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Wrist Measurement 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.

The provided text describes the clinical tests and acceptance criteria for the Wrist Measurement Electronic Blood Pressure Monitor (Models: KD-791, KD-792, KD-793, KD-795, KD-796, KD-797, KD-798).

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated for the clinical accuracy test. The document only mentions "Clinical tests were performed."
• 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:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For blood pressure monitoring, ground truth is typically established by trained medical personnel using a reference sphygmomanometer.

4. Adjudication method for the test set:

• Not applicable/Not specified. For automated blood pressure monitors, the device's readings are directly compared to the reference standard, rather than involving expert adjudication of "results."

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 an automated blood pressure monitor and does not involve human "readers" or AI assistance in the interpretation of complex medical imagery or data. Its primary function is to directly measure and display blood pressure and pulse rate.

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

• Yes, performance evaluation was done in a standalone manner. The device is designed to automatically measure and display readings without real-time human intervention in the measurement process itself. The clinical tests assessed the accuracy of the device's measurements against a recognized standard (ANSI/AAMI SP10-2002).

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

• For the blood pressure accuracy, the ground truth would be established by reference measurements taken simultaneously or sequentially by trained personnel using a validated, traditionally accepted method (e.g., a mercury sphygmomanometer or another validated reference device) as dictated by the ANSI/AAMI SP10-2002 standard.

8. The sample size for the training set:

• Not applicable/Not specified. This device is based on oscillometric technology and appears to be a deterministic algorithm rather than a machine learning model that would require a separate "training set" in the conventional sense. The "training" would be more akin to calibration and design optimization based on engineering principles and the chosen measurement method.

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

• Not applicable for the reason stated above. If any iterative development involved comparing prototype readings to known values, those known values would follow the same ground truth principles as outlined in point 7.

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Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.

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-30cm.

Fully Automatic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions that "Clinical tests were performed."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on the device's accuracy against a standard (ANSI/AAMI SP10-2002), not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The clinical tests were performed to assess the "Fully Automatic Electronic Blood Pressure Monitor" against the accuracy requirements of ANSI/AAMI SP10-2002. This implies an evaluation of the device's algorithmic performance in measuring blood pressure and pulse rate without human-in-the-loop adjustments during the measurement.

7. Type of Ground Truth Used

The ground truth used was the accuracy requirements of ANSI/AAMI SP10-2002. This standard defines the acceptable error limits for non-invasive blood pressure measurement devices.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. Given the context of a 510(k) for a blood pressure monitor, the "training set" concept (as understood in machine learning) might not be directly applicable in the same way. The device's underlying algorithm is likely developed based on established oscillometric principles rather than being "trained" on a large dataset in the modern AI sense.

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

The document does not provide information on how ground truth for a training set was established. (See the explanation in point 8 regarding the applicability of the "training set" concept here). The device's accuracy is evaluated against a pre-defined industry standard.

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KD-525E 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-30cm.

KD-525E Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance Study (K070395)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: Not specified in the provided text. The document only mentions "Clinical tests were performed."
• Data Provenance: Not specified. It's not mentioned if the data was collected retrospectively or prospectively, nor the country of origin.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified. The document only states "Clinical tests were performed."
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. For blood pressure monitors, the "ground truth" is typically established by comparing the device's readings against a reference method (e.g., auscultation by trained observers) as outlined in standards like ANSI/AAMI SP10. The text does not detail the specific methodology used for establishing reference measurements or any adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this submission. This type of study is more relevant for diagnostic imaging AI systems where human interpretation is a key component. This device is a standalone blood pressure monitor.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, the described "Clinical tests" evaluate the standalone performance of the KD-525E Fully Automatic Electronic Blood Pressure Monitor. The device itself is an automated system; its performance directly reflects the algorithm's capability. The comparison is against the accuracy requirements of ANSI/AAMI SP10-2002.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for evaluating the accuracy of the blood pressure monitor would have been established using a reference measurement method as defined by the ANSI/AAMI SP10-2002 standard. This typically involves simultaneous or closely timed measurements by trained observers using a mercury sphygmomanometer (or another validated reference) via auscultation. The standard specifies statistical comparisons between the automated device readings and these reference measurements.

8. Sample Size for the Training Set

• Sample Size: Not applicable/not specified. As an oscillometric blood pressure monitor, this device likely uses a pre-programmed algorithm based on general physiological principles for measuring blood pressure, rather than "training" on a specific dataset in the way a modern AI/machine learning model would. Therefore, a "training set" in that context is not relevant.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable. For the reason stated above, there isn't a "training set" in the common AI/ML sense with associated ground truth for this type of device. The algorithm's development and validation would rely on established oscillometric principles and calibration against precise pressure measurements.

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The KD-788 Wrist Measurement 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

KD-788 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an infernal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can divide into 4 groups and record 30 memory each group with the month, day and time of measuring.

Here's an analysis of the provided text regarding the KD-788 Wrist Measurement Electronic Blood Pressure Monitor, focusing on the acceptance criteria and the study proving it.

Important Note: The provided document is a 510(k) summary and FDA clearance letter. It states that clinical tests were performed, but it does not provide detailed reporting of the acceptance criteria nor the full study report. It only states that the device "complied with the accuracy requirements of ANSIIAAMISP10-1992" and "The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992." Therefore, I will derive the acceptance criteria from this standard and indicate where specific data would typically be found in a comprehensive study report, even if it's not present here.

Acceptance Criteria and Device Performance Study for KD-788 Wrist Measurement Electronic Blood Pressure Monitor

The KD-788 Wrist Measurement Automatic Electronic Blood Pressure Monitor is a non-invasive device intended to measure systolic and diastolic blood pressure and pulse rate at the wrist. The 510(k) submission, K052450, indicates that clinical tests were performed to demonstrate substantial equivalence and meet the accuracy requirements of the ANSI/AAMI SP10-1992 standard.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the ANSI/AAMI SP10-1992 standard, which is referenced, the acceptance criteria for automated sphygmomanometers typically involve two main components: mean difference and standard deviation of differences between the test device and a reference measurement (auscultation).

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

• Test Set Sample Size: The 510(k) summary does not explicitly state the specific number of subjects used in the clinical test set. The ANSI/AAMI SP10-1992 standard typically recommends a minimum of 85 subjects for validation studies. It is implied that at least this number, or more, was used to meet the standard's requirements.
• Data Provenance: The document does not specify the country of origin for the clinical data. Given the submitter's location (Tianjin, P.R. China), it is plausible the study was conducted there, but this is not confirmed. The study was prospective, as it involved performing clinical tests to evaluate the device’s accuracy.

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

• Number of Experts: The 510(k) summary does not explicitly state the number of experts used for ground truth. For blood pressure validation studies according to ANSI/AAMI SP10-1992, it is standard practice to use at least two trained observers (experts) to take auscultatory reference measurements.
• Qualifications of Experts: The document does not explicitly state the qualifications of the experts. However, per the AAMI standard, these observers would typically be trained healthcare professionals (e.g., nurses, physicians) who have demonstrated proficiency in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not explicitly describe the adjudication method used. For blood pressure validation, when multiple observers are used, a common method is to average their readings, or to use a specific protocol for assessing inter-observer variability, but the details are not provided here.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. This type of study (comparing human readers with and without AI assistance) is not applicable to an automated blood pressure monitor, which performs direct measurements rather than assisting human interpretation of images or signals. The device is designed for standalone measurement.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Performance: Yes, a standalone performance study was conducted. The clinical tests described in the K052450 summary relate directly to the accuracy of the device itself (KD-788 Wrist Measurement Electronic Blood Pressure Monitor) in measuring blood pressure and pulse rate, independent of human interpretation or assistance during the measurement process. The primary outcome was how well the device’s readings correlated with reference auscultatory measurements.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used would have been expert auscultatory measurements. This means trained human observers manually measured blood pressure using a stethoscope and sphygmomanometer, and these readings served as the reference standard against which the KD-788 device's readings were compared.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not explicitly mention a separate "training set" or its size. For a device like an automated blood pressure monitor based on oscillometric technology, the core algorithm is typically developed and refined using extensive datasets during the R&D phase. However, the 510(k) summary focuses on the validation or test set performance to meet the AAMI standard. Details of internal algorithm development and associated training data are generally not part of a 510(k) summary, which focuses on validation of the final product.

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

• Training Set Ground Truth: As with the training set size, the document does not provide details on how ground truth for any internal training data was established. Assuming standard practice, any internal data used for algorithm development and refinement would also have relied on expert auscultatory measurements or other well-established reference methods.

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The KD-322 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time except infants and unconscious people, with the air cuff around the left upper arm according to instruction in the user's guide manual.

The KD-322 Semi Automatic Electronic Blood Pressure Monitor is intended to measure the diastolic and systolic blood pressures and pulse rate of an intended to modules the a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.

KD-322 Semi Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be displayed on a LCD with an electronic interface. After wrapping the air cuff around the left upper arm 1-2cm above elbow joint, automatically inflated or inflated by an internal pump, the device can analyze the signals promptly and display the results.

Here's an analysis of the provided text to extract information about the acceptance criteria and the associated study for the KD-322 Semi Automatic Electronic Blood Pressure Monitor.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "...clinical tests were performed and complied the accuracy requirements of ... ANSt/AAMISP10-1992."

3. Number of Experts and Their Qualifications for Ground Truth

The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not state the adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an automated blood pressure monitor, so an MRMC study in the context of human reader performance with or without AI assistance is not applicable.

6. Standalone (Algorithm-Only) Performance Study

Yes, a standalone study was done. The clinical tests performed were for the device itself to verify its accuracy against a recognized standard (ANSI/AAMI SP10-1992). The device is an "Automatic Electronic Blood Pressure Monitor," implying its function is standalone in measuring and displaying blood pressure and pulse rate.

7. Type of Ground Truth Used

Based on the reference to "ANSI/AAMI SP10-1992 Accuracy Requirements," the ground truth for the accuracy assessment would typically be established by a reference method or gold standard for blood pressure measurement, as specified within that standard. This often involves a trained observer taking auscultatory measurements using a mercury sphygmomanometer, though the document does not explicitly state this.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set. This is not surprising as the device described is a semi-automatic electronic blood pressure monitor, not an AI/ML-driven diagnostic device that typically requires a large training set in the conventional sense. Its "training" would be more about calibration and internal algorithm development rather than machine learning from labeled datasets.

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

The document does not provide information on how the ground truth for any "training set" was established, given the nature of the device as a measurement instrument rather than an AI/ML diagnostic.

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The KD-768 Wrist Measurement 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

KD-768 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 120 times measuring result with the month, day and time of measuring.

Here's a breakdown of the acceptance criteria and the study information for the KD-768 Wrist Measurement Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided text describes clinical tests that were performed to comply with the accuracy requirements of ANSI/AAMI SP10-1992. However, it does not provide specific details on many of the requested categories.

Here's what can be extracted and what is not available in the provided text:

1. 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.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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):

   • Not specified. For blood pressure monitors, the "ground truth" often refers to reference measurements (e.g., auscultatory method by trained observers). The text does not elaborate on this.

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

   • Not specified.

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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor and does not involve AI or human readers in the context of diagnostic interpretation.

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

   • Yes, a standalone study was done. The "clinical tests" described, focusing on compliance with ANSI/AAMI SP10-1992, assess the device's accuracy in measuring blood pressure independently. The device itself is an automated system for measurement.

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

   • The "ground truth" for blood pressure monitor accuracy studies typically involves simultaneous measurements using a recognized reference standard, such as Riva-Rocci/auscultatory method performed by trained observers, as specified by standards like ANSI/AAMI SP10. The text does not explicitly state this, but compliance with ANSI/AAMI SP10-1992 implies such a method for ground truth.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is a physical measurement device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "clinical tests" described are for validation of the device's accuracy rather than training an algorithm.

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

   • Not applicable. (See point 7).

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The KD-575 Memory 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 8.6614 inches to 13.78 inches

KD-575 Fuily Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-575 Fully Automatic Electronic Blood Pressure Monitor:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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

The document does not specify the number of experts used or their qualifications. For blood pressure monitoring devices, the "ground truth" for accuracy studies typically involves a reference method (e.g., auscultatory measurement by trained observers) rather than expert consensus on images.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device. This study design is typically used for AI-powered diagnostic imaging tools where human readers interpret medical images. Blood pressure monitors are standalone devices that provide direct measurements.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Yes, a standalone performance study was done. The device itself is an automated blood pressure monitor, and the clinical tests evaluated its direct measurement accuracy against a standard (ANSI/AAMI SP10-1992). This means the device's algorithm and hardware were assessed in isolation to determine its performance.

7. Type of Ground Truth Used:

The ground truth used for assessing the device's accuracy was based on the requirements of the ANSI/AAMI SP10-1992 standard. For blood pressure monitors, this standard typically involves comparing the device's readings against simultaneous auscultatory measurements performed by trained observers using a mercury sphygmomanometer as the reference standard. While the document doesn't explicitly state "auscultatory measurements," adherence to this standard implies such a method.

8. Sample Size for the Training Set:

The document does not mention a training set size. This is expected as this is not an AI/machine learning device that requires a separate training phase with a distinct dataset. Its "algorithm" is embedded in the device's design and calibration.

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

As there is no mention of a training set in the context of this traditional medical device, the concept of establishing ground truth for a training set is not applicable. The device's calibration and design are likely based on engineering principles and validated against known standards, rather than by training on a labeled dataset in the machine learning sense.

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The KD-726 Memory Wrist 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) document for the KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor:

Acceptance Criteria and Device Performance Study for KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor

The device demonstrated compliance with the accuracy requirements of ANSI/AAMI SP10-1992.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not explicitly break down specific quantitative metrics (e.g., mean difference, standard deviation) for blood pressure accuracy as outlined in ANSI/AAMI SP10-1992. It broadly states compliance with the standard's accuracy requirements.

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

The document does not specify the sample size used for the clinical test set.
The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not explicitly stated. It can be inferred that the study was likely prospective given it's a clinical test for device validation.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For blood pressure monitors, ground truth is typically established by trained observers using a reference standard like a mercury sphygmomanometer, not necessarily "experts" in the sense of radiologists.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. For blood pressure monitor accuracy studies, a robust methodology typically involves multiple trained observers taking readings and potentially averaging them or performing statistical comparisons to a reference. However, these specific details are not provided.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For an automated blood pressure monitor, the focus is on the device's accuracy relative to a reference standard, not on human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical test described is inherently a standalone performance evaluation. The KD-726 is an automatic electronic blood pressure monitor, meaning its measurement is performed by the algorithm/device itself, without human intervention in the measurement process (though a human applies the cuff and initiates the reading). The clinical test assesses the accuracy of these automated measurements.

7. The Type of Ground Truth Used

Based on common practices for blood pressure monitor validation and the reference to ANSI/AAMI SP10-1992, the ground truth would typically be established by:

• Reference standard measurement: Simultaneous or near-simultaneous measurements taken by trained observers using a validated reference method (e.g., a mercury sphygmomanometer) on the same subjects.
• Expert consensus (implied for accuracy): While not 'expert consensus' in the typical imaging sense, the "correct" blood pressure readings used as ground truth would be agreed upon by qualified personnel following a standardized protocol.

The document itself does not explicitly state the type of ground truth beyond fulfilling the ANSI/AAMI SP10-1992 requirements, which implicitly defines the ground truth method.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. As an automated blood pressure monitor based on oscillometric technology, it is not a machine learning or AI device in the modern sense that typically requires a large 'training set' for model development. The device's algorithms are likely based on established physiological principles and signal processing, rather than learning from a large dataset.

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

Since there is no mention of a "training set" in the context of machine learning/AI, the question of how its ground truth was established is not applicable. The device's operational principles and algorithms would have been developed using engineering and physiological knowledge, not through a data-driven training process with ground truth labels.

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The KD-622 Fully 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 8.6614 inches to 13.78 inches.

KD-622 Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, presented in the requested format:

The provided text for K030358, the KD-622 Fully Automatic Electronic Blood Pressure Monitor, is a 510(k) summary and FDA clearance letter. It primarily describes the device, its intended use, and claims substantial equivalence to a predicate device. While it mentions "Clinical Tests" and "accuracy requirements of ANSI/AAMISP10-1992", it does not provide detailed information about the acceptance criteria or the study methodology, sample sizes, expert qualifications, or ground truth establishment for that study.

Therefore, most of the requested information cannot be extracted directly from the provided text.

1. A table of acceptance criteria and the reported device performance

2. 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.
• Data Provenance: Not specified in the provided document. The clinical tests were performed to comply with ANSI/AAMI SP10-1992. The submitter is a Chinese company, so the tests were likely conducted in China, but this is not explicitly stated. It is standard for these types of studies to be prospective, but this is not confirmed in the text.

3. 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.
• Qualifications of Experts: Not specified in the provided document. For blood pressure monitors, "experts" typically refers to trained observers following a standardized protocol (e.g., using a reference sphygmomanometer) as outlined by standards like ANSI/AAMI SP10.

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

• Adjudication Method: Not specified in the provided document. ANSI/AAMI SP10 typically involves a comparison against a reference method by independent observers, with predefined criteria for acceptable differences between readings.

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

• MRMC Comparative Effectiveness Study: Not applicable. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance Study: Yes, as the device is an automatic blood pressure monitor, its performance is considered standalone. The "Clinical Tests" mentioned assess its ability to accurately measure blood pressure on its own.

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

• Type of Ground Truth: The ground truth for blood pressure measurement studies typically involves simultaneous measurements by trained observers using a highly accurate, calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a standardized protocol as outlined in ANSI/AAMI SP10. The readings from the reference device are considered the "true" blood pressure against which the device under test is compared.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As a traditional medical device (non-AI/ML), there isn't a "training set" in the machine learning sense. The device is based on established oscillometric principles and calibrated during manufacturing. The "clinical tests" are for validation, not training.

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

• Ground Truth for Training Set: Not applicable for the reasons stated above (non-AI/ML device).

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