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The Bio-logic Sleepscan product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. Sleepscan Analysis performs calculations and presents recorded data in various ways on the computer screen and in reports. The Analysis features in the Sleepscan product are intended to be performed without patient hookup being necessary, and may even be performed on a different computer system from that which was used for the patient recording.

It can be used for patients of all ages, from children to adults, including geriatric patients. The use of the Sleepscan family of products is to be performed under the prescription of a physician or other trained health care professional.

The primary feature modification represented in this Special 510(k) is for the Microsoft Windows operating system and its associated user interface functionality.

The Bio-logic Sleepscan family of products is intended to be used for the recording and analysis of human physiological data for the purpose of diagnosis and treatment of Sleep-related disorders. The predicate vice referenced above was the first such system marketed by Bio-logic. Other related devices comprising the Sleepscan family include:

• 1 . 510(k) #K930790 - Addition of Oximeter to Sleepscan Product.
• 510(k) #K964132 Modification to Bio-logic Sleepscan product with Built-in Oximeter, 2.
• 3. 510(k) #K971501 - Sleepscan Airflow Pressure Transducer.

The predicate device performs both Sleep recording and analysis functions, providing up to 40 channels of simultaneous data recording from a variety of sensors and transducers, and a number of specialized analysis functions including event highlighting and Sleep stage identification. Related Device #1 above is a recording hardware modification to Bio-logic's standard 32-channel EEG recording system, incorporating a built-in Oximeter module and DC channels specifically designed for Sleep recordings. Related Device #2 above is another recording hardware modification, this one based on the Bio-logic "Ceegraph Traveler" (510(k) #K954954) device. Also incorporating a built-in oximeter, this is a smaller battery-operated device offering fewer recording channels at a lower price. Related Device #3 above is a very sensitive transducer for the recording of airflow associated with breathing, based on the measurement of air pressure variations instead of the more indirect method using temperature measurements.

Throughout the history of the Sleepscan product, from the introduction of the present, all Sleepscan software has been developed and based on the Microsoft MS-DOS Operating System. This new Special 510(k) is for the Device Modification of Sleepscan software, the primary new feature being the use of the Microsoft Windows Operating System. As such, although most of the standard Sleepscan functions are very similar to those used in the DOS version, much of the User Interface and presentation of graphical data is now performed using Windows-standard Graphical User Interface (GUI) methods. This 510(k) does not cover the recording functions of the Sleepscan family, which are defined in the predicate device and Related Devices #1 and #2 above. Data recording may be performed using any of the Bio-logic approved-for-market Sleepscan and Ceegraph recording devices with the associated recording software. Any recordings made for the diagnosis and treatment of Sleep disorders can be analyzed with either the existing DOS-based software or the new Windows-based software. This latter software package is the subject of this 510(k).

Most of the finctional features of the Bio-logic Sleepscan for Windows software package are similar to those of the predicate device. These include:

• Graphical presentation of the "raw data" as recorded by one of the recording devices. .
• Epoch-based data scaling to simulate paper recordings. ﻬ
• Variable time scaling of data (simulating a variety of "paper speeds") and variable epoch sizes for detailed or summary viewing.
• Rapid report generation based on operator review and interaction with the data presented by the Analysis software.
• Several summary graphs allow for the display of the complete night's Sleep recording on one screen, allowing the user to quickly identify periods of the study requiring closer scrutiny.
• Graphical Overlay with Zoom-In allows the user to quickly look at "interesting" periods of a night's Sleep recording at the raw data level.
• User-defined montages and comments.
• Screen presentations can be customized to display several different kinds of data in separate windows at the same time.
• Data analysis is performed on specific channels of raw data for the identification of possible respiratory or neurological events.
• • Color-coded events highlight areas of the data for further review by the technologist or physician.
• Computer-assisted highlighting of data events can be easily modified or deleted by the user, and new events not highlighted by the program can be added at the user's discretion.

New features in the Windows-based software include:

• ◆ Standard Windows GUI functionality.
• · Extensive On-line Help.
• · More extensive and user-configurable reporting features.
• · Patient database information features.
• · Enhanced sleep stage scoring features.

The provided text describes a 510(k) summary for a software modification to the Bio-logic Sleepscan product, moving it from a DOS-based operating system to a Windows-based one. The focus of the document is on establishing substantial equivalence to a predicate device for this software modification.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present formal acceptance criteria or quantitative performance metrics in the way one might expect for a new algorithmic device claiming improved diagnostic accuracy. Instead, it aims to demonstrate equivalence to a predicate device. The "Performance" parameter in the comparison table explicitly states "No differences."

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective or prospective) for validating the software modification. The approach taken is comparative to a predicate device, focusing on functional equivalence rather than new performance claims requiring a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no specific test set or clinical study to establish new performance claims is described, there is no mention of experts or ground truth establishment in this context. The assessment relies on a comparison of technological characteristics and functionalities.

4. Adjudication Method

There is no mention of an adjudication method as no test set requiring multi-expert review or consensus is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The document describes a software modification primarily focused on the operating system and user interface, aiming to maintain core functionality rather than demonstrate improved human reader performance with AI assistance. The device's analysis functions are described as computer-assisted highlighting, subject to user review and modification, emphasizing that the program does not make final diagnoses.

6. Standalone Performance Study

No standalone performance study was explicitly described. The document focuses on the functional similarity to the predicate device's analytical features, which include event identification and data highlighting, but these are presented as tools for a human expert, not as a standalone diagnostic algorithm. The emphasis is on the software supporting human diagnosis rather than replacing it.

7. Type of Ground Truth Used

Given the nature of the software modification (OS migration and GUI enhancement) and the absence of new performance claims, no specific type of ground truth (e.g., expert consensus, pathology, outcome data) was used or discussed in relation to validating this modification. Validation appears to be based on functional verification and equivalence to the predicate.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is understandable as the modification is to an existing analysis system, and the focus is on re-platforming the software functionality, not on training a new machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set, there is also no information on how ground truth for a training set was established. The software's "computer-assisted highlighting" suggests rule-based or historically developed algorithms rather than modern machine learning requiring extensive labeled training data.

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