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DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager®)-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes selfmanagement. The DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The DiabetesManager®-Rx System is not intended to replace the care provided by a Licensed healthcare professional, including prescriptions, diagnosis, or treatment.

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I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) substantial equivalence letter from the FDA for the WellDoc DiabetesManager® System and DiabetesManager® -Rx System. This type of letter confirms that a new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness.

Crucially, a 510(k) notification typically does not involve the FDA reviewing detailed clinical studies or setting specific performance acceptance criteria for the new device in the same way a PMA (Premarket Approval) does. The focus is on demonstrating equivalence to an existing device.

While the document outlines the indications for use for both the OTC and Prescription versions of the DiabetesManager® System, it does not contain the following information that would be necessary to answer your questions:

• Acceptance criteria table: There is no table detailing performance metrics and their acceptance thresholds.
• Study data: The letter does not describe any specific study conducted by WellDoc to prove the device meets acceptance criteria. It mentions "review of your Section 510(k) premarket notification" but does not detail the contents of that notification regarding clinical performance studies.
• Sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager®)-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes selfmanagement. The DiabetesManager®-Rx System analyzes and reports blood alucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The DiabetesManager®-Rx System is not intended to replace the care provided by a Licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Not Found

The provided text is a 510(k) substantial equivalence determination letter for the WellDoc DiabetesManager® System and DiabetesManager®-Rx System. It does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

The letter is primarily focused on:

• Notifying WellDoc, Incorporated of an administrative change to a previous substantial equivalence letter.
• Reaffirming the device's substantial equivalence to a predicate device.
• Outlining regulatory compliance responsibilities.
• Stating the Indications for Use for both the OTC and Prescription versions of the DiabetesManager® System.

Therefore, I cannot provide the requested information based on the input text. The document does not describe the specific performance characteristics, sample sizes, expert qualifications, or study methodologies that would be necessary to answer your questions.

Ask a specific question about this device