(142 days)
The Bio-logic Ceegraph family is indicated for use in the recording and analysis of routine EEG tests. Typical EEG tests are 20-30 minutes in duration. but the Ceegraph system can also be used for longer tests. including continuous lone-term EEG monitoring with patient video. EEG testing is indicated for use whenever it is necessary to measure and record the electrical activity of a patient's brain by attaching multiple electrodes at various locations on the scalp.
The 128 Channel Data Recording system has a similar intended use to that of the 32 channel Ceegraph recording system.
It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients.
The 128-Channel data collection system consists of a metal enclosure approximately 13.5' x 7.375' x 5.25" in size, weighing approximately 10.9 (when fully-equipped to handle all 128 channels). It can be configured to perform from 16 to 128 channel collection, depending on the hardware installed in the box. Power to the box is supplied with an external medical-grade power supply, which supplies regulated 12 volts and 5 volts DC to a connector at the rear of the box. Communication to the host computer is performed through a standard Ethernet interface connector capable of running at data rates up to 10 MHz (10 base-T). Four patient connectors are provided on the front of the box, each capable of interfacing to 32 channels of patient input. A sync connector is provided at the rear of the box, to provide synchronization and sampling rate information to external devices.
The system consists of a microprocessor board, a digital interface board, and up to eight (8) 16-channel analog boards connected to the system through a backplane interconnect board. The analog boards are identical to the 16-channel analog boards used in the patient connection module (headbox) of the predicate device. These boards provide patient isolation and signal amplification. Boards are connected in pairs to one of the four external connectors on the front of the unit. These 50-pin external connectors are identical to the auxiliary connector on the present headbox of the predicate device. This allows the use of existing patient connection hardware, such as electrode arrays and the 32-channel" electrode connection panel called the "quick disconnect box". The microprocessor board contains program and data memory and control functions for reading the analog data, converting it to digital, and communicating it to the host computer through the Ethernet cable. The digital interface board contains the interface to the A/D converters and the communications hardware.
Here's a summary of the acceptance criteria and study information for the Bio-logic Ceegraph 128-Channel Recording System, based on the provided text:
Acceptance Criteria and Reported Device Performance
The device is a modification of a predicate device (Bio-logic Ceegraph Digital EEG System, 510(k) #K933233) and is intended to demonstrate equivalence in terms of safety and effectiveness, and that additional features provide utility and product performance which exceeds that of the predicate device.
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance | Comments |
|---|---|---|---|
| Safety and Electrical | EMI/EMC Testing (multiple standards including CISPR, ENV, EN, Military Standard) | Completed satisfactorily with no adverse reports. | Demonstrates compliance with electromagnetic compatibility standards. |
| Current Leakage Tests (ANSI/AAMI) | Completed satisfactorily with no adverse reports. | Ensures electrical safety for patient and operator. | |
| Dielectric Withstand Test (FDA Reviewer's Guidance and IEC 601-1) | Completed satisfactorily with no adverse reports. | Verifies insulation integrity against high voltage. | |
| Power Line Variations (FDA Reviewer's Guidance) | Completed satisfactorily with no adverse reports. | Assesses performance under fluctuating power conditions. | |
| Power Line Transients (FDA Reviewer's Guidance) | Completed satisfactorily with no adverse reports. | Evaluates resistance to sudden power disturbances. | |
| Electrostatic Discharge Tests (ESD) (FDA Reviewer's Guidance and EN60601-2) | Completed satisfactorily with no adverse reports. | Confirms resistance to static electricity. | |
| Environmental | Temperature testing (FDA Reviewer's Guidance) | Completed satisfactorily with no adverse reports. | Assesses operational stability across temperature ranges. |
| Functional/Performance | Data Integrity Tests (demonstrate digital data is correct representation of analog signals) | Completed satisfactorily with no adverse reports. | Crucial for ensuring the accuracy of recorded EEG data. |
| Equivalence to Predicate | Substantially the same technical design approach as predicate device's patient connection module (headbox) | Confirmed through description of shared analog boards and updated digital components. | This is the overarching criterion for 510(k) clearance. The new device uses the same analog boards and has an updated digital design but the same core functionality for signal capture. |
Study Information
Based on the provided text, the documentation describes non-clinical testing designed to demonstrate substantial equivalence and enhanced performance. It is important to note that this is a 510(k) submission, which primarily focuses on demonstrating equivalence to a predicate device through non-clinical data, rather than requiring a full-scale clinical trial.
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of patient data. The non-clinical testing was performed on the device itself.
- Data provenance is not applicable as it's a device performance test, not a clinical data set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical device performance study where "ground truth" was established by engineering standards and specifications (e.g., correct representation of analog signals).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no human interpretation or adjudication of a test set in the clinical sense mentioned. The tests were objective engineering and performance evaluations.
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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. An MRMC study was not stated or implied. This device is a digital EEG recorder, not an AI-powered diagnostic tool requiring human reader studies to evaluate interpretative performance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The "Data Integrity Tests" assess the algorithm's (device's) ability to accurately represent analog signals digitally, independent of human interpretation at that stage. The entire suite of non-clinical tests are standalone performance evaluations of the device's hardware and software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the data integrity tests, the "ground truth" would be the known analog input signals that are fed into the system. The device's digital output is then compared against these known inputs to verify accuracy.
- For other tests (EMI/EMC, leakage, etc.), the ground truth is adherence to established engineering standards and regulatory thresholds.
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The sample size for the training set:
- Not applicable. This device is an EEG recording system, not a machine learning algorithm that requires a "training set" of data in the typical sense. Its function is to accurately capture and record signals, not to interpret or classify them using learned patterns from a dataset.
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How the ground truth for the training set was established:
- Not applicable. As the device does not employ a machine learning model that requires training data and a corresponding ground truth, this question doesn't apply.
§ 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).