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The Daytona Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Daytona Anterior Cervical Cage System is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. The Daytona Anterior Cervical Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Daytona Anterior Cervical Cage system was developed as an intracorporeal implant for anterior cervical spondylodesis. The Daytona Anterior Cervical Cage is a system of wedge shaped implants and instruments designed for anterior cervical interbody fusion (ACIF). To prevent migration, the Daytona Anterior Cervical Cage has teeth on its superior and inferior surfaces.

The provided document is a 510(k) summary for the Daytona Anterior Cervical Cage, a medical device. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.

However, the document explicitly states: "No clinical studies were performed."

Therefore, it is not possible to provide information about acceptance criteria and a study proving the device meets those criteria, as no such clinical study was conducted or reported in this document. The device's clearance was based on demonstrating substantial equivalence to already marketed devices through non-clinical (mechanical) testing.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria related to clinical performance are mentioned, as no clinical studies were performed. The non-clinical tests were conducted "per ASTM F2077 and ASTM F2267," which implies adherence to those standards, but specific pass/fail criteria or detailed performance results (beyond the statement that they were conducted) are not given for these tests.
2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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 device is an implant, not an AI diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth needed for this type of device submission.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) clearance for the Daytona Anterior Cervical Cage was based on demonstrating substantial equivalence to predicate devices through non-clinical bench testing, not clinical studies involving human patients or complex data analysis with AI.

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