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510(k) Data Aggregation
(224 days)
The Nihon Kohden MEB-2300A 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 device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
The device is available for use on any patient as determined by the medical professional including adults and children.
The MEB-2200A Neuropack Evoked Potential and EMG Measuring System consists of a main acquisition unit, operation control panel, foot switch, electrode junction box (head box), electrical stimulation box and commercially available computer, monitor, printer, keyboard, and mouse. The device also includes optional visual, and auditory stimulators. The monitor, keyboard, and mouse connect to the computer. The computer, electrode junction box, electrical stimulation box, and control panel connect to the main unit. All components requiring AC power plug into the main unit's built-in, isolated power supply. The main unit plugs into a hospital grade AC power source. All components fit onto a portable cart. A stand is also available for the electrode junction box and electrical stimulation box. Patient data is stored to a encrypted database on the local hard drive or a remote server. The data can also be archived to other commercially available storage medias.
This document is a 510(k) summary for the Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System. It describes the device, its intended use, technical characteristics, and a comparison to a predicate device (MEB-2200A). The submission aims to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with corresponding performance results in the classical sense of an AI/ML device showing specific metrics like accuracy, sensitivity, or specificity against predefined thresholds for a task like disease detection.
Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (MEB-2200A Neuropack). The key performance aspects are the technical specifications and the device's ability to perform the same medical functions as the predicate.
The following table summarizes the comparison between the new device (MEB-2300A) and the predicate (MEB-2200A) at a technical specification level, which serves as the "reported device performance" in this context.
| Feature / Specification | MEB-2300A New Device Reported Performance | MEB-2200A Predicate Device Performance |
|---|---|---|
| AMPLIFIERS: | ||
| Number of Channels | 6, 12 channels | 4, 8, 16 channels |
| Active Electrode jack | 4 ports | None |
| Input Impedance | 200 MΩ ±20% (Differential Mode), 1000 MΩ or greater (Common Mode) | Same |
| Noise | 0.6 µVrms | Same |
| CMRR | 106 dB or greater (Differential mode), 112 dB or greater (Isolation mode) | Same |
| Sensitivity | 1 to 500 µV/div and 1 to 10 mV/div | Same |
| Low-cut Filter | 0.01 Hz to 3 KHz at 6 dB/octave | Same |
| High-cut Filter | 10 Hz to 20 KHz at 12 dB/octave | Same |
| Electrode Impedance Check | 2, 5, 10, 20, 50kΩ indication | Same |
| Amplitude Calibration | 1, 10, 100 μV, 1, 10mV | Same |
| AC Filter | 50 or 60 Hz | Same |
| AVERAGERS: | ||
| A/D Converter | 18 bits | 16 bits |
| Conversion Speed | 5 µs/channel max. | 10 µs/channel max. |
| Monitor Time Base | 5 ms/div to 1 s/div | Same |
| Analysis Time Base | 0.1 ms/div to 1 s/div | Same |
| Time Base Modes | Individually selected for each channel | Same |
| Delay Time | -10 to +10 div in 1 div steps | Same |
| Trigger Modes | Recurrent, Random, Foot Switch, Signal, EXT1/2/3/4/5/6, Somato1, Somato3 | Recurrent, Random, Foot Switch, Signal, EXT1/2/3/4 Somato1, Somato3, Trig1/2/3/4End |
| Number of Averages | 1 to 9999 | Same |
| Artifact Reject Inhibit Range | ±1 to ±5 div or OFF | Same |
| DISPLAY: | ||
| Display | Color | Same |
| Number of Waveform Traces | 312 Maximum (26/channel x 12) | 416 Maximum (26/channel x 16) |
| Waveform Display Modes | Monitor, Sweep, Analysis | Same |
| Cursors | 2 horizontal, 2 vertical | Same |
| Scale | 5, 10, 15, 20 div | Same |
| Grid (graticule) Display | Line, Dot, OFF | Same |
| STIMULATOR COMMON FUNCTIONS: | ||
| Stimulus Modes | Single, Double, Train, Train series (Multi train, Number of train: 1 to 10) | Single, Double, Train |
| Stimulus Rates | 0.1 Hz to 100 Hz | Same |
| Delay Time | 0 to 10 seconds | Same |
| ELECTRIC STIMULATORS: | ||
| Number of Outputs | 4 | Same |
| Stimulus Intensity | 0 to 200 mA | 0 to 100 mA |
| Stimulus Pulse Duration | 0.01 to 1 ms | Same |
| AUDITORY STIMULATORS: | ||
| Output Type | Headphone | Same |
| Stimulus Modes | Click, Tone Burst | Same |
| Stimulus Phase | Condensation, Rarefaction, Alternating | Same |
| Stimulus Intensity | 0 to 135 dB SPL | Same |
| Contralateral White Noise Masking | 0 to -40 dB, or OFF | Same |
| Click Pulse Duration | 0.1 to 1 ms | Same |
| Tone Burst Frequency | 50 Hz to 10 KHz | Same |
| Plateau Time | 0 to 1000 ms | Same |
| Rise/Fall Time | 0.1 to 10 ms | Same |
| VISUAL STIMULATORS: | ||
| Stimulus Modes | Pattern Reversal, Flash (with LED goggles), External Visual Stimulation | Same |
| Patterns | Checkerboard, Horizontal Bars, Vertical Bars | Same |
| Number of Horizontal Divisions | 4, 8, 16, 32, 64, 128 | Same |
| RECORDER: | ||
| Recording Mode | Hard Copy, Review, Report | Same |
| DIMENSIONS / WEIGHT: | ||
| Main Unit | 390(W) x 55(H) x 304(D) mm, 3.2 kg | 670(W) x 1320(H) x 800(D) mm, 14.3 kg |
| Electrode Junction Box | 180(W) x 56.5(H) x 234.5(D) mm, 1.5 kg | (4/8 channels: 210x180x75mm, 1.8kg), (16 channels: 257x182x68mm, 2.4kg) |
| Power Unit | Main Unit includes Power Unit | Same |
| POWER REQUIREMENTS: | ||
| Line Voltage | 100-120 V AC, 220-240V AC | 117 V AC |
| Line Frequency | 50/60 Hz | Same |
| Power Input | Less than 75 VA | Less than 450 VA |
| ENVIRONMENT: | ||
| Operating Temperature | 10 to 35 °C | Same |
| Storage Temperature | -20 to +65 °C | -20 to +60 °C |
| Operating Humidity | 30 to 80% | 20 to 80% |
| Storage Humidity | 10 to 95% | 20 to 80% |
| Operating Atmospheric Pressure | 700 to 1060 hPa | Same |
| Storage Atmospheric Pressure | 700 to 1060 hPa | Same |
| TEST PROTOCOLS AVAILABLE: | ||
| Somatosensory evoked potential | SEP, SSEP, ECG-SSEP, ESCP, ELECTRIC | Same (only SEP listed explicitly) |
| Auditory evoked potential | ABR, MLR, SVR, ECOCHG, AUDITORY | Same (only ABR listed explicitly) |
| Visual evoked potential | PR-VEP, LED-VEP, EXT-VEP, ERG, EOG, VISUAL | Same (only PR-VEP listed explicitly) |
| EMG (electromyogram) | EMG, EMG 2, QEMG, SF EMG, MACRO | EMG, QEMG, SF EMG, MACRO |
| Nerve Conduction | MCS, SCS, NCS, REP.STIM, F-WAVE, H-REFLEX, BLINK, COLLISION | MCS, SCS, REP.STIM, F-WAVE, H-REFLEX, BLINK, COLLISION |
| Autonomic Nervous System | MICRO-N, SSR, R-R Interval | Same (only MICRO-N listed explicitly) |
| Event related potentials | P-300, MRCP, CNV | Same (only P-300 listed explicitly) |
| Trend Monitoring | IOM | Same |
Key Differences and Rationale for Changes (Improved Performance/Functionality):
- Number of Channels: Increased (e.g., 4 to 6, 8 to 12). Rationale: Increased channel capacity.
- Active Electrode jack: 4 ports added. Rationale: Noise is highly reduced by active electrode system.
- A/D Converter: Improved from 16 bits to 18 bits. Rationale: Higher resolution.
- Conversion Speed: Improved from 10 µs/channel max. to 5 µs/channel max. Rationale: Higher sampling speed.
- Stimulus Modes: "Train series" added. Rationale: New functional mode.
- Trigger Modes: External trigger input increased (EXT1/2/3/4/5/6) for complex waveform acquisition. Rationale: Increased connectivity and functionality.
- Stimulus Intensity (Electric): Increased from 0 to 100 mA to 0 to 200 mA. Rationale: More stimulus intensity, comparable to other devices (e.g., Medtronic NIM-Spine).
- EMG: "EMG2" added (Measuring mode with up to 4 measurement settings). Rationale: More flexible measurement settings.
- Nerve Conduction: MCS, SCS, and T-WAVE integrated into one program (NCS) for efficient routine examination. Rationale: Improved workflow efficiency.
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing performed for this submission."
Therefore, there is no "test set" in the context of clinical data for performance evaluation against human experts or ground truth. The evaluation is primarily based on non-clinical engineering and bench testing to demonstrate compliance with standards and equivalence in specifications to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical testing was performed and no test set was used to evaluate a clinical performance claim (e.g., diagnostic accuracy), there were no experts used to establish ground truth in this context. The "ground truth" for non-clinical testing typically refers to engineering specifications and measurements.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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
Not applicable. This device is an EMG/EP measuring system, not an AI-powered diagnostic algorithm that assists human readers in interpreting cases. No clinical MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for acquiring and displaying bioelectric signals, not an algorithm with standalone diagnostic performance. The device provides data for clinicians to interpret.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" implicitly refers to the device's technical specifications as measured on a bench, and verification against established engineering and safety standards (e.g., IEC 60601 series, CAN/CSA-C22.2 series). The design control process itself dictates verification against requirements and specifications.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. It is a hardware and software system for physiological signal acquisition.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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