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The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.

lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

The SPICCA Stand-Alone Cervical Fusion Cages are single-use, sterile, PEEK (ASTM F560) anterior cervical interbody fusion cages with integrated Ti-6Al-4V ELI (ASTM F136) screws that are intended to be implanted between two adjacent vertebral bodies as part of single or multilevel Anterior Cervical Discectory and Fusion (ACDF) procedures. The SPICCA Stand-Alone Cervical Fusion Cages which are offered in the SPICCA-SP version and SPICCA-S2 version are offered in a variety of sizes to accommodate various patient anatomies (Note: SPICCA-S2 differ in footprint options and endplate-contacting surface shape). The cages include Tantalum (ASTM F560) radiographic markers and are offered uncoated or coated with titanium plasma spray (ASTM F1580).

The provided text is a 510(k) premarket notification for a medical device called "SPICCA Stand-Alone Cervical Fusion Cages." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific acceptance criteria based on studies involving AI performance or human-in-the-loop assessments as typically seen in AI/ML medical device submissions.

Therefore, the information requested in the prompt, which is primarily applicable to an AI/ML enabled device, cannot be found or inferred from this document.

Specifically, this document does not contain:

• A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
• Details about sample sizes for test sets, data provenance, ground truth establishment methods (e.g., expert consensus, pathology, outcome data), or training set details.
• Information on experts used to establish ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, the performance data presented here refers to mechanical testing of the physical implant (e.g., Static & Dynamic Axial Compression, Subsidence), demonstrating its structural integrity and substantial equivalence to predicate devices in terms of mechanical strength for its intended use as an intervertebral fusion device.

In summary, this document describes a traditional medical device (implant) 510(k) submission, not an AI/ML-enabled device submission, and therefore does not contain the information requested about AI performance acceptance criteria and validation studies.

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