(135 days)
My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. My Dose Coach is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin titration) that are based on the patient's Fasting Blood Glucose ( FBG) as well as hypoglycemia occurrence.
My Dose Coach is not intended to replace the care or advice of a physician or HCP.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria for the My Dose Coach device or any study that proves the device meets such criteria. The document is an FDA 510(k) clearance letter and an "Indications for Use" statement, which largely discuss regulatory aspects and the intended use of the device.
Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).