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The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments that can accept a device construct up to 80mm in length 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

The PressON Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6Al-4V ELI (ASTM F-136).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

The document describes the PressON Spinal Fixation System, a Class II pedicle screw spinal system (21 CFR 888.3070 (b) (1)). It highlights its substantial equivalence to predicate devices in terms of materials, design, indications for use, and operational principles.

Acceptance Criteria and Device Performance:

The acceptance criteria for the PressON Spinal Fixation System are based on its substantial equivalence to legally marketed predicate devices through performance testing. The reported device performance indicates that the system meets these criteria.

Study Details:

• Sample Size for the Test Set and Data Provenance:

  • The document does not specify a sample size for a "test set" in the context of clinical data for AI or diagnostic purposes. The studies mentioned are mechanical and material performance tests (static and dynamic loading) conducted on the device itself.
  • The data provenance is from mechanical testing labs (implied, not explicitly stated as country of origin, but generally conducted in a controlled lab environment). These are prospective mechanical tests conducted on the device components.

• Number of Experts and Qualifications for Ground Truth of Test Set:

  • This information is not applicable (N/A) as the study is a mechanical performance verification and not a clinical study requiring expert assessment for diagnostic ground truth.

• Adjudication Method for the Test Set:

  • This information is not applicable (N/A) for mechanical performance testing.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No, an MRMC comparative effectiveness study was not done. This type of study is for comparing human readers with and without AI assistance in diagnostic tasks, which is not relevant for this device.

• Standalone (Algorithm Only) Performance Study:

  • No, a standalone algorithm performance study was not done. This device is a physical medical implant (spinal fixation system), not a software algorithm or AI-based diagnostic tool.

• Type of Ground Truth Used:

  • The "ground truth" for the mechanical performance studies is the established performance standards and criteria defined by the ASTM F1798-97(2008) and F1717-13 standards, and the comparative performance of the predicate devices. The device's ability to withstand these defined forces and loads, and perform comparably, establishes its "truth" of efficacy in this context.

• Sample Size for the Training Set:

  • This information is not applicable (N/A). There is no training set mentioned in the context of AI or machine learning for this physical product.

• How Ground Truth for the Training Set Was Established:

  • This information is not applicable (N/A) for the same reason as above.

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