(88 days)
EasyCare 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 transmitted remotely from the patient's flow generator located in the home to the care giver. EasyCare Online also provides remote settings capabilities.
It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
The performance and functional characteristics of EasyCare Online includes all the user features of the predicate device, ResTraxx Online (K083816).
EasyCare 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 a centralized server. This information can then be accessed by the clinician where the information can be displayed on the clinician's PC using a web browser application. Flow Generator settings changes, via wireless transmission can also be made from the clinicians PC. Access to the data is limited to subscribers of the system. Patients cannot access the system.
EasyCare 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 and stored on the EasyCare Online database.
Here's a breakdown of the acceptance criteria and study information for the ResMed EasyCare Online device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states: "All tests confirmed that EasCare Online met the predetermined acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria. Instead, the study focuses on demonstrating "Substantial Equivalence" to predicate devices through functional testing.
| Acceptance Criteria (Not explicitly stated quantitatively, inferred from text) | Reported Device Performance (as stated in the document) |
|---|---|
| Successful transfer of patient and treatment data from flow generator to EasyCare Online system. | "End-to-End testing that shows patient and treatment data can be successfully transferred from the flow generator to the EasyCare Online system." "All tests confirmed that EasCare Online met the predetermined acceptance criteria." |
| Successful sending of appropriate commands from PC to flow generator to update treatment parameters. | "If the user decides to update treatment parameters in the flow generator, this can be done by sending appropriate commands from the PC to the flow generator via the server and GSM network. The flow generator, via the GSM network, will send confirmation back to the user once these new settings have been implemented." |
| Performance in a new operating platform and software operating system (Windows 2000 NT to Windows 2008). | "Areas of difference relate to new operating platform and software operating system (Windows 2000 NT to Windows 2008) which provides improved performance in the connectivity and transfer of data... along with improved (GUI) which provides better usability." |
| Compliance with FDA guidance documents for software in medical devices, off-the-shelf software, and cybersecurity. | "The new device complies with the applicable requirements referenced in the FDA quidance documents: [lists 3 FDA guidance documents]." |
| Functionality and user features comparable to the predicate device, ResTraxx Online (K083816). | "The performance and functional characteristics of EasyCare Online includes all the user features of the predicate device, ResTraxx Online (K083816)." |
| Secure interface for accessing data. | "provide a secure interface into the system." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "End-to-End testing" and "System testing" but does not quantify the number of test cases, patient data sets, or flow generators used in these tests.
- Data Provenance: The testing was "bench testing." It is not specified if any real patient data was used for testing, or if simulated data was utilized. The document mentions the flow generators are "located in the patient's home," but the testing itself appears to be simulated environment testing ("bench testing"), not involving actual patients at home for the purpose of the 510(k) submission. Therefore, it's not strictly "retrospective or prospective" in terms of patient data collection for the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not stated. The ground truth for this device's performance was established through functional verification against defined requirements and specifications, not through expert consensus on medical diagnoses or interpretations. The "bench testing" would have been evaluated against technical specifications and expected system behavior.
- Qualifications of Experts: Not applicable/not stated, as the ground truth was not expert consensus.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/none. The testing involved verifying the system's functional performance against predetermined technical requirements, not subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable, as no MRMC study was performed. The device is a data management and remote setting system, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in essence, the "End-to-End bench testing" represents the standalone performance of the system. The device's primary function is to transfer, store, retrieve, display, and remotely set parameters, which are algorithmic and system-level functions. The testing focused on whether the system performed these functions correctly and reliably without human intervention during the data flow.
- The document explicitly states: "No clinical trials were needed to demonstrate Safety and Efficacy. Based upon the Risk Analysis, End-to-End bench testing alone is sufficient as no new features were added that could raise concerns regarding Safety or Efficacy." This reinforces that only the standalone system performance was evaluated.
7. Type of Ground Truth Used
- Ground Truth Type: The ground truth used was functional specification and predetermined acceptance criteria for system operations, data transfer, storage, display, and remote control. It was based on engineering and software design requirements, rather than clinical outcomes, pathology, or expert medical consensus.
8. Sample Size for the Training Set
- Sample Size: Not applicable/not stated. This device is a software system for data management and remote control, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The software development lifecycle and verification activities would involve testing against requirements, but not a distinct "training set" for model learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth to be established for it. The ground truth for the overall system's development and testing was its design specifications and functional requirements.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).