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The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile and sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.

The provided text is related to a 510(k) premarket notification for a medical device called the CODA™ Anterior Cervical Plate System. It details the regulatory review process, indications for use, and a comparison to a previously cleared predicate device.

However, the document does not contain information about acceptance criteria for a device, a study that proves the device meets specific performance criteria against those acceptance criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance. The document explicitly states: "Clinical data was not necessary for the determination of substantial equivalence." This means that rigorous performance studies involving clinical data or human-in-the-loop assessments as typically seen for AI/ML-based devices or diagnostics were not conducted or required for this submission.

The 510(k) submission for the CODA™ Anterior Cervical Plate System focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily addressing a change in the sterilization and packaging configuration ("to introduce sterile implants to the CODA™ Anterior Cervical Plate System"). The non-clinical testing mentioned was to show that this change "does not impact the safety or performance" compared to the predicate, rather than meeting specific performance metrics for a novel AI/ML application.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device performance using the provided text, as the necessary information is not present.

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The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion is skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes nonsterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.

This document is a 510(k) summary for the CODA™ Anterior Cervical Plate System. It describes the device, its intended use, and provides a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval based on demonstrating equivalence to an already marketed device, rather than detailed performance study results.

Ask a specific question about this device