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The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Description

The Comet Anterior Cervical Plate System consists of an anterior cervical plate offered in lengths ranging from 10mm through 22mm. Four (4) barbed plate fixation pins are permanently affixed to the plate. A set of two (2) plate fixation screws are used to secure the plate to the superior and inferior vertebrae. Plate fixation screws are offered in two (2) diameters, each in 14mm, 16mm lengths.

AI/ML Overview

The provided text describes a medical device, the Comet Anterior Cervical Plate System, and its clearance through the 510(k) process. This process is for demonstrating substantial equivalence to a predicate device, not for proving independent efficacy or safety through clinical trials in the way an AI/ML device would. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Comet Anterior Cervical Plate System were based on demonstrating substantial equivalence to a predicate device (Synthes Anterior Cervical Plate System) and meeting pre-determined criteria through bench testing.

Acceptance Criteria Category	Reported Device Performance (Comet Anterior Cervical Plate System)
Substantial Equivalence	Demonstrated substantial equivalence to the Synthes Anterior Cervical Plate System (K926453).
Risk Assessment	Risks associated with use were found acceptable when evaluated by Failure Mode and Effects Analysis (FMEA).
Bench Testing (General)	Met pre-determined acceptance criteria based on performance data.
Bench Testing (Specific)	Performed in accordance with FDA's May 2004 Guidance for Industry and Staff Spinal System 510(k)s and ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Assessed static and dynamic axial compression bending and static torsion.
Biocompatibility	No biocompatibility testing was conducted; all materials used have been previously cleared for similar devices.

The study that "proves" the device meets the acceptance criteria is the Performance Testing described, which consisted of bench tests.

Specific Information Requested - Not Applicable for this Device Type:

The following requested information is not applicable to this 510(k) submission for a physical medical implant device. These questions are typically relevant for AI/Machine Learning (AI/ML) powered devices or diagnostic tools that involve analyzing data sets with ground truth established by experts.

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

Explanation:

The Comet Anterior Cervical Plate System is a physical medical implant. Its clearance relies on demonstrating that its design, materials, and mechanical properties are comparable to an already legally marketed device (predicate device) and that it meets specific engineering performance standards via bench testing (laboratory tests, not clinical studies involving human patients or complex data analysis by AI). There is no "test set" of patient data, "ground truth" derived from expert consensus on images, or AI algorithms to train in this context.

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