(82 days)
The Neurovision Nerve Locator/Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surqical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment.
The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.
The EMGView Software is a Windows PC operating system software dedicated to viewing and documentation of the output of the Neurovision (Nerveäna) Nerve Locator/Monitor. The software is dedicated to the EMG device by a serial USB connection. The EMGView software is a read-only device and is thus incapable of modifying or controlling the Nerveäna Device.
The provided text describes the EMGView Software, an accessory to the Neurovision Nerve Locator/Monitor. It focuses on the software's safety and efficacy as part of a 510(k) submission.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
|---|---|
| Primary Requirement: The EMGView software must not adversely affect the performance of the Nerveäna device. | "The EMGView software, being a read-only device accessory, does not affect the performance of the Nerveäna device." |
| Safety and Efficacy: The Nervous device with EMGView software is as safe and effective as the Nerveäna device alone in locating and monitoring motor nerves during surgery. | The text claims this equivalence is met because: |
- "The EMGView software, being a read-only device accessory, does not affect the performance of the Nerveäna device."
- "No surgeon input is required for operation of the Nerveäna accessory."
- "The EMGView software provides additional troubleshooting tools for the surgeon to verify proper Nerveäna operation and electrode position."
- "The Database Feature of the Nerveäna provides focus by the surgeon on the issue of proper nerve location and preservation as well as providing postoperative review data that would otherwise be unobtainable in answering any questions about the relationship of nerve monitoring to the surgical outcome." |
| Clinical Use Conformance: The software's clinical use conforms to user needs. | "The software was validated by confirming that its clinical use conforms to user needs." |
| Requirements Verification: EMGView Software requirements were verified. | "The EMGView Software (v4.31, current version) requirements were verified using the Nerveana bench testing performance as a baseline." |
Study Information:
The provided document describes a validation process rather than a detailed clinical study with specific statistical endpoints. The primary argument for safety and efficacy relies on the software being a "read-only device accessory" that does not interfere with the core function of the predicate device (Nerveäna Nerve Locator/Monitor).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for a test set. The validation appears to be based on "bench testing performance" and "clinical use conformance" rather than a formal test set of patient data.
- Data Provenance: Not applicable, as human patient data for a test set is not mentioned. The validation involves "bench testing performance" of the Nerveäna device as a baseline.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. The "ground truth" for the software's performance is tied to the baseline performance of the predicate device (Nerveäna) through bench testing.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there is no mention of a formal test set with expert ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in this document. The focus is on the software being an accessory that doesn't alter the core device's performance, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The EMGView software itself is a standalone software component in terms of its digital functions (displaying data, troubleshooting, digital backup, database). However, its "performance" is evaluated as an accessory to the Nerveäna device, which is a surgical device requiring human-in-the-loop operation. The document emphasizes that "No surgeon input is required for operation of the Nerveäna accessory," indicating the software's functions are automated, but it's not a standalone diagnostic AI.
7. The Type of Ground Truth Used
- Ground Truth Type: The ground truth appears to be the established performance of the predicate device (Nerveäna) as determined by its existing "bench testing performance." The software's requirements were "verified" against this baseline. Its clinical use was "validated by confirming that its clinical use conforms to user needs," but the specific methodology for this conformance check is not detailed.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a training set. This is not an AI/machine learning device in the modern sense that would typically involve a training set. It is an accessory software displaying data and providing additional features for an existing medical device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.