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When used as a lumbar intervertebral body fusion device, the Zavation Ti 3Z Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation Ti 3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System.

The Zavation Ti 3Z Interbody implants offer a variety of heights, widths and lengths. There are five main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF. The different configurations allow for multiple surgical technique options. The implants are additively manufactured from medical grade Titanium Ti64ELI powder by way of laser sintering.

The Zavation Ti 3Z Interbody implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of the implants have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of each implant are printed simultaneously.

This is a 510(k) summary for a medical device called "Ti 3Z Interbody System". This document does not contain information about an AI/ML device or software. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI/ML device cannot be extracted from the provided text.

The document discusses the substantial equivalence of the Ti 3Z Interbody System to predicate devices based on mechanical test results and process validation.

Here's what the document does provide regarding performance data and equivalence for this medical device, which is not an AI/ML system:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a table with specific acceptance criteria and detailed performance results in the format requested for AI/ML. Instead, it states that "Mechanical test results demonstrated that the Zavation Ti 3Z Interbody System is substantially equivalent to the predicate devices." and lists the standards followed:

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device study. The "test set" would refer to physical devices tested, but specific quantities are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device study. Ground truth in this context would refer to material science and mechanical engineering standards.

4. Adjudication method: Not applicable as this is not an AI/ML device study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as this is not an AI/ML device study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device study.

7. The type of ground truth used: For mechanical tests, the "ground truth" is established by the specified ASTM and ISO standards for mechanical properties and biocompatibility.

8. The sample size for the training set: Not applicable as this is not an AI/ML device study.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device study.

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