(224 days)
The Embletta Gold is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta Gold records multiple physiological parameters for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel.
The Embletta Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies. Note the recorder is not equipped with an alarm device and is not intended to be used as a life monitor.
The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.
The Embletta GOLD polysomnographic recorder is intended for both clinical and research sleep applications, with 9 input channel capability of several types of physiological signals used by a physician or trained technician for the simultaneous acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient during sleep related studies.
The device will be capable of a minimum of 24 hours of recording and saving all 9 input channels either to an internal memory or to a connected computer.
The general intended environments are hospitals, institutions, sleep centers, sleep clinics, patient homes 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 recorder 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 recorded signals when downloaded and presented on a PC using a separate application software program.
Here's an analysis of the provided 510(k) summary for the Embletta GOLD™ Recorder, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device that does not incorporate AI/ML. As such, many of the requested points related to AI-specific testing (e.g., training set, MRMC studies improving human performance with AI) are not applicable to this submission. The device is a traditional hardware recorder.
Acceptance Criteria and Device Performance (Non-AI Device)
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a hardware device submission, the "acceptance criteria" are primarily based on established medical device safety and performance standards rather than specific diagnostic accuracy metrics typically found in AI/ML performance studies.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 / UL 60601-1 (Electrical Safety) | Demonstrated compliance |
| Applicable Particular Standards within IEC 60601-1 family | Demonstrated compliance |
| IEC 60601-1-2 (Electromagnetic Compatibility - Emissions) | Demonstrated compliance |
| IEC 60601-1-2 (Electromagnetic Compatibility - Immunity) | Demonstrated compliance |
| Functionality per Intended Use (24-hour recording, 9 input channels) | Demonstrated safety and effectiveness in accordance with intended use |
| Substantial Equivalence to Predicate Devices (Signals recorded) | All signals recorded by Embletta Gold are currently recorded by one or more predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical performance study with patient data for this traditional hardware device. The testing described is primarily engineering verification and validation testing to ensure compliance with electrical safety, EMC, and functional specifications.
- Data Provenance: Not applicable. The "data" here refers to engineering test results, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for this device's acceptance criteria relates to adherence to engineering standards and functional specifications, not diagnostic labels established by medical experts for a test set.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no reference to a clinical adjudication process for establishing ground truth from patient data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a data recorder, not an AI-powered diagnostic tool. The submission focuses on device safety, performance, and substantial equivalence to existing predicate devices.
- Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable, as no AI component is involved.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI without human-in-the-loop was not done. This device is a physiological signal recorder; its performance is defined by its ability to accurately acquire and record specified signals. The interpretation of these signals is explicitly stated to be performed by trained human personnel.
7. Type of Ground Truth Used
- Type of Ground Truth: For this traditional hardware device, the "ground truth" is based on:
- Engineering Test Specifications: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2).
- Functional Specifications: Verification that the device can acquire and record the specified physiological signals for the stated duration (e.g., 24 hours, 9 channels).
- Comparison to Predicate Devices: Demonstrating that the signals recorded by the Embletta GOLD are the same types of signals recorded by legally marketed predicate devices.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As there is no training set for an AI model, no ground truth was established for this purpose.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).