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The EL CAPITAN Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors, the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the Lumbar spine.

The EL CAPITAN Anterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis)

This document is a 510(k) summary for the EL CAPITAN Anterior Lumbar Interbody System, a medical device for spinal fusion. This device is not an AI/ML-enabled device, and therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable.

The document explicitly states: "No clinical studies were performed." This indicates that the device's substantial equivalence to predicate devices was based on non-clinical tests (mechanical and material properties), rather than clinical performance data. Therefore, there are no acceptance criteria related to AI/ML performance metrics, nor any studies proving such performance.

The non-clinical tests conducted establish the device's mechanical safety and performance, demonstrating equivalence to predicate devices. The acceptance criteria for these non-clinical tests would be the established ASTM standards mentioned (e.g., ASTM F2077, ASTM F1717, ASTM F2267).

To summarize why the specific points of your request cannot be answered from this document:

• Acceptance Criteria & Reported Device Performance (Table): Not applicable for AI/ML performance. The device's performance is shown through compliance with mechanical testing standards.
• Sample sizes & Data Provenance (Test/Training Sets): Not applicable as there is no AI/ML component. Mechanical tests have their own sample size requirements per ASTM standards.
• Number of experts & Qualifications: Not applicable as there is no AI/ML component and no clinical studies were performed requiring expert reading.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of ground truth: Not applicable for AI/ML. The "ground truth" for this device's safety and efficacy is derived from its mechanical properties, material biocompatibility, and demonstrated equivalence to previously cleared predicate devices through non-clinical testing.
• Sample size for training set & How ground truth established: Not applicable.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

1. Intended Use
2. Design
3. Materials Used (PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy, Nitinol)
4. Mechanical Safety and Performance (Non-clinical tests: Static/Dynamic Compression, Static/Dynamic Compression Shear, Subsidence, Expulsion per ASTM standards).

Therefore, this document does not contain the information required to answer your prompt, as it pertains to a traditional medical device, not an AI/ML-enabled one.

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