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KD-931D Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-931D Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified and displayed by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown on to the user. More over, it also has the function of averaging the last three measurements. Compared to KD-556, KD-931D does not contain an LCD, it will display the measurement result on the iPhone which is connected to the device.

Here's a breakdown of the acceptance criteria and study information for the KD-931D Fully Automatic Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The KD-931D Fully Automatic Electronic Blood Pressure Monitor states Performance: Similar when compared to its predicate device, KD-556. Both devices are designed and manufactured according to ANSI/AAMI SP10, which specifies performance requirements for manual, electronic, or automated sphygmomanometers. While specific numerical acceptance criteria (e.g., mean difference, standard deviation) are not explicitly stated in the provided text as a table, the device's conformance to AAMI SP10:2002 and its amendments implies meeting the accuracy standards outlined in that standard.

Implied Acceptance Criteria (based on AAMI SP10 compliance):

Note: The provided 510(k) summary only explicitly states conformance to AAMI SP10, which implies meeting its accuracy requirements. Specific tabular data for the KD-931D's performance (mean difference, standard deviation against a reference) is not included in this document but would be part of the testing supporting the AAMI SP10 compliance.

Study Details

The provided document is a 510(k) summary for premarket notification. It references the standards and comparisons used to demonstrate substantial equivalence, but it does not contain the detailed study report with specific statistical results from clinical trials that would prove the device meets all acceptance criteria. Instead, it makes claims of adherence to standards and similarity to a predicate device.

Here's what can be inferred from the text:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not provide details on the sample size, data provenance, or whether the study was retrospective or prospective. It only states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies testing was conducted, likely in accordance with AAMI SP10, but the specifics are not disclosed in this summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not provided. For blood pressure monitor validation against AAMI SP10, "experts" typically refers to trained observers (often two) using auscultation with a reference sphygmomanometer, whose readings are averaged or reconciled. Qualifications would usually involve specific training in blood pressure measurement.

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

   • This information is not provided. Standard AAMI SP10 testing often involves two independent observers and a third if there's a significant discrepancy, but the specifics are absent here.

4. 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:

   • No MRMC study was done or mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for "human readers."

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

   • Yes, the performance evaluation in this context would be considered standalone for the device itself. It's a fully automatic electronic blood pressure monitor, meaning its "algorithm" (oscillometric principle) measures blood pressure without direct human real-time intervention during the measurement process. The comparison would be against a "ground truth" (e.g., auscultation), not against human interpretation of device output.

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

   • The type of ground truth for blood pressure monitors adhering to AAMI SP10 is typically simultaneous auscultation by trained observers using a calibrated mercury sphygmomanometer or another validated reference device. This method establishes an "expert consensus" or reference standard for blood pressure.

7. The sample size for the training set:

   • Not applicable / not provided in this context. Blood pressure monitors like the KD-931D are typically developed based on established oscillometric principles and validated through clinical testing rather than "training" an AI model on a dataset. There is no mention of a machine learning or AI training set.

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

   • Not applicable / not provided as there is no mention of a training set for an AI model.

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