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The FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The FOCUS Spinal System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 for lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

FOCUS Spinal System consists of cannulated polyscrews, straight rods, curved rods, crosslinks and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.

The provided text describes a medical device, the FOCUS Spinal System, and its performance data relative to predicate devices. However, the document does not contain information about "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as requested by the prompt.

The "Performance Data" section explicitly states:

"Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, screw construct. The mechanical test results demonstrated that the FOCUS Spinal System performs as well as the predicate device."

This indicates a mechanical performance study for a physical spinal implant, assessed against a recognized industry standard (ASTM F1717) to show substantial equivalence to predicate devices.

Therefore, I cannot extract the following information because it is not present in the provided document:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (e.g., sensitivity, specificity, AUC) are mentioned for an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable to a mechanical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document pertains to the 510(k) summary for a physical medical device (spinal system) focusing on its mechanical equivalence to existing products, not an AI/ML device.

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