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The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.

The Choice Spine Cervical Interbody Spacer System implants ("spacers") have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.

This looks like a 510(k) premarket notification for a medical device called the "Choice Spine Cervical Interbody Spacer System." This document type primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the way an AI/ML device submission would.

Therefore, the information you're asking for, such as acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training data, is not typically found in this kind of 510(k) summary for a traditional implantable device.

Here's why and what can be extracted from the provided text:

• Type of Device: The Choice Spine Cervical Interbody Spacer System is an implantable medical device (an intervertebral body fusion device made of PEEK and tantalum markers). It's a physical product, not a software algorithm or an AI/ML diagnostic tool.
• Regulatory Pathway: This device went through the 510(k) premarket notification pathway. The core requirement for this pathway is to demonstrate substantial equivalence to a legally marketed predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate.
• Focus of the Document: The 510(k) summary explicitly states: "Documentation was provided that demonstrates the Choice Spine Cervical Interbody Spacer System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, material, method of stabilization, and performance." This highlights that the "performance" demonstrated is in comparison to a predicate, not against a predefined set of acceptance criteria from a de novo clinical study in the way an AI/ML device would.

Therefore, I cannot populate the table or answer most of your detailed questions because the provided text does not contain a study that establishes acceptance criteria and then proves the device meets them in the context of an AI/ML or comparative effectiveness study.

If this were an AI/ML device, the 510(k) would include a much more extensive section on clinical performance, validation, and potentially an MRMC study.

What can be extracted from the document that might be tangentially related to some of your points:

• Intended Use/Indications for Use: These act as the fundamental "criteria" the device is designed to meet, defining its purpose and patient population.
• Materials: PEEK-OPTIMA polymer and tantalum.
• Mention of "Performance": The document mentions "performance" in the context of substantial equivalence to the predicate, implying that the device's mechanical and biological performance is considered comparable. However, no specific data or metrics are provided here.

In summary, for this specific 510(k) document, the requested information about acceptance criteria and a performance study in the context of AI/ML or a comparative effectiveness trial is not available because the device and its regulatory submission pathway are different.

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