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When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.

When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine Spacer System is intended for use with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.

When used as an intervertebral body fusion device, the Vu ePOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in 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 level(s). The device is indicated for use with autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Vu e•POD Intervertebral Body Fusion Devices are intended for use with supplemental fixation.

Degenerative disc disease (DDD) is defined as back pain of discogenic origin 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.

When used as a vertebral body replacement (VBR) the Vu e•POD System is indicated for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture). The Vu e•POD VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Vu ePOD VBR System is intended for use with supplemental internal spinal fixation.

The SeaSpine Spacer System (Hollywood, Hollywood VI, Ventura, Pacifica), and Vu e-POD, are intervertebral fusion devices intended to promote spinal fusion by acting as a disc spacer and holding autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone. The implants have teeth on the superior and inferior surfaces and a central canal for receiving the autograft. The devices are available in a variety of shapes, lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All implants are manufactured from PEEK (per ASTM F2026) with radiographic markers manufactured from tantalum (per ASTM F560). The implants are offered either in all PEEK (ASTM F2026) or coated with commercially pure titanium (ASTM F67), NanoMetalene.

The NanoMetalene spacers are provided in gamma sterilized packaging, while the PEEK spacers are provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) premarket notification decision letter from the FDA regarding spinal intervertebral body fusion devices. It outlines the regulatory classification, intended use, and a summary of technological characteristics. Crucially, it explicitly states that "Clinical Testing" is "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide a table of acceptance criteria and reported device performance using this document, nor can I describe a study proving the device meets acceptance criteria. The document indicates that no clinical performance data or studies were required or used for this 510(k) clearance. The determination of substantial equivalence was based on non-clinical testing and comparison to predicate devices.

Here's why I cannot answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: No performance data from clinical studies are presented in this document. The FDA's determination is based on "substantial equivalence" to existing devices, not on meeting specific, de novo clinical performance criteria. The non-clinical testing mentioned (packaging, shipping, sterilization, bacterial endotoxin) relates to manufacturing and sterility assurance, not device efficacy or clinical performance.
2. Sample sizes used for the test set and the data provenance: No clinical test set data is provided or referenced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set data was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set data was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a medical device (spinal spacer), not an AI algorithm for image reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical test data was used for effectiveness.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

In summary, the provided FDA 510(k) letter explicitly states that clinical testing was "Not applicable" for the determination of substantial equivalence for these spinal spacer devices. Therefore, the information you are requesting regarding acceptance criteria and performance studies is not contained within this document, because such studies were not a prerequisite for this particular 510(k) clearance.

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