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The OsteoCentric Spine MIS Pedicle Fastener System is intended to provide immobilization 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.

The OsteoCentric Spine MIS Pedicle Fastem is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins 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/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the OsteoCentric Spine MIS Pedicle Fastener System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins 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/or lordosis); turnor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The OsteoCentric Spine MIS Pedicle Fastemer System is a posterior fusion spinal fixation system which consists of non-sterile pedicle fasteners (Ø4.5 - 08.5, 25 - 180 mm), cannulated pedicle fasteners (05.5 - 08.5, 25 - 100 mm), reduction fasteners, extended tab implants, locking caps, and rods (05.5, 30 - 180 mm). The fasteners are used to attach the system components to the non-cervical spine and allows a surgeon to build an implant construct with the intent to stabilize the operative site during the fusion process.

The implant components are manufactured from titanium alloy (ASTM F136).

The provided text is a 510(k) Summary for the OsteoCentric Spine MIS Pedicle Fastener System. This document is a regulatory submission to the FDA, demonstrating "substantial equivalence" to a legally marketed predicate device, rather than a study proving the device meets specific performance acceptance criteria for a new AI/software medical device.

Therefore, the information required to answer your prompt, which focuses on acceptance criteria and a study proving an AI/software device's performance (including sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.), is not present in the provided text.

The document states:

• "The OsteoCentric Spine MIS Pedicle Fastener System's components were previously cleared under predicate K151648. No additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate." (Page 5, Section VII. Performance Data)

This explicitly indicates that no new performance study was conducted or submitted for this specific 510(k) application (K221332) to demonstrate the device meets new acceptance criteria. Instead, it relies on the prior clearance of its components and its substantial equivalence to an existing predicate device (K151648) based on identical indications for use, materials, sterilization, and manufacturing methods.

In summary, based on the provided text, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment because no such performance study was conducted or submitted for this device's 510(k) clearance.

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