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The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineNet SSP System. It confirms the device's clearance and substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML powered device.

The document primarily focuses on the mechanical testing of the implant device itself (spinal intervertebral body fixation orthosis), confirming its mechanical performance is substantially equivalent to predicate devices.

Therefore, it is not possible to complete the requested table or answer the questions related to AI/ML device performance and validation based on the provided text. The document refers to "Performance Data" which states: "Mechanical testing of the worst case SpineNet SSP System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. The mechanical test results demonstrate that the SpineNet SSP System device performance is substantially equivalent to the predicate devices." This clearly indicates a physical device, not a software or AI/ML product that would require the type of performance evaluation outlined in your request.

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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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