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The NuVasive ACP4 System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive ACP4 System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The NuVasive ACP4 System consists of a variety of plates, screws, and screw-retaining covers designed to provide stabilization as an adjunct to cervical fusion.

The provided document is a 510(k) Summary for the NuVasive ACP4 System, a cervical plate and screw system. This document focuses on demonstrating the substantial equivalence of the device to a predicate device through mechanical testing and comparison of indications for use. It explicitly states that clinical tests are "Not Applicable."

Therefore, based on the provided document, the following information regarding acceptance criteria and a study proving the device meets those criteria is not available or not relevant to the type of submission:

1. Table of acceptance criteria and the reported device performance: Not available. This document pertains to mechanical testing (summary only) and equivalence to a predicate device. Performance criteria for clinical use with specific metrics (e.g., sensitivity, specificity, accuracy) are not included.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study with a test set is described. The document mentions "Mechanical testing was presented," but details of this testing (sample sizes, specific methods, results) are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study with a test set is described.
4. Adjudication method for the test set: Not applicable as no clinical study with a test set is described.
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 a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical study with a test set is described.
8. The sample size for the training set: Not applicable as no AI/algorithm training is described for this device.
9. How the ground truth for the training set was established: Not applicable as no AI/algorithm training is described for this device.

Summary of what is available from the document:

• Device Type: Cervical plate and screw system for anterior screw fixation of the cervical spine.
• Study Type: The submission relies on mechanical testing (details not provided in this summary) and a comparison of indications for use to a predicate device (SmartPlate Gradient Plus System by NuVasive) to demonstrate substantial equivalence.
• Clinical Tests: Explicitly stated as "(Not Applicable)" in section H.

Therefore, the provided document does not contain the specific information requested about acceptance criteria and clinical study performance in the context of an AI/diagnostic device. It is a 510(k) summary for a physical medical device (implant) where substantial equivalence is typically established through non-clinical (e.g., mechanical) testing and comparison of design and indications to a legally marketed predicate.

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