Search Results

The EBI® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spinc during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, turners, deformity (defined as kyphosis, lordosis or scoliosis), pscudarthroses and/or failed previous fisions.

Not Found

The provided document describes the mechanical performance testing of the EBI® Anterior Cervical Plate System. It is a 510(k) premarket notification for a medical device rather than an AI/ML-driven diagnostic device, thus many of the requested criteria concerning AI/ML studies are not applicable.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not explicitly stated in the document. The document refers to "mechanical testing" but does not detail the number of units or tests performed.
• Data provenance: Not applicable. The testing is described as mechanical performance testing of the device itself, not human-derived data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study involved mechanical performance testing of a physical device, not an assessment requiring expert interpretation of medical data.

4. Adjudication method for the test set:

Not applicable, as it was a mechanical performance study, not an assessment requiring adjudication of human readings.

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 is not an AI/ML-driven device or study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an AI/ML-driven device. The "standalone" performance refers to the device's mechanical integrity as per its design specifications.

7. The type of ground truth used:

The ground truth or benchmark for evaluation was the "design specifications" and "requirements established in design specifications for its mechanical performance," which were based on predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/ML-driven device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context. The design specifications and requirements were established based on previously cleared predicate devices.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device