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Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level 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 at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Elite™ Expandable Interbody Fusion System is designed for use as a lumbar intervertebral body fusion device and consists of medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. Components of the Elite™ IBF Expandable Lumbar Fusion System should not be used with components of any other system or manufacturer.

This document does not contain information about acceptance criteria, device performance metrics, or a study specifically designed to establish acceptance criteria for the Elite™ Expandable Interbody Fusion Device.

The document is an FDA 510(k) clearance letter and a 510(k) summary for the Elite™ Expandable Interbody Fusion Device. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving that the device meets specific performance acceptance criteria through a clinical study or detailed non-clinical performance report.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document lists mechanical tests performed (ASTM F2077, F2267) and bacterial endotoxin testing, but it does not specify quantitative acceptance criteria for these tests nor does it report specific numeric results against those criteria. It only states that these tests were "conducted in accordance with FDA's Class II Special Controls Guidance Document... and applicable American Society for Testing and Materials (ASTM) standards." This implies the tests were performed to demonstrate mechanical integrity and biocompatibility, but the specific performance values and acceptable ranges are not disclosed.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable as no specific clinical or performance test set (in the context of real-world patient data or detailed device performance metrics) is described in terms of a sample size. The "test set" here refers to the physical devices subjected to mechanical testing.
• Data Provenance: The document refers to non-clinical mechanical testing and bacterial endotoxin testing. This is laboratory-based testing, not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The document describes mechanical and biocompatibility testing of the device, not a study evaluating human interpretation or diagnosis. Therefore, there's no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method:

Not applicable. There's no adjudication method mentioned as this document does not describe a study involving expert review or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size:

No. An MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance, which is not relevant to this mechanical device submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical intervertebral body fusion device, not an algorithm or AI software. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. Type of Ground Truth Used:

Not applicable in the context of diagnostic or interpretive performance. For the mechanical and biocompatibility testing, the "ground truth" would be established by the physical properties of the materials and the manufacturing process, verified by standardized laboratory tests.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as point 8.

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