(115 days)
EasyCare Online is a web based solution for healthcare specialists intended to:
• assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an EasyCare Online compatible home sleep test device.
• transfer and display, usage and therapeutic information that has been transmitted remotely from the patient's therapy device located in the home. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. EasyCare Online also provides remote settings capabilities
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from (ResMed compatible flow generators) and diagnostic data from (ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module, or with the aid of an SD card and internet technology, to a central database and then displayed on the clinician's/DME's computer, through a web based application such as internet Explorer.
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 or home sleep test study device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users. Home Medical Equipment (DME) providers and other healthcare specialists can access data with ResMed approved user accounts. Also, clinical users and DMEs are able to address any clinical issues in a timely manner and provide the necessary patient support, including the modification of device settings. EasyCare Online supports physicians in the diagnosis Sleep Disordered Breathing, by reviewing home sleep test results via their web browser or download the clinical data to their PC for further analysis.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EasyCare Online device:
This 510(k) submission is for an expanded intended use of an existing device (EasyCare Online, K123557) by integrating functionality from another predicate device (ApneaLink Plus, K083575). Therefore, the "study" primarily focuses on demonstrating that the new integration does not negatively impact the existing functionality and accurately displays data from the newly integrated device. It does not involve a traditional clinical study for the diagnostic accuracy of the device itself.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate devices and the successful completion of non-clinical testing. The "reported device performance" is essentially the successful completion of verification activities.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Verification: Changes introduced in the code did not impact previous EasyCare Online (K123557) functionality and the addition of ApneaLink Plus (K083575) functionality into EasyCare Online was verified. | PASS: Regression and End-to-End system testing confirmed that changes did not impact previous ECO functionality and verified the addition of ApneaLink Plus functionality into ECO. |
| Side-by-Side Testing: EasyCare Online (modified) correctly and accurately displayed home sleep test data belonging to ApneaLink Plus devices, producing the same data as the predicate ApneaLink Plus PC software (K083575). | PASS: Side-by-side testing using three patient breathing pattern scripts demonstrated that ECO (modified) and ApneaLink Plus PC software produced the same home sleep test data and met predetermined pass/fail criteria. |
| General Performance: The device functions correctly with ResMed compatible devices (73 MNS and 73 MNR). | PASS: Confidence system level testing ensured integration of ALC was conducted and found not to change the performance of EasyCare Online, confirming correct function with compatible devices. |
| Safety and Efficacy: Changes do not affect the safety and efficacy of the device. | PASS: The EasyCare Online uses existing data types and communication mechanisms between therapy devices as supported by the predicate device (K123557), indicating no negative impact on safety and efficacy. |
Study Details
1. A table of acceptance criteria and the reported device performance:
Provided above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: "Three patient breathing pattern scripts" were used for the side-by-side testing.
- Data Provenance: Not explicitly stated. The scripts likely represent simulated or standardized data rather than individual patient data from a specific country or collected prospectively/retrospectively in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This submission does not involve human expert adjudication of diagnostic outcomes. The "ground truth" for the side-by-side testing was the output of the predicate ApneaLink Plus PC software. The study's goal was to ensure the modified EasyCare Online replicated this known output accurately. Therefore, no external experts were used to establish ground truth in the traditional sense of a clinical diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (in the context of human adjudication). The "adjudication" was a direct comparison of output data between the modified device and the predicate device's software.
5. 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. This was not an MRMC study. The device is a data management and display system, not a diagnostic AI system intended for direct human assistance in interpretation in the way a typical diagnostic image analysis AI would be.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The core of the "testing" was comparing the data processing and display capabilities of the modified EasyCare Online (algorithm/software only) against the known output of the predicate ApneaLink Plus PC software (also algorithm/software only). The "standalone" performance here refers to the software's ability to process and present data identically to an established, cleared device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the side-by-side testing was the output of the predicate ApneaLink Plus PC software (K083575). This means the existing, cleared device's performance served as the benchmark for accuracy for the data processing and display component. This is often referred to as "reference standard" or "comparator device" in such equivalence studies.
8. The sample size for the training set:
- Not applicable / Not explicitly stated. This submission does not describe the development of a novel algorithm that requires a "training set" in the machine learning sense. The changes primarily involved integrating existing functionalities and ensuring data integrity.
9. How the ground truth for the training set was established:
- Not applicable. As no training set for a novel algorithm was described, this question is not relevant to this submission. The "ground truth" for the device's expanded functionality was anchored to the performance of its predicate devices.
§ 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).