(288 days)
The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp.
The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions.
Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Seer Home is only to be used under the direction and supervision or EEG technologist or clinician.
The Seer Medical - Seer Home is an ambulatory electroencephalograph system designed to be used at the patient's home for up to week-long studies. The ambulatory EEG recorder (called "Seer Sense" or "Wearable") is worn around the patient shoulders. The Wearable has a single cable exiting from the bottom of the device and is routed inline to 3 disposable ECG electrodes which are positioned on the chest for ECG recording. Exiting from the rear of the Wearable is single flexible cable which has a junction at the top of the patient's head connected to the 22 EEG electrodes (disposable) which are positioned in the international '10-20' system for EEG recording.
The Wearable records the EEG and ECG signals and wirelessly transmits them to a nearby "Seer Sight Video Monitoring Hub" in the patient's house. The Video Monitoring Hub has two roles, first to store the wireless data from the wearable, and the second is to record video from an in-built camera that is synchronized to the EEG/ECG data. The use of the recorded video data provides additional information to the physician (such as body movement artifacts) to assist in diagnosis in the neurological conditions.
At the end of the study period (up to a week) the Wearable and Hub are returned back to the clinic for data download. The Seer Cloud Platform software downloads the data, stores the data, displays the EEG/ECG signals and video for reviewers to interpret, make annotations, and produce reports.
The Seer Home is intended to be used by qualified operators or physicians trained in the interpretation of EEG/ECG signals and visual cues of patient movements - and is viewed as a part of a range of assessments used by Neurologists to assist in making diagnosis of neurological conditions.
The accessories used with the Seer Home are disposable EEG electrodes, disposable ECG electrodes, Transport/Carry case, Medical Grade Power Adapter, IFU, and Rechargeable Batteries.
The Seer Home device, an electroencephalographic system, did not report any clinical study for assessing device performance against acceptance criteria. The submission states, "There is no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device." It relies on technical evaluations and non-clinical performance data to demonstrate substantial equivalence to the predicate device, MobileMedTek ElectroTek (K170441).
The non-clinical performance data and findings are summarized as follows:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical/Technical):
| Characteristic | Acceptance Criteria (Seer Home) | Reported Device Performance (Seer Home) | Predicate Device (ElectroTek K170441) |
|---|---|---|---|
| Technical - EEG | |||
| CMRR (Common Mode Rejection Ratio) | > 80 dB (EEG standard requirement) | > 84 dB | > 110 dB |
| Noise | 100 MΩ | > 100 MΩ | > 100 MΩ |
| Low Filter | Comply with American Clinical Neurophysiology Society EEG filter guideline of 1 Hz | 0.5 Hz to 10 Hz (complies with 1 Hz guideline) | 0.05 Hz to 39.8 Hz (complies with 1 Hz guideline) |
| High Filter | Comply with American Clinical Neurophysiology Society EEG filter guideline of 70 Hz | 15 Hz to 70 Hz (complies with 70 Hz guideline) | 1 Hz to 200 Hz (complies with 70 Hz guideline) |
| Notch Filter | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable |
| A/D Conversion | 24 bit | 24 bit | 24 bit (reported as 12 bit then 24 bit in two different sections, assuming 24 bit as per comparison text) |
| Sampling Rate (EEG) | 500 Hz (IEC standard requirement) | 500 Hz | 500 Hz |
| Trigger Mode | Manual event marker | Manual event marker | Manual event marker |
| Safety Standards | |||
| Medical Electrical Safety Standard | IEC 60601-1 ed3.1 | Complies | IEC 60601-1 ed3.1 |
| EMC | IEC 60601-1-2 ed4.0 | Complies | IEC 60601-1-2 ed3.0 |
| Medical Home Usage | IEC 60601-1-11 ed2.0 | Complies | Not specified for predicate |
| ECG | IEC 60601-2-25 ed2.0 | Complies | Not specified for predicate |
| EEG | IEC 60601-2-26 ed3.0 | Complies | IEC 60601-2-26 ed3.0 |
| Biocompatibility | ISO 10993-1 ed5.0 2018 | Complies | ISO 10993-1:2009 |
| Cytotoxicity | ISO 10993-5 | Complies | Not explicitly detailed for predicate |
| Sensitization & Irritation | ISO 10993-10 | Complies | Not explicitly detailed for predicate |
| Software | |||
| Software documentation | FDA Guidance for Software in Medical Devices ("Moderate" level of concern) & IEC 62304 | Complies | Complies |
| Usability | |||
| Usability evaluation | FDA Guidance, IEC 62366-1:2015 | Complies | Not explicitly detailed for predicate |
| Device Specific Verification | |||
| Package Drop | ASTM D5276 | Complies | Not explicitly detailed for predicate |
| Input Impedance tests | (Not explicitly stated, assumed to be part of >100MΩ) | Complies | Not explicitly detailed for predicate |
| Filter verifications | (Not explicitly stated, but verified) | Complies | Not explicitly detailed for predicate |
| Home Use compliance | IEC 60601-1-11 | Complies | Not explicitly detailed for predicate |
| Other verification tests | Event triggers, battery monitoring, audio/visual feedback | Complies | Not explicitly detailed for predicate |
2. Sample size used for the test set and the data provenance:
No clinical test set was reported. The technical evaluations mentioned were performed on the device itself as part of verification and validation processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set was reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set was reported.
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 MRMC study was reported. The device is for acquisition, display, and storage of EEG signals; it "does not draw any diagnostic conclusions" and as such, does not incorporate AI for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a system for signal acquisition and display, not an AI algorithm performing diagnosis or analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical test set with ground truth was reported. For technical evaluations, the ground truth was based on established industry standards and regulatory guidance for medical devices, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-25, IEC 60601-2-26, ISO 10993-1/5/10, ASTM D5276, and FDA/IEC guidance for software and usability.
8. The sample size for the training set:
Not applicable as no machine learning algorithm development with a training set was reported.
9. How the ground truth for the training set was established:
Not applicable as no training set was reported.
§ 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).