(153 days)
The EEG-1200A series Nerurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. This data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
The EEG-1200A with JE-120A is a digital EEG based on a minimum of a 32-bit computer with a filing function. The device uses Windows Graphic User Interface, receives physiological signals (up to 256 channels with JE-120 electrode junction box) from patients and digitizes the signals, the application of the software reproduces the waveforms, The EEG-1200A with JE-120A consists of a main unit, electrode junction box (head box), PC Unit, Isolation Unit and System Programs. The electrode junction box, monitor, keyboard and mouse connect to the computer. The computer and control panel connect to the main unit. Components requiring AC power plug into the main unit's 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. Patient data is stored to hard drive or other commercially available digital storage media. Inputs for Sp02 and EtC02 are available.
Here's a breakdown of the acceptance criteria and study information for the Nihon Kohden JE-120A Electrode Junction Box for EEG-1200A, based on the provided document:
This 510(k) pertains to a Special 510(k) Notification for a device modification, focusing on substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are primarily related to meeting performance specifications and regulatory standards to demonstrate that the new device is as safe and effective as the predicate. The "study" here refers to the testing performed to show compliance with these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison of technical characteristics between the new device (JE-120A) and the predicate devices (JE-212A/JE-921A). The "acceptance criteria" are implied by the values provided for the predicate devices, and the "reported device performance" is the value for the new device. The goal is to show the new device either meets or exceeds the predicate's performance, or that any differences do not raise new questions of safety or effectiveness.
| Characteristic | Predicate JE-212A + Accessories (e.g., JE-225AK/226AK/227AK+QI-122A) | Predicate JE-921A (K#050833) | New Device JE-120A+JE-125AK(JE-225AK)/JE-226AK/JE-227AK/JE-228AK+QI-123A | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (JE-120A) |
|---|---|---|---|---|---|
| Product used with | Electroencephalograph EEG-1200A K#080546 | Electroencephalograph EEG-1200A K#080546 | Electroencephalograph EEG-1200A K#080546 | Must be compatible with EEG-1200A | Compatible with EEG-1200A |
| Intended Use | Electrode junction box for EEG | Electrode junction box for EEG/PSG | Electrode junction box for EEG/PSG | Equivalent to predicate's intended use | Equivalent to predicate's intended use |
| Measurement parameters | EEG | EEG, ECG, EMG, EOG, respiration, SpO₂, and CO₂ | EEG, ECG, EMG, EOG, SpO₂, and CO₂ | Same or expanded measurement parameters | Same as JE-921A |
| Number of input terminals | 192 (EEG only) | 25 (general) | 256 (general) | At least 192 (EEG); 25 (general) | 256 (general) |
| EEG input terminals | 192 | 14 | 4 (JE-125AK) | Up to 192 | Up to 256 (via accessories) |
| Multi-purpose input terminals | 0 | 3 | 0 | Not applicable (difference noted in document) | 0 |
| Bipolar input terminals | 0 | 4 | 16 | At least 0 | 16 |
| Respiration input terminals | 16 | Input impedance 200M ohm | Input impedance 200M ohm | 16 (for respiration) | 16 (for respiration) |
| Input impedance | 200M ohm | Less than 1.5 micro Vp-p | Less than 1.5 micro Vp-p | At least 100M ohm | 200M ohm |
| Noise | Less than 1.5 micro Vp-p | More than 105dB | More than 110dB | Less than or equal to 1.5 micro Vp-p | Less than 1.5 micro Vp-p |
| Rejection ratio | More than 110dB | 0.08Hz (TC 2 seconds) | 0.016Hz(TC 10 seconds) or 0.08Hz (TC 2 seconds) | At least 105dB | More than 110dB |
| Low cut filter | 0.016Hz (TC 10 seconds) or 0.08Hz (TC 2 seconds) | 300Hz (-18dB/oct) | 3000Hz (-18dB/oct) | Same or improved filter characteristics | 0.016Hz or 0.08Hz |
| High cut filter | 3000Hz (-18dB/oct.) | Yes | Yes | Same or improved filter characteristics | 3000Hz (-18dB/oct) |
| Electrode impedance check | Yes | 16 bit (97nV/LSB) | 16 bit (97nV/LSB) or 16 bit (388nV/LSB) | Yes | Yes |
| A/D resolution | 16 bits (97nV/LSB) | 1000Hz | 10000Hz | Equivalent or higher resolution | 16 bits (97nV/LSB) or (388nV/LSB) |
| Maximum Sampling frequency | 10000Hz | None | 10000Hz | Equivalent or higher sampling frequency | 10000Hz |
| SpO₂ input | None | SpO₂ adapter is connected to this unit directly. | SpO₂ adapter is connected to this unit directly. | SpO₂ input capability (if applicable) | Directly connected |
| EtCo2 input | None | EtCo2 adaptor is connected to this unit directly. | EtCo2 adaptor is connected to this unit directly. | EtCo2 input capability (if applicable) | Directly connected |
| Body position sensor | None | DC input terminals | None | Not applicable (difference noted in document) | None |
| Mini electrode junction box | Option | Option | Option | Option available | Option available |
| Interface with EEG | Ethernet | USB | Ethernet | Ethernet or USB | Ethernet |
| Safety | Class I, Type BF | Class I, Type BF | Class I, Type BF | Compliant with Class I, Type BF | Class I, Type BF |
Note: The document implies acceptance criteria by comparing the new device's specifications to those of the predicate devices. The new device is generally shown to be equivalent or to offer improvements (e.g., more channels, higher sampling frequency) without raising new safety/effectiveness concerns.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of patient data or clinical trials for evaluating diagnostic accuracy or performance like an AI algorithm would. This is a 510(k) for a hardware component (electrode junction box) of an EEG system.
The testing conducted was primarily engineering verification and validation of the device's hardware, software, and compliance with standards. Therefore, the "sample size" would refer to the number of units tested, the number of software modules, or test cases, not patient data.
- Sample Size: Not applicable in the context of patient data. The testing involved multiple system components and software units.
- Data Provenance: Not applicable in the context of patient data. The testing was internally conducted by Nihon Kohden Corporation. The reports listed (e.g., A100-000336B, A152-005167, A275-000544, etc.) are internal technical reports from the design control process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of information is relevant for studies evaluating diagnostic performance (e.g., an AI algorithm's ability to classify images). For this device, "ground truth" refers to the expected performance characteristics based on engineering specifications and regulatory standards. The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists at Nihon Kohden Corporation, who conduct and review the testing.
4. Adjudication Method for the Test Set
Not applicable for this type of device submission. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where disagreement among human readers or evaluators needs to be resolved to establish a definitive ground truth for an outcome. Here, performance is verified against predefined technical specifications and standards.
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 is a hardware component (electrode junction box) for an EEG system, not an AI-powered diagnostic tool requiring human reader studies to assess improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrode junction box, a hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on:
- Engineering Specifications: Designed performance parameters (e.g., input impedance, noise levels, frequency response, channel count).
- Predicate Device Performance: Performance data from the existing, legally marketed predicate devices (EEG-1200A with JE-212A / JE-921A) serves as a benchmark for substantial equivalence.
- Voluntary Industrial Standards: Compliance with recognized medical electrical equipment safety and performance standards (e.g., IEC 60601-1 series, EN 60601 series, CAN/CSA-C22.2 series).
- User Needs/Functional Requirements: Verification that the device meets its intended functional requirements as defined by Nihon Kohden (Report # A100-000336B).
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI algorithm, there is no training set or corresponding ground truth establishment process in this context.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).