Search Results

KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J 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 upper arm. The cuff circumference is limited to 22cm-48cm.

KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J 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 upper arm. The cuff circumference is limited to 22cm-48cm.

They are 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.

The provided text is a 510(k) summary for a Fully Automatic Electronic Blood Pressure Monitor. It includes information about device descriptions, intended use, and comparisons to predicate devices, but it does not contain the detailed clinical study information typically required to fully address your request in the context of advanced AI/medical imaging devices.

Specifically, for a blood pressure monitor, the "acceptance criteria" generally refer to accuracy standards set by organizations like AAMI (Association for the Advancement of Medical Instrumentation) or ISO (International Organization for Standardization). The study that proves the device meets these criteria would involve comparative measurements against a reference standard.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

The document states the device conforms to AAMI SP10:2002 (and its amendments), which is the standard for manual, electronic, or automated sphygmomanometers. This standard defines the acceptance criteria for accuracy.

2. Sample size used for the test set and the data provenance

The document mentions clinical tests were done for predicate devices and that those reports are applicable to the subject devices due to identical or similar design principles and algorithms.

• "The clinical test report of KD-598(K083395) is applicable to our subject devices."
• "the clinical test report of KD-5961 is applicable to KD-5031NJ."

However, the document does NOT provide the following specific details for the test sets:

• Sample size: Not explicitly stated for any of the devices.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For blood pressure monitors, the "ground truth" in clinical validation studies is typically established by trained observers using auscultatory methods with a mercury sphygmomanometer (or an equivalent reference standard) as per the AAMI SP10 protocol. The document does not detail how many observers were used or their qualifications for the underlying studies it references.

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

This information is not provided. In blood pressure validation studies following standards like AAMI SP10, often multiple trained observers measure blood pressure, and their readings are compared to ensure agreement, playing a role similar to an "adjudication method" in establishing the reference. However, the exact methodology is not detailed here.

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

N/A. This device is a fully automatic electronic blood pressure monitor, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this type of device.

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

Yes, the device itself is a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner, providing measurements without direct human interpretation in the measurement process. The clinical tests mentioned (conforming to AAMI SP10) would evaluate this standalone performance against a reference standard.

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

For blood pressure monitors, the ground truth is typically established by simultaneous measurements using a recognized reference standard, usually a mercury sphygmomanometer with trained observers using auscultatory methods, as defined by protocols like AAMI SP10. The document states conformance to AAMI SP10, which implies this type of ground truth methodology.

8. The sample size for the training set

N/A / Not provided. Blood pressure monitors based on oscillometric technology generally do not employ machine learning models in the same way modern AI systems do, which require "training sets." Their algorithms are typically fixed based on established physiological principles and signal processing. Therefore, the concept of a "training set" in the AI sense is not applicable to this device, or at least not described in the provided regulatory document.

9. How the ground truth for the training set was established

N/A / Not applicable for the reasons stated in point 8.

Ask a specific question about this device

KD-388BD Semi 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-388BD Semi 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, the result will be shown on a LCD with an electronic interface module, the memory capability of KD-388BD is 2×60 times.

The provided text describes a 510(k) summary for the KD-388BD Semi Automatic Electronic Blood Pressure Monitor. While it mentions adherence to standards like AAMI SP10, it does not contain detailed information about specific acceptance criteria for blood pressure accuracy performance or a study proving the device meets those criteria, as typically found in clinical validation reports.

Here's a breakdown of the information that is available in the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states that the device "conforms to the following standards," including AAMI SP10:2002. AAMI SP10 is the key standard for non-invasive sphygmomanometers, and it outlines specific accuracy requirements for systolic and diastolic blood pressure measurements (e.g., mean difference ≤ ±5 mmHg with a standard deviation ≤ 8 mmHg). However, the document does not provide a table comparing these AAMI SP10 acceptance criteria with the actual performance data (mean difference, standard deviation) obtained from a study.

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

Missing. The document only generally states, "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." It does not specify any sample size for a test set or the provenance of any data.

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

Missing. There is no mention of experts or ground truth establishment for a test set. For blood pressure monitors, ground truth is typically established by trained observers using auscultation with a reference sphygmomanometer, following a defined protocol (e.g., AAMI SP10).

4. Adjudication Method

Missing. No adjudication method is mentioned as there is no description of a separate test set requiring such a process.

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

No. This type of study is not relevant for a blood pressure monitor, which measures a quantifiable physiological parameter rather than interpreting complex medical images or cases. Therefore, there is no mention of such a study or effect size.

6. Standalone (Algorithm Only) Performance

Partially Addressed, but without specific data. The device itself is a "Semi Automatic Electronic Blood Pressure Monitor," implying it's an automated device that provides a reading. Its performance, as per the AAMI SP10 standard it claims to conform to, would be a standalone assessment of its accuracy against a reference method. However, specific standalone performance data (e.g., mean difference and standard deviation of blood pressure readings against a reference) is not provided.

7. Type of Ground Truth Used

Implicitly, but not explicitly stated or detailed. For a blood pressure monitor, the "ground truth" used for validation against AAMI SP10 typically involves simultaneous or closely timed measurements by trained observers using a mercury or an equivalently validated reference sphygmomanometer (auscultatory method). The document states conformance to AAMI SP10, which implies this method would have been used, but it does not explicitly state it or provide details of the ground truth method or its establishment.

8. Sample Size for the Training Set

Missing. Training sets are generally relevant for machine learning algorithms. While an oscillometric device uses an algorithm, the document doesn't discuss a "training set" in the context of a machine learning model. It describes testing against a standard rather than training an AI model.

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

Missing. As no training set is discussed, this information is also absent.

Summary of what is present:

• Conformance to standards: The device claims to conform to AAMI SP10, IEC 60601-1, and IEC 60601-1-2. AAMI SP10 sets the performance criteria for non-invasive blood pressure monitors.
• Predicate Device: KD-322 (K083395) is identified as the predicate device, with the new device (KD-388BD) being "substantially equivalent."
• Minor differences from predicate: The document notes minor differences like appearance, additional memory, and a slight change in pulse rate range (30-180 to 40-180 times/min). It states that "[t]he test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies some level of testing was performed, likely to re-verify compliance with AAMI SP10 for the modified device, but the details are not provided.

*In conclusion, while the device claims conformance to AAMI SP10 (which defines the acceptance criteria for blood pressure monitors), the provided 510(k) summary does not contain the specific acceptance criteria in a table, nor does it present the detailed results of a study (sample size, performance metrics, ground truth methodology, etc.) that demonstrate the device explicitly meets those criteria. This level of detail is typically found in the full testing report, which is not part of this summary.

Ask a specific question about this device