Search Results

The Seneka II Polyscrew Pedicle Fixation System is intended for posterior non-cervical fixation as an adjunct to fusion in skeletally mature patients 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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Seneka II Polyscrew Pedicle Fixation System may also be used for the same indications as an adjunct to fusion.

The Seneka II Polyscrew Pedicle Fixation System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, reduction screws, domino connectors, offset connectors, hooks and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Seneka II system can be implanted via the open surgical approach.

Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, cobalt chrome per ASTM F1537 or CP Titanium per ASTM E2371-13.

This document is a 510(k) premarket notification from the FDA regarding the "Seneka II Polyscrew Pedicle Fixation System." It declares the device substantially equivalent to previously marketed predicate devices.

However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of clinical accuracy or effectiveness.

The document discusses pre-clinical testing for mechanical properties, but this is distinct from clinical performance criteria for an AI/device's diagnostic or predictive accuracy. The "Performance Standards" section only mentions:

• Pre-clinical testing performed includes static and dynamic compression bending, and static torsion per ASTM F1717-14.

This is about the mechanical integrity of the pedicle fixation system components, not its diagnostic or clinical performance, nor does it involve any AI component.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance (in terms of clinical accuracy), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/diagnostic device. This document describes a surgical implant, not an AI or diagnostic medical device with performance metrics related to accuracy.

Ask a specific question about this device

The Seneka I Polyscrew Pedicle Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Seneka I Polyscrew Pedicle Fixation System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, reduction screws, domino connectors, offset connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Seneka I system can be implanted via the open surgical approach.

Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, cobalt chrome per ASTM F1537 or CP Titanium per ASTM E2371-13.

The provided text is a 510(k) summary for a medical device (Seneka I Polyscrew Pedicle Fixation System). It focuses on demonstrating substantial equivalence to predicate devices, primarily through material and mechanical performance testing, rather than clinical efficacy through human-centric studies with acceptance criteria for algorithm performance.

Therefore, the information required to answer the prompt directly, such as acceptance criteria for device performance in terms of diagnostic accuracy/sensitivity/specificity, a multi-reader multi-case study, or standalone algorithm performance, is not present in the document.

The document mainly covers:

1. Device Description and Indications for Use: The system is for posterior, non-cervical pedicle fixation as an adjunct to fusion for various spinal conditions.
2. Predicate Devices: Moss Miami System (DePuy Spine) (K022623), Optima System (U&I) (K031585), and Xia Spinal System (Stryker) (K001319).
3. Performance Standards/Testing: Pre-clinical testing included static and dynamic compression bending, and static torsion per ASTM F1717-10. These are mechanical tests for the physical device, not related to diagnostic or AI performance.
4. Technological Characteristics: Comparison to predicate devices regarding indications for use, materials, function, sizes, and mechanical test results.

In summary, this document does not contain the type of information requested about acceptance criteria for AI/algorithm performance, multi-reader studies, or ground truth establishment relevant to an AI-powered device. It is a regulatory submission for a physical implantable device.

Ask a specific question about this device