(87 days)
The Easy Care Tx 2 software is intended to be used with ResMed compatible therapy devices in a clinical environment. EasyCare Tx 2 provides therapy device setting changes and displays real-time data and treatment settings from compatible ResMed therapy devices when used together with the TxLink 2 module.
EasyCare Tx 2 is a personal computer application designed to allow clinicians to monitor real-time data from the ResMed compatible therapy device and adjust the therapy device settings from the control room of the sleep lab.
The device in question is the EasyCare Tx 2, a therapy titration software developed by ResMed Corp. The provided document is a 510(k) Premarket Notification summary to the FDA. The submission seeks to prove substantial equivalence to a predicate device, the EasyCare Tx System (K113780).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in a quantitative sense as might be seen for diagnostic device performance (e.g., sensitivity, specificity). Instead, it focuses on comparing the technological characteristics and intended use of the EasyCare Tx 2 with its predicate device to demonstrate substantial equivalence. The "performance" here relates to functional capabilities and parameter ranges rather than diagnostic accuracy.
| Feature/Parameter | Predicate Device (EasyCare Tx - K113780) | Subject Device (EasyCare Tx 2) | Comparison/Performance Notes |
|---|---|---|---|
| Intended Use | To be used with ResMed compatible therapy devices via Tx Link; provides real-time data and treatment settings display, and can also provide therapy device setting changes remotely; intended for clinical environment. | To be used with ResMed compatible therapy devices in a clinical environment; provides therapy device setting changes and displays real-time data and treatment settings from compatible ResMed therapy devices when used together with TxLink 2 module. | Similar. |
| Technological Characteristics | |||
| Prescription Use | Yes | Yes | Same. |
| Intended Environment of Use | Hospital or Sleep Lab | Hospital or Sleep Lab | Same. |
| Display Type | PC | PC | Same. |
| Hardware Requirements | Standard PC platform with microprocessor and ancillary controllers | Standard PC platform with microprocessor and ancillary controllers | Same. |
| Operating System | Microsoft Windows | Microsoft Windows | Same. |
| Accessories | CD for downloading to PC, Tx Link | CD for downloading to PC, Tx Link 2 | Similar (Tx Link vs. Tx Link 2). |
| Compatible Therapy Devices | BZD, MNS, MNT | BZD | Similar. EasyCare Tx 2 does not support product codes MNS and MNT. |
| Therapy Device Adjustments (Settings) | |||
| Adjust Device Therapy Mode | Yes | Yes | Same. |
| Adjust Device Therapy Settings | Yes | Yes | Same. |
| Available Therapy Modes | CPAP, AutoSet, AutoSet for Her, S, ST, TVAuto, ASV, ASVAuto, PAC, iVAPS | CPAP, AutoSet, AutoSet for Her, S, ST, TVAuto, ASV, ASVAuto, PAC | The PAC and iVAPS modes are no longer used and supported as they are for devices under MNS and MNT product codes, and not in scope for EasyCare Tx 2 with BZD devices. |
| Humidifier Control | Humidifier on/off | Humidifier on/off, level control, auto | Similar. Auto mode added for the attached therapy device optimizes humidifier temperature. EasyCare Tx 2 controls humidifier settings. |
| Tubing Control | Tube Temperature on/off, auto | Tube Temperature on/off, auto | Same. Therapy device optimizes tube temperature. |
| Ramp | 0 to 45 min | 5 to 45 min, off, auto | Similar. Off mode added for usability. Auto mode stops ramp when sleep detected. |
| Output Parameters | |||
| Pressure | -3 to 35 cm H2O | 0 to 30 cm H2O | Similar. Therapy for EasyCare Tx 2 only supports OSA devices requiring lower pressure, removing the -3 cm H2O which was for a niche case in older devices. The therapy range has not changed for the relevant BZD devices. |
| Flow | -120 to 120 L/min | -240 to 240 L/min | Similar. Increased range due to larger data model and scalable architecture. Risks are considered by the parent therapy device. |
| Leak | -30 to 120 L/min | 0 to 2 L/s | Similar. Leak parameters are sent from the attached therapy device in L/s. EasyCare Tx 2 allows toggling between L/s and L/min. |
| Respiratory Rate | 6 to 35 BPM | 0 to 90 BPM | Similar. Higher range supports pediatric patients using AirSense 11. |
| Tidal Volume | 0.01 to 3 L | 0 to 4 L | Similar. |
| Target Ventilation | 0 to 30 L/min | 0 to 30 L/min | Same. |
| Minute Ventilation | 0 to 30 L/min | 0 to 30 L/min | Same. |
| Ti (Inspiration Time) | 0 to 9 seconds | 0.3 to 4 seconds | Similar. |
| Pulse Rate | 18 to 300 BPM | 0 to 300 BPM | Similar. Expansion of range due to new sensor supporting increased data monitoring. |
| SpO₂ | 40 to 100% | 0 to 100% | Similar. Expansion of range due to new sensor supporting increased data monitoring. |
The acceptance criteria here are implicitly met by demonstrating that the EasyCare Tx 2 has similar intended use and technological characteristics to the predicate device, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" are the parameter ranges and functional capabilities described for EasyCare Tx 2.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Non-clinical verification and validation testing completed for EasyCare Tx 2 demonstrated that the device met all intended performance requirements. Testing included: Software verification and validation."
It also mentions: "The verification testing performed with EasyCare Tx 2 was software verification and validation against the non-functional requirements and end-to-end functional testing."
This indicates that the "test set" consisted of various software testing scenarios (unit, integration, system, performance, usability tests) to verify functionality and non-functional requirements. However, no specific sample size (e.g., number of data points, cases, or patients) for a test set is provided, nor is the data provenance (country of origin, retrospective/prospective) for any specific clinical data mentioned. The testing described is primarily software-centric, not based on a dataset of patient outcomes.
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 information is not provided. The testing described is software verification and validation, which typically involves engineering and quality assurance professionals, not clinical experts establishing ground truth in the context of medical image analysis or similar diagnostic tasks.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the software verification and validation, adjudication methods typical for clinical or image-based studies are not relevant here.
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 MRMC comparative effectiveness study was done. This device is a software application for clinicians to monitor and adjust therapy device settings, not a diagnostic AI intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a human-in-the-loop software. Its purpose is to allow clinicians to monitor and adjust therapy settings. The "performance" is the software correctly displaying data and applying setting changes, not standalone diagnostic accuracy. The testing performed was "software verification and validation against the non-functional requirements and end-to-end functional testing," indicating validation of its functional integrity, not standalone diagnostic capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the software verification and validation, the "ground truth" would be the defined software requirements and expected behavior based on engineering specifications and design documents. For example, if a setting is changed from X to Y, the ground truth is that the software should correctly register and apply that change to the therapy device and display it accurately. It's not a clinical ground truth like pathology or outcome data.
8. The sample size for the training set
This information is not applicable/not provided. The EasyCare Tx 2 is described as therapy titration software, not an AI/ML model that would require a "training set" in the context of learning from data to make predictions or classifications. The software's functionality is based on programming and engineering, not machine learning.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a machine learning training set.
§ 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).