FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Inrange Remote Medication Management System is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. The system provides a means: for the patient's prescribed medications to be stored in a delivery unit; for a medical provider to remotely schedule the patient's prescribed medications; to provide notification to the patient when the prescribed medications are due to be taken; to release the prescribed medications to a tray of the delivery unit accessible to the patient's command; and to provide to the medical provider a history of the event.

Device Description

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AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to Inrange Systems, Incorporated for their Inrange Remote Medication Management System (EMMA). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device. This is a regulatory clearance letter, not a performance study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided text. The document only outlines the device's indications for use:

Indications for Use:
The Inrange Remote Medication Management System is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. The system provides a means:

for the patient's prescribed medications to be stored in a delivery unit;
for a medical provider to remotely schedule the patient's prescribed medications;
to provide notification to the patient when the prescribed medications are due to be taken;
to release the prescribed medications to a tray of the delivery unit accessible to the patient's command; and
to provide to the medical provider a history of the event.

To answer your request, a different type of document, such as a clinical study report or a technical performance assessment, would be required.

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K Number

DEN060002

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Device Name

INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM

Manufacturer

INRANGE SYSTEMS, INC.

Date Cleared

2007-06-13