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When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the ORIA Natura Spacer is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

The ORIA Natura has a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet-shaped anterior surface. It is available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements.

This 510(k) summary describes a spinal implant device (ORIA Natura Spacer), not an AI/ML powered device, therefore the information requested in the prompt is not applicable. The provided text is a standard regulatory submission for a medical device and does not contain details about acceptance criteria, device performance metrics, or study designs related to AI model validation.

Here's why each point below cannot be addressed from the given text:

• 1. A table of acceptance criteria and the reported device performance: This information is related to the performance of an AI/ML algorithm against defined metrics, which is not present in the given text. The document refers to "substantial equivalence" to predicate devices, which is a regulatory pathway for non-AI devices based on similar features and intended use.
• 2. Sample sized used for the test set and the data provenance: Not applicable for this type of device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document focuses on the physical characteristics, intended use, and materials of the ORIA Natura Spacer, and its substantial equivalence to other legally marketed predicate devices, as required for a 510(k) submission for a traditional medical device like a spinal implant.

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