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DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals acquired from a patient, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile.

While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve:

• use alone as an apnea monitor or as a critical component in an apnea monitoring system; or
• use alone as a life support device or as a critical component of a life support system.

DreamClear is a physiological signal amplifier and medical device data system that captures and streams various physiological parameters via Bluetooth for remote data analysis and diagnosis of sleep disorders. DreamClear features analog sensor interface circuits for Electroencephalograph (EEG), Electrooculography (EOG) and Electromyography (EMG) signals. Additionally, the device includes digital sensor interface circuits for nasal and oral airflow (breathing pattern), microphone (snoring), heart rate and blood oxygen saturation with pulse oximeter (SpO2).
The DreamClear may be used in either a Basic Kit or Extended Kit configuration. The DreamClear device in its Basic Kit configuration includes the chest belt, pulse oximeter, and nasal cannula. The Basic Kit configuration has the following channels: thoracic effort, nasal pressure, pulse rate, SpO2, body position, and snore. The data recorded by the Basic Kit may be exported for optional display and analysis using third-party software products.

When the DreamClear device is used in the Extended Kit configuration, the additional channels of EEG and EOG are used, which gives the DreamClear a total of eight (8) channels.

The provided text is a 510(k) summary for the DreamClear device and focuses on establishing substantial equivalence to a predicate device (Nomad Sleep System Recorder) and a reference device (Alice PDx) for physiological signal amplification. It primarily discusses the device's intended use, functionality, and compliance with general medical device safety standards.

Crucially, this document does NOT contain information about a study that proves the device meets specific performance acceptance criteria related to its accuracy in aiding the diagnosis of sleep disorders (e.g., measuring sleep stages, apnea events, etc.). The text explicitly states: "Substantial equivalence was also established through a testing protocol that used bench data to evaluate the performance of DreamClear. Testing demonstrated that DreamClear amplified physiological signals sufficient for use with polysomnography software to aid in the diagnosis of sleep disorders, which is substantially equivalent to the intended use of the predicate Nomad device." This "bench data" refers to electrical and electromagnetic safety and performance testing, not clinical performance for diagnosis.

Therefore, I cannot fulfill most of your request based on the provided text, as the information regarding specific acceptance criteria for diagnostic performance, a test set, expert involvement, and MRMC studies is absent.

However, I can extract the following relevant information:

Device Name: DreamClear

Device Type: Physiological Signal Amplifier (specifically for sleep studies)

Intended Use: To collect, amplify, and transmit physiological signals (EEG, EOG, limb movement, respiration effort, air pressure, SpO2) for various medical diagnostic procedures, primarily for use with polysomnography software to aid in the diagnosis of sleep disorders.

Here's an attempt to answer your questions based on the limited information provided, and where the information is not present in the text, I will explicitly state that.

Acceptance Criteria and Device Performance (Based on Provided Text)

As the document focuses on substantial equivalence for a physiological signal amplifier rather than a diagnostic algorithm, the acceptance criteria mentioned are primarily related to its ability to collect, amplify, and transmit signals in a physiological range, and its compliance with safety and usability standards.

1. A table of acceptance criteria and the reported device performance

Since the document describes the type of testing performed (bench testing for signal amplification, and usability), but does not provide specific quantitative acceptance criteria or precise performance metrics in a table format, a direct table cannot be created.

However, the general performance claim is:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "bench data" and a "usability study." Bench testing typically involves laboratory setups, not patient data in the sense of a clinical test set. The usability study would have involved human participants, but the number is not provided.
• Data Provenance: Not specified. "Bench data" suggests laboratory testing rather than clinical patient data. For the usability study, the origin of participants (e.g., country) is not mentioned.
• Retrospective or Prospective: Not specified. "Bench data" implies a controlled, non-clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable for the described studies. The testing described (bench data for signal amplification sufficiency and a usability study) does not involve establishing ground truth for diagnostic purposes in the way you might for an AI algorithm interpreting medical images or signals. The device is an amplifier, not an interpreter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No ground truth establishment for diagnostic performance is mentioned.

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. The document does not describe an MRMC study. The DreamClear device is a physiological signal amplifier, not an AI that aids human readers in interpretation. It outputs raw physiological signals for third-party polysomnography software and physician interpretation.

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

• Yes, implicitly in the context of signal amplification. The "bench data" testing of the DreamClear device's ability to amplify physiological signals is a standalone performance evaluation of the hardware's function. However, this is not a diagnostic standalone performance. The device itself does not interpret or diagnose; it provides the raw data for interpretation.

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

• Not applicable in the context of diagnostic ground truth. For the stated purpose of the device (signal amplification), the "ground truth" would be the known input signals used in bench testing to verify the amplified output, adhering to engineering and signal processing principles. For the usability study, the ground truth would be user feedback and observed user behavior against defined usability metrics.

8. The sample size for the training set

• Not applicable. This device is a hardware physiological signal amplifier, not an AI/ML diagnostic algorithm that requires a training set.

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

• Not applicable. This device is a hardware physiological signal amplifier, not an AI/ML diagnostic algorithm that requires a training set.

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