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When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The T-Rex™ Standalone ALIF is a lumbar Intervertebral Body Fusion Device with integrated fixation made from HA Enhanced PEEK-OPTIMA (HAPEEK) incorporating titanium bone screws. The implants are available in various heights, widths, lengths, and angles of lordosis to accommodate patients' anatomy. The implants are provided sterile with surgical instruments provided non-sterile to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), are included in each implant to allow radiographic visualization.

The provided document is a 510(k) Summary for the T-Rex Standalone ALIF Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. This type of regulatory submission does not typically include detailed clinical studies or performance data related to AI/algorithm performance against acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text for an AI-powered device.

The document indicates:

• No FDA performance standards have been established for the T-Rex Standalone ALIF. Instead, safety was demonstrated based on current industry standards through non-clinical mechanical testing.
• The tests performed were:
  • Static and dynamic compression and compression shear (per ASTM F2077)
  • Subsidence (per ASTM F2267)
  • Expulsion
  • Push out test on the screws
• The conclusion is that the device is substantially equivalent to predicate devices based on these tests, similar indications for use, and equivalent technological characteristics.

In summary, this document describes a traditional medical device (an intervertebral body fusion device) that demonstrated safety and effectiveness through mechanical testing and comparison to predicate devices, not through a study involving an algorithm or AI performance against clinical acceptance criteria.

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