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Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

• degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation);
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• stenosis, and
• failed previous fusion (pseudoarthrosis)

The Spinal Fixation System 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 sacrum) with removal of the attainment of a solid fusion.

In addition, the Spinal Fixation System is intended to provide immobilization 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 neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured using Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 10.0mm diameters with lengths from 20 to 150mm.

The provided text is a 510(k) summary for the OpenLoc-L Spinal Fixation System, which describes a medical device rather than an AI/ML powered device. As such, it does not contain the specific information required to answer the questions about AI/ML device performance and validation studies.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No AI/ML Device: The document describes a physical spinal fixation system (screws, rods, hooks), not a software or AI-powered diagnostic/treatment aid.
• Performance Testing Focus: The "Performance Testing" section (Section 8) explicitly states: "The additional size and components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the OpenLoc-L Spinal Fixation System as described in the worst case justification reports. Therefore, we substitute mechanical test data of additional components of OpenLoc-L Spinal Fixation System with the one of the unmodified device (K171813)." This indicates that the performance evaluation is based on mechanical testing (e.g., strength, durability) of the physical implants, not on the accuracy or effectiveness of an algorithm.
• Missing Information: All your specific questions (acceptance criteria for AI, sample sizes for test/training sets, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types) are relevant to the validation of AI/ML models, which are not discussed in this document.

Therefore, since the input pertains to a traditional medical device and not an AI/ML powered one, I cannot extract the requested information.

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