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The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The MOJAVE Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for bone ingrowth and engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F1472, ASTM F136, ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in a variety of heights to accommodate anatomical variations.

This is a 510(k) summary for a medical device called the "MOJAVE Expandable Interbody System," which is an implant used in spinal fusion surgery. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study against specific acceptance criteria for performance metrics.

Therefore, many of the requested details, such as acceptance criteria table with device performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, are not present in this summary. These types of studies are typically not required for 510(k) submissions focusing on substantial equivalence for orthopedic implants.

Here's what can be inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly provided as a table with specific performance metrics and acceptance criteria. The "Non-clinical Performance Evaluation" section vaguely describes the types of tests performed.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "worst case MOJAVE Expandable Interbody System implants" for mechanical testing and "simulated use (cadaver) testing." The number of cadavers or implants tested is not provided.
• Data Provenance: The mechanical and simulated use testing would be laboratory/pre-clinical data, not human patient data. No country of origin is mentioned for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests performed are mechanical and simulated use, not those requiring expert interpretation of patient data for ground truth.

4. Adjudication method for the test set:

Not applicable.

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 device is an implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is an implant, not an algorithm.

7. The type of ground truth used:

• For mechanical testing: Engineering specifications and measurements of force, torque, displacement, and cycles.
• For bacterial endotoxin testing: Laboratory measurement of LAL activity against established endotoxin limits.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

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