Search Results

The OutologousTM Spinal Fixation System is a pedicle screw fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

In addition, the Outologous Spinal Fixation System is intended to provide immobilization and stabilization of the 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 spines: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture of the vertebral body, dislocation, scoliosis, kyphosis, spinal tumor, and failed fusions (pseudoarthrosis).

Not Found

This looks like a 510(k) summary for a medical device called the "Outologous Spinal Fixation System." This type of document is for proving substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI algorithm might.

Therefore, the requested information about acceptance criteria, study design, ground truth, and expert adjudication as typically applied to performance claims of AI/ML devices is not present in this document. The document primarily focuses on regulatory classification, intended use, and the FDA's marketing clearance.

Here's a breakdown of why the requested information cannot be extracted from the provided text according to the specific prompt questions:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria in the sense of a clinical trial for efficacy or diagnostic accuracy. It's about demonstrating substantial equivalence structurally and functionally to existing devices.

2. Sample size used for the test set and the data provenance: Not applicable. There is no specific "test set" for performance evaluation in this context. The demonstration of substantial equivalence relies on design, material, and mechanical testing, but not on clinical performance data in the way an AI algorithm would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established or reported in this type of submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This is a spinal fixation system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable. There is no "training set" for an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory clearance for a physical medical device (spinal fixation system) based on substantial equivalence, and therefore the types of studies and performance metrics typically associated with AI/ML-based diagnostic devices (which your questions are geared towards) are not relevant or reported here.

Ask a specific question about this device