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Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.

The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.

The provided text is a 510(k) Summary for the "Respiration Data Management Software." It highlights the device's indications for use and its substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document focuses on:

• Software Verification and Validation: Stating that it was conducted according to FDA guidance.
• Cybersecurity: Stating that it was considered and evaluated according to FDA guidance.
• Comparison to Predicate Device: Detailing similarities and differences in functionality, compatible devices, and communication mediums, and asserting that differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed performance study.

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