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The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

The Respironics SleepEasy CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The SleepEasy CPAP System also includes the flex therapy feature cleared in K021861 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its device predicates, the SleepEasy CPAP System 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, an exhalation device, and a patient interface device.

The Respironics SleepEasy CPAP System (K091112) is a modified device, and its acceptance criteria and the study proving it meets these criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

However, the specific acceptance criteria (e.g., precise pressure ranges, flow rates, noise levels, reliability metrics) and the detailed results of these tests are not provided within the given text. The document only states that the tests were performed and met the criteria.

Without the specific details, a table cannot be fully constructed. Based on the provided information, the table would appear as follows:

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). The verification tests are described as "design verification tests," which typically involve testing a representative sample of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given document. The verification tests described are likely engineering design tests rather than clinical studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Given that the tests are described as "design verification tests," adjudication in the context of clinical or diagnostic performance assessment is unlikely to be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The Respironics SleepEasy CPAP System is a positive airway pressure delivery device for Obstructive Sleep Apnea, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device type.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided in the document. As this is not an AI-based or algorithm-driven diagnostic device in the sense of image interpretation or complex data analysis, the concept of a "standalone" algorithm performance study is not relevant. The device operates mechanistically to deliver positive airway pressure.

7. The Type of Ground Truth Used

The document does not explicitly state the "type of ground truth" used. For "design verification tests" of a mechanical device like a CPAP system, the "ground truth" would likely refer to established engineering and medical device standards, specifications, and performance targets (e.g., accuracy of pressure delivery, stability of flow, noise levels within acceptable limits, safety features functioning correctly). These are typically verified against calibrated measurement equipment and established protocols.

8. The Sample Size for the Training Set

This information is not provided in the document. The Respironics SleepEasy CPAP System is not an AI/machine learning device that requires a "training set" in the conventional sense. Its functionality is based on predefined engineering principles and control algorithms, not learned from data.

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

This information is not provided in the document. As noted above, the concept of a "training set" and associated "ground truth" is not applicable to this type of device.

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The Respironics REMstar Pro M Series CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.

The Respironics REMstar Pro M Series CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M Series CPAP System also includes the flex therapy feature cleared in K021861 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicate, the REMstar Pro M Series CPAP System 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, an exhalation device, and a patient interface device.

This document describes the 510(k) summary for the Respironics REMstar Pro M Series CPAP System. It is a premarket notification to the FDA to demonstrate substantial equivalence to a previously cleared predicate device.

Based on the provided text, a formal study to prove the device meets acceptance criteria, in the sense of a clinical trial with specific performance metrics and statistical analysis, was not performed or reported in this 510(k) summary.

Here's an analysis of the requested information based only on the provided text:

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

The document states: "Design verification tests were performed on the Respironics REMstar Pro M Series CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, the document does not provide a table of specific acceptance criteria or the reported device performance metrics from these design verification tests. It only generally states that the tests met the criteria.

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

The document does not provide any information regarding the sample size used for the design verification tests (e.g., number of devices tested), the country of origin of the data, or whether it was retrospective or prospective.

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)

This information is not applicable as the document describes design verification tests for a medical device (CPAP system) and not an AI or diagnostic imaging device that would require expert-established ground truth for a test set. The "ground truth" for a CPAP system's performance would typically be based on engineering specifications and physical measurements, not expert consensus on interpretations.

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

This information is not applicable for the same reasons as point 3.

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

An MRMC study was not done and is not applicable for this type of device (CPAP system). This is not an AI-assisted diagnostic or interpretative device.

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

This information is not applicable as the device is a physical CPAP system, not an algorithm, and its performance is inherently "standalone" in that it performs its function (delivering positive airway pressure) without direct continuous human interpretation loops.

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

As indicated in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For design verification of a CPAP system, the "ground truth" or reference for meeting acceptance criteria would be based on:

• Engineering specifications: The device is expected to deliver specific pressure, flow, and other parameters within defined tolerances.
• Performance standards: Compliance with relevant national and international standards for medical devices.
• Risk analysis requirements: Addressing identified risks through specific design and testing.

8. The sample size for the training set

This information is not applicable as the device is not an AI system that requires a "training set."

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

This information is not applicable for the same reason as point 8.

Summary from the provided text:

The 510(k) summary for the Respironics REMstar Pro M Series CPAP System indicates that "Design verification tests were performed... All tests were verified to meet the required acceptance criteria." However, it does not provide details about these tests, such as:

• Specific acceptance criteria values (e.g., pressure output range, noise levels, temperature control).
• The results of these tests (e.g., actual measured pressure output, actual noise levels).
• The number of units tested (sample size).
• The methodology of these tests.

The submission focuses on demonstrating substantial equivalence to a predicate device (Respironics REMstar Pro with C-Flex CPAP System K021861) based on shared intended use, operating principles, technology, and manufacturing processes, and the general statement that design modifications had "no impact on the safety and effectiveness" as evidenced by meeting acceptance criteria in internal design verification. This is typical for a 510(k) clearance, which is not a full clinical trial.

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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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