Search Results

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 RESmart CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include a smaller and quieter blower. The air circuit, embedded software, and controller board were upgraded to provide better performance. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).

This document is a 510(k) summary for the RESmart CPAP and Auto CPAP nP1.5 system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not available within the provided text. The document states that "Extensive non-clinical testing was conducted in according Non-Clinical Testing with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment." and "Performance Bench Testing demonstrated substantial equivalence with the predicate device." However, it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.

Here's a breakdown of what can be extracted and what is not available:

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

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

• Not available. The document refers to "non-clinical testing" and "performance bench testing" but does not specify sample sizes or data provenance.
• Data Provenance: The manufacturing company is BMC MEDICAL CO., LTD in Beijing, CHINA. The testing location is not specified, but typically, this type of non-clinical bench testing would be conducted in a lab environment.

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 available. This device is a CPAP machine, not an AI diagnostic tool requiring expert ground truth for image interpretation or similar tasks. The "testing" mentioned is non-clinical bench testing against a standard and comparison to a predicate device, not a study involving human experts to establish ground truth on patient data.

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

• Not applicable/Not available. Adjudication methods are typically used in clinical studies where expert disagreement on ground truth needs to be resolved. This document describes non-clinical bench testing for device equivalence.

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. This is a CPAP device, not an AI-assisted diagnostic device. Therefore, MRMC studies are not relevant to its evaluation.

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

• Yes, implicitly. The "Performance Bench Testing" and "non-clinical testing" would represent standalone testing of the device's physical and functional performance (e.g., pressure output, noise levels, flow characteristics) without human interaction. This is the nature of testing for a standalone medical device like a CPAP.

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

• Not applicable in the conventional sense. For a CPAP device, the "ground truth" for performance would likely be established according to the requirements and specifications of the ISO 17510-1:2007 standard. This standard dictates the acceptable ranges for parameters like pressure accuracy, flow rates, humidification, and noise levels. The performance of the predicate device would also serve as a reference point for substantial equivalence.

8. The sample size for the training set

• Not applicable/Not available. This is a hardware medical device with integrated software, not a machine learning algorithm that undergoes "training" on a dataset in the typical sense.

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

• Not applicable/Not available. As above, there is no "training set" in the context of this device.

Summary of what is known from the document:

• Device: RESmart CPAP and Auto CPAP nP1.5 system.
• Intended Use: Deliver positive pressure for the treatment of Obstructive Sleep Apnea.
• Key Change from Predicate: Smaller and quieter blower, upgraded air circuit, embedded software, and controller board.
• Basis for Approval: Substantial equivalence to predicate device RESmart CPAP and Auto CPAP (K110629).
• Testing Conducted: Extensive non-clinical testing according to ISO 17510-1:2007, and Performance Bench Testing.
• Conclusion: The device is substantially equivalent to the predicate device due to the same intended use, operating principle, technology, materials, and manufacturing process, supported by design validation, verification, and performance bench testing.

Ask a specific question about this device