(105 days)
Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality 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 and snoring.
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 meeting defined specifications, including signals acquired with the Advanced Brain Monitoring X4 System. 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: a) sleep stage, b) snoring frequency and severity, c) pulse rate, d) cortical (EEG), sympathetic (pulse) and behavioral (actigraphy and snoring) arousals. A single channel of electrocardiography, electrooculargraphy, electromyography, or electroencephalography can be optionally presented for visual inspection and interpretation. 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) (a condition that cannot be diagnosed with Sleep Profiler) so an appropriate referral to a sleep physician is made. 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 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 in a web-based module which emulates the desktop functionality. The same analysis and report generation software is used for both the desktop and web-portal applications.
The provided text describes a 510(k) submission for the Advanced Brain Monitoring, Inc. Sleep Profiler (K130007). This submission is for modifications to an already cleared device (K120450) to introduce a web-based module for patient information entry and report generation/download. The core analysis and report generation software remains unchanged from the predicate device.
Therefore, the acceptance criteria and study information provided in this document focus exclusively on the non-clinical testing performed to demonstrate that the new web-based module functions equivalently to the desktop application. There is no clinical study described here that would involve human readers, ground truth establishment through expert consensus or pathology, or outcome data for performance metrics like sensitivity, specificity, etc.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Key Metric for Software Verification) | Reported Device Performance |
|---|---|
| Confirmation of identical performance using either the desktop or portal for key functions: | The results of the verification and validation activities demonstrate that the software meets requirements for safety, function, and intended use, including: |
| - Enter questionnaire responses | - Performance is identical for entering questionnaire responses via desktop or portal. |
| - Edit study data | - Performance is identical for editing study data via desktop or portal. |
| - Initiate generation of a study report | - Performance is identical for initiating generation of a study reports via desktop or portal. |
| - Download a study report | - Performance is identical for downloading study reports via desktop or portal. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The verification and validation activities tested the functionality of the web-based module against the desktop application, indicating a comparative test of functionalities. It does not refer to a "test set" in the context of clinical data.
- Data Provenance: Not applicable in the context of clinical data, as this was a non-clinical software verification study. The tests would have involved functional verification of the software.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission focuses on software functionality verification, not clinical performance requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This was a non-clinical software verification, not a clinical study requiring adjudication of expert interpretations.
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. An MRMC study was not conducted or described in this document. The submission explicitly states that "The modifications ... did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, indirectly. The Sleep Profiler is described as a "software-only device" that "automates recognition of: a) sleep stage, b) snoring frequency and severity, c) pulse rate, d) cortical (EEG), sympathetic (pulse) and behavioral (actigraphy and snoring) arousals." The verification discussed here specifically confirms that the web-based module performs these functions identically to the pre-existing desktop version, which does perform these analyses automatically without continuous human intervention during the analysis phase. However, it's intended to be "used under the supervision of a clinician" and the reporting can be "visually inspected and edited prior to the results being integrated into a sleep study report," implying a human-in-the-loop for final interpretation. The performance of the automated algorithm itself was established in the predicate device (K120450) and is not being re-evaluated for K130007.
7. The Type of Ground Truth Used
- Not applicable for clinical performance. For the software verification described, the "ground truth" was the expected functional output and behavior of the established desktop application (K120450). The web-based module was verified to produce identical results.
8. The Sample Size for the Training Set
- Not provided/not applicable. This submission does not discuss algorithmic development or training sets. It is a modification to an already existing software application. The predicate device (K120450) would have had this information.
9. How the Ground Truth for the Training Set Was Established
- Not provided/not applicable. As above, this information relates to the original algorithmic development, not the current submission for a web-based module.
§ 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).