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FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.

The FORZA XP Expandable Spacer System is comprised of an assortment of single use spacers made from titanium alloy and PEEK Polymer with height expansion capability. The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The implants are offered in non-lordotic, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).

The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device and must be used with a supplemental fixation system.

The provided text describes a 510(k) premarket notification for the FORZA XP Expandable Spacer System. However, it does not contain any information about acceptance criteria or a study proving the device meets performance criteria, especially regarding AI/algorithm performance.

The document explicitly states:

• "No new mechanical testing was performed for the FORZA XP Expandable Spacer System because there were no design changes to the device."
• "The proposed sterile package offering does not change the design, materials, function, performance for the FORZA XP implants most recently cleared thru 510(k) K211704."
• "FORZA XP Expandable Spacer System has the same intended use, indications for use, technological characteristics, materials, the same principles of operation and same design as the predicate device FORZA XP Expandable Spacer System (K211704)."

This 510(k) submission is a "Product Line Extension" for a physical medical device (an expandable spinal spacer), primarily addressing a sterile packaging configuration change from a previously cleared device (K211704). It does not involve any AI/algorithm component.

Therefore, I cannot fulfill your request for information about acceptance criteria or a study related to AI/algorithm performance, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for AI, as this information is not present in the provided document.

If you have a document describing an AI/algorithm-based device, please provide that document, and I would be happy to describe the acceptance criteria and study as requested.

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