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The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

In the treatment of sleep disorders, CPAP is well established and common practice as a means to prevent upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction. There are a number of devices legally marketed in the United States for this application, including self-adjusting CPAP systems such as the predicate ResMed Sullivan Autoset T. The self-adjusting systems accommodate pressure requirements that may vary (e.g., as patients change bodies positions or enter different sleep stages).

The Breas PV10i CPAP is similar to the predicate Breas PV100 CPAP System, but with the addition of self-adjusting pressure features. Both Breas devices are microprocessor controlled based on firmware (embedded software). Both designs incorporate pressure sensors that monitor output pressure and provide feedback to the microprocessors. The PV10i also incorporates an airflow sensor and flow signal processing means in firmware to provide self-adjusting capability.

The therapy delivered by the Breas PV10i CPAP System can be either:

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

The primary hardware component is a blower that generates airflow. The blower assembly consists of a brushless DC motor that drives a fan, entraining ambient air through a filter and pressurizing it to provide the prescribed airflow with CPAP for the patient. The microprocessor controls the motor and hence the speed of the fan.

The PV10i pressure range is 4 - 20 cmH20. Starting pressure and self-adjusting pressure limits are settable by clinical personnel in accordance with the patient's prescription.

The CPAP 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 minimum output pressure setting of 4 cm of H20 are recommended for use with the PV10i.

The pressure transducer incorporated in the PV10i continuously monitors output pressure to the patient and reference ambient pressure. This enables the device to automatically compensate for altitude changes.

The PV10i has 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 - 24 VDC power source when AC mains line voltage is not available. This DC power source capability is not intended as a battery power back-up system for any critical treatment applications. An accessory Remote Control Module may be connected that enables clinicians to operate the PV10i without using the control and setting panels on the device itself. A PC-based software program may also be supplied that provides an optional means for clinicians to set patient parameters (e.g., start and limit pressures) and track patient compliance.

The PV10i and its accessories are not sterile. The outer dimensions of the PV10i housing are 6.3 × 4.5 × 9.3 inches, and the device weighs 3.7 pounds.

The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA). The studies performed aimed to demonstrate the device's efficacy and safety, particularly for its self-adjusting pressure features, and its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several types of testing rather than explicit, quantified acceptance criteria in a pass/fail table for each feature. However, the overarching acceptance criterion is that the device meets its stated performance specifications and demonstrates substantial equivalence to predicate devices. The reported performance indicates this criterion was met.

2. Sample Sizes Used for the Test Set and the Data Provenance:

• Clinical Study 1 (Three-way randomized crossover study):
  • Sample Size: 12 patients with symptomatic obstructive sleep apnea, of whom 11 completed all treatments.
  • Data Provenance: Not explicitly stated, but clinical studies are generally considered prospective. Given the context of a 510(k) summary, it's highly likely to be prospective data collected specifically for this submission. The country of origin is not specified.
• Clinical Study 2 (Randomized treatment study):
  • Sample Size: Initially 100 patients with apnea-hypopnea syndrome.
  • Data Provenance: Not explicitly stated, but likely prospective for the reasons above. The study included a titration night and a period of home use with follow-up after three and six months. The country of origin is not specified.

3. 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 the number or qualifications of experts used to establish "ground truth" in the way one might for diagnostic imaging studies.

• In the clinical studies, ground truth for efficacy (e.g., AHI, sleep parameters) would have been established through nocturnal polysomnography (PSG), which is the gold standard for diagnosing and assessing sleep disorders. Polysomnography results are typically interpreted by sleep physicians or sleep specialists.
• The "human readers" in this context are the clinicians who would interpret the PSG data. While not explicitly mentioned, it's presumed these studies were conducted by qualified medical professionals in sleep medicine.

4. Adjudication Method for the Test Set:

Not applicable in the direct sense of adjudicating conflicting expert opinions on a specific case, as these were clinical trials assessing objective physiological parameters (like AHI) and patient outcomes. The "adjudication" would be based on statistical analysis of the measured parameters from polysomnography.

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, an MRMC study was not done. The studies were designed to compare the efficacy of the device (Breas PV10i) itself against predicate devices and conventional CPAP, rather than evaluating how human interpretation or diagnosis would improve with AI assistance.
• The device being evaluated is a CPAP system, not an AI diagnostic/interpretive tool for human readers.

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

• This question is less directly applicable to a CPAP device which is an active treatment rather than a diagnostic algorithm. However, the device itself operates in a "standalone" fashion in its "self-adjusting" mode, where its internal algorithm adjusts pressure based on detected patient breathing patterns.
• The clinical studies evaluate the performance of this "algorithm only" (self-adjusting) mode in comparison to constant CPAP and other self-adjusting devices. For instance, the mean AHI values reported (PV10i: 6.8, AutoSet T: 4.0, constant CPAP: 1.8 in the first study, and PV10i: 7.5 after 6 months in the second study) represent the "standalone" clinical effectiveness of each device's therapy delivery (including its internal algorithms).

7. The Type of Ground Truth Used:

• The primary ground truth used for evaluating efficacy was objective physiological data from nocturnal polysomnography (PSG). This includes measurements of apnea-hypopnea index (AHI), sleep parameters, and ventilatory variables.
• Additional ground truth included patient-reported outcomes such as quality of life assessment, subjective preference (comfort), Epworth Sleepiness Scores, and patient compliance.

8. The Sample Size for the Training Set:

The document refers to "software algorithm validation" and mentions "firmware (embedded software)" and "airflow sensor and flow signal processing means in firmware to provide self-adjusting capability." However, it does not specify a distinct "training set" sample size for the development of these algorithms.

• Typically, algorithms are developed and refined using varied data, but this summary focuses on the final validation studies. The clinical studies (12 patients and 100 patients) are presented as validation/test sets, not explicitly as training sets.
• It's possible that internal testing and development involved retrospective patient data, but this information is not provided in the 510(k) summary.

9. How the Ground Truth for the Training Set was Established:

As no explicit "training set" is described for algorithm development in this document, the method for establishing its ground truth is not provided. If a training set were used, its ground truth would likely have been established similarly to the test sets, using polysomnography and other clinical assessments by qualified medical personnel.

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