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The Foundation™ 3D Interbody Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Foundation™ 3D Interbody Lumbar Cage 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 L2-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). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Foundation™ 3D Interbody Cervical Series Interbody System is an additively manufactured implant comprising of cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The cervical line has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to help optimize implant fit.

The Foundation™ 3D Interbody Lumbar Series Interbody System is an additively manufactured implant comprising of lumbar interbody spacers. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.

The Foundation™ 3D series of intervertebral body fusion devices are made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F-136 specifications.

This document is a marketing clearance (510(k)) for a medical device, specifically an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared devices based on mechanical and material testing, rather than clinical performance or AI algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for AI algorithms, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI training/testing cannot be extracted from this document. This document describes engineering performance tests, not clinical or AI performance studies.

Here's what can be extracted related to the device and its testing:

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

The document lists performance tests conducted, but does not provide specific numerical acceptance criteria or the quantitative results of these tests. It only states that the results "show that the strength of the Foundation™ 3D Interbody is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Regarding the other points, the document does not contain the required information:

• 2. Sample sized used for the test set and the data provenance: Not applicable for mechanical/material testing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 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: This is not an AI/software device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this refers to physical/mechanical properties, not diagnostic accuracy.
• 8. The sample size for the training set: Not applicable (no AI training involved).
• 9. How the ground truth for the training set was established: Not applicable (no AI training involved).

In summary, this document is a 510(k) clearance for a physical medical implant, not an AI-powered diagnostic device, and therefore does not contain information about AI acceptance criteria, clinical study designs for AI, or ground truth establishment for patient data. The "performance data" section refers to mechanical engineering tests demonstrating the device's physical strength and equivalence to predicate devices, not its diagnostic or clinical efficacy in a patient population aided by an algorithm.

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