(90 days)
THIS DEVICE IS INTENDED FOR USE IN LONG-TERN RECORDING OF VOLTAGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW WITH A DIGITAL WORK-STATION SUPPLIED BY THE MANUFACTURER (TELEFACTOR BEEKEEPER) OR SIMILAR COMPATIBLE DEVICE. AN INTEGRATED PULSE OXIMETER PROVIDES SUPPLEMENTAL DIAGNOSTIC DATA IN THE FORM OF BLOOD OXYGEN SATURATION (SpO2 percent).
The H2O system is battery powered, wearable, 32 channel EEG amplifies/recorder. The H2O system operates on a pack of eight Alkaline batteries for twelve hours or a pack of two lithium batteries for 24 hours. Unlike DEEG-LITE, the H2O recorder never operates from mains power, but only from batteries. Like DEEG-LITE, a binary, optically isolated output data stream is utilized by a notebook or desktop computer for initial setup. Unlike DEEG-LITE, all data recording in H2O is performed internally in the wearable device in a Flash-RAM for short recordings, or on an internal rotating disk for long recordings. The DEEG-LITE utilizes DSPs (Digital Signal Processors) for data manipulation and preparation. It uses a Intel-486 or Pentium processor in a notebook computer for data recording and display. H2O uses a single internal INTEL 186 processor for data manipulation and recording and an external notebook or desktop computer only for initial setup and electrode application to verify good EEG waveform at the beginning of the data recording session. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The provided text, a 510(k) summary for the H2O device, focuses on demonstrating substantial equivalence to a predicate device (DEEG-LITE) rather than outlining specific, quantifiable acceptance criteria and a detailed study against them. This is typical for a 510(k) submission where the primary goal is to show the new device is as safe and effective as a legally marketed device.
Therefore, the "acceptance criteria" are implied through the comparison to the predicate device's performance, and the "study" is largely a non-clinical (bench) test demonstrating identical or better performance.
Here's the breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (H2O vs. DEEG-LITE) |
|---|---|
| EEG Recording Performance: Equivalent to predicate device. | H2O System has "recording performance identical" to the Telefactor DEEG-LITE System. |
| Signal-to-Noise Ratio (SNR): Equal to or better than predicate device. | The wearable amplifiers (H2O) have "equal or better signal to noise ratio" compared to DEEG-LITE. |
| Digital Resolution: Equal to predicate device. | The wearable amplifiers (H2O) have "equal digital resolution" compared to DEEG-LITE. |
| Sample Rates: Identical to predicate device. | The wearable amplifiers (H2O) have "identical sample rates" compared to DEEG-LITE. |
| Electrical Safety: Compliance with UL2601-1 and IEC601-1 standards. | Design of H2O electronics was carried out "with careful attention to compliance with these standards." |
| Intended Use: Long-term monitoring of EEG for suspected seizure and sleep disorders, with SpO2 data. | The H2O is intended for "long term monitoring of EEG of patients with suspected seizure disorders, and sleep disorders" and includes an integrated pulse oximeter for "supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent)." This is consistent with the predicate device's use, with the added oximeter paralleling frequent external use with the DEEG-LITE. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified, as only non-clinical (bench) tests were deemed necessary. No patient data or clinical sample size is mentioned for testing.
- Data Provenance: Not applicable, as there are no clinical studies or human data mentioned for the H2O device's performance evaluation against the predicate. The "Bench Tests" would typically involve laboratory measurements on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There are no clinical studies or expert-driven ground truth establishment mentioned for the performance evaluation.
4. Adjudication Method for the Test Set
- Not applicable. There are no clinical studies or expert adjudication processes described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Because of the identical performance confirmed by Bench Tests, clinical performance tests are deemed unnecessary." This indicates no human reader comparison was performed or considered necessary.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question isn't directly applicable in the context of this device. The H2O is an EEG recorder/amplifier, a hardware medical device that generates data for a clinician to review, not an algorithm that autonomously interprets data. The performance evaluation focuses on the fidelity of the recording itself, rather than an AI's interpretation of it. The "Bench Tests" would serve as the standalone performance assessment of the hardware's electrical characteristics.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance appears to be established through engineering specifications and direct measurements against the predicate device's known performance characteristics. The document highlights "equivalent noise performance," "equal or better signal to noise ratio," "equal digital resolution," and "identical sample rates" verified through bench tests. The predicate device (DEEG-LITE) itself, having been previously cleared, serves as the de facto performance standard.
8. The Sample Size for the Training Set
- Not applicable. The H2O device is a hardware EEG recorder and amplifier, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
Summary of the Study:
The "study" to prove the H2O device meets its acceptance criteria (which are defined by its equivalence to the predicate DEEG-LITE) consists solely of Nonclinical (Bench Tests). These tests are described as documenting "equivalent noise performance" and verifying that the H2O's wearable amplifiers have "equal or better signal to noise ratio, equal digital resolution, and identical sample rates" compared to the DEEG-LITE system. The H2O also incorporated electrical safety design in accordance with UL2601-1 and IEC601-1 standards. The conclusion drawn from these bench tests is that "the nonclinical (Bench Tests) demonstrate that the device is safe, effective and performs as well as the predicate device." No clinical studies or human performance evaluations were conducted or deemed necessary.
§ 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).