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The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space for the treatment of cervical degenerative disc discogenic pain with degeneration ofthe disc confirmed by history and radiographic studies) using autograft bone.

Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.

The Arcadius X C spinal system is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy procedures. The system consists of a PEEK cage and two bone screws. The PEEK cages are manufactured from a radiolucent material medical grade LT1 polyetheretherketone (PEEK) per ASTM F2026, with a titanium layer and a vacuum titanium plasma spray coating (PlasmaporeXP). The Arcadius N C implants are offered in various heights and geometrical options to fit the anatomical needs of a wide variety of patients. The Arcadius C implant is available in two footprints. The wide central opening holds optimal graft material. The screws are 4mm in diameter and offered in three lengths. The fixation screws and radiographic markers are manufactured of titanium alloy, (Ti6Al4V) according to ISO 5832/3.

The provided text is a 510(k) Summary for the Arcadius C Spinal System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing. It does not contain information about studies involving human readers, AI assistance, or the establishment of ground truth for a test set in the context of diagnostic or interpretive tasks.

Therefore, many of the requested items cannot be extracted from this document.

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

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

The document states that the Arcadius C Spinal System "meets or exceeds the performance of the predicate devices" for various tests. However, it does not provide specific acceptance criteria (e.g., minimum load values, maximum wear rates) or detailed reported device performance values for these tests. It only lists the types of tests performed.

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 describes non-clinical (mechanical) testing of a medical implant, not a study involving a test set of data (like images or patient records) for an AI device.

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. Ground truth for non-clinical mechanical testing is established by measurement instruments and scientific standards, not human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

Not applicable. This is not an AI or diagnostic 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)

For the non-clinical performance data, the "ground truth" is based on established ASTM standards and methodologies for mechanical testing of implants, utilizing precise measurement devices and engineering principles.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable.

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