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The MEB-2200A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The MEB-2200A device is intended for medical purposes to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The provided text describes a 510(k) summary for the Nihon Kohden MEB-2200A Neuropack Evoked Potential and EMG Measuring System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically sought for AI/ML devices.

The document focuses on:

• Device Classification: Identifies the device as Class II with multiple classifications (Diagnostic Electromyograph, Electroencephalograph, Nerve Conduction Velocity Measurement Device, etc.).
• Predicate Device: States the predicate device is the Nihon Kohden MEB-5500A Neuropack Sigma (K950208).
• Intended Use: Details the device's intended uses for EMG, NCV, EP, autonomic responses (GSR), and EEG, and the intended users/settings.
• Compliance: Lists compliance with various IEC and CAN/CSA standards, and mentions compliance with 21 CFR Part 898 for electrode lead wires and patient cables.
• Testing: Briefly mentions that the MEB-2200A underwent "electromagnetic, environmental, safety and performance testing procedures" and "Software validation tested the operation of the device." It concludes that "The results confirmed that the device performed within specifications."
• Substantial Equivalence: The primary conclusion is that the device is substantially equivalent to the predicate device.

Missing Information:

The document lacks the specific details requested regarding acceptance criteria and performance studies. Specifically, it does not provide:

1. A table of acceptance criteria and reported device performance: While it states "performed within specifications," it doesn't quantify what those specifications are (e.g., accuracy, sensitivity, specificity, or specific error rates for any diagnostic task).
2. Sample size used for the test set and data provenance: No test set is described, nor is the origin of any data.
3. Number of experts used to establish ground truth and their qualifications: No ground truth establishment process is mentioned.
4. Adjudication method for the test set: Not applicable as no test set is described.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a measurement system, not typically an AI-driven diagnostic aid that would assist human readers in this context.
6. Standalone (algorithm-only) performance: The device is a measuring system, not an AI algorithm in the typical sense of generating a diagnostic output without human interpretation of the bioelectric signals.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable, as it's not described as an AI/ML device that requires training.
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

Based on the provided text, the Nihon Kohden MEB-2200A is a traditional medical device (neurological testing equipment) and not an AI/ML diagnostic system. Therefore, the detailed performance metrics, ground truth establishment, reader studies, and sample sizes typically associated with AI/ML device evaluations are not present in this 510(k) summary. The "study" mentioned is general safety, electromagnetic, environmental, and performance testing to ensure the device operates as intended and meets relevant safety standards and specifications, rather than a diagnostic performance study against a specific clinical outcome.

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