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The Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications:
• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
·Spondylolisthesis,
·Trauma (i.e., fracture or dislocation),
·Spinal Stenosis,
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
·Tumor,
·Pseudoarthrosis,
·and failed previous fusion.

The Admiral ACP System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Admiral plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Admiral ACP System implant components are made from titanium allov per ASTM F136. Associated instruments are available to facilitate the implantation of the device.

The provided text is a 510(k) summary for the Admiral ACP System, a spinal implant. It describes the device, its indications for use, and a summary of non-clinical testing. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria for software or AI-driven performance.

The document states:

• "The Admiral ACP System demonstrated equivalent performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717."
• "The submitted data demonstrate that the Admiral ACP System is substantially equivalent to the cited legally marketed predicate device."

This indicates that the "performance" referenced is mechanical performance of a physical implant (plates and screws), not the performance of an AI/software device. The regulatory submission (510(k)) is for a physical medical device, not a software as a medical device (SaMD) or an AI-powered diagnostic tool.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for an AI/software device.
2. Sample sizes used for the test set and the data provenance: Not applicable, as there's no AI/software performance test.
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: Not applicable.
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: 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.

The document focuses on demonstrating mechanical equivalence to a predicate device, which is typical for physical orthopedic implants.

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