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The Choice Spine Anterior Cervical Plate (ACP) System is intended for anterior screw fixation of the cervical spine (levels C2 to C7) and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include: failed previous fusion, pseudoarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis, or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

The Choice Spine Anterior Cervical Plate (ACP) System is an anterior cervical spinal fixation system consisting of plates and screws. The plates are available in multiple lengths to accommodate single or multi-level surgeries and different anatomies.

The provided text is related to a 510(k) premarket notification for a medical device called the "Choice Spine Anterior Cervical Plate (ACP) System." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications, materials, and performance, rather than presenting a study proving a device meets specific performance acceptance criteria with numerical outcomes.

Therefore, many of the requested elements (like sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance, and detailed acceptance criteria tables) are not present in the provided text.

Here's an analysis based on the information available:

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

The document does not specify quantitative acceptance criteria or detailed reported device performance in the context of a clinical or analytical study. Instead, it states that "Documentation was provided that demonstrates the Choice Spine ACP System to be substantially equivalent to a previously cleared device. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, primary material of manufacture, and performance." This implies that the device's performance was deemed equivalent to the predicate, likely through design specifications, material testing, and potentially bench testing, but no specific performance metrics or acceptance thresholds are numerically reported.

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

Not applicable. The document describes a regulatory submission for substantial equivalence, not a clinical or analytical study with a test set of data.

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 in the context of a diagnostic or AI device is discussed.

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. An AI component is not mentioned, and no MRMC study is described.

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

Not applicable. This is a spinal implant, not a diagnostic or AI algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (an anterior cervical plate system) seeking market clearance based on substantial equivalence to a predicate device. It does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert involvement, ground truth, MRMC studies) that would be relevant for a diagnostic device or AI algorithm.

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