(192 days)
The devices are intended to acquire and store physiological signals for EEG and Sleep Studies, and to transfer the data to separate polysomnographic analysis software.
The devices are intended for use by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.
The device function is the acquisition of bloelectric signals, as is typical for EEG amplifiers and holter recorders. The device receives and amplifies patient input signals, converts them to digital format, packs them by a programmable logic and sends them to an internal microcontroller. The microcontroller stores them in a RAM buffer, from where they are written at defined time to the Compact Flash memory. The data can be viewed directly on the display or downloaded by using elther specific interface modules (BQUSB towards the USB port of the PC or BQNET towards an Ethernet link) or the built-in Bluetooth® link. Data can also be read directly from the Compact Flash card via a memory card reader. In PC a typical polysomnographic analysis software application manages the storage and the on-line or off-line display of the data. In the main version, the device is provided with 32 input channels:
- 24 channels for EEG (BW: 0.15-220 Hz) .
- DC channels (0-330 Hz) .
- 2 channels for the built-in flow sensors .
- 2 channels for external inductive belts (respiratory effort sensors) .
- 1 channel for a built-in body position sensor .
- 1 channel for digital data from the oximeter (SpO2, heart rate and plethysmographic signal)
The device is enclosed in a (2.5 -> 3.5) h x 7.5 x 11.4 cm plastic case and weighs 200g. It is powered by 2 AA 1,5V alkaline batteries, by the BQUSB interface (via the connected PC) or the BQNET module (via separate AC mains adapter).
The device has a LCD allowing the menu to be display gives information on the recording mode, acquisition time, remaining memory, impedance measure and allows the rough display of the acquired traces both on-line and after the recording. The user interface includes 4 membrane keys enclosed in the label below the display.
The device has no patient contacting parts. Input signals are collected by commercially available accessories like EEG electrodes, oximeter sensors, cannulae and respiratory effort sensors (elastic band). The patient and operator can eventually touch the plastic external enclosure but the device is usually worn above the clothes in a synthetic fabric bag.
The manufacturer does not intend to limit the utility of this device by listing a finite set of commercially available sensors. The device is only a recorder that receives and records input form sensors and subsequently downloads those recordings to a PC resident polysomnological application software for clinical analysis: it is very versatile in the range of input sensors that can be used in various sleep study dinical settings. The sensors, kits and application software are not intended in this application for dearance.
For connection with the sensors and the PC, the devices are provided with:
- touch proof connectors for patient electrodes (EEG channels)
- touch proof (BRAIN SPY PLUS) or 3-pin connector (MORPHEUS/TITANIUM) connectors for DC channels
- 1 screw-lock and 2 hose barb connectors for flow sensor cannulae (MORPHEUS/TTTANIUM version)
- 2 connector for the resplratory effort elastic band (MORPHEUS/TTTANIUM version)
- 3-pin (MORPHEUS/TITANIUM) or 4-pin (BRAIN SPY PLUS) connectors for the oximeter
- 4 pin push-pull connector for the connection to the BQUSB or BQNET module.
The communication lines with the BQUSB or BQNET module are optically isolated.
In the PC data coming from either USB, Ethernet or Bluetooth® ports are then acquired by an acquisition software. The submitted device is supported by PC based application software such as Embla's Somnologica Studio (version 5.1), or Micromed's System Plus (version 1.03). The application software is not intended to be included in this application for clearance.
Battery power is provided to make the device safer, ergonomic and able to acquire good signals even in electromagnetically nolsy environment. Low power consumption allows 24 hours of consecutive recording with a pair of standard alkaline battery. Maximum power consumption is 80-100 mA, plus 30 mA in wireless transmission mode. In stand-by, the power consumption is less than 100µA.
When voltage and communication signals are present on the cable connection, the device is powered by the USB interface modules through a DC/DC converter.
The device can also be connected to the PC through a radio (Bluetooth®) link using the RADIOEEG. built-in module. The microcontroller communicates with the radio module through Its serial port and transmits the data to a Bluetooth® receiver on the PC.
The Compact Flash storage memory capacty determines the duration of the recording to the number of the channels used. The commercially available (1 GB) allow more than 24 hours recording of 32 channels at 128 Hz sampling rate, without data compression. If data compression algorithm Is used, recording time can be increased by 25-30%.
The device family is composed of two basic models all sharing the same case, internal hardware and firmware. The BRAIN SPY PLUS model is obtained by a MORPHEJS model without the internal sensors and with a different input panel (less and different connectors). The Embla TITANIUM model Is identical to MORPHEUS, differing only in labeling (distributor brand and device name).
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Micromed devices:
This 510(k) summary does not include detailed acceptance criteria or a study proving the device meets them in the way typically expected for performance claims. Instead, it focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and compliance with safety and EMC standards.
The document does not report numerical performance metrics or statistical results from a comparative effectiveness study or a standalone algorithm performance study. It emphasizes that the device functions as an acquisition and storage unit, and does not perform analysis or make judgments on the displayed signals. The analysis software is explicitly stated as separate and not included in the clearance application.
Therefore, the following information is extracted based on the provided text, and where information is not present, it is explicitly stated as such.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Complies with IEC 60601-1/UL2601-1-1 and IEC 60601-2-26 to ensure no potential hazards on patients, other persons, or surroundings. |
| Electromagnetic Compatibility (EMC) - Emissions | Complies with IEC 60601-1-2 to ensure no intolerable magnetic disturbances are introduced into its electromagnetic environment. |
| Electromagnetic Compatibility (EMC) - Immunity | Complies with IEC 60601-1-2 to ensure the EEG equipment has the ability to operate satisfactorily in its electromagnetic environment. |
| Firmware Verification | Firmware ensures the system conforms to all system design requirements. Device is correctly and safely controlled through remote and local commands. |
| Functional Performance | Functional testing performed to confirm devices are capable of meeting stated performance specifications. |
| Signal Acquisition & Storage | Acquires, digitizes, and stores biopotentials and data from patient-connected sensors in internal compact flash memory. |
| Recording Duration | 1 GB storage allows >24 hours recording of 32 channels at 128 Hz sampling rate (without compression). Data compression increases recording time by 25-30%. Sufficient to store whole-night examination data. |
| Battery Life | Allows 24 hours of consecutive recording with a pair of standard alkaline batteries. Expected battery life comparable or greater than predicate devices. |
| Channel Numbers | 32 input channels (24 EEG, 2 DC, 2 flow sensor, 2 external inductive belts, 1 body position sensor, 1 digital oximeter data). Comparable to predicate devices. |
| Connectivity | Touch proof connectors for electrodes, specific connectors for DC channels, flow sensor cannulae, respiratory belts, oximeter. Optical isolation for USB/Ethernet modules. Bluetooth® link available. |
| Display/User Interface | LCD for menu, recording mode, acquisition time, remaining memory, impedance, rough display of acquired traces (on-line/off-line). 4 membrane keys. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document. The document refers to "Safety Tests," "Electromagnetic Compatibility tests," "Immunity tests," "Verification of firmware," and "Functional testing" but does not specify the number of devices or data sets used for these tests.
- Data Provenance: Not explicitly stated. The document refers to compliance with international standards (IEC, UL) and internal verification/functional testing, implying laboratory testing, but does not specify if patient data (retrospective or prospective) was used for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The document describes compliance with technical standards and functional verification, which typically do not involve expert-established ground truth in the context of clinical performance, as the device is an acquisition and storage unit, not an analytical one.
4. Adjudication Method for the Test Set
- This information is not provided in the document. Given the nature of the tests mentioned (safety, EMC, functional verification), an adjudication method for a "test set" as understood in clinical performance evaluation is not relevant or 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
- No, an MRMC comparative effectiveness study was not done and is not described in this document.
- The device is an acquisition and storage system, not an AI-assisted diagnostic tool.
- The document explicitly states that the "separate polysomnographic analysis software" (which would include any AI part) is "not intended to be included in this application for clearance."
- The device "does not make any judgment of normality of the displayed signals."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done and is not described. As mentioned above, the device itself is an acquisition and storage unit and does not contain analytical algorithms for which standalone performance would be measured.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document focuses on engineering and regulatory compliance rather than clinical performance (e.g., diagnostic accuracy). Therefore, "ground truth" in the sense of clinical reference standards (like pathology, expert consensus on disease presence) is not applicable and not mentioned for the tests described. The "ground truth" for the tests performed would be compliance with electrical, safety, and functional specifications.
8. The sample size for the training set
- Not applicable / Not provided. Since this device is an acquisition and storage unit, and not an AI/ML system performing analysis or diagnosis, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is not relevant.
§ 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).