(23 days)
The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.
The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.
The Nicolet Electrocautery Detector is an accessory device designed to mute external audible outputs from a nerve monitor when electrocautery interference is detected. The device's performance is compared to a predicate device, the XOMED NIM-2 XL.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device: XOMED NIM-2 XL) | Reported Device Performance (Nicolet Electrocautery Detector) |
|---|---|---|
| Indication for Use | As a feature of nerve monitoring, an electrocautery detection and muting feature is provided. | Accessory device supporting muting of external audible outputs when electrocautery interference is detected. |
| Environment of Use | Hospitals and clinics | Wherever nerve monitors and stimulators are used. Typically hospitals and clinics. |
| Number of electrocautery detector inputs | 4 | 2 |
| Technology | Detection of electrocautery Radio Frequency energy and muting of audible output. | Detection of electrocautery Radio Frequency energy and muting of audible output. |
| Recovery Time After Mute | ≤ 5 seconds | ≤ 1 second |
| Electrocautery Detector Sensitivity Adjustment | Yes - User Selectable | Yes - User selectable |
| Adjustable Sensitivity to Electrocautery Interference Detection | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not contain information regarding a specific "test set" in the context of clinical trials or performance testing with human subjects. The comparison is based on device specifications and features, not a study involving a particular sample size of cases or patients. The data provenance is derived from the technical specifications and design of the Nicolet Electrocautery Detector and its predicate device. This is a comparison of product specifications, not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there is no mention of a "test set" for a clinical study or performance evaluation with human data, there is no information on the number of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set
As there is no mention of a "test set" involving expert review of cases, there is no information on an adjudication method.
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
The document does not describe an MRMC comparative effectiveness study. This device is an accessory for a nerve monitor, designed to automatically mute auditory signals, not an AI-based diagnostic tool requiring human reader interpretation or improvement. Therefore, there is no information on an effect size for human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not describe a standalone algorithm performance study. The device functions as an accessory that performs an automated action (muting) based on detecting electrocautery interference. The "performance" is implicitly evaluated by comparing its technical specifications (like recovery time and detection method) to those of the predicate device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the technical specifications and functional design of the device and its predicate. The assessment is made by comparing these attributes, particularly the method of electrocautery detection and muting, and key performance parameters like recovery time. There is no mention of ground truth established by expert consensus, pathology, or outcomes data in a clinical trial setting.
8. The Sample Size for the Training Set
The provided document does not mention a "training set". This type of device, an electro-mechanical accessory, is not typically developed using machine learning or AI models that require a training set of data. Its functionality is based on detecting physical RF energy.
9. How the Ground Truth for the Training Set was Established
Since there is no mention of a training set, there is no information on how ground truth for a training set was established.
§ 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.