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Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance and data storage. These two differences will not affect the safety and effectiveness of the device.

The provided text describes the 510(k) summary for an Electronic Blood Pressure Monitor (K131558). However, it focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant standards rather than detailing a specific clinical study with granular data on acceptance criteria and study design as requested.

Based on the provided information, I can extract the following:

1. Table of acceptance criteria and the reported device performance

Note: The text states, "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ... AAMI SP10:2002/(R) 2008 & A1:2003, Manual, electronic or automated sphygmomanometers."
This implies that the device achieved the accuracy requirements outlined in AAMI SP10. The value of ± 3 mmHg is explicitly listed under "BP Accuracy" in the Substantial Equivalence comparison table, indicating it's the target and achieved accuracy.

Regarding other requested information:

• 2. Sample size used for the test set and the data provenance: Not specified in the provided text. The text only mentions "bench tests."
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Clinical expert involvement is not mentioned for accuracy testing.
• 4. Adjudication method for the test set: Not specified.
• 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: Not applicable. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the accuracy testing for the blood pressure monitor itself is a standalone test of its algorithm and hardware performance.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, the ground truth for accuracy is typically established by comparing the device readings against a validated reference method, often auscultation by trained observers using a mercury sphygmomanometer, as outlined in standards like AAMI SP10. While not explicitly stated as "ground truth method," compliance with AAMI SP10 implies this type of reference measurement.
• 8. The sample size for the training set: Not applicable/Not specified. This device likely uses a deterministic algorithm based on oscillometric principles, not a machine learning model requiring a distinct "training set" in the common sense. Calibration during manufacturing takes place, but this is different from a data-driven training set.
• 9. How the ground truth for the training set was established: Not applicable/Not specified for the reasons above.

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