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KD-936 Fully Automatic Wireless 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-936 Fully Automatic Wireless 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-936 Fully Automatic Wireless Blood Pressure Monitor is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results.

KD-936 Fully Automatic Wireless Blood Pressure Monitor achieves its function by integrate the device with an iPhone, ipod or ipad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, iPod or iPad containing a support software to constitute a complete blood pressure measurement system. And the new device connect iPhone, iPod or iPad through bluetooth,

Here's a breakdown of the acceptance criteria and the study details for the KD-936 Fully Automatic Wireless Blood Pressure Monitor, based on the provided FDA 510(k) files:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for blood pressure monitors generally stem from the ANSI/AAMI SP10 standard. While the document doesn't explicitly list numerical thresholds in a table, it states that the device "met all applicable requirements of the standard." For context, ANSI/AAMI SP10 typically requires:

Explanation of "Met all applicable requirements of the standard" for accuracy:

While not explicitly stated in the document, ANSI/AAMI SP10 (and its derivatives, such as ISO 81060-2) typically requires the following for blood pressure measurement accuracy:

• Mean Difference: The average difference between the device's readings and a reference standard (e.g., auscultatory measurement) should be ±5 mmHg or less.
• Standard Deviation: The standard deviation of the differences should be 8 mmHg or less.

The statement "the device met all applicable requirements of the standard" implies that these numerical thresholds were achieved in the clinical test.

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

• Sample Size: The document does not explicitly state the sample size used for the clinical test. It only mentions, "a new clinical test is done in accordance with ANSI/AAMI SP10." ANSI/AAMI SP10 typically requires a minimum of 85 participants for clinical validation. This would likely be the sample size used, though it's not confirmed.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but clinical validation studies for device approval are almost always prospective.

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

• Number of Experts: The document does not explicitly state the number of experts used. However, for blood pressure monitor validation according to ANSI/AAMI SP10, it typically requires at least two independent trained observers to perform reference measurements (e.g., auscultatory method).
• Qualifications of Experts: The document does not specify the qualifications of the experts, but in clinical validation studies for blood pressure monitors, these would typically be clinicians or trained personnel (e.g., nurses, physicians) proficient in manual auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not explicitly detail an adjudication method. In the context of ANSI/AAMI SP10 for blood pressure monitors, the "ground truth" (reference measurement) is typically established by simultaneous measurements by two independent observers, and their readings are averaged or compared for agreement. If disagreements exceed a certain threshold (e.g., 4 mmHg for systolic/diastolic readings), a third observer might be involved, or the readings might be discarded. This implies an implicit "2 (+1 if needed)" type of approach for establishing reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No MRMC study was done. This type of study is not typically applicable or required for the approval of a non-invasive blood pressure measurement system like the KD-936. MRMC studies are usually relevant for image-based diagnostic aids where human readers interpret medical images with and without AI assistance.

6. If a Standalone (Algorithm only without Human-in-the-Loop Performance) Was Done

• Yes, a standalone study was done. The clinical test performed "in accordance with ANSI/AAMI SP10" evaluates the device's performance directly against a reference standard, without human intervention in the measurement process (other than proper cuff placement and activation). The device itself (the algorithm for blood pressure determination) is being tested for its accuracy.

7. The Type of Ground Truth Used

• Expert Consensus/Reference Standard Measurement: The ground truth for the clinical test would have been established using a reference standard method, which for blood pressure monitors is typically auscultatory measurement performed by trained observers, potentially with a mercury sphygmomanometer or a validated electronic device used as the reference. This aligns with the requirements of ANSI/AAMI SP10.

8. The Sample Size for the Training Set

• The document does not provide information about a specific "training set" sample size. For traditional medical devices like blood pressure monitors, the concept of a distinct 'training set' and 'test set' in the machine learning sense is not always explicitly delineated. The development and internal validation (or "training and tuning") of the oscillometric algorithm would happen during the device's engineering phase, likely using proprietary data, before the formal clinical validation study (test set). The 510(k) summary focuses on the final validation.

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

• Since a specific "training set" is not detailed, the method for establishing its ground truth is also not provided. However, any internal development or optimization of the device's algorithm would have used reference blood pressure measurements, likely obtained through similar standard auscultatory methods, to "train" or refine its oscillometric algorithm.

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