(309 days)
The Connect App for iHealth Next is intended for use in home settings as an aid for people to view vital signs which are measured by iHealth devices (noninvasive blood pressure monitor and pulse oximeter).
The Connect App for iHealth Next should not be used to either self-diagnose a disease state or exclude it. Please consult your physician if you find the reading is above a normal threshold.
The Connect App for iHealth Next is a software for using it with health devices, including iHealth medical devices such as Blood Pressure Monitor and pulse oximeter, etc. It can also be used with non-medical devices, such as active monitor, weight scale, etc.
The Connect App for iHealth Next can:
(1) Connect to blood pressure monitor and control the meter to complete measurement, and the data can be transferred to the Connect App for iHealth Next;
(2) Connect to pulse oximeter and transfer data from the pulse oximeter to the Connect App for iHealth Next.
This document describes the Connect App for iHealth Next, a data management software. No specific acceptance criteria for diagnostic or prognostic performance are described in the provided text, as this device primarily focuses on data management and control of other medical devices. Therefore, a comprehensive table of acceptance criteria and reported device performance related to diagnostic accuracy cannot be generated from this submission.
However, the document does describe validation activities for other aspects of the device:
1. A table of acceptance criteria and the reported device performance
As mentioned above, no specific diagnostic or prognostic acceptance criteria are provided in the text. However, a "Performance summary" section mentions non-clinical tests performed:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Software validation according to FDA guidance | "The result conforms that the proposed device is as safe and effective as the predicate device." |
| Usability for lay users and professionals in intended environments | "The study results demonstrate that the Connect App for iHealth Next are understood by a variety of users, and provide sufficient information for the safe and effective use of the device." |
| Wireless coexistence in intended environments | "Wireless coexistence test has been performed to verify that the proposed device can be used in intended environments." |
2. Sample size used for the test set and the data provenance
- Usability Study: 20 lay users and 20 professionals participated in the usability study. The provenance is not explicitly stated but implies testing in "their actual use environment such as home, hospital, clinic and office etc."
- For software validation and wireless coexistence, specific sample sizes (e.g., number of test cases) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as the device is data management software, and the "ground truth" for the usability study would be user feedback and successful task completion, not diagnostic ground truth established by medical experts for a clinical condition. The participants were "20 lay users and 20 professionals," with no further qualification details provided.
4. Adjudication method for the test set
Not applicable. The usability study involved observing user interaction and feedback, not a traditional adjudication process for clinical endpoints.
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 performed or described. This device is data management software, not an AI-powered diagnostic tool requiring human reader comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is software for managing data and controlling medical devices. Its "performance" revolves around software functionality, usability, and wireless connectivity, which were tested in a standalone manner (without continuous human interaction to refine its core functions) but with human users evaluating its user-facing aspects.
7. The type of ground truth used
- Software Validation: The "ground truth" for software validation would be adherence to specified requirements and established software engineering best practices, verified through testing against expected outputs.
- Usability Study: The "ground truth" was defined by successful task completion, understanding of warnings/precautions, and overall user experience as observed and reported by participants (lay users and professionals) against predetermined critical tasks and usability goals.
8. The sample size for the training set
Not applicable. This device is software for data management and device control, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable (see point 8).
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).