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The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.

The FORTICO Anterior Cervical Fixation System is a cervical plating system that consists of a cervical plate that includes bone screw holes and blocking mechanisms to prevent screw back-out.

This document is a 510(k) submission summary for a medical device, the FORTICO Anterior Cervical Fixation System. It describes the device and its intended use, and argues for substantial equivalence to existing devices.

The document does not describe a study that uses acceptance criteria in the context of device performance related to a specific metric, such as sensitivity, specificity, or accuracy, which would typically be included in a software algorithm or diagnostic device submission. This submission focuses on the mechanical and physical performance of an orthopedic implant.

Therefore, the requested details regarding acceptance criteria for device performance based on metrics like sensitivity, specificity, sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not applicable to this type of device submission.

Here's a breakdown of what the document does provide in relation to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific numerical acceptance criteria for mechanical performance in the format of a typical diagnostic device. Instead, it states that testing was performed per ASTM F1717 and that the device is "as mechanically sound as similar devices which are legally marketed for sale in the United States."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each test, but standard ASTM F1717 testing involves a defined number of samples per test type.
• Data Provenance: The testing was performed by Camber Spine (the manufacturer) or a contracted lab. This is internal testing to support the 510(k) submission. It's prospective in the sense that the tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Mechanical testing does not involve establishing ground truth through expert consensus in the way a diagnostic algorithm would. The "ground truth" is established by the specified parameters and methodologies of the ASTM standard.

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

• Not applicable. Adjudication methods are for clinical interpretations, not mechanical testing.

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 a mechanical implant, not an AI or diagnostic device.

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

• Not applicable. This is a mechanical implant, not an algorithm.

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

• For mechanical testing, the "ground truth" is adherence to the specified test methodology and performance metrics outlined in the ASTM F1717 standard. It's based on engineering specifications rather than clinical interpretations or pathological findings.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of mechanical device submission.

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

• Not applicable for the same reason as above.

In summary, this document is a regulatory submission for an orthopedic implant. The "acceptance criteria" and "study" described relate to engineering and mechanical performance against recognized industry standards (ASTM F1717) to demonstrate substantial equivalence to predicate devices, rather than clinical performance metrics of a diagnostic or AI-driven device.

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