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When used as a vertebral body replacement: The Octane™ device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral book due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spiral oord ard neural tissues, and to restore the height of a collapsed vertebral body. The Schnal Corner Tor device 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 Octane™ device may be used with allograft or autograft.

When used as an intervertebral body fusion device: The Octane™ device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The Octane™ device is intended to be used with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

Like the predicate Octane™ Vertebral Body Replacement System, or Octane™ VBR System, the Octane™ device that is the subject of this "Special" 510(k) submission is an implant composed of pure Poly(Etheretherketone), or PEEK OPTIMA®, Grade LT1, When used as a vertebral body replacement, the device is intended to serve as a partial or total replacement of a vertebral body that is collapsed, damaged, or unstable as a result of tumor or trauma (i.e., fracture). When used as an intervertebral body fusion device, the device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). As a vertebral body replacement, the device is intended for use with allograft or autograft, and as an intervertebral body fusion device, it is intended for use with autogenous bone graft.

Octane™ implants are available in a range of sizes and shapes, to accommodate different surgical approaches and anatomical needs, and may be implanted by cither conventional surgical methods, or via minimally-invasive techniques.

The provided document is a 510(k) PreMarket Notification for a medical device (Octane™ Vertebral Body Implant System) and primarily describes the device, its intended use, and its substantial equivalence to a predicate device. It explicitly states: "No clinical testing was conducted to support this submission."

Therefore, based on the provided text, I cannot answer the questions related to acceptance criteria and the study proving the device meets them, as no such study is described.

Summary of what can be extracted based on the prompt's questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "all acceptance criteria were met" for non-clinical tests but does not specify the criteria or detailed performance.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method for the test set: Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. "No clinical testing was conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant device, not an AI algorithm.
7. The type of ground truth used: Not applicable. No clinical test data or AI algorithm.
8. The sample size for the training set: Not applicable. No AI algorithm.
9. How the ground truth for the training set was established: Not applicable. No AI algorithm.

Additional Information (from the document):

• Non-Clinical Tests: "Such verification and validation tests as were identified as appropriate to address the results of a risk analysis for the subject Product Line Extension to the Octane™ VBR System were completed, and all acceptance criteria were met." However, no details on these tests or criteria are provided.
• Substantial Equivalence: The submission relies on demonstrating substantial equivalence to a predicate device (Octane™ Vertebral Body Replacement System - K070218) through rigorous design control processes and comprehensive risk analysis, rather than new clinical data.

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