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The Paramount® Anterior Cervical Cage System 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 from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. Paramount® Anterior Cervical Cage System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.

The Paramount® Anterior Cervical Cage System consists of a selection of sterile, single use cervical interbody cages indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. The Paramount® Anterior Cervical Cage System cages are multi-component devices comprised of a cage body, anchor plate and graft containment plate. Spine Wave supplies the cage body and anchor plate as a paired combination, and the surgeon assembles the graft cap in situ. The Paramount® Anterior Cervical Cage system cages are offered in a variety of sizes and shapes to accommodate different patient anatomies and manufactured from titanium alloy (Ti-6Al-4V per ASTM F136), commercially pure titanium (ASTM F67) and PEEK-OPTIMA with 6% BaSO4. Using the Paramount® Anterior Cervical Cage Inserter, the surgeon places the cage body with undeployed anchor plate into the disc space. After placement, the surgeon uses the cage inserter to deploy the superior and inferior portions of the anchor plate into the adjacent vertebral bodies and pack the open end of the cage with autograft. Once grafting is complete, the surgeon snaps the graft cap into the open end of the cage.

The provided text describes a 510(k) premarket notification for a medical device called the "Paramount® Anterior Cervical Cage System." This submission is primarily to offer the implant as a sterile-packed option. There is no study described that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. The document focuses on demonstrating substantial equivalence to a predicate device and validating the sterilization process, biocompatibility, and shelf life of the sterile-packed product.

Therefore, many of the requested items regarding acceptance criteria and performance studies for diagnostic or clinical effectiveness cannot be answered from this document.

Here's a breakdown of what can be extracted and what cannot:

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

No specific clinical acceptance criteria or reported clinical performance is described in this document. The "performance testing" section refers to validation of sterilization, biocompatibility, and shelf life, not clinical outcomes.

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

Not applicable. This document does not describe a clinical performance study with a test set of patients or data. The "testing" mentioned is for product characteristics (sterilization, biocompatibility, etc.).

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. No ground truth establishment for a test set is described as this is not a clinical performance study.

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

Not applicable. No adjudication method is described.

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 is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This is a physical intervertebral cage, not an algorithm.

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

Not applicable. No ground truth for clinical performance is mentioned.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable.

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