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Cervical System Indications:
The Tyber Medical PT Interbody Spacer System is indicated for use as an intervertebral body fusion device in sketally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to faciliate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used.

Lumbar System Indications:
The Tyber Medical PT Interbody Spacer System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

This submission is to update language in the Indications for Use, and update language in the package insert in reference to MR testing.

There is no change with this submission from the primary predicate.

This submission does not change or add any new instruments.

The Tyber Medical PT Interbody System, manufactured from PEEK-Optima® LT1, with a plasma-sprayed integrated commercially pure titanium. The system consists of implants available in various foot prints, heights, and lordotic configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

The provided text is a 510(k) summary for the Tyber Medical PT Interbody Spacer System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML powered device meets acceptance criteria through a specific study.

Therefore, the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance studies for an AI/ML device is not present in this document.

The document states:

• "No new mechanical testing was performed, because there is no change to the device."
• "MR testing was performed per ASTM F2052-15, ASTM F2119-07, ASTM F2213-06, ASTM F2503-13 & ASTM F2182-11a." (This refers to MRI compatibility testing, not AI performance.)
• "Clinical data and conclusions were not needed for this device."

This indicates that the submission relies on the prior clearance of the predicate device and standard non-clinical testing (like MR compatibility and mechanical testing) to establish substantial equivalence for a physical implant, not the performance of an AI/ML algorithm.

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