(167 days)
Mobile Application allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.
The Connected Care Mobile Application is intended to receive, display and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers.
The mobile application is designed to operate on various platforms including tablet computers and smart phones, guiding a user through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:
- . Scale
- Glucose meter
- NiBP .
- . SPO2
The provided text details the 510(k) summary for the Watermark Medical Connected Care Mobile Application. However, it does not include specific acceptance criteria, a detailed study proving performance against those criteria, or the granular information about sample sizes, ground truth establishment, or expert qualifications that you requested.
The document primarily focuses on the regulatory submission, device description, intended use, and substantial equivalence to a predicate device. The "Performance Data" section is very brief and general.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated | "The software validation results demonstrated that the Mobile Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software." |
| (Implied Criteria based on Device Functionality) | (The device is intended to receive, display, and transmit patient information, specifically vital signs data from connected peripherals.) |
| Accuracy of data display/transmission | Not explicitly stated, but implicitly validated as part of "specifications and functional requirements." |
| Data integrity during transmission | Not explicitly stated, but implicitly validated as part of "specifications and functional requirements." |
| Compatibility with specified peripherals | Not explicitly stated, but implicitly validated as part of "specifications and functional requirements." |
Explanation:
The document states that the software validation demonstrated compliance with guidelines and standards, and that it performed within its specifications and functional requirements. However, it does not list these specific specifications or functional requirements as acceptance criteria in measurable terms (e.g., "data transmission success rate > 99%," "display accuracy within X% of source"). Therefore, a detailed table with explicit acceptance criteria and corresponding performance metrics cannot be constructed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not mentioned in the provided text.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned in the provided text. The device is intended for "personal use" and collects data for "retrospective review," implying the data, once collected, is historical. However, details about the origin of data used for testing are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not mentioned in the provided text.
- Qualifications of Experts: Not mentioned in the provided text.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned or implied in the provided text. This device is a data collection and display application, not an AI interpretation tool for medical images, which are typically the subject of MRMC studies.
- Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study was mentioned and the device is not an AI interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? The "Performance Data" section refers to "software validation results" and performance "within its specifications and functional requirements." This implies testing of the software's functionality in isolation (standalone), but no specifics of such a study are provided (e.g., methodology, metrics, results beyond a general statement of compliance).
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For a device like this, ground truth would likely involve verifying the accuracy of displayed and transmitted data against the raw data received from the connected physiological sensors. However, the document doesn't detail how this was established.
8. Sample Size for the Training Set
- Training Set Sample Size: Not mentioned in the provided text. Given this is a mobile application for data collection and display, it's unlikely to have a "training set" in the sense of machine learning algorithms. The "training" would be more akin to software development and debugging, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable in the context of machine learning. If "training set" refers to data used during software development and testing, ground truth would be established by verifying the software's output against the expected correct output for given inputs, likely through various testing methodologies (unit tests, integration tests, system tests). The document does not provide these details.
§ 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).