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The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels int he lumbar spine, from L2 to S1, for the treatment of degenerative dise disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.

The provided text appears to be a 510(k) summary for a medical device called the "Reliance Lumbar IBF System." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the way a diagnostic AI model might.

Therefore, much of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document as it describes a structural intervertebral body fusion device, not a diagnostic algorithm.

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing (mechanical and material properties) and comparison to predicate devices, rather than clinical efficacy involving human readers or AI.

Here's an attempt to answer the applicable questions based on the provided text:

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

This information is not presented in a table format in the document, nor are there explicit "acceptance criteria" for clinical performance in the sense of accuracy, sensitivity, or specificity for a diagnostic device. The document states that the "design verification testing results were equivalent to the identified predicate device" and "results show that the subject implants do not create a new worst case condition for mechanical testing, performance testing, sterilization, biocompatibility, cleaning or packaging."

The non-clinical testing involved various ASTM Standard tests and Finite Element Analysis (FEA).
The acceptance criterion for the FEA was that the new components "are not the new worst case when compared to the approved Reliance Lumbar IBF component."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is an implantable medical device, and the testing described is non-clinical (mechanical, material, and sterilization). There are no "test sets" of patient data in the context of an AI or diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a diagnostic device requiring expert interpretation of results. The "ground truth" for non-clinical testing would be the physical properties and performance metrics measured according to established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" or adjudication method in the context of clinical interpretation for this device.

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 not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" would be established by:

• ASTM Standard Tests: Results measured according to specific, recognized engineering standards for material strength, fatigue, etc.
• Predicate Device Performance: The established mechanical and performance characteristics of the legally marketed predicate devices (K113540, K160463 & K173283).

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device and testing.

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

Not applicable.

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