Search Results

The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.

Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.

Bioscope Neuromonitor Device is a nerve locator and monitor. The device has 3 infrastructure;

• Electronic
• Mechanic
• Software

These infrastructures are integrated with each other and work with the principle of stimulating current at 0.01-10 mA levels, conceiving EMG signals from related muscles groups. Collected signals are interpreted by the device and auditory and visual notifications will be given.

The device basically consists of stimulation and EMG subsystems. Both stimulation and EMG lines can send and collect signals from 2 channels. Depending on the operation, an EMG Endotracheal Tube or needle electrode is inserted into the muscles innervated by the relevant nerves for EMG reading. The electrode parts of the EMG tube are placed in contact with the muscles attached to the vocal cords. Needle electrodes are also inserted into the relevant muscle. Appropriate current is sent with the stimulation probe. The electrical changes in the muscles in the region and are transmitted to the device as a signal. The device gives audible and visual warnings.

Channels works on the principle of potentially stimulating the critical region through monopolar or bipolar probe connection and completing the circuit, allowing the device to make a nerve-tissue separation audibly and visually. It allows the detection of nerves such as the recurrent laryngeal nerve, which are connected to the vocal cords. The doctor brings the probe into contact with the area of potential nerve risk. The current sent to the patient through the probe causes a change in the electrical activity of the nerves and the muscles to which the nerves are connected, and this change can be detected by the device. Based on the collected data, the device gives clear audible alerts for nerve-tissue separation. The EMG signal collected from the patient is displayed as a both voltage value and latency times on the output. These values can be recorded and the interface can be used to select specific details, such as the right and left sides of the vagus, and recurrent laryngeal nerves.

The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.
Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative performance acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) for the Bioscope Neuromonitor Device. Instead, the acceptance criteria are implied through adherence to recognized medical device standards and the demonstration of "similar technical features" and "safety and effectiveness" compared to predicate and reference devices.

The reported device performance is primarily described as compliance with various international standards for medical electrical equipment, software life cycle processes, and specific requirements for nerve and muscle stimulators. The conclusion from nonclinical tests is that the device is "as safe, as effective, and perform as well as the legally marketed predicate device."

Table of Acceptance Criteria (Implied) and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document describes non-clinical performance testing. This type of testing typically involves laboratory-based evaluations, bench testing, and simulations to demonstrate compliance with standards and functional requirements. It does not mention clinical studies involving patient data or human subjects. Therefore, there is no information provided regarding a "test set" in the context of patient data (e.g., sample size, country of origin, retrospective/prospective).

The "test set" in this context refers to the device itself and its components undergoing various engineering, electrical, and software validation tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

As the testing described is non-clinical performance testing (bench testing, standard compliance), the concept of "ground truth" established by experts for a test set of patient cases is not applicable here. The "ground truth" in this context would be the specifications and expected performance values defined by the relevant standards and the device design. The "experts" would be the engineers, quality assurance personnel, and regulatory specialists conducting and reviewing these tests. No specific number or qualifications of such experts are mentioned beyond the general reference to "Test results demonstrate that the Bioscope Neuromonitor Device complies with the applicable standards."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Again, since this is non-clinical performance testing and not a clinical study involving human assessment of cases, the concept of an "adjudication method" for a test set is not applicable. Test results are typically evaluated against established technical specifications and standard requirements, not through expert consensus on case interpretations.

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 MRMC comparative effectiveness study was mentioned or performed. This submission describes a conventional medical device that provides intra-operative monitoring and stimulation. It is not an AI-assisted diagnostic or interpretative device that would typically involve human readers or AI assistance for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The Bioscope Neuromonitor Device is an active medical device that provides real-time information to a surgeon during surgery. It is not an "algorithm only" device or an AI system that operates without human-in-the-loop performance. Its function is to assist the surgeon by providing auditory and visual notifications based on EMG signals. Therefore, the concept of a "standalone (algorithm only)" performance study without human interaction is not applicable to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance testing, the "ground truth" used is the defined technical specifications, functional requirements, and the pass/fail criteria established by the international standards listed (e.g., IEC 60601-1, IEC 62304, etc.). For instance, for accuracy of current output, the ground truth would be the known, calibrated output of measurement equipment used to verify the device's output.

8. The sample size for the training set

No information about a "training set" is provided. As this is a conventional neuro-monitoring device based on electrical stimulation and EMG signal detection, it does not appear to involve machine learning or AI models that would require a training set in the typical sense. The software validation is mentioned in the context of IEC 62304, which focuses on software life cycle processes and validation, not on training an AI model.

9. How the ground truth for the training set was established

Since no training set is mentioned or applicable to this type of device, there is no information on how its ground truth would have been established.

Ask a specific question about this device