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The Positional Sleep Assessment System (PoSAS) Software is a software-only device intended for use by healthcare professionals to access previously recorded data for review and interpretation of sleep length, sleep disruptions, snoring, and positional sleep disordered breathing events in adults. The PoSAS Software is used in healthcare facilities to generate sleep study reports from data obtained with the Night Shift and pulse oximeter devices; reports include sleep/wake, position, snoring, SpO2, pulse rate, pulse event (6 bpm change), and/or desaturation event information. The report requires clinician interpretation of the results; it does not suggest a course of treatment or generate a diagnosis.

The Positional Sleep Assessment System (PoSAS) Software is a standalone desktop software application that provides the capability to generate reports from the data acquired with the Advanced Brain Monitoring (ABM) Night Shift (K140190) and/or a pulse oximeter. The PoSAS Software is currently compatible with the Nonin WristOx> (model 3150) cleared in K102350. The Night Shift is a small neck-worn device with software indicated for use in reporting position, movement, and sound so that positional changes in sleep quality and snoring can be assessed for adult patients only. The Nonin WrisOx₂ is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of adults and pediatric patients. The PoSAS Software is intended to be used in healthcare facilities (e.g. Clinician's office) to transfer and analyze data obtained with the Night Shift and WristOx2 by adult patient's in the home or sleep lab. The Night Shift uses a USB 2.0 data cable to transfer data via Standard USB 2.0 flash drive and the WristOx₂ uses a proprietary USB 2.0 data cable to transfer data via USB 2.0 Virtual COM Port. Once the devices are recognized, the PoSAS Software graphical user interface (GUI) enables the user to synchronize the devices by writing the same computer date/time (down to the second) to each of the devices. The PoSAS Software also allows for the data to be erased from both the Night Shift and WristOx2 devices, and allows for the Night Shift device settings (I.e. Vibration feedback on, Vibration feedback off, or Trial mode) to be updated prior to recording. Once the clock times from the two devices are synchronized, and the user has set the desired settings of the Night Shift device (i.e., identical to features available using Night Shift software), the Night Shift and WristOx2 are worn by a patient to record sleep study data. The PoSAS Software reads the study files and recognizes the respective clock times within each file, and aligns the data for generation of a PoSAS report. The PoSAS Software report presents the Night Shift data, analyzed pulse oximeter data, and combines the positional data from the Night Shift with the analyzed results from the pulse oximetry data. A PoSAS Software report can be generated either from the data saved on the connected Night Shift and pulse oximeter devices or from data saved to the hard disk of the personal computer. Data from the Night Shift is displayed on the PoSAS Software report without modification. The PoSAS Software calculates oximetry data based on the once per second SpO₂ and pulse data acquired by the pulse oximeter. 3% or 4% desaturations and pulse events (6 bpm change) are also calculated. The PoSAS software combines Night Shift position information with calculated oximetry data to present metrics based on the patient's position (supine or non-supine).

Here's a breakdown of the acceptance criteria and the study details for the Positional Sleep Assessment System (PoSAS) Software, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal table of specific acceptance criteria with corresponding performance metrics for all features. However, it does highlight key performance aspects and claims of equivalence.

From the text, the core acceptance criteria are implied to be:

• Accuracy and Sensitivity of Pulse Oximeter Event Recognition: The software must accurately recognize pulse events and 3%/4% desaturation events.
• Equivalence of SpO2 and Pulse Metrics: The PoSAS software's calculation and reporting of SpO2 and pulse rate metrics must be equivalent to the reference Sleep Profiler software.
• Equivalence of Position-Related Metrics: The display of position-related metrics, particularly when combining Night Shift data with oximetry, must be equivalent to what the predicate device or comparable reference software provides.

Reported Device Performance:

Study Used to Prove Device Meets Acceptance Criteria:

The document describes a non-clinical study that involved several components:

• Software Verification and Validation Testing: Conducted in compliance with FDA guidance for software in medical devices, ISO 14971:2007 (risk management), "General Principles of Software Validation," and "Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
• Performance Testing with Pulse Oximeter Tester: This test specifically assessed the software's ability to recognize pulse and desaturation events.
• Retrospective Comparative Analysis: Data from sleep studies acquired with a different device (Advanced Brain Monitoring X8/PSG2) were analyzed independently by both the PoSAS software and the reference Sleep Profiler software (K153412). The goal was to demonstrate agreement and equivalence of SpO2 and pulse metrics between the two software applications.

Detailed Study Information:

1. Sample Size used for the Test Set and the Data Provenance:

   • Sample Size: Not explicitly stated. The document mentions "Retrospective data from sleep studies acquired with the Advanced Brain Monitoring X8/PSG2 device." It does not provide the number of patients or studies included in this retrospective test set.
   • Data Provenance: The data was retrospective and acquired using the Advanced Brain Monitoring X8/PSG2 device (K152040). The country of origin for the data is not specified.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • The document does not explicitly state that human experts established the ground truth for the test set in the comparative analysis between PoSAS and Sleep Profiler. Instead, the Sleep Profiler software itself (a cleared reference device) served as the "ground truth" or reference for comparison against PoSAS for SpO2 and pulse metrics.
   • For the performance testing using the Pulse Oximeter Tester, the "ground truth" would be the known, programmed patterns of SpO2 and pulse changes generated by the tester.

3. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

   • No adjudication method involving human experts is described for the test set used in the comparative analysis between PoSAS and Sleep Profiler. The comparison was directly between the outputs of the two software programs.

4. 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 comparative effectiveness study was not done. The PoSAS software is a standalone desktop application for report generation and analysis of recorded data. It does not describe a human-in-the-loop scenario or evaluate the improvement of human readers with AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance assessment was conducted. The entire performance testing and retrospective comparative analysis described (comparing PoSAS to a Pulse Oximeter Tester and to Sleep Profiler software) evaluates the algorithms and software without explicit human intervention in the interpretation process of those specific tests. The intended use states the report "requires clinician interpretation of the results; it does not suggest a course of treatment or generate a diagnosis," indicating that while the software is standalone in its analysis, clinical interpretation remains a human task.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For SpO2 and pulse metrics: The "ground truth" for demonstrating equivalence was the algorithms and output of the legally marketed reference device software, Sleep Profiler (K153412).
   • For recognition of pulse events and 3%/4% desaturation events: The "ground truth" was the known, generated patterns from a Pulse Oximeter Tester.
   • For Night Shift data (e.g., position, snoring metrics): The "ground truth" for demonstrating equivalence was the Night Shift software (K140190), which provides "identical" processing and reporting for these metrics.

7. The sample size for the training set:

   • The document does not provide information on a training set or its sample size. This is common for software systems that replicate or combine existing, cleared algorithms rather than developing new predictive models requiring extensive supervised learning. The PoSAS software primarily harmonizes and displays data, and uses algorithms "identical" or "similar" to previously cleared devices.

8. How the ground truth for the training set was established:

   • As no training set is mentioned, no information on establishing its ground truth is provided.

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