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SleepSense sensors provide a qualitative measure of a patient's physiological parameters for recording onto an FDA-cleared data acquisition system. Their target population: Children and adult patients who are screened during sleep disorder studies. Their environment of use is usually at a sleep laboratory or sometimes at the patient's home.

Monitoring various physiological parameters is standard practice in sleep disorder testing. Standard overnight recordings show, among others, traces of parameters like respiration movement, leg and arm movement, snoring sounds, respiration airflow and body position during sleep.

In order to record tracings showing these parameters, sensors are needed to convert the physiological parameter into an electrical signal. These sensors are very simple sensing elements like piezo-crystals that convert mechanical force or vibrations to an electrical signal. Other sensing elements may be thermocouples which generate a signal proportional to temperature, or gravity switches, that switch and electrical circuit on and off depending on their position.

In practice, these sensing elements are packaged in small, patient-friendly enclosures which are applied to the patient, and connected to the recording system via a long and flexible cable. There is no electrical contact of any kind between the sensors and the patient.

All signals received from the sensors are qualitative, and are only used to record the dynamic nature or existence of the physiological parameter recorded. A specially trained sleep technician called "scorer" reviews the overall recording in the morning following the study. The signals recorded, together with additional channels like EKG or EEG, are analyzed to arrive at a diagnosis of a sleep disorder like sleep apnea or insomnia.

This 510(k) summary for the SleepSense Sleep Sensors outlines the device's classification, intended use, and substantial equivalence to predicate devices. However, it does not include any specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document states:

• "No performance standards are specified for physiological sensors for sleep disorder testing."
• The manufacturer claims substantial equivalence because they are the OEM manufacturer for the predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

Based on the provided text, I can only confirm the following:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
• 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 provided.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
• 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: Not provided. The device is a sensor, not an AI system for clinicians.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a sensor providing qualitative signals for human interpretation.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
• 8. The sample size for the training set: Not applicable, as it's a sensor without a "training set" in the context of an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

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