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510(k) Data Aggregation
(71 days)
MDRIVE
The N7000 system (with MDrive) is intended for clinical sleep applications, with recording and/or amplification capability of numerous types of physiological signals used by a physician or trained technician for the acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient connected Headbox and/or Patient Unit during sleep related studies.
The general intended environments are hospitals, institutions, sleep centers, and sleep clinics, but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably.
The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria.
The N7000 system does not provide any alarms and is not intended to be a monitor.
A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the N7000 data when it is communicated and presented on a PC using a separate application software program.
The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.
The original cleared N7000 system consists of 3 separate components; a mains connected Communication Unit (CU) for signal amplification and transmission to a host PC, a Headbox that is cable connected to the CU, and a Patient unit that is cable connected to the Headbox. Patient electrodes are connected to the Headbox and the Patient Unit with several electrodes and sensors non-invasively attached to a patient during sleep.
The MDrive device is intended as an alternate upgrade for the current CU component and provides all original functionality and system connectivity that exists with the CU.
The major additions that the MDrive provides over the existing CU component in the N7000 svstem are:
- A wireless connection option to the host PC, in addition to a wired connection, . 1.
- a local keypad and display for the user to perform electrode impedance checking 2. and biocalibration locally rather that from a remote PC, and
- study recording capability using an SD card in the event of PC host 3. communication interruption. The SD card study can then be uploaded to the host PC.
The provided 510(k) summary for the Embla N7000 with MDrive describes its acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Signals received, amplified, recorded, and transmitted by the MDrive are identical to those of the predicate device's Communication Unit (CU). | "all signals received, amplified, recorded and transmitted by the MDrive were identical to signals received, amplified and transmitted by the predicate devices." |
| Compliance with IEC 60601-1/UL60601-1 (Electrical Safety) | "Safety tests... have been performed to verify compliance... with acceptable results." |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Emissions) | "Electromagnetic Compatibility tests... have been performed to ensure that no intolerable electro-magnetic disturbances are introduced." |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Immunity) | "Immunity tests... have been performed to ensure that the device operates satisfactorily in an electromagnetic environment." |
| Performance specifications meet acceptable results. | "The internal testing, verification in various design phases, and validation of performance specifications have been completed with acceptable results." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in the traditional sense of patient data. The "study" described is a bench test comparison of the signals generated by the new MDrive component against the signals generated by the predicate device's Communication Unit using internal testing, verification, and validation.
The data provenance is internal testing and validation conducted by Embla Systems. There is no mention of country of origin for data or whether it was retrospective or prospective, as it does not appear to involve human subject data for performance claims.
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. Given that the testing focuses on the electrical signal equivalence between the new and predicate devices, the "ground truth" would likely be established through instrumental measurements and technical specifications rather than expert interpretation of medical images or physiological data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable in the context of electrical signal comparison. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. The device is a component upgrade (MDrive) for an existing polysomnography system (N7000) that measures and transmits physiological signals. The testing focuses on the technical equivalence of the signals produced, not on how human readers interpret those signals with or without AI assistance. The device itself is not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
The study described is inherently a standalone performance assessment of the device's ability to receive, amplify, record, and transmit signals. It compares the MDrive's signal output to the predicate device's output. There is no "human-in-the-loop" aspect to this specific performance study as it pertains to the device's core function of signal processing and transmission.
7. Type of Ground Truth Used
The ground truth used was the signals produced by the predicate device's Communication Unit. The objective was to demonstrate that the MDrive produces "identical" signals, representing a technical equivalence. This isn't pathology, outcomes data, or expert consensus on clinical diagnoses, but rather engineering verification of signal integrity.
8. Sample Size for the Training Set
Not applicable. The device is a hardware component (MDrive) that processes physiological signals; it does not involve machine learning or any training set in the conventional AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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