI device.
The document details the mechanical properties and materials of the Venus Facet Screw System through performance testing, which is standard for implantable medical devices. However, it does not involve any AI, software, or imaging analysis that would require the typical components of device performance studies (like sample size for test/training sets, expert ground truth, adjudication methods, or MRMC studies) that you've listed.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI/software.
- Sample sizes for test sets or data provenance for AI/software.
- Number/qualifications of experts for AI/software ground truth.
- Adjudication method for AI/software test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness study information.
- Standalone (algorithm only) performance information.
- Type of ground truth used for AI/software.
- Sample size or ground truth establishment for a training set (AI/software).
The study mentioned in the document focuses on mechanical performance standards for the physical screw system:
- Performance Standards: Performance testing and engineering analysis were conducted to characterize the performance of the Apollo Spine Venus Facet Screw System.
- Testing Performed: Dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion and axial pull-out testing per ASTM F543.
- Device Performance: "The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."
- Conclusion: "Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. Equivalency of this device to the predicate devices is based on similarities in intended use, materials and design in combination with acceptable mechanical performance properties."
This information speaks to the physical integrity and strength of the implant, not the diagnostic or analytical performance of an AI or software device.
N/A