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The EasyCare Tx System comprises of the Titration Software, EasyCare Tx, and the Connection Module accessory, Tx Link.

Indication for Use

EasyCare Tx is intended to be used with ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel device setting changes remotely.

EasyCare Tx is intended to be used in a clinical environment.

The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol. The Tx Link relays real-time signals measured by the CPAP or Bilevel device to a polysomnograph (PSG).

The Tx Link is intended to be used in a clinical environment.

ResMed's EasyCare Tx System enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control room within the sleep lab clinical setting.

The EasyCare Tx System includes:

• EasyCare Tx, a software application that executes on the end-user's PC and interfaces with the . accessory Tx Link to view and set various flow generator parameters and settings; and
• Tx Link, a hardware accessory that connects to a flow generator incorporating ResMed's proprietary D communication protocol, and interfaces to a remote PC via an Ethernet connection. The Tx Link also provides analog flow generator signals to third party Polysomnograph (PSG) systems, such as Embla (K971813).

The EasyCare Tx System is a software and hardware system designed for clinicians to monitor and adjust settings of ResMed CPAP or Bilevel devices in a sleep lab clinical setting. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding specific studies, sample sizes, and expert adjudication to prove performance against acceptance criteria is not typically found in this type of submission.

Here's a breakdown of the available information and what cannot be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary explicitly states: "Design and Verification activities were performed on the EasyCare Tx System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria." However, it does not provide a table detailing those specific acceptance criteria nor the quantitative performance metrics achieved for each criterion. The submission focuses on substantial equivalence based on similar intended use, operating principle, technology, and manufacturing process to the predicate devices (TxControl K072615 and ResControl II K040944).

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

This information is not provided in the 510(k) summary. The submission does not detail specific studies with test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for proving device performance against acceptance criteria.

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

This information is not provided in the 510(k) summary. As no explicit studies for establishing clinical performance against ground truth are detailed, there is no mention of experts or their qualifications for establishing such ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the absence of detailed performance studies, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or, at least, not reported in this 510(k) summary. The device's primary function is to facilitate clinicians' interaction with a CPAP/Bilevel device, rather than to make interpretations or diagnoses from data that would typically require MRMC studies.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop performance) was not detailed as a separate clinical study in this 510(k) summary. The system integrates software and hardware to enable human clinicians to monitor and adjust device settings. While components would undergo verification (e.g., software functionality, hardware connectivity), a "standalone" clinical performance study in the sense of an AI algorithm making independent decisions is not applicable here given the device's intended use.

7. Type of Ground Truth Used

The 510(k) summary does not specify a type of ground truth used, as it doesn't describe clinical studies with endpoints requiring a "ground truth" (e.g., expert consensus, pathology, or outcomes data). The "verification activities" mentioned are likely related to engineering and system functionality, ensuring the device accurately displays data and transmits setting changes as intended, rather than clinical diagnostic accuracy.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The EasyCare Tx System is a control and monitoring system, not a device that employs machine learning or AI models requiring a training set in the typical sense.

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

This information is not provided in the 510(k) summary, as it's not applicable to this type of device and submission.

Summary based on the provided document:

The 510(k) summary for the EasyCare Tx System indicates that "Design and Verification activities were performed... All tests confirmed the product met the predetermined acceptance criteria." However, it does not elaborate on these criteria, the specific studies performed, sample sizes, expert involvement, or adjudication methods beyond that statement. The submission primarily relies on demonstrating substantial equivalence to its predicate devices based on similar intended use, operating principle, technologies, and manufacturing processes, rather than presenting de novo clinical performance data against new acceptance criteria.

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