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510(k) Data Aggregation
(305 days)
EMBLA N7000
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 Embla N7000 system is a full polysomnography system with expanded EEG capability. It is used to perform online sleep studies in the sleep lab, hospital or clinical environment under the supervision of a clinician or sleep technician. It does not do the recording, monitoring or analysis of this data.
The Embla N7000 system integrates digital technology and precision engineering into a flexible, rugged, full polysomnography system. The system itself, featuring an Ethernet network connection, is simple to assemble and the cables have been streamlined to provide a comfortable and reliable system. Meeting the most demanding clinical and research needs by offering 32 referential EEG channels, 8 bipolar channels plus an extensive set of respiratory signals, the system also includes auxiliary inputs for additional devices such as CPAP and CO2 machines.
The provided text describes the Embla N7000 EEG Amplifier system and its substantial equivalence to a predicate device (Artisan™ Acquisition System). However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, information on ground truth establishment, or expert involvement as typically found in studies for AI/ML-driven medical devices.
Instead, the document focuses on regulatory compliance, technical characteristics, and a general verification and validation process for a medical device that primarily functions as an acquisition and transmission system, not an artificial intelligence for diagnosis or analysis.
Here's how the information provided maps to your request, with a clear indication of what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in terms of performance metrics like sensitivity, specificity, accuracy, or similar for diagnostic/analytic capabilities. The document refers to compliance with safety and electrical standards and functional equivalence. | The Embla N7000 successfully acquired EEG and polysomnography (PSG) signals and transmitted them to a PC during neurophysiologic or sleep examinations. |
| Compliance with FDA "Electroencephalograph Devices Guidance for 510(k) Content, Draft Document, Version 1.0" | Certified to carry the CE mark (CE 0413), indicating compliance with EU Medical Device Directive 93/42/EEC. |
| Conformity to various specific standards (e.g., EN60601-1, EN60601-1-2, IEC 60601-2-26 for EEG, UL 2601-1, CAN/CSA C22.2 No.601.1-M90, AS/NZS 3200.1.0) | "Testing performed and the results verify that the Embla N7000 is safe and effective for its intended use." (General statement, no specifics provided). |
| Functional equivalence to the Artisan™ Acquisition System for amplifying and digitizing EEG and other polygraph channels and their transmission. | The amplification and data acquisition functions are similar to the Artisan™ system. The N7000 offers "expanded EEG capability" and "extended hardware possibilities of re-referencing." Software differences (microprocessor vs. PLD) were verified as meeting requirements. |
| Patient mains-isolation equivalent to predicate, fulfilling reinforced requirements of over 4000V manufacturing test voltage. | Met the reinforced requirements of over 4000V manufacturing test voltage, set by EN60601-1 and UL-2601. |
| Isolation from external devices equivalent to predicate. | Achieved in a similar way to the predicate device (special external box with AD converters and opto-couplers in predicate vs. built-in in N7000). |
| Communication construction equivalent to predicate. | Achieved via signal-transformer isolation and standard Ethernet communication (vs. fiber-optic and proprietary standard in predicate). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "internal verification and validation as well as external testing/validation" and "bench testing and practical testing in a simulated sleep lab setting." There's no numerical sample size provided for patients or data points.
- Data Provenance: Not specified. The testing described is primarily focused on engineering verification and compliance with standards rather than clinical data testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states the device is "intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals" and that "It does not do the recording, monitoring or analysis of this data." This implies the analysis is done by human experts, but the experts involved in testing the device itself are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. Given the nature of the device as an acquisition system, the "ground truth" would likely relate to the fidelity and accuracy of the signal acquisition and transmission, rather than a diagnostic outcome requiring adjudication.
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
- MRMC Study: No. This device is an EEG amplifier system for signal acquisition and transmission, not an AI or diagnostic tool that assists human readers with interpretation. Therefore, an MRMC study demonstrating improvement with AI assistance is not relevant or listed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The Embla N7000 is explicitly stated as not performing "any patient monitoring or diagnosis." Its purpose is to acquire and transmit signals for human interpretation. It is not an algorithm-only device for analysis or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated as "ground truth" in the diagnostic sense. For this type of device (signal acquisition), the "ground truth" would likely involve known, accurately generated electrical signals or physiological measurements against which the device's acquired signals are compared for accuracy, fidelity, and reliability according to engineering and safety standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. This device is a hardware system with embedded software, not a machine learning model that undergoes a "training" phase with a dataset in the conventional AI sense. The software development was "done according to the firmware development process at Medcare Flaga and it was verified that the software requirements are met."
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. See point 8.
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