(110 days)
Sleep Profiler is intended for use for the diagnostic evaluation by a physician to assess sleep quality and score sleep disordered breathing events in adults only. The Sleep Profiler is a software-only device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results; including the staging of sleep, detection of arousals, snoring and sleep disordered breathing events (obstructive apneas, hypopneas and respiratory event related arousals). Central and mixed apneas can be manually marked within the records.
The Sleep Profiler is a software application that analyzes previously recorded physiological signals obtained during sleep. The Sleep Profiler software can analyze any EDF files acquired with the Advanced Brain Monitoring X4 System and the X8 System models SP40 and SP29. Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of: Sleep stages Rapid Eye Movement (REM) and nREM (N1, N2, N3) and wake, Heart/pulse rate, Snoring loudness, Sleep/wake, Head movement and position, Snoring, sympathetic, behavioral and cortical arousals, ECG,EOG, EMG waveform, SpO2, Airflow, Respiratory Effort, Apneas and Hypopneas, Oxygen desaturations. The software identifies and rejects periods with poor electroencephalography signal quality. The full disclosure recording of derived signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report. Medical and history information can be input from a questionnaire. Responses are analyzed to provide a pre-test probability of Obstructive Sleep Apnea (OSA). The automated analyses of physiological data are integrated with the questionnaire data, medical and history information to provide a comprehensive report. Several report formats are available depending on whether the user has acquired more than one night of data, wishes to obtain a narrative summary report or provide patient reports. The Sleep Profiler software can be used as a stand-alone application for use on Microsoft Windows 7 & 8 operating system platforms (desktop model). Alternatively, the user interface (i.e., entry or editing of information) can be delivered via a web-portal (portal model). The capability to enter or edit patient information, call the application to generate a study report, and/or download a report is provided using either the desktop PC application or web-portal application. The same analysis and report generation software is used for both the desktop and web-portal applications.
Here's a breakdown of the acceptance criteria and study information for the Sleep Profiler device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint | Acceptance Criteria (Equivalent to Predicate Device) | Reported Device Performance (Sleep Profiler) |
|---|---|---|
| AHI for OSA Diagnosis | Minimum targeted positive likelihood ratios for AHI > 5 and AHI > 15 are 3.5 and 5.0 respectively (equivalent to predicate ARES). | Overall AHI: |
- AHI ≥ 5: Positive Likelihood Ratio = 6.67
- AHI ≥ 15: Positive Likelihood Ratio = 33.0
REM AHI: - AHI ≥ 5: Positive Likelihood Ratio = 8.84
- AHI ≥ 15: Positive Likelihood Ratio = 18.33
(These values exceed the minimum targeted likelihood ratios indicating equivalence) |
| Sleep Staging (Agreement with Expert Consensus) | Comparison of auto-detected staging to PSG results obtained by expert raters, showing equivalent agreement to the predicate Sleep Profiler (K130007). No specific numeric thresholds are explicitly stated as acceptance criteria, but generally high concordance is expected for substantial equivalence. | Overall (n=43 subjects, 3 raters): - Wake: Positive Agreement 0.73, Negative Agreement 0.94
- N1: Positive Agreement 0.25, Negative Agreement 0.93
- N2: Positive Agreement 0.77, Negative Agreement 0.84
- N3: Positive Agreement 0.76, Negative Agreement 0.94
- REM: Positive Agreement 0.74, Negative Agreement 0.97
(The document states "met" for this endpoint by comparison to the predicate.) |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size (for AHI/OSA detection): 60 subjects for overall AHI, 40 subjects for REM AHI.
- Sample Size (for Sleep Staging): A subset of 43 subjects from the AHI study, with at least 4 hours of raw X8 diagnostic recording time.
- Data Provenance: The document states "signals acquired with the X8 System concurrent to polysomnography (PSG)." This implies the data was prospectively collected for this evaluation, likely from a clinical setting, but the country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts:
- For AHI/OSA detection: "one rater per study" for PSG results.
- For Sleep Staging: "weighted majority agreement of three raters" for the 43-subject subset.
- Qualifications of Experts: Not explicitly stated beyond being "rater(s)" for PSG and "expert scoring" for sleep staging. Standard practice for such studies would imply board-certified sleep technologists or physicians experienced in PSG scoring.
4. Adjudication Method for the Test Set
- For AHI/OSA detection: "one rater per study." This implies no formal adjudication/consensus process among multiple independent reviewers, as only a single rater's PSG results were used as ground truth for each case.
- For Sleep Staging: "weighted majority agreement of three raters." This indicates an adjudication method where the consensus of three experts established the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is explicitly described where human readers' performance with and without AI assistance is compared. The study primarily focuses on the standalone performance of the Sleep Profiler software against expert-scored PSG.
6. Standalone Performance Study
- Yes, a standalone study was performed. The "Sleep Profiler software accuracy was clinically validated with signals acquired with the X8 System concurrent to polysomnography (PSG)." The results presented for AHI and sleep staging are for the algorithm's performance without human intervention, compared to human-scored PSG.
7. Type of Ground Truth Used
- Expert Consensus / Human Scoring: The primary ground truth for both AHI detection and sleep staging was derived from Polysomnography (PSG) results scored by human experts/raters. For sleep staging, it was specifically based on the "weighted majority agreement of three raters."
8. Sample Size for the Training Set
- The document does not explicitly state the sample size used for the training set of the Sleep Profiler software. It describes the clinical validation study (test set) but not the development data.
9. How Ground Truth for the Training Set Was Established
- The document does not provide details on how the ground truth for the training set was established. Typically, for such devices, training data would also be derived from expert-scored PSG, similar to the test set, but this information is not included in the 510(k) summary.
§ 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).