(149 days)
The Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological Monitor device and other FDA Cleared patient monitors and Remote Data Displays (RDDS), the Caretaker Software Library provides a well-defined interface for 3rd party data integrations.
In addition to providing data display and forwarding, the Remote Display App can operate as an MDDS for 3rd party wireless medical devices. The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention.
The Software Library is intended only for use by licensed partners of the company, and the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel. Both the Remote Display App and Software Library are for prescriptive use only.
CareTaker Medical's App ("CareTaker Remote Display App") is a software App that runs on Commercial, Off the Shelf (CoTS) hardware to provide additional controls and features to the CareTaker4 Physiological Monitor, K163255, as well as an interface to other devices.
The App is a software platform that displays and stores physiological parameters and waveforms from patient monitoring medical devices. CareTaker Remote Display App can also forward this data to third party systems, including Electronic Medical Records systems.
The integrated CareTaker Software library provides new control and configuration functions to a connected CareTaker4 Physiological Monitor. This library can also be used by 3rd parties to develop their own Apps that are capable of controlling a CareTaker4 as well. The library does not and cannot control any other medical devices or systems it is connected with.
CareTaker Remote Display App can function without the CareTaker Software Library, in which case it is the same as the RDDS in K163255.
The provided text describes the 510(k) premarket notification for the CareTaker Remote Display App and CareTaker Software Library (K181196). However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices (VIOS Monitoring System, K150992, and Airstrip ONE Web Client, K160862) and confirming safety and effectiveness through nonclinical testing, usability, and risk assessment.
Based on the available information, I can extrapolate some aspects, but many details regarding specific acceptance criteria, performance metrics, sample sizes, expert qualifications, and study methodologies (like MRMC or standalone performance) are not explicitly stated in this document.
Here's an attempt to answer the questions based on the provided text, highlighting where information is not available:
Acceptance Criteria and Device Performance Study (K181196)
1. A table of acceptance criteria and the reported device performance
The document does not provide a quantitative table of acceptance criteria and reported device performance. Instead, it makes general statements about safety and effectiveness and substantial equivalence to predicate devices. The "performance" described relates to the functionality of displaying, storing, forwarding, and alarming patient data, and controlling a connected physiological monitor.
| Feature/Criterion Field | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Effectiveness | Demonstrated through nonclinical testing, conformance to vital signs monitoring, usability, and risk assessment. | "The safety and effectiveness of the CareTaker Remote Display App have been confirmed through nonclinical testing and conformance to vital signs monitoring, usability, and risk assessment." |
| Substantial Equivalence | No significant differences in technologies, operating principles, or intended use compared to predicate devices (VIOS Monitoring System, K150992, and Airstrip ONE Web Client, K160862). | "The Caretaker Remote Display App and CareTaker Software Library are safe to use as they are substantially equivalent to the predicate devices. There are no significant differences in technologies, operating principles, or intended use." |
| Storing, Displaying, and Forwarding Patient Data | The device should reliably store, route, and display patient data. | Confirmed to be safe and substantially equivalent for these functions. "The App was tested by connecting to a CareTaker4 Physiological Monitor Device using the CareTaker Software Library and to both a SpO2 monitor and a temperature patch using industry standard BLE Protocols to receive data. Data forwarding was tested using both WiFi and USB protocols to an external RDDS." |
| Alarm Functions | Visual and audio alarms should indicate when a received parameter exceeds an operator-set limit. No processing of physiological data by the App/Library. Alarms latch and are not intended for time-critical intervention, but for historical review. | "The Caretaker Remote Display App and CareTaker Software Library are safe to use as the visual and audio alarms only indicate when a received parameter exceeds a limit set by the operator. No processing of physiological data is done by the App or library. The alarms latch to ensure they are viewed by the operator, but are not intended for time-critical intervention. The alarms are retained for review of historical data." |
| Controlling the CareTaker4 Physiological Monitor | Control functions must be the same as available on the previously cleared CareTaker4 Physiological Monitor Device (K163255) and not alter its safety or efficacy. | "The Caretaker Remote Display App and CareTaker Software Library are safe to use as the control functions are the same as are available on the previously cleared CareTaker4 Physiological Monitor Device, K163255, and do not alter the safety or efficacy of the CareTaker4 Physiological Monitor itself. The App provides a more convenient method to control the device rather than using the 1-button interface on the device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "nonclinical testing" and testing for interoperability using a CareTaker4 Physiological Monitor, a SpO2 monitor, and a temperature patch.
- Data Provenance: Not specified. The nature of the "nonclinical testing" implies it was likely laboratory or simulated data, rather than patient data from a specific country, but this is not explicitly stated. It is described as "nonclinical" which typically refers to bench or simulated tests.
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)
Not applicable. This device is an app and software library for displaying and forwarding vital signs data and controlling a monitor. It does not involve interpretation of medical images or complex diagnostic tasks that would require human expert ground truth establishment in the way an AI diagnostic device would. The "ground truth" for its performance would be the accuracy of data transmission, display, and control commands, which are validated through technical and interoperability testing, not expert consensus on medical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as described above. The validation focuses on technical functionality and interoperability, which are typically assessed against technical specifications and communication protocols, not subjective human interpretations requiring adjudication.
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 study was done or mentioned. This is not an AI diagnostic device that assists human interpretation. Its function is to display, store, and forward data from an existing medical device and provide control.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a software application. Its "standalone" performance would refer to its ability to correctly receive, display, store, forward, and transmit control commands. The document indicates that "nonclinical testing" was performed, including testing connections to the CareTaker4 Physiological Monitor, SpO2 monitor, and temperature patch, and testing data forwarding via WiFi and USB. This can be considered the standalone performance evaluation of the software's core functionalities. No human-in-the-loop performance study is described beyond the intended use by clinicians.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the accurate transmission, display, and storage of physiological parameters, and the correct execution of control commands. This is verified against the known outputs/states of the connected medical devices and standard communication protocols. It is not based on expert medical consensus or pathology.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device in the context of image interpretation or diagnostic prediction that requires a "training set." It's a software application designed for data display, forwarding, and control.
9. How the ground truth for the training set was established
Not applicable (as it's not an AI/ML device requiring a training set).
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).