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The Scarlet® AL-T system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system.

When used as a lumbar intervertebral fi.e. without the bone screws provided), the Scarlet® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion device with integrated fixation intended to provide mechanical support to the lumbar spine and maintain adequate disc space until fusion occurs. The Scarlet® AL-T system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as to adapt individual pathology and different patient's anatomical conditions. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Scarlet® AL-T spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished.
The Scarlet® AL-T interbody spacer has a monolithic design that incorporates solid, lattice and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant.
When used as a stand-alone system with its integrated fixation, the spacer is crossed by three (3) bone screws protruding into the vertebral endplates. The bone screws are secured by the mean of two (2) cam locks that prevent backing out.
The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).

The provided text describes the Scarlet® AL-T intervertebral body fusion device and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets acceptance criteria related to a machine learning or AI algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses the mechanical and material testing for a physical medical device (intervertebral body fusion device) to demonstrate its substantial equivalence to previously cleared devices under a 510(k) premarket notification. The tests mentioned are:

• Static and dynamic axial compression (per ASTM F2077-17)
• Static and dynamic Shear compression (per ASTM F2077-17)
• Expulsion (per ASTM Draft F-04.25.02.02)
• Subsidence (per ASTM F2267-04)
• Bacterial endotoxin testing (per USP standard)

The conclusion states that these non-clinical tests demonstrate comparable mechanical properties to the predicate devices and that the Scarlet® AL-T has demonstrated substantial equivalence based on design, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing.

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