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ResTraxx Online is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been wirelessly transmitted from the patient's flow generator located in the home to the care giver. ResTraxx Online also provides remote settings capabilities.

It is intended to be used in the home only and with compatible S7 Elite, AutoSet Respond, S8 Series CPAP Systems, VPAP III, VPAP III ST, VPAP Malibu, VPAP Auto 25, VPAP S and VPAP ST variants positive airway pressure flow generators.

The performance and functional characteristics of ResTraxx Online includes all the user features of the predicate device, ResTraxx System (K070746).

ResTraxx Online is designed to function with ResMed OSA treatment systems for the transfer, storage, retrieval and display of stored information from the flow generator to the clinician's PC, including remote settings functionality, via wireless transmission and web-based applications. Access to the data is limited to subscribers of the system. Patients cannot access the system.

ResTraxx Online comprises two distinct components, the wireless transmitter/receiver located on the flow generator and the Server System. Data taken from the flow generator is transmitted via a wireless network, stored in the ResTraxx Online database, transmitted via the Internet and displayed on the Clinical reviewer's PC.

The provided text is a 510(k) summary for ResTraxx Online. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, device performance metrics, or a study design to prove these criteria were met.

The document states: "Design and Verification activities were performed on ResTraxx Online as a result of the risk analysis and product requirements. All tests confirmed the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate device (K070746)." This is a general statement indicating that testing was done and predefined criteria were met, but it does not elaborate on what those criteria were or how the device performed against them.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on regulatory compliance and demonstrating substantial equivalence to a predicate device based on similar intended use, operating principles, technologies, and manufacturing processes, rather than a detailed performance study with specific metrics.

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