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

The NuVasive HELIX ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.

This document describes the NuVasive HELIX ACP System, a cervical plate and screw system. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study that proves the device meets them based on the provided input.

Here's a breakdown of why I cannot answer each point from the input:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample sized used for the test set and the data provenance: Not provided in the text. The document mentions "Mechanical testing was presented" but doesn't detail the test set size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set with ground truth is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as a clinical test set is not 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 is a medical device (spinal implant), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (spinal implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as a clinical test set with ground truth is not described.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/algorithm-based device.

The document explicitly states under "H. Summary of Clinical Tests": "(Not Applicable)". This confirms that no clinical studies (which would typically involve ground truth, test sets, and performance criteria for a diagnostic/AI device) were part of this 510(k) submission for the NuVasive HELIX ACP System. The basis for clearance was "substantial equivalence" to a predicate device and mechanical testing (details of which are not provided here).

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