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The Rubicon screening device is a small battery-powered device designed to assess and record nasal and oral airflow in adult patient during sleep in the home setting. The device is intended as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography (PSG) based on the patient's test data.

The Rubicon Screening Device is comprised of 3 components and software. For the physical device. Rubicon is comprised of an Airflow sensor, cable connecting air flow sensor and a single inline module (SIM) as described below:

Airflow sensor: The airflow sensor is placed under the user's nose where it converts temperature and pressure changes to a voltage signal. Polarized Polyvinylidene Fluoride (PVDF) is a temperature-sensing material. PVDF generates a small electrical charge in response to temperature change. The sensor is permanently connected to the SIM via two lead wires. The temperature difference between patient exhaled air and ambient air, as well as airflow pressure on the sensor generates a small voltage signal, which can be recorded as airflow by recording equipment. The vibration of breath sounds (snoring) produces a small voltage signal, which can be recorded as snoring by recording equipment. As integrated into the Rubicon, the airflow sensor provides two channels of output data from the same PVDF sensor. One channel focuses on sinusoidal airflow waveforms for identification of airflow events, and the second channel provides snore data.

Cable: The lead wires are a typical cable pair. The lead wires were reviewed as part of the IEC 60601-1 safety evaluation. The lead wires transmit signals from the airflow sensor to the SIM and are permanently attached to the airflow sensor and the SIM.

SIM (Housing and PCB): The SIM's primary function is to collect raw electrical signals from the airflow sensor. These signals include airflow and snore analog data. These analog signals are filtered and acquired by the SIM's A/D converter, then transmitted in real time to a nearby Smartphone, which must be running the Rubicon companion app. The SIM PCB is powered by a small coin cell battery.

Software: The basic purpose of the software is to: Collect data from the sensor device by transmitting the data to a collection hub, which is a Smartphone + a mobile software application (app). Transmit data to a remote data center, which is accomplished via the cellular network. Store, process, and display data to a health care professional or end user via the Rubicon Analysis Software PC application and its report. The system consists of three major components: Sim Software (firmware), Rubicon App and Rubicon Desktop Software

The Rubicon Screening Device is intended to assess and record nasal and oral airflow in adult patients during sleep in a home setting. It functions as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography (PSG) based on the patient's test data.

The provided document, K200654, mainly focuses on establishing substantial equivalence to a predicate device (IMS-SleepCheck, K022294) and a reference device (Dymedix – Airflow Sensor, K040069). It describes the device's design, components, and indications for use, and outlines non-clinical testing performed (biocompatibility, electrical safety, electromagnetic compatibility, and comparative performance testing). However, it does not present a detailed study demonstrating specific acceptance criteria with reported performance metrics, nor does it provide the detailed information requested in points 2-9.

The document states, under "Comparative testing," that "Data and scoring compared to PSG collected and analyzed data and reviewed by independent sleep specialists." This implies a comparative study was conducted, likely to establish the performance of Rubicon in identifying airflow events relevant to sleep disorders. However, the results, sample sizes, and other specifics of this study are not provided in the submitted text.

Therefore, based on the provided text, a full answer to all your questions cannot be completed. Below is a summary of what can be extracted and what information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and specific performance metrics for the Rubicon Screening Device are not explicitly stated in the provided document. The document mentions "comparative performance testing" and that "Data and scoring compared to PSG collected and analyzed data and reviewed by independent sleep specialists," but it does not present the results of this comparison or any pre-defined acceptance thresholds.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set in any comparative performance study. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that data was "reviewed by independent sleep specialists" to establish ground truth through comparison with PSG. However, it does not specify the number of experts, nor their detailed qualifications (e.g., years of experience, board certifications).

4. Adjudication method for the test set

The adjudication method used for establishing ground truth from the "independent sleep specialists" is not described in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

The document mentions "comparative performance testing" where "Data and scoring [were] compared to PSG collected and analyzed data and reviewed by independent sleep specialists." This implies a comparison against PSG, which is typically considered the gold standard for sleep studies. However, it does not specify if this was an MRMC study designed to assess reader performance with and without AI assistance, nor does it provide an effect size for human reader improvement.

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

The document describes the device's components, including software for data collection, transmission, storage, processing, and display to a healthcare professional. The statement "We are not diagnosing but reporting detected airflow events for further consideration by the clinician" suggests that the device's output (airflow events) is intended to be used by a clinician, implying a human-in-the-loop scenario. It does not explicitly state whether a standalone algorithm performance study was done without human interpretation.

7. The type of ground truth used

The ground truth for the comparative testing was established by comparing the device's collected and analyzed data and scoring to Polysomnography (PSG), reviewed by independent sleep specialists. PSG is generally considered the gold standard for diagnosing sleep disorders.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size. This submission focuses on substantial equivalence and non-clinical testing rather than detailed algorithm development and validation.

9. How the ground truth for the training set was established

As no training set is mentioned, there is no information on how its ground truth would have been established.

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