(69 days)
The NeuroVision System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.
The NeuroVision JJB System consists of a Patient Module, a Control Unit comprised of an embedded computer with touch screen controls and an interface card, and an assortment of disposable and reusable conductive probes, electrodes, and electrode leads.
The provided document, K072343, is a 510(k) summary for the NuVasive NeuroVision JJB System. It states that "Summary of Non-Clinical Tests (Not Applicable)" and "Summary of Clinical Tests (Not Applicable)".
Therefore, based on the provided document, the following questions cannot be answered as no acceptance criteria or study data are presented:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).