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The Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
5. Pseudoarthrosis
6. Revision of previous surgery

The Elegance® Anterior Cervical plate is designed for use as a cervical plate system. The device has a shape which restores the intervertebral height and lordosis. The Elegance® Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw's holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are self-drilling or self-tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance® plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy.

The provided document is a 510(k) summary for the Clariance Elegance® Anterior Cervical plate, which is a medical device for spinal fixation. This document does NOT describe the acceptance criteria and study for a software device or an AI/ML device. Therefore, it does not contain the specific information requested in the prompt about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Instead, the document details the non-clinical performance testing conducted for a physical medical device. Here's a breakdown of what the document does provide, aligning with the spirit of the request but recognizing the device type:

1. Table of Acceptance Criteria and Reported Device Performance

The detailed numerical results for these tests, which would constitute the specific "reported device performance" and the "acceptance criteria" (e.g., minimum load, maximum displacement) set by the ASTM F1717 standard, are not explicitly provided in this summary document. The summary only states that the results demonstrate substantial equivalence to the predicate device.

Remaining Information (Not applicable for this type of device/document):

Since this is a physical medical device (spinal plate) and not a software/AI device, the following points are not addressed in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable. Tests are typically on physical prototypes, not "test sets" of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and material science testing, often against established standards.
4. Adjudication method: Not applicable. Material tests follow standardized protocols.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This pertains to AI/software evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI/software evaluation.
7. The type of ground truth used: For a physical device, the "ground truth" would be the measured physical properties and performance characteristics against established engineering standards (like ASTM F1717).
8. The sample size for the training set: Not applicable. This pertains to AI/software development.
9. How the ground truth for the training set was established: Not applicable. This pertains to AI/software development.

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