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The 3B and BMC RESmart CPAP and Auto-CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The BMC RESmart™ CPAP System (Private labeled in the USA as the "3B CPAP System") and the BMC RESmart" Auto CPAP System (Private labeled in the USA as the "3B Auto CPAP System") are microprocessor controlled, blower-based systems that generate positive airway pressures from 4-20 cm H2O. The devices are intended for use with a patient circuit that is used to connect the device to the patient interface, i.e., the mask.

The CPAP and Auto CPAP devices consist of a blower, pressure/flow monitoring, pressure controlling, user interface and optional heated humidifier. The air blower consists of a DC brushless motor, turbofan, and shell, Fresh air is sucked in via an inlet due to the vacuum created by the air blower. The inlet foam filters dust and other floating particles. The filtered air is compressed to a certain pressure and blown out via an outlet. The outlet pressure is determined by the motor rate speed, which is controlled by the pressure control system.

The device has a real time pressure/flow monitoring system. Sensors monitor the outlet air pressure/flow, providing feedback, which is used to control the rate of speed of DC brushless motor, which regulates outlet air pressure in real time. The leakage of the mask and tubing will lead to a decrease of the outlet air pressure. This can be detected by the monitoring system and feedback allows the pressure controlling system to modify the rate speed of motor. In this way, the lost pressure caused by leakage will be compensated. When system is in standby, the pressure/flow change caused by respiratory via mask will also be detected by monitoring system and the automatically turning on of the function will be achieved. Pressure/flow changes caused by removal of the mask and/or tubing will also be detected, triggering the device alert and stopping the pressure output of the device.

Device control, setting and system status are displayed and achieved by user interface including buttons and LCD. The backlit LCD can display the system status and parameters. The buttons consist of start/stop, humidifier, ramp and +/- user buttons. User and medical equipment vendor service personnel can control and set the device via these buttons.

The two models bundled into this 510(k) submission (RESmart© CPAP and Auto CPAP) are mechanically identical. The difference in functionality is determined by the software. In the standard CPAP model, the automated pressure regulation module of the software is disabled. The CPAP System provides only one level of pressure. In contrast the Auto CPAP provides varying levels of pressure that automatically adjusts, based on the patient's needs. The pressure required to overcome obstruction may vary, based upon body position, sleep stage, weight, neck size, congestion, or other factors. The Auto CPAP System will adjust the pressures throughout the night as the patient's pressure requirements change. The Auto CPAP System will maintain an optimal pressure, which, in most cases, will be lower that the pressure provided by the CPAP System.

No mask is included with the device, and the mask must be purchased separately. The integrated humidifier is optional. It also is packaged and sold separately. This humidifier moistens the air delivered by the CPAP and Auto CPAP Systems. It is used only on a single patient and must not be re-used on another person in order to avoid the risk of cross-infection.

The heated humidifier is used to increase the outlet air temperature and humidity. The humidifier is an optional component packaged and sold separately, but when added, is integrated by simple snap in place mechanism to the CPAP device. The humidifier consists of a heated platform and water chamber. The water is heated, which raises the temperature and humidity of the air in contact. The humidifier is controlled via infrared port and powered by the main device. The temperature sensors ensure the desired temperature and safety.

The RESmart CPAP and Auto CPAP devices are mechanically identical. The two devices operate on the same principles; utilize the exact same components and circuit, design, and manufacturing approach. The only difference consists of the software algorithm driving the fan controller board. A summary of the software algorithm is attached to the Appendix. The output treatment pressure of the CPAP device is set by the physician and fixed. By contrast, the pressure delivered in an Auto CPAP device is adjusted automatically in real time by the Auto CPAP system by tracking patient's respiration and airflow.

The RESmart CPAP and Auto CPAP, and integrated humidifier, complies with IEC 60601-1 and EN ISO 17510-1

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

Clinical Testing (5.8 SUMMARY OF CLINICAL TESTING)

1. Sample size used for the test set and the data provenance:

   • Sample Size: 30 patients.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that the device's performance is being compared to an existing predicate. It's unclear if the data collected for the 30 patients was prospective for this study or if existing patient data was re-evaluated. "Clinical testing was conducted on 30 patients" suggests prospective data collection for this study.

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

   • Number of Experts: "an expert" (singular)
   • Qualifications: "masked to the performance of the device" is mentioned, implying objectivity, but no specific medical qualifications (e.g., "radiologist with 10 years of experience") are provided.

3. Adjudication method for the test set:

   • "manual scoring by an expert masked to the performance of the device" - This indicates a single expert was responsible for scoring, effectively making the adjudication method "None" in the sense of consensus or multiple reader review.

4. 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 comparative effectiveness study was not done. The study was focused on the device's substantial equivalence to a predicate device, not on how human readers' performance might improve with the device's assistance.

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

   • Yes, the clinical testing seems to evaluate the device (algorithm and hardware) in a standalone capacity by comparing its output (respiratory event detection, sensitivity, therapy delivery pressure) against a predicate device and manual scoring by an expert. It's evaluating the device's inherent performance.

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

   • "manual scoring by an expert" - This indicates expert scoring/evaluation, which serves as the ground truth.

7. 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 the performance and equivalence of the already developed device.

8. How the ground truth for the training set was established:

   • Since no information about a training set is provided, how its ground truth was established is also not available in this document.

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The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders in adult patients weighing more than 30kg in the home, hospital or other clinical setting.

The Stardust II is intended for use during sleep disorder studies to detect up to 5 physiological signals: percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort and body position (i.e., supine or non-supine).

The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events:

Airflow* Effort SpO2 Pulse rate Apnea Hypopnea Desaturation

*Nasal airflow can be acquired with a pressure cannula or thermistor sensor.

The Stardust II can also interface with various Respironics pressure therapy devices to report available device/patient information (i.e., event flags and real time streamed data). When used with these devices, the Stardust II is not intended to be a diagnostic application, but rather a portable recorder to assess the quality of the at home titration of an auto-titrating device and determine if there are still events occurring and to assess the therapeutic benefit of the already diagnosed OSA patient.

The provided document for the Respironics Stardust II (K021845) does not contain detailed information about specific acceptance criteria or the study that proves the device meets these criteria in the format requested. The document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Design verification tests were performed on the Respironics Stardust II as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, it does not provide a table with specific acceptance criteria (e.g., accuracy thresholds for SpO2, airflow, etc.) nor the reported device performance measurements against those criteria.

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

This information is not provided in the document. The document mentions "design verification tests," but does not specify the sample size of patients or data samples used for these tests, nor the country of origin of the data, or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The document refers to the device aiding "Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders," implying clinical validation, but it doesn't detail how ground truth was established for any test sets.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided in the document. The filing is for a device to aid in diagnosis, but it does not detail any studies comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The document states: "The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events: Airflow, Effort, SpO2, Pulse rate, Apnea, Hypopnea, Desaturation."

This indicates that the device has an algorithmic component that processes signals and determines events, suggesting a standalone algorithmic function. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are not provided for these algorithms.

7. Type of Ground Truth Used:

This information is not explicitly stated in the document for any test sets. Given the device's intended use for diagnosing sleep-related breathing disorders, ground truth would typically be established by polysomnography (PSG) scored by a sleep expert, or clinical diagnosis. However, this is not described as part of the "design verification tests."

8. Sample Size for the Training Set:

This information is not provided in the document. The document mentions "proprietary algorithms" but does not detail their development or any training data used.

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

This information is not provided in the document.

Summary of available information regarding acceptance criteria and studies:

The provided 510(k) summary indicates that design verification tests were conducted, and "All tests were verified to meet the required acceptance criteria." However, the document does not disclose the specific acceptance criteria themselves, nor the detailed results of these tests, nor the methodologies, sample sizes, or ground truth establishment relevant to those tests.

The focus of this 510(k) is demonstrating substantial equivalence to predicate devices (Respironics Stardust and Respironics REMstar Auto) based on similar operating principles, technology, and manufacturing processes, rather than providing detailed clinical performance data from new studies.

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The REMstar Auto with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Auto with C-Flex may be used in the home or hospital/institutional environment.
The REMstar Auto with C-Flex CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only. The device is for use in the home or hospital/institutional environment.

The Respironics REMstar Auto with C-Flex CPAP System is a microprocessor controlled blower based continuous positive pressure system. Respironics is adding an additional therapy feature to provide pressure relief during exhalation. The REMstar Auto with C-Flex CPAP System provides CPAP or Auto CPAP therapy with or without the C-Flex function and is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases, and a patient interface device.

The provided text does not contain detailed acceptance criteria for the device's performance, nor does it describe a specific study proving the device meets acceptance criteria with quantitative results. Instead, it makes a general statement that "Design verification tests were performed on the Respironics REMstar Auto with C-Flex CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can be inferred or explicitly stated:

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

   • Acceptance Criteria: Not explicitly stated in terms of specific performance metrics or thresholds. The text only mentions "required acceptance criteria" in a general sense.
   • Reported Device Performance: Not provided in quantitative terms. The document focuses on demonstrating substantial equivalence rather than presenting detailed performance data against specific criteria.

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

   • Not mentioned. The text refers to "Design verification tests" but does not specify the sample size of the devices or any patient data used for these tests. Data provenance is also 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 applicable/Not mentioned. The submission describes a medical device (CPAP system) that directly provides therapy, not a diagnostic imaging or AI-driven system that requires expert ground truth for a test set in the traditional sense of a clinical or image-based study.

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

   • Not applicable/Not mentioned. This typically relates to expert review of diagnostic assessments, which is not the focus of this device submission.

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 MRMC study was done. This device is a therapeutic CPAP system and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.

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

   • Not applicable in the context of "algorithm only." The device is a "microprocessor controlled blower based continuous positive pressure system" with a C-Flex function. Performance would be assessed for the device's function in delivering pressure and managing C-Flex, not as a standalone AI algorithm. The text implies the device's overall performance was tested, but details are not provided.

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

   • Not explicitly stated. For a therapeutic device like this, "ground truth" would likely refer to engineering specifications, physiological measurements (e.g., pressure delivery accuracy, response to exhalation), and potentially clinical outcomes in broader studies (though not detailed here for this submission).

8. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not describe an AI that learns from a "training set" in the machine learning sense. The device is "microprocessor controlled" but operates based on defined algorithms and parameters.

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

   • Not applicable/Not mentioned for the same reasons as #8.

Summary based on available information:

The submission confirms that "Design verification tests were performed" and "All tests were verified to meet the required acceptance criteria." However, it does not provide the specific details of these acceptance criteria or the quantitative results of the tests. The focus of the provided text is on establishing substantial equivalence to predicate devices based on intended use, operating principle, technology, and manufacturing process, rather than presenting detailed performance data from a clinical or diagnostic study.

Table of Acceptance Criteria and Reported Device Performance (as much as can be inferred):

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