(115 days)
EasyCare Online transfers and displays to clinicians, usage and therapeutic information that has been transmitted remotely from the patient's flow generator located in the home. EasyCare Online also provides remote settings capabilities.
EasyCare Online is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed flow generator for the treatment of obstructive sleep apnea or respiratory insufficiency.
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from ResMed flow generators. The data is transferred from the flow generators either wirelessly through a communications module or with the aid of an SD card, to a central database and then displayed in a clinician computer, through a web application.
EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance. Clinical users, Home Medical Equipment (HME) providers and other healthcare specialists can access data to monitor patient compliance. Also, clinical users and HMEs are able to address any noncompliance issues in a timely manner and provide the necessary patient support, including the modification of device settings.
The provided text is a 510(k) summary for the EasyCare Online device. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, or information about ground truth establishment.
The document states:
"Design and non-clinical verification activities were performed on EasyCare Online as a result of the risk analysis and design process. Verification testing included end-to-end testing to verify data transfer integrity between the flow generator and EasyCare Online. All tests confirmed the product met the predetermined acceptance criteria."
This statement indicates that verification testing occurred and acceptance criteria were met, but it does not provide the details requested in your prompt.
Therefore, I cannot populate the table or provide specific details about the study, as they are not present in the provided text.
Based on the available information, here's what can be inferred and what cannot be determined:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Data Transfer Integrity (between flow generator and EasyCare Online) | "All tests confirmed the product met the predetermined acceptance criteria." (Specific metrics and criteria are not provided) |
Study Information (Based on available text)
- Sample size used for the test set and the data provenance: Not specified in the provided text. The testing mentioned is "end-to-end testing to verify data transfer integrity," which sounds like functional verification rather than a clinical study with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. The testing described focuses on data transfer integrity, not diagnostic or therapeutic accuracy that would require expert-established ground truth on patient data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not specified.
- 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. EasyCare Online is a data transfer and display system for clinicians, not an AI diagnostic or assistive tool that would involve human readers or MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "end-to-end testing to verify data transfer integrity" can be considered a standalone functional test, but it does not evaluate "performance" in the sense of clinical accuracy or decision-making.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for verifying data transfer integrity would likely involve comparing transmitted data against source data, rather than clinical ground truth.
- The sample size for the training set: Not applicable. The device is a data management and display system, not a machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document implies about the "study":
The "study" was primarily functional verification and non-clinical testing to ensure data transfer integrity and compatibility with new flow generator models. It was not a clinical effectiveness study assessing diagnostic accuracy or therapeutic outcomes, nor did it involve the use of AI algorithms on patient data that would necessitate the detailed ground truth and expert validation methods you've inquired about. The device is described as a system for transferring and displaying patient usage and therapeutic information, rather than a device making automated clinical decisions.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).