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510(k) Data Aggregation
(126 days)
iCare APP
The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team.
The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.
The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team.
iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.
The provided text is a 510(k) Summary for the iCare App, focusing on its substantial equivalence to a predicate device. It primarily details regulatory information, device description, and non-clinical test summaries. It does not contain information about a study that proves the device meets specific performance acceptance criteria for a medical diagnostic or screening function.
The iCare App is classified as a "Medical Device Data System" (MDDS) that transmits, displays, and stores data from connected medical devices. Its function is to aid users and healthcare professionals in viewing test results for health management. It explicitly states: "Both devices make no interpretation, evaluation, medical judgments, or recommendations for treatment." This means the app itself doesn't perform diagnostic functions that would require specific performance metrics like sensitivity, specificity, or AUC against a ground truth.
Therefore, many of the requested criteria, such as acceptance criteria for diagnostic performance, a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not provided in this document because the device is a data management system, not a diagnostic algorithm.
Here's a breakdown of the applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of quantitative performance acceptance criteria for diagnostic accuracy, sensitivity, or specificity, because the iCare App is an MDDS for data management, not a diagnostic tool. Instead, acceptance criteria are implied through the successful completion of non-clinical tests that demonstrate the basic functionality, safety, and effectiveness for its intended use as a data display and storage system.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Verification & Validation | Compliance with FDA guidance for "moderate" level of concern software; no minor injury to patient/operator due to failure or latent flaw. | "Software verification and validation has been performed according to FDA guidance... The iCare App software was considered a 'moderate' level of concern...". All tests passed. |
| Wireless Coexistence Test | Ability to be used in intended environments without harmful interference. | "Wireless coexistence test has been performed to verify that the subject device can be used in intended environments." All tests passed. |
| Cybersecurity | Adherence to FDA guidance for cybersecurity; appropriate risk-based assessment and testing. | "Cybersecurity activities were conducted in accordance with FDA Guidance... The iCare App underwent appropriate risk-based cybersecurity assessment and testing..." All tests passed. |
| Usability Testing | Safe and effective use by lay users with provided labeling. | "Usability testing was conducted in accordance with FDA guidance... The test result demonstrates that the iCare App can be used by lay users with only provided labeling, the device is safe and effective for the intended use." All tests passed. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for diagnostic performance as the device is not a diagnostic algorithm. The document mentions non-clinical testing (software, wireless, cybersecurity, usability) but does not specify "test set" sizes in the context of clinical data for diagnostic performance.
- Data Provenance: Not applicable in the context of clinical diagnostic data. The document focuses on the technical aspects of the software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as the device does not perform diagnostic interpretations requiring expert-established ground truth for clinical cases.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as there is no clinical test set requiring ground truth adjudication for diagnostic performance.
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
- MRMC Study: No, an MRMC study was not done. The iCare App is an MDDS and does not involve AI assistance for human readers in a diagnostic capacity. It makes "no interpretation, evaluation, medical judgments, or recommendations for treatment."
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance study in the context of diagnostic accuracy was not done. The device's function is data transmission, display, and storage, not diagnostic algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for clinical diagnostic performance. For the software verification and validation, the "ground truth" would be the successful execution against specified requirements and accepted software engineering practices and FDA guidance.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document does not describe a machine learning model that was trained on a dataset. The iCare App is a software application for data management, not an AI/ML algorithm requiring a training set of clinical data for diagnostic purposes.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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