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The DicaTM Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The KEYSTONE Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1 whose condition requires use of interbody fusion combined with supplemental fixation. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the KEYSTONE Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implanted via a minimally invasive lateral approach.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Shanghai Sanyou Cage System (K163422) consists of four different models of fusion devices -- Caro™ Cervical Cage System, Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System – that are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. These previously cleared devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft material.

Additionally, the KEYSTONE Cage System (K211689) consists of lumbar intervertebral body fusion devices (IBDs), provided in parallel or lordotic options with varying footprints to accommodate patient anatomy. The subject KEYSTONE cages (IBDs) contain serrations across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates to provide expulsion resistance. These previously devices are manufactured from medical grade polyetheretherketone (PEEK) material per ASTM F2026 and contain radiopaque tantalum pin markers per ASTM F560 for imaging purposes. Implants are to be inserted via a crenel-lateral (CLIF) approach.

The subject submission seeks to add additively manufactured versions of all families in the Shanghai Sanyou Cage System, except the Caro™ Cervical Cage System, along with the KEYSTONE cages. The subject cages are similar to the previously cleared devices above with the exception that they are additively manufactured from titanium alloy (Ti6Al4V ELI) per ASTM F3001 and the finished product conforms to ASTM F2924. The subject additively manufactured implants (also referred to as "metal additive manufacturing cages" or "MAM") are provided sterile via gamma irradiation. The additively manufactured cages will also be offered in an extended size range.

The provided document is a 510(k) premarket notification decision letter and related information for intervertebral body fusion devices. It describes the devices, their indications for use, and a summary of the testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain specific acceptance criteria for a device's performance (e.g., a software algorithm or diagnostic tool) or a comparative study proving an AI device's performance. The performance testing mentioned (static/dynamic axial compression, static shear compression, and subsidence testing) are mechanical tests for the physical interbody fusion cages, not for an AI or software-based device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, or MRMC studies, as these concepts are not applicable to the physical intervertebral body fusion devices described in this document.

The document pertains to the clearance of physical medical devices (interbody fusion cages), not an AI or software device.

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