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The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

• · spondylolisthesis,
• · trauma (i.e. fractures or dislocations),
• tumors,
• · deformity (defined as kyphosis, lordosis, or scoliosis),
• · pseudoarthrosis.
• · failed previous fusion,
• · spinal stenosis.

The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.

This document describes the premarket notification for the CastleLoc-P Anterior Cervical Plate System. It is a Special 510(k) submission to add new components to an already cleared device (K143271). Therefore, the provided information does not contain the typical details about acceptance criteria and comprehensive study results for an AI/ML medical device. In this case, the acceptance criteria are based on mechanical performance equivalence to a previously cleared device.

Based on the provided text, here's an analysis of the acceptance criteria and the "study" (mechanical performance testing) proving the device meets them:

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

• Static compression
• Static torsion
• Static tension
• Fatigue strength. | Demonstrated by Substitution: "Mechanical performance of additional components are the same with the legally marketed device (unmodified) CastleLoc-P Anterior Cervical Plate System (K143271). Therefore, we substitute mechanical test data of additional components of CastleLoc-P Anterior Cervical Plate System with the one of unmodified device (K143271)."
  The original tests were conducted according to ASTM F1717. |
  | Overall Equivalence: As safe, as effective, and performs as well as the predicate device. | Conclusion Stated: "The additional components of CastleLoc-P Anterior Cervical Plate System are as safe, as effective and perform as well as the predicate device. Therefore, the additional components of CastleLoc-P Anterior Cervical Plate System are substantially equivalent to the predicate device (K143271)." |

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

• Sample Size: Not explicitly stated as a number of devices or units. The "test set" here refers to the mechanical testing performed on the original cleared device (K143271). The submission substitutes this existing data for the new components. For mechanical testing of medical devices, specific sample sizes are typically defined by the relevant ASTM standards (e.g., ASTM F1717).
• Data Provenance: Not explicitly stated through location or retrospective/prospective. The data is from mechanical testing of the primary predicate device (K143271).

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):

• This is not applicable for this type of submission. This device is a mechanical implant, not an AI/ML diagnostic tool. Ground truth is established through engineering and biomechanical testing standards (ASTM F1717), not expert interpretation of medical images.

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

• Not applicable. See point 3.

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/ML device, so no human reader studies were performed.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" for this device's performance is defined by biomechanical engineering standards (ASTM F1717), which establish the minimum mechanical properties (strength, fatigue life, etc.) required for such an implant. Compliance with these standards is the "truth" that determines acceptable performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. See point 8.

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