(164 days)
KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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 wrist. The cuff circumference is limited to 14cm-25cm.
KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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 wrist. The cuff circumference is limited to 14cm-25cm.
It 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, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The supplied document is a 510(k) summary for the KD-7902BTJ, KD-7963NJ, KD-7971J, and KD-7966 Fully Automatic Electronic Blood Pressure Monitors. This document primarily focuses on establishing substantial equivalence to a predicate device and outlines non-clinical and clinical tests performed.
Crucially, the document does not explicitly state specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation between device and reference method). Instead, it relies on compliance with the ANSI/AAMI SP10 standard as the benchmark for performance.
Therefore, I will extract the information based on the implicit acceptance criteria defined by adherence to ANSI/AAMI SP10 and the clinical study referenced.
Acceptance Criteria and Device Performance
The core acceptance criterion for the device's accuracy is its compliance with the ANSI/AAMI SP10: 2002 standard (including amendments A1:2003 and A2:2006). This standard sets forth requirements for the performance of manual, electronic, or automated sphygmomanometers.
The document states that the clinical test report of the predicate device, KD-7971 (K093452), is applicable to the subject devices because the "difference between the subject devices and their predicate device do not affect the clinical accuracy in terms of blood pressure detection."
Without the specific clinical report (K093452) for KD-7971, it is not possible to provide numerical reported device performance in the form of mean differences and standard deviations. The document only confirms that the device conforms to the standard.
| Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance (Implicitly Meets SP10 Requirements) |
|---|---|
| Accuracy (Systolic BP): Implicitly meets requirements for mean difference and standard deviation against a reference standard. | Conforms to ANSI/AAMI SP10:2002 and its amendments. |
| Accuracy (Diastolic BP): Implicitly meets requirements for mean difference and standard deviation against a reference standard. | Conforms to ANSI/AAMI SP10:2002 and its amendments. |
| Pulse Rate Accuracy: (Not explicitly mentioned in the summary, but typically included in SP10 compliance for these devices). | Conforms to ANSI/AAMI SP10:2002 and its amendments. |
| Safety: Electrical safety (IEC 60601-1), EMC (IEC 60601-1-2). | All non-clinical tests (including electrical safety and EMC) demonstrate no new questions of safety and effectiveness. |
| Performance Characteristics: (As per SP10 for function, pressure measurement, display, alarms, etc.) | Conforms to ANSI/AAMI SP10:2002 and its amendments. |
Study Details
Since the document relies on the clinical test report of the predicate device (KD-7971, K093452), the following information is based on the presumption that the original study for KD-7971 followed standard AAMI SP10 clinical validation protocols. The provided K111830 summary document does not contain these granular details itself.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided document. For AAMI SP10 validation, a typical minimum sample size is around 85 subjects, ensuring a broad range of blood pressures are captured.
- Data Provenance: Not specified in the provided document. Such studies are typically prospective clinical trials. The manufacturer is based in Tianjin, P.R. China, so the study could have been conducted there, but this is not confirmed.
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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):
- Number of Experts: Not specified in the provided document. For AAMI SP10 validation, the ground truth (reference blood pressure) is typically established by at least two (and sometimes three) trained observers (e.g., clinicians, nurses, or trained technicians) using a calibrated mercury sphygmomanometer, auscultatory method.
- Qualifications of Experts: Not specified, but they would be trained in the auscultatory measurement of blood pressure according to a standardized protocol.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified in the provided document. For AAMI SP10, a simultaneous dual observer auscultatory measurement is typically used. If the readings between the two observers differ by more than a predefined threshold (e.g., 4 mmHg), a third observer might be used, or the measurement discarded. This is sometimes referred to as a "double blind" or "three-way auscultation" approach if a third person is also involved or if the device operator is blinded.
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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:
- MRMC Comparative Effectiveness Study: No, this type of study was not done. The device is an automated blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The clinical study of the predicate device (KD-7971) assessed the accuracy of the automated device (algorithm only, as it's fully automatic) against a human auscultatory reference standard. This is the definition of a standalone performance evaluation for this type of device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: Expert consensus/Reference Standard. The ground truth for blood pressure measurement in devices conforming to AAMI SP10 is established by trained human observers using a calibrated mercury sphygmomanometer (or an equivalent validated reference method) via the auscultatory technique.
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The sample size for the training set:
- Training Set Sample Size: Not applicable/Not specified. For a traditional medical device like a blood pressure monitor, there isn't typically a "training set" in the machine learning sense with a separate ground truth for training. The oscillometric algorithm is developed and refined based on engineering principles and potentially internal validation, but not typically through a distinct, externally validated "training set" with ground truth in the way an AI algorithm for image analysis would be. The clinical study described is for validation, not training.
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How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable. See point 7 above. The intrinsic algorithm development would involve internal testing and calibration, but not against a "ground truth for a training set" as typically understood in AI/ML validation studies.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).