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bp Limbo XL, bp Salsa XL and bp Tango XL are designed for Adult Blood Pressure Only or persons 18 years or older.

bp Limbo XL, bp Salsa XL and bp Tango XL are intended to be used as a personal blood pressure log to record patient measured results from a personal blood pressure monitor aiding in the management of hypertension as directed by a patient's physician or health care provider. The printed reports, and subsequent information contained within, are intended for review and interpretation by a physician and not as a stand alone diagnostic tool.

If bp Limbo XL, bp Salsa XL or bp Tango XL are used without a physician or health care provider relationship, all information must be considered educational, relating to the user's condition, and not as medical advice for the purpose of diagnosis, administration of treatment(s) or to prescribe medication(s).

DataDancer Blood Pressure (bp) Log Software, Model "bo Limbo XL", is a Microsoft Excel software application designed to log one (1) daily set of blood pressure results obtained from a user's personal blood pressure monitor, for a period of one (1) year. The device provides users, who have a personal computer and Microsoft Excel software installed, a method of logging, organizing, plotting, printing and viewing their personal blood pressure performance.

The device is composed of twelve (12) monthly blood pressure (bp) Logs, a Meds Log, an Example Screen, a Help Screen, a Year Screen, a MD Letter and a Title or Welcome Screen. Instant Help is provided on most screens by moving the computer's screen pointer over designated items of interest. Each monthly bp Log is designed to print all logged results, graphs and supplementary data for easy physician review and insertion into a personal medical file. User Instructions are available on the Help Screen and can also be downloaded from the DataDancer web site in PDF format.

Users can enter the following intormation into monthly blood pressure (bp) Logs: Time of bp measurement, Body Weight, Systolic Pressure, Diastolic Pressure, Pulse Rate and Comments. Pulse Pressure, Mean Arterial Pressure, Body Mass Index, parameter averages and the Classification of Blood Pressure (*) are automatically calculated. A Year Screen is provided to view, compare and print the averaged results of all monthly bp Logs in tabular and graphical formats.

DataDancer Blood Pressure (bp) Log Software, Model "bp Salsa XL", is a Microsoft Excel software application designed to log blood pressure results obtained from a user's personal blood pressure monitor. The device provides users, who have a personal computer and Microsoft Excel software installed, a method of logging, organizing, plotting, printing and viewing their personal blood pressure performance within and across different blood pressure treatments.

The device is composed of ten (10) identical blood pressure (bp) treatment Logs, a Meds Log, an Example Screen, a Help Screen, a Summary Screen, a MD Letter and a Title or Welcome Screen. Instant Help is provided on most screens by moving the computer's screen pointer over designated items of interest. Each bp treatment Log is designed to print all logged results, graphs and supplementary data for easy physician review and insertion into a personal medical file. User Instructions are available on the Help Screen and can also be downloaded from the DataDancer web site in PDF format.

Users can enter the following within-treatment information into blood pressure (bp) treatment Logs: Date and Time of bp measurement, Body Weight, Systolic Pressure, Diastolic Pressure, Pulse Rate and Comments. Pulse Pressure, Mean Arterial Pressure, Body Mass Index, parameter averages and the Classification of Blood Pressure (*) are automatically calculated. A Summary Screen is provided to view and compare across treatment performance and print the averaged results of all treatment Logs in tabular and graphical formats.

DataDancer Blood Pressure (bp) Log Software, Model "bp Tango XL", is a Microsoft Excel software application designed to log two (2) daily set of blood pressure results obtained from a user's personal blood pressure monitor, for a period of one (1) year. The device provides users, who have a personal computer and Microsoft Excel software installed, a method of logging, organizing, plotting, printing and viewing their personal blood pressure performance.

The device is composed of twelve (12) monthly blood pressure (bp) Logs, a Meds Log, an Example Screen, a Help Screen, a Year Screen, a MD Letter and a Title or Welcome Screen. Instant Help is provided on most screens by moving the computer's screen pointer over designated items of interest. Each monthly Log is designed to print all logged results, graphs and supplementary data for easy physician review and insertion into a personal medical file. User Instructions are available on the Help Screen and can also be downloaded from the DataDancer web site in PDF format.

Users can enter the following information into monthly blood pressure (bp) Logs: Times of bp measurement, Body Weight, Systolic Pressure, Diastolic Pressure, Pulse Rate and Comments. Pulse Pressure, Mean Arterial Pressure, Body Mass Index, parameter averages and the Classification of Blood Pressure (*) are automatically calculated. A Year Screen is provided to view, compare and print the averaged results of all monthly bp Logs in tabular and graphical formats.

Here's a breakdown of the acceptance criteria and study details based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device, DataDancer Blood Pressure Log Software (bp Limbo XL, bp Salsa XL, and bp Tango XL), is a software application. Its acceptance criteria appear to be based on demonstrating "substantially equivalent results" to its predicate devices for specific functionalities when processing identical blood pressure data.

Study Details

2. Sample Size and Data Provenance

The document states that "identical sets of blood pressure data" were used. However, it does not specify the sample size (i.e., the number of data points or patient records) within these datasets.

Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It only mentions that the data was used to subject both the predicate and test devices to "identical sets of blood pressure data." This suggests that the data was pre-existing or synthetically generated to test the algorithms rather than derived from a live medical study.

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable. The study did not involve human experts establishing ground truth for a test set in the traditional sense of clinical interpretation or diagnosis. Instead, the "ground truth" was essentially the known correct calculations and classifications as performed by the predicate devices or based on established algorithms.

4. Adjudication Method for the Test Set

Not applicable. There was no human interpretation or subjective judgment that required adjudication. The evaluation was based on direct comparison of computational outputs between the test device and predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study was not performed. This study focused on the functional equivalence of the software's calculations and displays, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes. The study performed was a standalone performance evaluation of the algorithms within the DataDancer software. It compared the outputs of the DataDancer software directly against the outputs of the predicate devices using identical input data, without human intervention in the interpretation loop during the testing phase. The conclusion explicitly states, "We have demonstrated that the DataDancer Blood Pressure Log Software... are as safe and effective as the predicate devices... based upon testing results using identical data sets."

7. Type of Ground Truth Used

The ground truth used was based on the outputs and algorithms of the predicate devices and the accepted standards they implemented.

• For calculations (averages, PP, MAP), the ground truth was the expected output from the Microlife PC-link predicate given the input data.
• For blood pressure classification, the ground truth was what the Panasonic predicate device's algorithm would produce, which itself was based on "The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure"; NIH Publication Number 03-5233, May 2003.

8. Sample Size for the Training Set

Not applicable. The device is described as a "Microsoft Excel software application designed to log" and calculate. This implies a rule-based or formula-based system rather than a machine learning model that would require a separate training set. The existing documentation does not indicate any machine learning components, and thus, no training set would have been used or required based on the description.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a training set was not used for this rule-based software device.

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