(31 days)
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.
Not Found
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.
§ 880.6315 Remote Medication Management System.
(a)
Identification. A remote medication management system is a device composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended to store the patient's prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient's prescribed medications, to notify 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 on the patient's command, and to record a history of the event for the health care professional. The system is intended for use as an aid to health care professionals in managing therapeutic regimens for patients in the home or clinic.(b)
Classification. Class II (special controls). The special control is: The FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System.” See § 880.1(e) for availability of this guidance document.