(279 days)
The Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes on the head of patients. It acquires, records and transmits two channels of electroencephalogram (EEG) data. The medical use of data acquired by the Byteflies Kit is to be performed under the direction of a licensed medical professional. The Bytellies Kit does not provide any diagnostic conclusions about the patient's condition.
The Byteflies Kit is a wearable medical device for continuous recording of non-invasive physiological signals in healthcare and home settings. The Byteflies Kit is intended to be configured by a trained healthcare professional and consists of 3 main components:
- Sensor Dot: a biopotential wearable sensor that measures up to 2 bipolar channels of electroencephalography (EEG). It is powered by a rechargeable battery, can record data for up to 24 hours on a single charge, and has an LED indicator to report the operating status to the user. The sample-level EEG data is continuously stored on the Sensor Dot for later retrieval.
- Sensor Patch: the interface between a Sensor Dot and non-invasive biopotential electrodes (not provided). It attaches magnetically to the Sensor Dot and has four DIN 42802 connectors. Two commercial disposable EEG electrodes per Sensor Patch channel are connected to the head of the subject in a reduced EEG montage. The Sensor Dot attached to the Sensor Patch is carried by the patient to continuously measure electrical brain activity.
- Docking Station: up to 5 Sensor Dots can connect magnetically to the Docking Station and transfer recorded data to the Docking Station, while charging their batteries. The recorded sample-level EEG signals can then be downloaded from the Docking Station's Management Interface to a computer via a local WiFi network for long-term storage and further review by a healthcare professional. An AC/DC adapter with micro-USB cable supplies power to the Docking Station.
The provided text is a 510(k) summary for the Byteflies Kit, an electroencephalograph device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often found in clinical trial reports for AI/CAD devices.
Therefore, much of the requested information regarding acceptance criteria, test set details (sample size, provenance, expert adjudication), MRMC studies, standalone performance, and ground truth for training/testing is not available in the provided document. The document primarily relies on non-clinical (bench) testing and comparison to a predicate device.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
Acceptance Criteria and Device Performance
The Byteflies Kit is an electroencephalograph (EEG) device, not an AI/CAD system for diagnostic purposes. Its performance is evaluated against electrical safety and electromagnetic compatibility standards, and its ability to accurately acquire, record, and transmit two channels of EEG data. The document asserts that the device meets these requirements and is substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an EEG device primarily asserting substantial equivalence based on technical specifications and adherence to standards, explicit "acceptance criteria" and "reported device performance" in the context of an AI/CAD diagnostic study (like sensitivity, specificity, AUC) are not present. Instead, the "performance" is demonstrated through compliance with various safety and electrical standards.
| Acceptance Criteria (Inferred from regulatory compliance) | Reported Device Performance (as stated in the document) |
|---|---|
| Electrical Safety Standards: | |
| IEC 60601-1:2005 | Meets the requirements of IEC 60601-1:2005 |
| IEC 60601-1-11:2015 (Home Healthcare) | Meets the requirements of IEC 60601-1-11:2015 |
| IEC 60601-2-26:2012 (Particular EEG requirements) | Complies with IEC 60601-2-26:2012 |
| Electromagnetic Compatibility (EMC) Standards: | |
| IEC 60601-1-2:2014 | Meets the requirements of IEC 60601-1-2:2014 |
| Biocompatibility Standards: | |
| ISO 10993:2018 (Cytotoxicity, Sensitization, Skin Irritation) | Meets all applicable requirements of ISO 10993:2018; all external parts were tested |
| Usability Standards: | |
| IEC 60601-1-6:2010 | Meets all applicable requirements of IEC 60601-1-6:2010 |
| Alarms and Alarms Systems Standards: | |
| IEC 60601-1-8:2006 | Meets all applicable requirements of IEC 60601-1-8:2006 |
| Functional Equivalence to Predicate Device: | |
| Acquire, record, and transmit two channels of EEG data | Acquires, records, and transmits two channels of EEG data |
| No diagnostic conclusions provided | Does not provide any diagnostic conclusions |
| Intended for prescription use | Intended for prescription use |
| Operates in home, healthcare, clinical research | Operates in home, healthcare, clinical research |
2. Sample Size Used for the Test Set and the Data Provenance
The document states, "The Byteflies Kit is an electroencephalographic device comprised of hardware and software that has been bench tested to assess safety and effectiveness, and to establish substantial equivalence with the predicate device. We believe further clinical data is not required to demonstrate performance of the Byteflies Kit for the indications for use subject to this submission."
- Sample Size for Test Set: Not applicable/not provided. The "testing" referred to is primarily bench testing for electrical, EMC, and biocompatibility standards, not a clinical test set of patient data.
- Data Provenance (Country of origin, retrospective/prospective): Not applicable, as no clinical test set data is described. The tests were performed by "Independent UL-certified laboratory testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable/not provided. No clinical ground truth establishment process is described as clinical data was deemed "not required."
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. No clinical test set requiring adjudication is 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
- MRMC Study: No. This device is an EEG acquisition and recording system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device that assists human readers with interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This device is not an algorithm for diagnostic interpretation. Its "performance" is in signal acquisition and adherence to technical standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. The device's function is to acquire EEG signals. The accuracy and quality of these signals are determined by compliance with the aforementioned technical standards (e.g., signal fidelity under IEC 60601-2-26), rather than by comparison to a "ground truth" of a disease state. The document explicitly states the device "does not provide any diagnostic conclusions about the patient's condition," meaning it's not classifying or diagnosing.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a hardware device for signal acquisition, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As it is not an AI/ML device, there is no training set or associated ground truth.
§ 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).