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The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical fusion 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),
• · pseudarthrosis.
• · failed previous fusion,
• · spinal stenosis.

The Quantum Anterior Cervical Plate is a titanium alloy plate, conforming to ASTM F3001, intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selfdrilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (08 mm - 110 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm. and 4.75 mm) and a variety of lengths (10 mm - 20 mm). Screws are made from titanium alloy per ASTM F136.

This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a medical device called the "Quantum Anterior Cervical Plate." It details the device's characteristics, intended use, and the rationale for its substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is NO information regarding Acceptance Criteria or any study testing AI/ML-driven device performance. This document pertains to a physical medical implant (a cervical plate) and its mechanical testing, not a diagnostic or prognostic AI/ML system.

Therefore, I cannot provide the requested information as it is not present in the provided text. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document does not describe.

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The Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic only with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (lordosis, kyphosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.

The Quantum Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine (C2-C7). Plates and screws are available in a variety of sizes to suit the individual pathology and unatomic condition of the patient. The device is manufactured from titanium alloy.

The provided text does not contain detailed acceptance criteria and the results of a study proving a device meets these criteria in the format requested.

The document is a 510(k) summary for the Quantum Anterior Cervical Plate System. It describes the device, its intended use, and states that substantial equivalence was shown to previously cleared devices. Under the "Performance Data" section, it only briefly mentions:

"Mechanical testing indicates that the Quantum Anterior Cervical Plate is capable of performing in accordance with its intended use."

This statement is very general and does not provide:

• Specific acceptance criteria: There are no quantifiable thresholds or targets mentioned for performance metrics.
• Detailed study results: There are no data tables, sample sizes, or methodologies of the mechanical testing.
• Information on ground truth, expert involvement, or comparative studies.

Therefore, I cannot populate the requested table or provide the detailed study information as the input text does not contain it. The document primarily focuses on establishing substantial equivalence to predicate devices, which often relies on comparison of design, materials, and intended use, rather than extensive new clinical or detailed standalone performance studies with specific statistical acceptance criteria.

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