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The PSS System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion,

The PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws and hooks. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, titanium alloy described by such standards as ASTM F-138, ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

This document is a 510(k) premarket notification for the "PSS System," a pedicle screw spinal system. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically seen in studies for novel high-risk devices or AI/ML-driven diagnostics.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable to this 510(k) submission. This submission primarily relies on comparing the new device's design, materials, and intended use to existing legally marketed predicate devices.

Here's why and what information is available:

• Type of Device: The PSS System is a pedicle screw spinal system, a mechanical implant.
• Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a predicate device. This pathway typically relies on engineering and performance testing (e.g., mechanical strength, fatigue), material characterization, and comparison of design features and intended use with already cleared devices. It does not usually involve clinical trials to establish sensitivity, specificity, or reader performance improvements.
• Focus of Submission: The conclusion explicitly states: "Based on the results, the overall designs of the PSS System which consists of pedicle screws, rods, cross links, locking cap screws and hooks are substantially equivalent to the predicate devices."

Therefore, the specific questions related to AI/ML device study design, acceptance criteria, sample sizes, expert ground truth, and MRMC studies cannot be answered from the provided text because these elements are not part of a typical 510(k) for a mechanical spinal implant.

If this were an AI/ML device, the detailed information requested would be crucial. However, for this specific document, that information is not relevant or present.

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