Search Results

The Breas iSleep 20i System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

The iSleep 20i system is a CPAP system that provides a continuous positive airway pressure. This can prevent the user's upper airways from collapsing and therefore avoid breathing problems associated with collapse and obstruction.

In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application.

The iSleep 20i system can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.

It must always be prescribed by a licensed physician.

It is not intended for life support applications or for transport of critical care patients.

The therapy delivered by the Breas iSleep 20i CPAP System can be either:

• 1. Self-adjusting in response to variations in patient breathing patterns (CPAP "";" mode), or
• 2. Set to a constant pressure level (constant CPAP mode).

The iSleep 20i airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended.

The iSleep 20i systems have an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available.

The outer dimensions of the iSleep 20i housing is 6.8 x 8.2 inches, and the device weighs 3.1 pounds including empty humidifier.

The Breas iSleep 20i System is a CPAP device intended to deliver continuous positive airway pressure therapy for the treatment of adult Obstructive Sleep Apnea (OSA). The 510(k) submission (K063476) indicates that no clinical studies were required to support substantial equivalence. The acceptance criteria and the study proving the device meets these criteria are based on non-clinical and comparative bench testing, and compliance with various standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through its successful completion of various tests, rather than a direct comparison to specific numerical acceptance criteria in a table format within the provided document. The overarching acceptance criterion is that the device "meets its stated performance specifications" and is "capable of operating safely in their intended environments and will be effective in fulfilling its intended use."

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

The provided document does not specify a "test set" in the context of patient data or clinical samples. Instead, the testing described is primarily bench testing and compliance testing against recognized standards and guidance documents. There is no mention of a traditional "test set" involving patient data. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).

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

Not applicable. As described above, there was no "test set" involving patient data or a need for expert-established ground truth in the context of clinical outcomes. The testing was technical and engineering-focused.

4. Adjudication method for the test set

Not applicable, as there was no "test set" requiring adjudication.

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 applicable. The Breas iSleep 20i System is a CPAP device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. The device itself is a standalone medical device (CPAP machine). Performance was evaluated intrinsically through its ability to meet specifications and comply with standards, not as an algorithm's performance.

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

The "ground truth" for the device's performance was established by engineering specifications, validated test methodologies (e.g., those defined in IEC 60601-1, ISO 17510-1), and compliance with FDA guidance documents. There was no clinical "ground truth" (like pathology or outcomes data) required, as it was a substantial equivalence determination based on non-clinical data.

8. The sample size for the training set

Not applicable. The device is not an AI/machine learning model that requires a training set.

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

Not applicable. (See #8)

Ask a specific question about this device