Search Results

The SentiCare PillStation is intended for medical purposes to provide alerts to patients and healthcare providers for pre-determined medication dosing schedules. The device incorporates wireless communication and electronic imaging.

The SentiCare PillStation includes an electronic pillbox for home use (the PillStation), and server software for communicating and programming the PillStation (PillStation Manager Software). The SentiCare PillStation is designed to assist individuals with medication organization, self administration, and adherence. Specifically, the PillStation is designed to aid individuals in medication organization and reconciliation: identify incomplete or inappropriate removal of medications with corrective feedback; teach and coach about medications and daily medical procedures; provide alerts of dose times; and ensure timely relills of all medications self-administration. The SentiCare PillStation is a daily assist device with many features to alert users and caregivers of pre-determined scheduled medication times: easy to use pill tray, pill bins highlighted by light-up indicators, pill alarms, and LCD serven messaging. Through PillStation's built in scanning system, high quality, static digital images are sent from the PillStation to PillStation Manager software. Remote monitors, are other alled "Call Center Advisors", monitor and verify PillStation's medication contents with PillStation users' prescriptions in order to keep track of medication aterts and verify that the user and/or caregiver has loaded their prescribed medications into the PillStation pill tray. This monitoring is accomplished through the PillStation Manager software. The SentiCare PillStation is a novel approach to medication organization and may be of great assistance to those individuals and caregivers who look to improve upon their own medication organization, adherence, and self administration.

The SentiCare PillStation is a daily activity assist device (medication reminder). The 510(k) summary states that "Applicable tests were carried out as part of the software design process, where the key functions of the SentiCare PillStation (including both the PillStation and the PillStation Manager software) were verified and/or validated. The results of the testing met specifications, and established the device as safe and effective for its intended use, which is comparable to other predicate devices."

However, specific acceptance criteria and detailed study results beyond this general statement are not provided in the 510(k) document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, particularly highlighting the unique feature of imaging the pill tray contents.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.

Here is what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 specified. The document indicates that "Remote monitors, are other alled 'Call Center Advisors', monitor and verify PillStation's medication contents with PillStation users' prescriptions." These 'Call Center Advisors' might be considered the "experts" in the context of the device's function, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified. The text mentions "Remote monitors... monitor and verify PillStation's medication contents," which implies a form of verification, but no specific adjudication method (like 2+1) is described.

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 is mentioned. The device's primary function is to assist users and caregivers, with "Call Center Advisors" monitoring. The document does not describe a study comparing human performance with and without AI assistance for tasks like image recognition, as the device itself does not perform image recognition.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The device's core functionality involves imaging and uploading data, which is then monitored by human "Call Center Advisors." The 510(k) explicitly states: "the SentiCare PillStation does not perform image recognition or prohibit access to medications stored in the device." Therefore, a standalone algorithm-only performance study for image recognition would not be applicable, as that is not a function the device performs autonomously. The "standalone" testing described is of the system's "key functions" meeting specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for verifying medication contents appears to be the user's prescriptions, as verified by "Call Center Advisors." The document states they "monitor and verify PillStation's medication contents with PillStation users' prescriptions."

8. The sample size for the training set

• Not applicable/Not specified. This is not a machine learning device that requires a distinct "training set" in the conventional sense. The testing described is performance validation of software and hardware functions.

9. How the ground truth for the training set was established

• Not applicable/Not specified, as there is no mention of a training set for a machine learning model.

Ask a specific question about this device