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ResTraxx System 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 home to the care giver.

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

The performance and functional characteristics of the ResTraxx System includes all the user features of the predicate device, ResTraxx Data Center System (K053205).

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

The ResTraxx System comprises two distinct components, the wireless transmitter/receiver located on the flow generator (referred to as, ResTraxx or S8 ResTraxx) and the web-based application, referred to as ResTraxx Online. 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.

ResTraxx™ and S8 ResTraxx™ - are wireless modules designed to attach to a compatible ResMed flow generator using a docking mechanism. This mechanism allows the device to be electrically connected via the existing expansion port located at the rear of the flow generator. When attached, the ResTraxx or S8 ResTraxx can automatically collect patient and machine information stored within the flow generator's memory. The ResTraxx and S8 ResTraxx sends information utilizing existing messaging networks providing wireless coverage to large portions of the USA population (The VPA) Museus uses the ResTraxx model).

ResTraxx Online – consists of several functional software modules that are designed to retrieve information from ResMed flow generators through ResTraxx via a wireless messaging network, store the information in a database and provide a secure interface into the system, allowing users to schedule information retrieval and view patient and machine information.

The provided document, K070746, does not contain the detailed information necessary to fully address all aspects of the request. The document is primarily a 510(k) summary for a substantial equivalence determination, focusing on the similarities between the ResTraxx System and its predicate device, and confirming that the device meets predetermined acceptance criteria through design and verification activities. It does not describe a clinical study with detailed performance metrics, ground truth establishment, or reader studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All tests confirmed the product met the predetermined acceptance criteria." However, it does not provide a table outlining specific acceptance criteria or the reported performance metrics of the device. The device in question (ResTraxx System) is a data transfer and display system for CPAP usage, not a diagnostic or treatment delivery device with typical performance metrics like sensitivity, specificity, or image quality. Its "performance" would relate to data transmission reliability, accuracy of display, data security, etc., but these details are not provided.

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

The document does not mention a specific "test set" in the context of a clinical study involving patients or patient data. The "Design and Verification activities" refer to engineering and functional testing of the device itself (ResTraxx System with the inclusion of the VPAP Malibu). No information is provided regarding data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable and not available in the document. The ResTraxx System is a data management system, not a device requiring expert interpretation for establishing ground truth of a medical condition.

4. Adjudication Method for the Test Set

This information is not applicable and not available in the document. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. The device is for data display, not for aiding human readers in interpretation or diagnosis in a way that would warrant an MRMC study to measure improved effectiveness.

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

The ResTraxx System's primary function is to collect, transmit, store, and display data. While it performs these functions "stand-alone" from direct human intervention in the data transfer process (e.g., wireless transmission, database storage), it is inherently designed to deliver information to a human caregiver. Therefore, the concept of "standalone performance" in the context of an algorithm interpreting data is not directly applicable or described here. The document focuses on the system's functional integrity.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to diagnostic or prognostic performance is not relevant to this device. The ResTraxx System handles existing usage and therapeutic information from a flow generator. The "truth" would be the accurate transmission and display of this factual usage data. The document implies that the device accurately conveys the data generated by the CPAP devices, which would be the "ground truth" for its function.

8. The Sample Size for the Training Set

No information regarding a "training set" is provided. The device is not based on machine learning or AI that would require a distinct training set for model development.

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

This information is not applicable as no training set is mentioned or implied for this device.

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