(98 days)
The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).
Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.
The listed modalities do include overlap in functionality. In general. Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.
The Natus VikingQuest is intended to be used by a qualified healthcare provider.
The Natus VikingQuest is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.
The provided text describes the 510(k) premarket notification for the Natus VikingQuest, a diagnostic electromyograph. The information focuses on its substantial equivalence to predicate devices and adherence to various medical device standards. However, it does not contain specific details about acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test sets, data provenance, ground truth establishment, or clinical study designs (like MRMC or standalone performance).
The document primarily outlines the regulatory compliance, technological characteristics, and intended use of the device, rather than detailed clinical performance evaluations against specific acceptance criteria.
Therefore, for aspects related to acceptance criteria and a study proving device performance, the information is largely absent in the provided text.
Here's what can be extracted based on your request, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Accessories with patient contact materials must be made from medical grade biocompatible materials in accordance with ISO 10993-1: 2009. | Appropriate component materials for accessories were previously verified to be biocompatible in accordance with ISO 10993-1: 2009. |
| Software Compliance | Software designed and developed according to a robust software development process, verified and validated consistent with FDA guidance documents and standards (e.g., "The content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation," "Content of premarket submissions for management of cybersecurity in medical devices," IEC 62304: 2006+A1:2015). | Results indicate that the Natus VikingQuest software complies with its predetermined specifications, applicable guidance documents, and applicable standards. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1: 2005/(R)2012, A1: 2012. | Results indicate that the Natus VikingQuest complies with the applicable standards. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2014. | Results indicate that the Natus VikingQuest complies with the applicable standards. |
| Usability & Safety of EMG/Evoked Response Equipment | Compliance with IEC 60601-1-6: 2013, IEC 60601-2-40: 2016, and IEC 62366-1: 2015. | Results indicate that the Natus VikingQuest complies with its predetermined specifications and the applicable standards. |
| Clinical Performance (Accuracy/Effectiveness for diagnosis/monitoring) | Not specified in the provided text. | Not specified in the provided text. The document states "Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications... The results... demonstrate that the Natus VikingQuest is as safe, as effective, and performs as well as or better than the predicate devices." This is a general statement of equivalence, not a detailed performance report. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified. The document describes engineering and regulatory compliance testing rather than clinical study data.
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 test set or ground truth establishment by experts for performance against a diagnosis is described. The "ground truth" mentioned pertains to compliance with engineering and safety standards.
4. Adjudication method for the test set:
- Not applicable as no human adjudication of clinical results 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:
- No mention of an MRMC study or AI assistance. The Natus VikingQuest is a diagnostic electromyograph for acquiring, displaying, analyzing, and reporting electrophysiological information, not an AI-driven interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes a medical device (electromyograph) for use by a qualified healthcare provider. It does not describe a standalone algorithm or AI performance. The performance verified is for the entire device as a system.
7. The type of ground truth used:
- For the regulatory and engineering tests (biocompatibility, software, electrical safety, EMC, usability), the "ground truth" is compliance with established international standards (ISO, IEC, AAMI/ANSI) and FDA guidance documents. There is no mention of pathology, expert consensus on clinical findings, or outcomes data in the context of the device's diagnostic accuracy proving.
8. The sample size for the training set:
- Not applicable. The document describes a medical device, not an AI/machine learning algorithm with distinct training and test sets in the typical sense. Software development was "rigorously verified and validated consistent with FDA guidance documents and standards," implying traditional software testing, not machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable, for the same reasons as point 8.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).