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510(k) Data Aggregation
(762 days)
The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor.
The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.
The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home under direct supervision of a medical professional.
The AE-918P is an 8 channel digital Electroencephalography (EEG) that connects to a Nihon Kohden patient monitor. It receives EEG data from patients and digitizes the signals, the waveforms and analysis are displayed on a Nihon Kohden Patient Monitor.
The AE-918P is contained in a small enclosure that contains the EEG amplifier and digital circuitry. This enclosure is mounted to the bottom of the patient monitor and connects to the patient monitor through the multilink cable.
The Nihon Kohden AE-918P Neuro Unit is an 8-channel EEG measuring unit that connects to a Nihon Kohden patient monitor. It amplifies and analyzes EEG and displays the EEG waveform and analysis results on the patient monitor, intended for monitoring brain function.
Here's an analysis of its acceptance criteria and the study proving its performance, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity. Instead, the performance testing focuses on ensuring the device meets established safety and performance standards for electroencephalographs and demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, stating that the device "performed within specifications" and was "equivalent in safety and effectiveness" to its main predicate.
| Acceptance Criteria (Implied from testing standards and predicate comparison) | Reported Device Performance |
|---|---|
| Safety and Electrical Performance: Conformance to IEC 60601-1 (various parts) for general requirements, electromagnetic compatibility, and particular requirements for electroencephalographs. | "The AE-918P was subjected to safety and performance testing procedures. The AE-918P has undergone validation and verification testing to ensure conformance to all design requirements.""Testing to the following standards was done: IEC 60601-1 Part1: General requirements for safety 1998-12, Amendment 1 (1991-11), Amendment 2 (1995-03); IEC 60601-1-2 2nd edition (2001-09), Amendment 1 (2004-09); IEC 60601-2-26 Part 2-26: Particular Requirements for the safety of electroencephalograph 2002-11." |
| Biocompatibility: Electrodes used with the device are biocompatible. | "Electrodes used as accessories with the device are the same as those of the predicate device and have previously been testing for biocompatibility for a surface contacting device of prolonged duration according to ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." |
| Quantitative EEG Measures (SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, Abs Gamma, aEEG): Calculation and display of trends are substantially equivalent to predicate devices. | "Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of EEG trends. These tests verified that the device performed within specifications."The device includes calculation of these measures, with specific functions like MDF, TP, and aEEG being supported by additional predicates (K051178, K963644, K021185, K120485, K131789). |
| Overall Equivalence: Safety and effectiveness are equivalent to the main predicate device EEG-1200A. | "Based on the comparison information in the technical comparison chart above and confirmed by verification/validation testing in compliance with the Design Control requirements, the AE-918P was shown to be equivalent in safety and effectiveness to the main predicate device EEG-1200A." |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "No Clinical testing was required." This indicates that the performance testing for this device primarily relied on bench testing, comparison to predicate devices, and internal validation/verification testing according to design control processes. Therefore, there is no test set of patient data and consequently, no specified data provenance (country of origin, retrospective/prospective).
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 patient-specific "test set" was used, there were no experts used to establish ground truth for such a set. The "ground truth" for the device's technical specifications and performance was based on engineering validation against established standards and comparison to well-characterized predicate devices.
4. Adjudication Method for the Test Set
Since no clinical test set was used, there was no adjudication method employed for a test set.
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 done. This device is an EEG measuring unit, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output. Its function is to amplify, analyze, and display EEG waveforms and quantitative measures for medical personnel to interpret in conjunction with the original waveform.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device's functionality involves "amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor." The quantitative EEG measures "should always be interpreted in conjunction with review of the original EEG waveform." This implies the device provides analytical output that is not intended to be used in a standalone, algorithm-only fashion without human interpretation and review of the raw EEG data. The performance testing verified the device's ability to calculate and display these measures and trends accurately, rather than its diagnostic performance in a standalone mode.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating the device's performance was primarily:
- Engineering specifications and design requirements: Verifying that the device met its intended technical parameters.
- Regulatory standards: Conformance to IEC 60601 series for safety and performance of medical electrical equipment, particularly for electroencephalographs.
- Predicate device characteristics: The comparison testing aimed to show "substantial equivalence" of the calculation and display of EEG trends to those of legally marketed predicate devices. This indicates that the established, accepted performance of existing devices served as a benchmark for "ground truth."
8. The Sample Size for the Training Set
The document does not mention any "training set" of data. As previously noted, no clinical testing was required, and the device's validation appears to be based on engineering tests and comparison to existing technologies, not on machine learning or AI models that require specific training data.
9. How the Ground Truth for the Training Set Was Established
Since there was no mention of a training set, the method for establishing its ground truth is not applicable to this submission.
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(300 days)
The Nihon Kohden TG-970P and is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.
The device is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patient weighing 2kg or more.
The TG-970P Series CO2 Sensor Kit is comprised of three main components, a CO2 Sensor (photo detector and light emitter) with cable and connector, a CO2 Adapter and an airway adapter. The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the CO2 adapter. The adapter then reads the data and converts the data so it can be displayed on the patient monitor.
Here's a breakdown of the acceptance criteria and study information for the Nihon Kohden TG-970P Sensor Kit with the new Airway Adaptor, based on the provided document:
Acceptance Criteria and Device Performance
The core of this submission is about demonstrating that the new YG-213T airway adapter for the existing TG-970P CO2 Sensor Kit is substantially equivalent to the predicate device, specifically extending its use to smaller patients (2kg to 7kg). The acceptance criteria are implicitly tied to maintaining the accuracy and safety established by the predicate device (TG-970P with YG-211T) for this new patient population.
Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Predicate YG-211T Performance/Expectation for YG-213T) | Reported Device Performance (YG-213T) | Comments |
|---|---|---|---|
| Intended Use | To measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. | Same (with extended patient population) | The new airway adapter (YG-213T) expands the patient population from >7kg to 2kg or more, while maintaining the same fundamental intended use. |
| Use Frequency | Single Patient Use | Same | No change. |
| Shelf Life | 36 months | Same | No change. |
| Patient Population | For patients more than approx. 7kg. | For patients 2kg to 7kg. | This is the primary change and where the new adapter needs to demonstrate equivalence. The document states: "Validation/verification testing confirms that the accuracy of the measured gas is substantially equivalent to the predicate device. No new questions of safety or effectiveness were raised." This implies the acceptance criteria for accuracy (e.g., within a certain deviation from a reference measurement) were met for this new population. However, the specific quantifiable accuracy criteria are not explicitly detailed in the provided text. |
| Dead Space | 4mL (with YG-211T) | 1mL (with YG-213T) | The dead space changed due to the smaller airway adapter. The document states: "Validation/verification testing confirms that the smaller dead space does not affect the accuracy of the measured gas and is substantially equivalent to the predicate device. No new questions of safety or effectiveness were raised." This implies that despite the change, the impact on measurement accuracy remained within acceptable limits. |
| Function | Airway adapter with windows through which infrared light of the CO2 sensor kit can pass, connected to respiratory circuit. | Same | No change to the fundamental principle. |
| Transmissivity | More than approx 45% (at 4.27um±0.02um) | Same | The optical properties of the window material are maintained. |
| Optical Length | 6mm±0.2mm | Same | The physical dimension crucial for CO2 measurement is maintained. |
| Antifogging Performance (Ratio of fog) | Less than 5% (at 15°C to 35°C, 20% to 80RH, 10 minutes later) | Same | Critical for maintaining optical clarity and accurate readings in challenging environments. |
| Antifogging Performance (Ratio of Wet) | Less than ±8% (at 15°C to 35°C, 20% to 80RH, 10 minutes later) | Same | Critical for maintaining optical clarity and accurate readings when moisture is present. |
| Continuous Use Time | 24 hours (for predicate YG-211T) | 72 hours (for YG-213T) | This is an improvement in performance. The document states: "Validation/verification testing confirms that the accuracy of the measured gas is not changed with longer continuous use time. No new questions of safety or effectiveness were raised." This indicates that the device met its accuracy criteria even over the extended 72-hour period. |
| Safety Standards | Compliance with relevant IEC and ISO standards | IEC 60601-1, IEC 60601-1 Amendment 1 & 2, ISO 10993-1, ISO 14971 | The new adapter maintains compliance with these regulatory standards, indicating safety and risk management are addressed. |
Study Information
The document describes a "verification and validation testing" process to demonstrate substantial equivalence, rather than a formal human clinical trial in the traditional sense.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size for the test set used in the verification/validation testing.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the company (Nihon Kohden Corporation) and Nihon Kohden America, Inc. being the sponsor, it's likely the testing was conducted by or in collaboration with the manufacturer, potentially in Japan or the US, but this is not confirmed. The study appears to be retrospective in the sense that the testing was performed to validate a design change rather than a new device from scratch with prospective patient enrollment. However, the exact nature of the testing (e.g., simulated breath patterns, animal models, limited human subjects) is not detailed.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of experts to establish ground truth for a test set. This type of device relies on objective physical measurements of CO2 concentration rather than subjective interpretation like medical images. Ground truth would typically be established by a highly accurate reference gas analyzer or a calibrated gas mixture.
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Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" for a CO2 sensor is a quantitative physical measurement (e.g., from a reference gas analyzer or known gas concentration), an adjudication method by human experts is not relevant.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and comparing human performance with and without AI assistance. The Nihon Kohden TG-970P is a CO2 sensor, which provides objective physiological measurements, not an AI-assisted diagnostic tool for human interpretation.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, implicitly. The "verification and validation testing" performed by Nihon Kohden to confirm the accuracy of the measured gas and the substantial equivalence to the predicate device would be a standalone performance assessment of the device, independent of human operators, beyond the normal operation. The device essentially is the algorithm/measurement system for CO2 concentration. However, it's important to clarify that this isn't an "AI algorithm" in the conventional sense (e.g., for image recognition or predictive analytics), but rather the performance of a physical sensor and its associated signal processing.
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Type of Ground Truth Used:
- The ground truth would have been established using reference gas mixtures with known CO2 concentrations or a highly accurate and calibrated reference CO2 analyzer. The document refers to "accuracy of the measured gas," implying comparison against a standard. It does not mention pathology or outcomes data.
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Sample Size for the Training Set:
- Not applicable in the typical AI/ML sense. The Nihon Kohden TG-970P is a hardware device based on infrared absorption principles, not a machine learning algorithm that undergoes a "training" phase with a dataset. The design and calibration would have been based on physical principles and engineering specifications, not statistical learning from a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 7.
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(231 days)
The PSG-1100 Sleep Diagnostic System is intended to record the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.
The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies. The device consists of an amplifier box (head box) and main interface unit. The head box operates with commercially available sensors and interfaces with a main unit which connects to and communicates with computer hardware/ software via Ethernet connection.
The Nihon Kohden PSG-1100 Sleep Diagnostic System is a polysomnograph intended to record electrical activity of the brain (EEG) and other biopotential signals as an aid in diagnosing sleep disorders, epilepsies, and other disorders.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant industry standards. The acceptance criteria are implicitly defined by matching or exceeding the specifications of the predicate devices and adhering to safety and performance standards for medical electrical equipment.
| Acceptance Criteria Category | Specific Criteria (from Predicate/Standards) | Reported Device Performance (Nihon Kohden PSG-1100A) |
|---|---|---|
| Functional/Technical | Number of Channels: 32 (JE-912A) | 34 |
| Input Impedance: 100 M ohm | 100 M ohm | |
| Calibration Check: Step square or Sine wave, 2 to 1000 uV (9 steps) | Step square, 50 uV (1 step) | |
| Impedance Check: All inputs with Screen and Input box readout | All inputs with Screen and Input box readout | |
| Common-Mode Rejection Ratio (CMRR): 105 dB or more | 105 dB or more | |
| Noise Level: < 1.5 uV p-p (0.53 to 60 Hz) | < 1.5 uV p-p (0.53 to 60 Hz) | |
| Frequency Response: 0.08 to 120 Hz | 0.08 to 300 Hz | |
| High-pass Filter (Low-cut): 0.016 to 159 Hz, DC standard | 0.08 to 53 Hz, DC standard | |
| Low-pass Filter (High-cut): 15 to 120 Hz | 15 to 300 Hz | |
| AC Filter: 50 or 60 Hz (rejection ratio > 1/25) | 50 or 60 Hz (rejection ratio > 1/25) | |
| Sensitivity: OFF, 1 to 200 uV/mm (15 steps) DC: OFF, 10 to 200 mV/mm (10 steps) | OFF, 0.1 to 200 uV/mm (20 steps) DC: OFF, 10 to 200 mV/mm (10 steps) | |
| A-D Conversion: 16 bits | 16 bits | |
| Sampling: All channels, 100, 200, 500 Hz | All channels, 200, 250, 500, 1000, 2000 Hz | |
| Display Resolution: N/A, 1600 x 1200 | 1600 x 1200 | |
| Power: 120 V +/- 10%, 50/60 Hz, 750 VA (incl PC and display) | 100-240 V +/- 10%, 50/60 Hz, 42 VA (Main unit only) | |
| Environmental | Operating Temperature: 10 to 35 C | 10 to 35 degree C |
| Operating Humidity: 30 to 80 % | 30 to 80 % | |
| Safety and Effectiveness | Equivalent in safety and effectiveness to predicate devices; no new questions of safety or effectiveness. | Confirmed by verification/validation testing in compliance with Design Control requirements and risk analysis. |
| Standards Compliance | IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-26, CAN/CSA-C22.2 No. 601.1-M90 and related amendments | Confirmed by compliance testing with all listed standards. |
| Labeling | Equivalent to predicate devices | Confirmed by verification/validation testing. |
Study Proving Acceptance Criteria:
The study described is a design control and verification/validation testing process rather than a traditional clinical study with human subjects to evaluate diagnostic accuracy. The primary method used to prove the device meets acceptance criteria is a demonstration of substantial equivalence to legally marketed predicate devices.
- Study Type: Design Control and Verification/Validation Testing for Substantial Equivalence.
- Methodology: Comparative analysis of technical characteristics, performance specifications, and compliance with recognized consensus standards.
2. Sample Size for the Test Set and Data Provenance
This submission does not involve a "test set" in the sense of a clinical dataset of patient recordings for diagnostic accuracy evaluation. Instead, the "test set" refers to the device itself and its components undergoing engineering and performance testing.
- Sample Size for Test Set: Not applicable in the context of diagnostic accuracy, as this is a device performance and safety evaluation. The "sample" would be the manufactured device units undergoing verification/validation.
- Data Provenance: The data arises from internal company testing (Nihon Kohden Corporation) and compliance with international and national safety and performance standards. No specific country of origin for clinical retrospect/prospective data is mentioned because it's not a clinical diagnostic performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth for this type of submission is established by engineering specifications, performance standards, and regulatory requirements, not by expert interpretation of patient data for diagnostic accuracy.
- Qualifications of Experts: The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists at Nihon Kohden, along with the standard bodies and regulatory agencies (like the FDA) whose criteria the device must meet.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for a traditional diagnostic accuracy adjudication. The "adjudication" in this context is the process of verifying that the device's technical specifications and performance meet the established design requirements, predicate device specifications, and relevant standards. This is typically done through documented testing procedures, review by quality assurance, and compliance checks against standards by certified bodies or internal personnel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence, not on the improvement of human reader performance with or without AI assistance. This device is an amplifier and diagnostic system, not an AI-driven image analysis or interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Not applicable. This device is a measurement and recording system; it does not contain a standalone algorithm for diagnosis that would operate without human interaction. Its function is to acquire and present physiological data to a clinician.
7. Type of Ground Truth Used
- Ground Truth: The "ground truth" for this device's acceptance is based on:
- Engineering Specifications: The design parameters and performance targets set by Nihon Kohden.
- Predicate Device Performance: The established specifications and performance of the legally marketed predicate devices (JE-912A PSG Input Box, JE-921A junction Box, EEG-1200A Series Neurofax).
- Consensus Standards: Compliance with international and national standards for medical electrical equipment (e.g., IEC 60601 series, CAN/CSA-C22.2 series).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware system for signal acquisition and display, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
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(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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(240 days)
The Nihon Kohden GR-210R Multi-Gas Module is intended to measure carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and following anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a Nihon Kohden bedside monitor. The GF-210R can measure two anesthetic agents simultaneously.
The system is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patients as determined by the qualified medical personnel.
The GF-210R Multi-Gas Module is a fully integrated anesthesia gas detection unit that measures Carbon dioxide (CO2), nitrous oxide (N20), oxygen (O2), and five anesthetic agents and displays the results on a Nihon Kohden bedside monitor.
The GF-210R is an enclosure that contains an OEM Gas Analyzer (Draeger Module # 6871620). There is a sample gas exhaust port that allows the GF-210R to sample gas from a anesthetic or respiration circuit through exhaust gas tube. A multi-link connector allows the GF-210R to comunicate the measured gas value and display the value on a Nihon kohden bedside monitor
The provided text describes the Nihon Kohden GF-210R Multi-Gas Module, a medical device for measuring various gases during anesthesia. The crucial detail is that this submission is a 510(k) Premarket Notification, which means the device is being compared to already legally marketed predicate devices to establish substantial equivalence, rather than providing completely new clinical performance data. Therefore, the "study" demonstrating that the device meets acceptance criteria is primarily an equivalence comparison to predicate device specifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the technical characteristics of the predicate devices. The reported device performance is the specifications of the Nihon Kohden GF-210R. The table below excerpts the key measurement parameters and their reported performance for both the new device and the predicate devices, highlighting where the new device meets or is equivalent to the predicates.
| Parameter | Predicate Device (K#020046) Nihon Kohden AG-920RA | Predicate Device (K040188) Draeger SC 6802XL w/Scio | New Device Nihon Kohden GF-210R | Comments |
|---|---|---|---|---|
| CO2 Measurement | ||||
| Measuring range | 0 to 76 mmHg | 0 to 10 % | 0 to 10 Vol.% (Ref. 0 to 76 mmHg @ambient pressure 760mmHg) | The value using Vol.% is the spec by Draeger. See the value, which is converted to mmHg for reference. |
| Measuring accuracy | ± 2 mmHg (0 to 40 mmHg)± 3 mmHg (40 to 55 mmHg)± 4 mmHg (55 to 76 mmHg) | ± (0.5 Vol% or ±12% rel) | ± (0.43 Vol.% + 8 % rel.) (Ref.±(3.3 mmHg + 8 % rel.) @ambient pressure 760 mmHg) | The value using Vol.% is the spec by Draeger. See the value, which is converted to mmHg for reference. Essential performance in EMC standard |
| Rise Time (10 to 90%) | 250 ms @ 200mL/min | < 350 ms @ 150mL/min | 350 ms | |
| N2O Measurement | ||||
| Measuring range | 0 to 100 % | 0 to 100 % | Same (0 to 100 %) | |
| Measuring accuracy | ± 3 vol.% | ± (2 Vol. % + 8 % rel.) | ± (2 Vol.% + 8 % rel.) | |
| Rise Time (10 to 90%) | 250 ms @ 200mL/min | < 500 ms | 500 ms | |
| O2 Measurement | ||||
| Measuring range | 0 to 100 % | 0 to 100 % | 5 to 100 % | |
| Measuring accuracy | +/- 2 vol.% (0 to 55 %)+/- 3 vol.% (55 to 100 %) | +/- 3 vol.% | +/- (2.5 Vol.% + 2.5 % rel.) | Essential performance in EMC standard |
| Rise Time (10 to 90%) | 500 ms | < 600 ms @150mL/min | Same (500 ms) | |
| Anesthetic Agent Measurement | ||||
| Measuring range (Halothane) | 0 to 5 % | 0 to 8.5 % | 0 to 8.5 % | |
| Measuring accuracy | +/- 0.2 vol.% (0 to 5 %)+/- 0.4 vol.% (5 to 10 %)+/- 0.6 vol.% (10 to 15 %)+/- 1.0 vol.% (15 to 18 %) | +/- (0.15 Vol% +15 % rel.) | +/- (0.2 vol% +15.0 % rel.) | Essential performance in EMC standard |
| Rise Time (10 to 90%) | 300 ms (Halothane, Isoflurane, Sevoflurane, Desflurane) @ 200mL/min500 ms (Enflurane) @ 200mL/min | < 500 ms @ 150mL/min | 500 ms | |
| Respiration Rate | ||||
| Measuring range | 4 to 60 counts/min | 0 to 90 Counts/min | Same (0 to 90 Counts/min) | |
| Measuring accuracy | 1 counts/min | 1 Counts/min (0 to 60 counts/min) not specified (>60 counts/min) | Same (1 Counts/min (0 to 60 counts/min) not specified (>60 counts/min)) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical study with patients or distinct data samples. For a 510(k) submission based on substantial equivalence to predicate devices, the primary "test" is the comparison of technical specifications.
The provided data is a table of technical specifications. There is no information about country of origin of data or whether it is retrospective or prospective, as it's not a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. The ground truth for this type of device (gas analyzer) is established by the accuracy/precision of its physical measurements against known gas concentrations, as detailed in the technical specifications. This typically involves laboratory testing and calibration against NIST-traceable standards, rather than expert human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess cases and their disagreements need to be resolved. This device measures gas concentrations, not subjective 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
This section is not applicable. The device is a multi-gas module, not an AI-powered diagnostic tool for image analysis or other human interpretation tasks where a MRMC study would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a physical gas measurement device. The device's "standalone" performance is its ability to accurately measure gas concentrations as per its technical specifications, which are implicitly studied and verified during product development and regulatory testing. The provided data summaries indicate "Software and hardware verification and validation" and "Safety standard compliance" testing were performed, which covers the device's standalone functional performance.
7. The Type of Ground Truth Used
The ground truth for this device's performance relies on calibration gases with known concentrations for accuracy and precision measurements. This is a form of objective, physical measurement standard. It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The device is not based on machine learning models that require a "training set" in the conventional sense. Its functionality is based on established physical principles of gas analysis (infrared ray absorption, paramagnetic detection) and engineered hardware/software.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no "training set" for this type of device.
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(171 days)
When the Low output is selected the MS-120BK is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders.
When High output is selected the MS-120BK is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
The system is intended for use by qualified medical personnel within a hospital or clinical environment. The stimulator is available for use on any patients as determined by the qualified medical personnel.
The Nihon Kohden MS-120BK is a dual (high & low) output constant current stimulator. The high and low setting, stimulation current and frequency of stimulation is selected by the user. The Nihon Kohden MS-120BK is connected to the MEE 1000A through the JB-116BK or JB-132BK amplifier.
In the Low output setting the Nihon Kohden MS-120BK applies cortical stimulation energy through the Nihon Kohden stimulation pod (JS-102B) which is connected to commercially available cortical electrodes (strip and grid electrodes).
In the High output setting, the MS-120BK outputs electrostimulation pulse through the Nihon Kohden extension cord (BM-121B) which is connected to commercially available stimulation electrode(s).
This document describes a 510(k) submission for the Nihon Kohden MS-120BK Electric Stimulator (Extension Unit), primarily focusing on demonstrating its substantial equivalence to previously cleared predicate devices. Therefore, the study doesn't present typical "acceptance criteria" and "reported device performance" in the way one might expect for a novel AI/software device. Instead, the focus is on showing technical characteristics are equivalent and that the device complies with recognized safety standards.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission demonstrates equivalence by comparing the technical characteristics of the new device to predicate devices. The "acceptance criteria" here are effectively that the new device's specifications fall within acceptable ranges similar to or better than the predicate devices, and that it complies with relevant safety and performance standards. The "reported device performance" is a direct comparison of these specifications.
| Characteristic | Predicate Device (Nihon Kohden SEN-4100A) | Predicate Device (Digitimer D185) | New Device (Nihon Kohden MS-120BK) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|---|
| High Output Setting | |||||
| Voltage | 1000V | 1000V | 350V | Similar or acceptable range | 350V |
| Current | 1A (1k Ω load) | 1A (1k Ω load) | 200mA (1k Ω load) | Similar or acceptable range | 200mA (1k Ω load) |
| Maximum Stimulation Energy | 50mJ | 50mJ | 40mJ | Similar or acceptable range | 40mJ |
| Output Impedance | less than 120 Ω | less than 120 Ω | 50 Ω | Similar or acceptable range | 50 Ω |
| Stimulation Mode | Constant Voltage | Constant Voltage | Constant Current | Demonstrates different, but acceptable and defined mode | Constant Current |
| Pulse Duration | 50 μs | 50 μs | 50-1000 μs | Similar or acceptable range | 50-1000 μs |
| Output Frequency Range | 1 Hz | 1 Hz | 0.1-1Hz | Similar or acceptable range | 0.1-1Hz |
| Number of Pulse Trains | 1-9 | 1-9 | 1-9 | Matches | 1-9 |
| Interpulse Interval | 1.0-9.9ms | 1.0-9.9ms | 1.0-1000ms | Similar or acceptable range | 1.0-1000ms |
| Limitation of Voltage/Current and Pulses | Varies with predicates | Varies with predicates | Varies (e.g., 200mA: 3 Pulses) | Similar or acceptable range | Varies |
| Polarity Change | OK | OK | OK | Matches | OK |
| Monophasic | OK | OK | OK | Matches | OK |
| Biphasic | NO | NO | OK | Demonstrates additional capability | OK |
| Alternate | NO | NO | OK | Demonstrates additional capability | OK |
| Maximum Charge | 50 micro-Coulomb | 50 micro-Coulomb | 200 micro-Coulomb | Similar or acceptable range | 200 micro-Coulomb |
| Pulse Shape | Rectangular | Rectangular | Rectangular | Matches | Rectangular |
| Maximum Energy Per Pulse | 50mJ | 50mJ | 40mJ | Similar or acceptable range | 40mJ |
| Maximum Energy Per Second | 150mJ | 150mJ | 40mJ | Similar or acceptable range | 40mJ |
| Electrode Minimum Size | 0.5cm2 | 0.5cm2 | 0.5cm2 | Matches | 0.5cm2 |
| Maximum Charge Density | 100 Micro-C/cm2 | 100 Micro-C/cm2 | 400 Micro-C/cm2 | Similar or acceptable range | 400 Micro-C/cm2 |
| Interface Control | MEE-1000A | NO | Only MEE-1000A | Specifies compatibility | Only MEE-1000A |
| Trigger Input | OK | OK | OK*2 | Matches | OK*2 |
| Trigger Output | OK | OK | OK*2 | Matches | OK*2 |
| Foot Switch Control | OK | OK | OK*2 | Matches | OK*2 |
| Low Output Setting | |||||
| Constant Current Stimulator | Yes (Nicolet) | Yes (Ojemann) | Yes | Matches | Yes |
| Maximum Stimulation Charge | 15 micro-Coulomb (Nicolet) | 20 micro-Coulomb (Ojemann) | 4.5 micro-Coulomb | Similar or acceptable range | 4.5 micro-Coulomb |
| Current Stimulation Range | 0.1 to 15mA (peak) (Nicolet) | 0 to 10mA (peak) (Ojemann) | 0 to 15mA (peak) | Similar or acceptable range | 0 to 15mA (peak) |
| Stimulation Frequency | 1 to 100Hz (Nicolet) | 5, 10, 20, 50, 75, 100Hz (Ojemann) | 0.1 to 50Hz | Similar or acceptable range | 0.1 to 50Hz |
| Stimulation Pulse Width Duration | 0.1 to 1.0 msec Per Phase (Nicolet) | 0.1 to 2.0 msec Per Phase (Ojemann) | 0.05 to 0.3 msec Per Phase | Similar or acceptable range | 0.05 to 0.3 msec Per Phase |
| Pulse Shape | Rectangular (Nicolet) | Rectangular (Ojemann) | Rectangular | Matches | Rectangular |
| Electrode Minimum Size | 0.04cm2 (Nicolet) | 0.5cm2 (Ojemann) | 0.04cm2 | Similar or acceptable range | 0.04cm2 |
| Maximum Charge Density | 375 micro-C/cm2 (Nicolet) | 40 micro-C/cm2 (Ojemann) | 113 micro-C/cm2 | Similar or acceptable range | 113 micro-C/cm2 |
| Maximum RMS Current Density Per Pulse | 119 mA RMS/cm2 (Nicolet) | 8.9 mA RMS/cm2 (Ojemann) | 46 mA RMS/cm2 | Similar or acceptable range | 46 mA RMS/cm2 |
2. Sample Size Used for the Test Set and Data Provenance
This is a physical medical device (electrical stimulator), not an AI/software device that processes data. Therefore, the concept of a "test set" with "data provenance" (country of origin, retrospective/prospective) in the context of image analysis or diagnostic algorithms does not apply here.
The "testing" mentioned is focused on verifying the device's hardware and software performance against its specifications and compliance with safety standards. The document states:
- "Testing of the Nihon Kohden System with the MS-120BK was performed in compliance with the Nihon Kohden Corporation design control process."
- "Testing included: Software and hardware verification and validation, and the device is in compliance with the following voluntary industrial standards..." (followed by a list of IEC, EN, and CAN/CSA standards).
This implies standard engineering and regulatory compliance testing rather than a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As noted above, this device does not function by interpreting patient data for diagnosis, so there is no "ground truth" established by experts in this context. The "truth" is whether the device meets its technical specifications and safety standards.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. This type of study is typically performed for diagnostic or AI-assisted devices to assess the impact on human reader performance. The MS-120BK is an electrical stimulator, and its effectiveness is determined by its physical output and adherence to specifications, not by how it affects human interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical stimulus device, not an algorithm. Its operation is inherently with a "human-in-the-loop" (qualified medical personnel).
7. The Type of Ground Truth Used
The "ground truth" for this type of device is its technical specifications and compliance with international safety and performance standards. Testing involved verifying that the device's electrical outputs, timing, and other physical parameters matched the design specifications and met the requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, etc.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
In summary, the provided document is a 510(k) summary for a traditional medical device (an electric stimulator). The "study" referenced is the internal design control process and associated testing to ensure the device meets its technical specifications safely and effectively, and is substantially equivalent to predicate devices, rather than a clinical study evaluating an AI/software's diagnostic or interpretive performance.
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(170 days)
EEG- 1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.
The PE-210AK Switch Box is an optional accessory for the EEG-1200A device. It is used with the EEG-1200A to switch between EEG recording and cortical stimulation using the same cortical electrode. The software is used for functional brain mapping to support diagnostic and surgical epilepsy procedures.
The device is intended for use within a hospital or medical facility under direct supervision of a medical professional
The PE-210A Switch Box is an optional accessory for the EEG-1200A device cleared under 510k # K080546. The PE-210AK Hardware is made up of electronic switches inside a box enclosure and cable connections on the outside of the box enclosure. The PE210AK Hardware switch box does not have any controls or adjustment for the operator. All settings, controls, and adjustments are made using the PE-210AK software installed on the EEG's (off the shelf) PC. Utilizing the EEG's CPU. Data storage, keyboard, mouse, and display, the PE-210AK switch box software allows the user switch electrode stimulation sites between the EEG recording and the cortical stimulator. The PE-210AK software allows the user to query the data recorded on the EEG's PC and create a report of the stimulation sites, including duration and intensity settings.
The Nihon Kohden PE-210AK Switch Box for EEG-. 1200A is an accessory that facilitates switching electrodes between an electroencephalograph (EEG) and a cortical stimulator, primarily for functional brain mapping in the context of diagnostic and surgical epilepsy procedures. The 510(k) submission K110376 does not explicitly detail acceptance criteria in a quantitative manner as would be expected for a diagnostic or AI-powered device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, the Excel Tech EMU 128s Switch Matrix (K040360), and verified through design validation and various testing procedures.
The provided document describes the device's functional capabilities and compares them to the predicate device to establish substantial equivalence. The "study" proving the device meets these criteria is a design validation that confirmed the operation of the software and hardware according to design specifications, along with electromagnetic, environmental, safety, and performance testing. However, there is no information provided about a clinical study involving human subjects, diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC), or a comparison against a defined ground truth for specific clinical outcomes.
Here's an attempt to structure the information based on your request, understanding that the given document focuses on functional equivalence rather than quantitative performance metrics for diagnostic accuracy.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied from Substantial Equivalence and Design Validation) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: | Met: The PE-210AK Switch Box performs the core functions of switching electrode output from a stimulation unit to EEG electrodes connected to the patient and EEG instrument, similar to the Excel Tech EMU 128s Switch Matrix. |
| - Software Capabilities (e.g., electrode arrangement, stimulation site selection, data display, report generation) | - Met: The software allows electrodes to be arranged on a brain map, selection of STIM SITE (+) and STIM REF (-) electrodes, display of selected electrode names, and creation/saving/printing of functional mapping reports and stimulation event tables. Minor differences (e.g., zoom feature, display of current values) were noted as not impacting safety or effectiveness. |
| - Hardware Characteristics (e.g., electronic switch, trigger out) | - Met: The device utilizes an electronic switch and provides trigger out for external stimulator, consistent with the predicate. |
| Operational Conformance to Design Specifications: | Met: Design validation confirmed the operation of both software and hardware in accordance with design specifications. |
| Safety and Effectiveness: | Met: Electromagnetic, environmental, safety, and performance testing procedures were conducted, and these tests "verified the proper operation of the device." The manufacturer asserts that features differing from the predicate (e.g., zoom feature, check-up program for switch/trigger signals) have "no impact on patient safety or effectiveness of device." The device is non-sterile and does not contact patients. |
| Intended Use Fulfillment: | Met: The device is used with the EEG-1200A to switch between EEG recording and cortical stimulation using the same cortical electrode, and its software supports functional brain mapping for diagnostic and surgical epilepsy procedures, as intended. |
Study Details Proving Acceptance Criteria
The provided 510(k) summary does not detail a clinical study with human subjects, diagnostic performance metrics, or specific quantitative acceptance criteria that would typically be associated with an AI or diagnostic device. Instead, the "study" is a collection of engineering tests and a comparison to a predicate device to establish substantial equivalence.
Here's an analysis based on the available information:
-
Sample size used for the test set and the data provenance: This information is not provided. The document states "Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications" and "The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device." These are internal engineering and verification tests, not typically clinical trials with defined test sets of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As the "study" described is a design validation and technical testing, there's no mention of expert-established ground truth in the context of clinical accuracy or a diagnostic outcome.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not applicable/not provided. There is no indication of a clinical test set requiring adjudication of findings.
-
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: This information is not applicable/not provided. The Nihon Kohden PE-210AK Switch Box is an accessory for switching electrodes and assisting with functional brain mapping, not an AI-powered diagnostic tool that directly interprets data or assists human readers in a diagnostic task in a way that would warrant an MRMC study comparing AI-assisted vs. non-assisted performance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not applicable/not provided. The device is an accessory controlled by software and is intended for use by medical professionals; it does not operate as a standalone algorithm without human interaction or supervision.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided/not explicitly defined in a clinical context. For the design validation, the "ground truth" would be the engineering and functional specifications that the device's hardware and software were designed to meet. The verification tests confirmed conformance to these specifications.
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The sample size for the training set: This information is not applicable/not provided. The device is not an AI/ML-based system that requires a "training set" of data in the conventional sense. Its software performs control and display functions based on predefined logic and parameters, rather than learning from data.
-
How the ground truth for the training set was established: This information is not applicable/not provided for the same reasons as point 7.
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(143 days)
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.
The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers/transmitters. Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters.
The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005). Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005).
The provided text is a 510(k) summary for the Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station. The submission is for a software change to an existing predicate device, primarily allowing the central nurse station itself to perform alarm determination, which was previously handled exclusively by the telemetry receivers/transmitters.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection, or alarm-related performance). Instead, it relies on substantial equivalence to a predicate device and general validation of software and hardware operation.
The "device performance" reported is largely that the device operates according to design specifications and that the non-clinical tests (electromagnetic, environmental, safety, and performance) verified proper operation.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Operation of software and hardware in accordance to design specifications. | Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications. |
| Proper operation verified by non-clinical tests. | The device was subjected to electromagnetic, environmental, safety, and performance testing, which verified the proper operation of the device. |
| Substantial equivalence to predicate device. | Nihon Kohden asserts that the device is substantially equivalent to the predicate devices (Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station and ORG 9700A Multiple Patient Receiver) based on technical characteristics and testing. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a "test set" in the context of clinical performance evaluation (e.g., patient data for arrhythmia detection). The studies mentioned are primarily non-clinical: electromagnetic, environmental, safety, and general performance testing, as well as design validation. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Since the submission focuses on a software change to an existing device and relies on non-clinical testing and substantial equivalence, there is no indication of expert-established ground truth for a clinical test set.
4. Adjudication method for the test set
This information is not provided. No clinical test set with human-adjudicated ground truth is described.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a central nurse station for physiological monitoring and alarm generation, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that "Arrhythmia detection is a function of the telemetry receivers/transmitters" and "Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters." This implies that the device (or its components) performs alarm determination algorithmically and automatically. However, the exact performance metrics of this standalone algorithmic detection (e.g., sensitivity, specificity, positive predictive value for arrhythmia detection) are not provided in this summary. The summary focuses on the functionality of the alarm determination rather than its specific performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (physiological monitor and alarm system) and the type of information provided, the ground truth for "performance testing" and "design validation" would likely involve:
- Engineering specifications and test protocols: Verification that the device functions as designed against pre-defined engineering requirements (e.g., alarm triggers correctly at set limits, data display is accurate).
- Simulated physiological signals: For testing arrhythmia detection and alarm generation, simulated ECG signals with known arrhythmias would likely be used.
However, the document does not explicitly detail the type of ground truth used beyond "design specifications" and verification of "proper operation." There is no mention of ground truth established through expert consensus on clinical data, pathology, or outcomes data.
8. The sample size for the training set
This information is not provided. The document describes a software change to an existing device, not the development of a new algorithm that would typically involve a separate training set.
9. How the ground truth for the training set was established
This information is not provided, as there is no mention of a training set.
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(109 days)
The CNS-6200 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry received transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit.
This product will be available for use by medical personnel on all patient populations within a medical facility.
The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor.
The provided document describes a 510(k) premarket notification for the Nihon Kohden CNS-6200 Series Central Nurse Station. This device is an update to a previously cleared predicate device (CNS-9701A). The submission focuses on demonstrating substantial equivalence rather than a new performance claim, therefore, details on specific acceptance criteria for a new device's performance, a comprehensive study proving those criteria, or a standalone performance study are not explicitly included in the provided text as one might find for a novel AI/software medical device.
However, based on the information provided, we can infer some aspects related to acceptance criteria and validation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Electrical Standards Compliance: | CNS-6200 Series Central Nurse Station complies with IEC 60601-1 subclause 56.3 (C), implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. |
| Proper Operation according to Design Specifications: | Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications. |
| Electromagnetic, Environmental, and Safety Performance: | The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the proper operation of the device. |
| Functional Equivalence to Predicate Device: | The technical characteristics of the CNS-9701A predicate and the new CNS-6200 Series are the same with the exception that the new device has new hardware such as CPU and LCD monitor. (This implies that the new device performs the same functions, including cardiac and vital signs monitoring, display, recording, and alarm mimicking, as the predicate.) |
| Intended Use Compliance: | The device's operation aligns with its intended use: "cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry received transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study in the typical sense of a novel device requiring a test set of patient data for performance evaluation (e.g., sensitivity, specificity for arrhythmia detection algorithms). Instead, the validation is focused on engineering verification and validation (V&V) activities and demonstrating substantial equivalence to a predicate device.
- Sample Size for Test Set: Not applicable or not specified in the context of clinical performance data. The "test set" would primarily refer to the device itself undergoing various engineering and functional tests.
- Data Provenance: Not applicable, as this submission isn't based on retrospective or prospective patient data for an algorithm's performance. The validation is based on the device's adherence to design specifications and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For this type of device (a patient monitoring system that displays and relays information, rather than autonomously making a diagnosis or interpretation), "ground truth" established by clinical experts on a test set of patient cases is not a requirement for this 510(k) submission. The ground truth would reside in the functioning of the connected bedside monitors or telemetry units for arrhythmia detection.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of a human-reviewed test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or interpretative aids where human reader performance is a key metric. The CNS-6200 Series Central Nurse Station is a monitoring and display system, not a diagnostic interpretation tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, a standalone performance study (in the context of an algorithm's diagnostic or interpretive accuracy) was not described or performed. The device's function is to display and record physiological data and mimic alarms from other primary devices (bedside monitors and telemetry units). The core arrhythmia detection function, for example, resides in the connected telemetry receivers/transmitters or individual bedside monitors, not the central station itself. The central station's "performance" is in accurately receiving, displaying, recording, and relaying these statuses and alarms.
7. The Type of Ground Truth Used
- Type of Ground Truth: The concept of "ground truth" as typically applied to algorithmic performance (e.g., pathology, outcomes data) is not directly relevant here. The ground truth for the CNS-6200 Series would be:
- Design Specifications: The device accurately performs according to its documented design.
- Predicate Device Functionality: The new device replicates the functions and technical characteristics of the legally marketed predicate device.
- Regulatory Standards: The device adheres to mandated safety and electrical performance standards (e.g., IEC 60601-1, 21 CFR 868).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set of data. Its development is based on engineering design principles for hardware and software, not on machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set was used.
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