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The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.

The Osteonics" Halifax " Plus Interlaminar Clamp System consists of three sizes (C1, 7mm, and 13mm) of threaded and matching unthreaded clamps made from titanium alloy. The system also features three lengths (10, 20, and 30 mm) of associated threaded screws made from commercially pure titanium and used to secure the aforementioned sets of matching threaded and unthreaded clamps.

This document is a 510(k) summary for a medical device called the "Osteonics Halifax Plus Interlaminar Clamp System." It is a submission to the FDA to demonstrate substantial equivalence to a previously approved device. As such, it does not contain the information you requested regarding acceptance criteria and a study proving device performance as would be found in a clinical trial report or a performance validation study for an AI/CADe device.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The Osteonics Halifax Plus Interlaminar Clamp System is a physical medical device (spinal fixation components), not a diagnostic algorithm or AI software.
• Regulatory Pathway: The 510(k) pathway for physical devices primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical performance studies against specific acceptance criteria for a novel algorithm.
• "Performance Data" Section: The document explicitly states: "As the components of the Osteonics Halifax Plus Interlaminar Clamp System remain identical to those of the previously marketed, predicate AME Halifax Plus Interlaminar Clamp System, which has been determined substantially equivalent via 510(k) Premarket Notification #K850039, no additional performance data is deemed necessary." This means no new performance studies were conducted for this particular submission.

Therefore, I cannot provide a table of acceptance criteria, details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission does not contain that kind of data or evaluation.

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