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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.

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The provided text is a 510(k) clearance letter for the My Dose Coach device and its indications for use. It does not contain information regarding specific acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment methods.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the given input. The document focuses on regulatory approval, not on the technical validation study details.

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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.

Ask a specific question about this device