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The APB for Windows is a software package to be used by a trained physician or health care provider to load, download, review and print data from the Mobile-O-Graph blood pressure monitor. The software will store and playback systolic, diastolic pressures as well as patients heart rates to be reviewed by a trained physician.

The ABP for Windows Software is a software designed to be used in conjunction with I.E.M's Mobile-O-Graph Blood Pressure Monitor, Model ABP Control (K964235). The software will allow the user to program the Mobile-O-Graph using the software by inputting patient identification, protocols and setting recorder clock. The software will have the ability to download the data recorded from the Mobile-O-Graph to the computer to be reviewed by a trained professional. The software will allow the data to be printed and e-mailed in PDF or HTML format if desired. The ABP for Windows does not perform any diagnosis or provide any interpretation of data, it can only display and print the downloaded data such as systolic, diastolic, heart rates and mean arterial blood pressure in tabular or graphical form which was recorded by the Mobile-O-Graph. The physician will be able to review, edit and print the data collected. The ABP for Windows will provide information such as when patient events occurred , errors during recording and when day and night were marked on the Mobile-O-Graph. The software ABP for windows will be shown to be substantially equivalent to the software which is provided by I.E.M.'s Mobile-O-Graph Blood Pressure Monitor, Model ABP Control.

The provided document is a 510(k) premarket notification for the "ABP for Windows" software, which is designed to be used with the Mobile-O-Graph Blood Pressure Monitor (K964235). The submission focuses on demonstrating substantial equivalence to the predicate device's software.

Based on the provided text, the ABP for Windows software does not perform any diagnosis or provide any interpretation of data. It is purely for displaying, storing, and printing data recorded by the Mobile-O-Graph, which is then reviewed by a trained professional. Therefore, the concept of "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, AUC) and a "study that proves the device meets the acceptance criteria" in the traditional sense of AI/CADe devices for interpretation is not applicable here.

The "study" described is a comparison of technological characteristics to demonstrate substantial equivalence, rather than a clinical performance study.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As the device is software for data management (displaying and printing) and not for diagnostic interpretation, the acceptance criteria are related to its functional compatibility with the predicate device's software and its ability to process and display the blood pressure data accurately.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study involving a "test set" of patient data for diagnostic performance evaluation. The "tests" mentioned are for software safety and efficacy, likely functional testing and compatibility, not based on patient data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There is no diagnostic "ground truth" establishment described, as the software does not perform diagnosis or interpretation.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is not relevant for this software's intended use, which is data management, not diagnostic assistance.

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

Yes, in a conceptual sense related to software functionality. The comparison of technological characteristics against the predicate software evaluates the "algorithm only" in terms of its ability to manage and display data, rather than interpret it. The software's performance is standalone in that it processes and presents data without human intervention in the data processing step, but human review is required for interpretation.

7. The type of ground truth used

Not applicable for diagnostic performance evaluation. For functional equivalence, the "ground truth" would be the demonstrated functionality of the predicate device's software and the specified technical requirements for the new software.

8. The sample size for the training set

Not applicable. This software does not use machine learning or AI models that require a "training set" of data.

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

Not applicable. No training set is involved.

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