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The Animas ezManager Plus diabetes management software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or health care professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.

The Animas ezManager Plus will also allow download of information from Animas pumps and commercially available blood glucose meters to a hand-held electronic device for display of the information.

The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on health care professional prescribed settings and user entered data.

The Animas ezManager Plus diabetes management system is software that is loaded onto a patient's or health care professional's personal computer to allow for downloading information from Animas insulin pumps and specified commercially available blood glucose meters. The system allows for users to view data stored in the pump and meter history such as basal deliveries, bolus deliveries and blood glucose measurements. The data can be displayed in numerous formats and configurations to facilitate trending and better diabetes management.

The Animas ezManager Plus diabetes management system also allows for Animas pump users to upload personal setting information to their pump. Personal setting information includes basal programs and rates, insulin to carbohydrate ratios, insulin sensitivity factors, target blood glucose ranges, and when available pump food database information (food, serving size and carbohydrate information). This feature allows users the convenience of programming and saving all of this information on their personal computers. Once the information is uploaded to the pump, the user is prompted to verify the active basal program before initiating therapy.

For Animas pumps the download and upload is completed using an IR dongle and the IR window on the back of the pump. For the specified meters, the download is accomplished by using the manufacturer specified connection cables.

The provided text is related to a 510(k) submission for the "Animas ezManager Plus Diabetes Management Software". It describes the device, its intended use, and the FDA's decision regarding its substantial equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, the study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices rather than providing detailed performance study results against predefined acceptance criteria for a new, groundbreaking technology. This type of submission often relies on a comparison of features, intended use, and historical safety/efficacy of predicate devices.

Therefore, I cannot populate the requested table and answer many of the questions from the provided text.

Here's what I can extract and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document does not define specific performance metrics (e.g., accuracy of insulin dose calculation, data transfer integrity rates) or corresponding acceptance thresholds for these metrics. It is a 510(k) summary, which generally focuses on demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. (The document does not describe a clinical or lab study that would generate this data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable, as no ground truth establishment for a test set is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable, as no test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: Not applicable. The device is a diabetes management software, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting cases.
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Standalone Performance Study: Not described. The software's function is to manage data and calculate doses based on user-entered data and professional settings; it's inherently a human-in-the-loop system where the user interacts with the generated information.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable, as no ground truth for a performance study is described. The "ground truth" in the context of this device would likely refer to the accuracy of data transfer from pumps/meters and the correctness of insulin/carbohydrate dose calculations based on specified algorithms and user inputs. However, no study demonstrating this is provided.

8. The sample size for the training set:

• Not applicable, as the document does not describe a machine learning model that would require a training set. This is a software system for data management and calculation, not an AI/ML diagnostic or predictive model.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of what is available from the document:
The document primarily provides descriptive information about the device, its intended use, and the regulatory pathway. It identifies the device as an insulin infusion pump accessory (software) that allows for:

• Downloading data from Animas insulin pumps and blood glucose meters.
• Viewing data in various formats.
• Uploading personal settings (basal programs, ratios, etc.) to Animas pumps.
• Calculating insulin or carbohydrate doses based on prescribed settings and user input.

The document states that the predicate devices were:

• Animas ezManager Plus, K022394
• Deltec, CoZmanager, K062323

The FDA determined the device to be substantially equivalent to these predicate devices for its stated indications for use. This regulatory conclusion is the primary outcome of the 510(k) submission described.

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