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The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SpineFrontier Lumbar Interbody Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

The SpineFrontier Lumbar Interbody Fusion Device System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of PEEK Optima® LT1 or titanium coated PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implantation.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML algorithm. Instead, it is an FDA 510(k) clearance letter for a SpineFrontier Lumbar Interbody Fusion Device System, which is a physical medical device (an intervertebral body fusion device).

Therefore, I cannot provide the requested information, which pertains to AI/ML device performance studies and associated details like training/test set sizes, ground truth establishment methods, or human reader effectiveness with AI assistance.

The document discusses:

• Device Name: SpineFrontier Lumbar Interbody Fusion Device System
• Regulatory Class: Class II (under 21 CFR 888.3080)
• Indications for Use: Intervertebral body fusion of the spine for skeletally mature patients with degenerative disc disease (DDD) at L2-S1 (one or two contiguous levels), potentially with Grade I spondylolisthesis.
• Device Components: Made of PEEK Optima® LT1, possibly with Tantalum markers and a Titanium Coating.
• Performance Testing: "engineering rationale was performed in lieu of bench testing. No performance data was required because none of the modifications to the subject from its previous clearance under K142504 present a worst case for mechanical testing to the worst case tested for that clearance." This indicates that for this physical device modification, previous mechanical testing from the predicate device (K142504) was considered sufficient.
• Conclusion: The device is substantially equivalent to the predicate (K142504) based on similar intended uses, indications, technological characteristics, and principles of operation, with modifications raising no new safety or effectiveness questions.

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The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

The SpineFrontier Ti-Coated Lumbar Interbody Fusion Device System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of titanium coated PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.

The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.

The provided document describes a 510(k) premarket notification for the SpineFrontier Lumbar Interbody Fusion Device System. This document is a regulatory submission for a medical device and, as such, does not contain information about the performance of an AI/ML powered device, nor does it include a study that proves a device meets acceptance criteria in the context of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics and non-clinical mechanical performance testing. The 'Performance Data' section lists various ASTM standards used for mechanical testing of the device and its coating, but these are related to the physical properties and durability of the implantable device, not the performance of an AI/ML algorithm.

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