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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 15cm-48cm (approx. 5.9"-18.9").

Fully Automatic Electronic Blood Pressure Monitor (BP-300C, BP-300CV, BP-300V, BPM1, BPX1, KD-338N, KD-553, KD-557BR, KD-558, KD-558BR, KD-595, KD-5031N, KD-5810, KD-5810B, KD-5811, KD-5811A, KD-5811V, KD-5815, KD-5920, KD-5920L, KD-5920TL, KD-5923, KN-550LT) is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on Oscillo-metric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure and display the result. 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.

The provided document is a 510(k) clearance letter for various blood pressure monitors. It outlines the regulatory approval process and compares the new devices to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format typically used for AI/software devices.

Specifically, this document describes validation against standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and automated non-invasive sphygmomanometers (IEC 80601-2-30, ISO 81060-2). It focuses on the substantial equivalence of the physical blood pressure monitors and their underlying oscillometric and pressure sensor technology, rather than the performance of an AI algorithm based on a test set, ground truth, and expert interpretations.

Therefore, many of the specific questions about AI/software device validation (e.g., sample size for the test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) cannot be answered from this document.

However, I can extract information related to the performance of the blood pressure monitors themselves, based on the included standards.

Acceptance Criteria and Device Performance (for Blood Pressure Monitor functionality, not AI):

Since this is a blood pressure monitor, the primary performance criteria relate to its accuracy in measuring blood pressure and pulse rate, and compliance with relevant safety and performance standards for automated non-invasive sphygmomanometers.

• IEC 60601-1:2005+AMD1: 2012+AMD2: 2020
• IEC 60601-1-2:2014+AMD1: 2020
• IEC 60601-1-11: 2015+AMD1: 2020
• IEC 80601-2-30: 2018 | All listed standards were met, demonstrating basic safety, essential performance, EMC, and home healthcare environment compliance. |

Unable to Answer from Document (Common for AI/Software Device Submissions, but not for this type of device):

The following questions are not applicable or cannot be answered from this 510(k) summary because the device described is a physical blood pressure monitor, not an AI/software device that interprets medical images or other complex data requiring expert adjudication, training sets, or MRMC studies.

• Sample size used for the test set and the data provenance:
  • Test Set Size: "A total of 231 patients (107 males and 124 females) were enrolled in the study." This is the clinical study population for blood pressure measurement accuracy.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study," which implies prospective data collection for the purpose of the study.
• 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 applicable. Ground truth for blood pressure measurement is established through a standard auscultation method (manual measurement by medical professionals using a stethoscope and sphygmomanometer), not by interpretation of images by experts.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Not applicable. Ground truth is direct measurement by a reference method.
• 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 is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • The device is a standalone blood pressure monitor. No human-in-the-loop interaction for interpretation (as in AI devices) is relevant. Its performance is its direct measurement accuracy.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Ground Truth: "Standard auscultation method was used as the reference blood pressure monitor measuring." This is the established clinical standard for direct comparison.
• The sample size for the training set:
  • Not applicable. This is not an AI/machine learning device requiring a training set.
• How the ground truth for the training set was established:
  • Not applicable.

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The Automatic Blood Pressure Monitor is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 7.1 inches (18.0 cm) to 16.5 inches (42 cm).

The Automatic Blood Pressure Monitor (models: CH-S693L, CH-B601L, CP-B01, CH-S603, CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L) is a kiosk-type, automated, single upper-arm cuff oscillometric BP monitor developed for measurement of BP and pulse rate in healthcare facility/hospital or at home.

It is designed for BP measurements on either the right or left upper arm and has a fixed tubular (Arm barrel) opening to insert the user's arm, with an integral single-arm cuff, which when inflated surrounds the upper arm. It is suitable for arm circumference range 18~42 cm. The device has an elbow groove to ensure correct positioning of the arm and measures BP during inflation. A wide LED screen presents systolic and diastolic BP, heart rate and time of measurement. After the user pushes the start button, the cuff is inflated automatically by an internal pump, the systolic and diastolic blood pressures are determined by oscillometric method.

Principle of operation:

The product uses the Oscillometric Measuring method to detect blood pressure.

When the user presses the "START" button to initiate the measurement, the winding mechanism, driven by a geared motor, begins to operate. It stops winding when it starts to encounter resistance from the arm. At this point, the cuff is adapted to the arm size. Subsequently, the cuff is automatically inflated by an internal pump to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.

This document is a 510(k) clearance letter for an Automatic Blood Pressure Monitor, which means it describes a non-invasive blood pressure measurement system, not an AI/ML device in the context of the requested questions. The provided text is a standard FDA 510(k) summary for a traditional medical device and does not contain information about AI model performance, expert ground truth adjudication (for AI), or MRMC studies.

Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text because they pertain to AI/ML device studies, which is not what this document describes.

However, I can extract information related to the device's performance based on the provided clinical accuracy testing for the Automatic Blood Pressure Monitor.

Acceptance Criteria and Device Performance (Non-AI/ML Device):

The device's clinical accuracy was tested according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01. The document explicitly states:

"The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01."

This standard outlines the requirements for clinical investigations of intermittent automated measurement type non-invasive sphygmomanometers. While the specific numerical performance metrics (e.g., mean difference and standard deviation of differences between device and reference measurements) are not quantitatively stated in the summary table, the statement of compliance confirms that the device met the acceptance criteria defined by this international standard for blood pressure measurement accuracy.

The summary also specifies instrumental accuracy for blood pressure and pulse rate:

• Blood Pressure Measurement Accuracy: ±3 mmHg
• Pulse rate measurement accuracy: ±5%

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Regarding the specific questions about AI/ML studies:

1. A table of acceptance criteria and the reported device performance: See table above. More specific quantitative clinical performance results (e.g., mean difference and standard deviation of differences of BP readings compared to reference) are not explicitly detailed in the provided summary but are implied by the compliance statement.
2. Sample size used for the test set and the data provenance:
   • Test Set Sample Size: 85 subjects.
   • Data Provenance: Not specified (e.g., country of origin). It's a clinical trial, implying prospective data collection for the validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is for a traditional blood pressure monitor validated against a reference sphygmomanometer (aneroid/auscultation method), not an AI/ML device requiring expert consensus for ground truth. The reference device was a "CM-BPM-D Aneroid sphygmomanometer" by Shanghai Caremate Medical Device Co. Ltd.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device and study. The accuracy is determined by comparison to the reference measurements.
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 is a traditional medical device, not an AI/ML product assisting human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone automatic blood pressure monitor. Its performance is measured directly, not as an algorithm's output to be interpreted by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the clinical accuracy study was established by measurements from an "Aneroid sphygmomanometer" using the "Aneroid/auscultation method." This is the established reference method for validating automatic BP monitors per ISO 81060-2.
8. The sample size for the training set: Not applicable. This is a traditional device; there is no "training set" in the AI/ML sense. The device's measurement algorithm is predetermined and fixed.
9. How the ground truth for the training set was established: Not applicable. No AI model training set.

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This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose. Environments of use: Hospital and other medical establishment. Patient population: Adult (exclude pregnant women ).

Clinical Automatic blood pressure monitor have two models that are DBP-01HP and DBP-01P,The Clinical Automatic blood pressure monitor is used to measure the blood pressure of adult in hospital or other medical establishment. It's contain of main body , power wire.it can show the time and measure result, print the measure result .There is a difference between DBP-01HP with DBP -01P. DBP-01HP show the measure result and time by the LCD screen,DBP-01P show the measure result and time by the LED screen.

This document is a 510(k) premarket notification for a Class II medical device, the "Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP)," manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (UA-1200BLE Ultraconnect Digital Blood Pressure) to secure FDA clearance.

The information provided does not include detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device, as the filing is for a traditional, non-AI medical device (a blood pressure monitor). Therefore, I will extract the closest equivalent information related to performance testing and "acceptance criteria" for this type of device, which is primarily based on established international standards for non-invasive sphygmomanometers.

Here's an interpretation of the request in the context of the provided document:

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

The relevant "acceptance criteria" for a blood pressure monitor are its accuracy specifications, as defined by international standards.

Note: The document references ISO 81060-2:2018, which has two main criteria for accuracy. Criterion 1 (Mean and SD of device-observer difference) and Criterion 2 (SD of the differences for all subjects). The reported performance satisfies both.

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

• Sample Size for Test Set: 85 subjects.
• Data Provenance: The document states the study was a "clinical investigation" and does not specify a country of origin for the patients, but given the manufacturer's location (Shenzhen, China), it can be inferred the study likely took place in China. It was a prospective study conducted for the purpose of validating the device.

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

For a blood pressure monitor, the "ground truth" is typically established by trained observers (human auscultatory method) using a reference sphygmomanometer. The document does not specify the exact number, training, or qualifications of the observers, but adherence to ISO 81060-2 standards implies that qualified personnel performed these measurements.

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

The document does not explicitly describe an adjudication method for the "test set" in the sense of expert consensus for classification. For blood pressure validation, the comparison is typically between the automated device readings and simultaneous auscultatory measurements by human observers. Discrepancies are handled according to the specific methodology described in ISO 81060-2, which involves multiple readings and specific statistical analysis, rather than an "adjudication" in the AI sense.

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 Study: No, an MRMC study was not done.
• AI Assistance: This device is a traditional blood pressure monitor and does not incorporate AI. Therefore, there is no AI assistance to measure improvement in human readers. The clinical validation method directly assesses the device's accuracy against a known standard, not against human performance or human-AI collaboration.

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

Yes, in a sense, the primary clinical validation described is a "standalone" performance assessment of the device's measurement accuracy. The device's measurement (algorithm's output) is compared directly to the gold standard (human auscultatory readings). The human "in the loop" here is the observer performing the reference measurement, not interacting with AI.

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

The ground truth used was simultaneous auscultatory measurements performed by trained human observers using a reference sphygmomanometer, in accordance with the ISO 81060-2 standard. This is considered the expert-derived reference standard for non-invasive blood pressure.

8. The sample size for the training set

This document describes the validation of a traditional medical device (blood pressure monitor), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design is based on established oscillometric principles, not on learned data.

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

As there is no "training set" for an AI/ML algorithm, this question is not applicable to the submitted device.

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The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

The proposed devices, ABPM50 Automaitc Blood Pressure Monitor, CONTEC08A and CONTEC08C Electronic Sphygmomanometers are battery driven automatic non-invasive Blood Pressure Monitor. They can automatically complete the inflation and BP measurement, which can measure systolic, and diastolic blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 and CONTEC08A and CONTEC08C can be only used on adult individuals.

The devices have the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure and pulse rate.

ABPM50 and CONTEC08A have physiological over-limit prompt function which can be turned on or off by users. When the measurement results exceed the over-limit prompt limit, the physiological over-limit prompt function will be triggered. The over-limit can be set by users, and the low limit must be lower than the corresponding high limit.

In addition, all of the three proposed devices have technical over-limit prompt function, which will be triggered when the battery voltage is low, and this technical over-limit prompt function can not be cancelled unless being closed or the power replaced.

The provided FDA 510(k) summary (K202757) for the Electronic Sphygmomanometer, Automatic Blood Pressure Monitor CONTEC08A/CONTEC08C/ABPM50 details the non-clinical and clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device, being a non-invasive blood pressure measurement system, are primarily based on established international standards for accuracy and safety. The reported device performance is presented as compliance with these standards and specific measurement ranges.

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

• Sample Size: "Total 85 subjects are included in each clinical study." (Page 6)
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that the manufacturer and correspondent are based in China, it is highly probable the clinical study was conducted in China. The study appears to be prospective as it describes a clinical investigation for the purpose of regulatory submission.

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

The document states that the clinical study was conducted "in accordance with ISO 81060-2". ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type) outlines specific requirements for the observers and the comparison method to establish ground truth.

While the exact number and qualifications of experts (e.g., clinicians, trained observers) are not explicitly stated in this FDA submission summary, ISO 81060-2 typically requires:

• At least two trained observers to measure blood pressure using a reference sphygmomanometer simultaneously with the device under test.
• These observers must be trained and certified to perform auscultatory blood pressure measurements (e.g., using a mercury column or validated alternative) with high accuracy and reproducibility. The standard often specifies requirements for their training and regular performance validation to ensure inter-observer agreement.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication" method in the context of expert consensus, as this is typically seen in studies where multiple readers interpret images or data and discrepancies need resolving. For blood pressure measurement, ISO 81060-2 mandates a specific comparison method where the device's measurements are compared against simultaneous auscultatory measurements obtained by trained observers. The standard defines how these measurements are to be collected and statistically analyzed (e.g., mean difference and standard deviation between the device and the reference measurements) to determine accuracy, rather than an "adjudication" of differing expert opinions on a specific diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance

This device (Electronic Sphygmomanometer/Automatic Blood Pressure Monitor) is a medical measurement device, not an AI-based diagnostic tool that assists human readers in interpreting complex data like medical images. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which is common for AI tools in radiology or pathology, was not performed or applicable here. The study focused on demonstrating the device's accuracy and safety against established standards and a predicate device through direct measurement comparison.

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

Yes, the primary evaluation of this device is a standalone performance assessment. The device is designed to automatically measure and display blood pressure and pulse rate without continuous human intervention during the measurement process. The clinical study evaluated the device's direct measurement performance against a gold standard (auscultatory measurements) as per ISO 81060-2.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was expert consensus/reference measurement through a standardized protocol. Specifically, it involved:

• Simultaneous blood pressure measurements taken by trained observers using a reference method (typically auscultation with a mercury sphygmomanometer or validated equivalent) alongside the device under test.
• This is the standard approach defined in ISO 81060-2 for validating automated non-invasive sphygmomanometers.

8. The Sample Size for the Training Set

The document does not mention a training set because this medical device approval is for a physical measurement device, not a machine learning or AI algorithm that requires a separate training set. The "study" described is a clinical validation study to confirm the accuracy and safety of already developed hardware and software, rather than a development and training phase for a learning algorithm.

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

Since there is no "training set" in the context of an AI/ML algorithm for this type of device, this question is not applicable. The device's underlying measurement algorithms are based on established oscillometric principles and do not "learn" from a dataset in the way a deep learning model would.

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The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.

Digital Automatic Blood Pressure Monitor MD36 Series (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.

The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The Subject Device equipped with Bluetooth transmission which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.

Here's an analysis of the acceptance criteria and the study conducted for the Digital Automatic Blood Pressure Monitor MD36 Series, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for blood pressure monitors is accuracy. The document refers to ISO 81060-2 for clinical accuracy testing.

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

• Sample Size: 100 patients for each cuff size (standard: 49 males and 51 females; universal: 44 males and 56 females).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given that the manufacturer is Grandway Technology (Shenzhen) Limited, China, and the study was likely conducted to support a US FDA submission, it's possible the study was conducted in China or a region where clinical studies for international regulatory submissions are common. It is a prospective study, as patients were "invited for the study" and measurements were "repeated alternatively."

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

• Number of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals. While the exact number isn't specified, it would imply at least one, and likely multiple, trained personnel performing the auscultation measurements.
• Qualifications of Experts: The document states "Standard auscultation method was used as the reference blood pressure monitor." This implies trained medical personnel (e.g., nurses, doctors) who are proficient in manual blood pressure measurement using a stethoscope and sphygmomanometer. Specific qualifications like experience level (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set beyond obtaining measurements from the "standard auscultation method" and directly comparing them to the device's readings. The study design mentions measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2," suggesting a direct comparison without a separate adjudication panel.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. This device is an automated blood pressure monitor, not an AI interpretation system for human readers.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was conducted. The clinical accuracy testing described in "Clinical Test Summary" is a standalone performance study, assessing the device's accuracy (algorithm only, as it's an automated device) against a reference standard (auscultation) without human-in-the-loop interpretation adjustment.

7. Type of Ground Truth Used

• The type of ground truth used was expert consensus (via standard auscultation method). The auscultation method, performed by a trained professional, serves as the clinical reference standard against which the automated device's measurements are compared.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" or its sample size. This is typical for a medical device that relies on established physical principles and calibrated hardware (oscillometric methodology) rather than a machine learning model that requires explicit training data. The development and internal validation of the device would have involved calibration and testing, but not in the same sense as "training data" for an AI algorithm.

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

• As mentioned above, the concept of a "training set ground truth" as it applies to AI/ML is not directly applicable here. The device's underlying principles are based on the oscillometric method. The accuracy claims are validated through the clinical performance study against the auscultation method.

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The GMC Upper Arm Automatic Blood Pressure Monitor, Model X3, is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

The GMC Upper Arm Automatic Blood Pressure Monitor, Model X3, measures systolic and diastolic blood pressure and pulse rate of an adult individual. The method used to define blood pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The electrical signals are analyzed and used to define the systolic and diastolic measurements and determine the pulse rate. An irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: 85 patients (39 males and 46 females).
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical validation studies for a new device are typically prospective.

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

• The document implies that the ground truth for blood pressure measurements was established using the standard auscultation method. It does not specify the number of experts (e.g., clinicians, physicians) performing the auscultation, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It's standard practice for trained medical professionals to perform auscultation, but their specific experience level is not detailed here.

4. Adjudication Method for the Test Set:

• The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in #3-122 ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
• This suggests a direct comparison method between the device and the auscultation reference. The specific adjudication method (e.g., 2+1, 3+1) is not detailed. However, ISO 81060-2 has specific requirements for the number of observers and how their readings are handled to establish criteria for ground truth.

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:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed for this device. This is a blood pressure monitor, not an AI-powered diagnostic imaging device that would involve human readers interpreting cases. The study focuses on the accuracy of the automated measurement against a reference method.

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

• Yes, the clinical testing described is primarily a standalone performance evaluation of the device's algorithm. The "GMC Upper Arm Automatic Blood Pressure Monitor, Model X3" is an automated device, meaning its algorithm determines the blood pressure readings without direct human interpretation of a raw signal, other than possibly initiating the measurement. The clinical study validates the accuracy of these automated readings against a standard reference.

7. The Type of Ground Truth Used:

• The ground truth used was expert auscultation measurements. The document states, "Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm." Auscultation by a trained professional is considered a clinical gold standard for blood pressure measurement in this context.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a training set. This is typical for a device like a blood pressure monitor, which relies on established oscillometric principles and calibration, rather than a machine learning model that requires a distinct training phase.

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

• As no training set is mentioned or implied, the document does not provide information on how ground truth for a training set was established.

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The GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

The device has an irregular heartbeat (IHB) indicator. The appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

The GMC Wrist Automatic Blood Pressure Monitor, Model BO705, measures systolic and diastolic blood pressure and pulse rate of an adult individual. The method used to define blood pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The electrical signals are analyzed and used to define the systolic and diastolic measurements and determine the pulse rate. An irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

The provided text describes the GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, and includes information about its performance testing and clinical investigation.

Here's a breakdown of the requested information:

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

The document explicitly states that the device complies with several standards, including IEC 80601-2-30 and ISO 81060-2, which define performance criteria for non-invasive blood pressure monitors. The "Accuracy" row in the comparison table indicates the 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: 85 patients (38 males and 47 females) were invited for the clinical study.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, based on the phrasing "were invited for the study" and the mention of a "Clinical Investigation Report," it strongly implies a prospective clinical study.

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)

The ground truth was established using the "Standard auscultation method." While it doesn't specify the number or qualifications of the individuals performing the auscultation, for clinical studies involving blood pressure, the auscultatory method typically involves trained medical professionals. The mention of "standard auscultation method" implies adherence to established clinical practices for blood pressure measurement.

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

The document does not describe an adjudication method for reconciling differences between experts for establishing ground truth. The "Standard auscultation method" implies a direct measurement taken by a trained individual, which serves as the reference, rather than a consensus approach among multiple independent observers for establishing ground truth.

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

There is no indication of an MRMC comparative effectiveness study in the provided text. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, a standalone performance study was done. The device itself is designed to automatically measure blood pressure and pulse rate using the oscillometric method. The clinical testing comparing its measurements against the standard auscultation method demonstrates its standalone performance.

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

The ground truth used was "Standard auscultation method" measurements. This serves as a direct clinical reference standard for blood pressure.

8. The sample size for the training set

The document does not provide information on the sample size used for the training set of the device's algorithm. The provided information focuses on the clinical validation of the device.

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

The document does not provide information on how the ground truth for the training set was established. This information is typically proprietary to the device manufacturer and not always included in 510(k) summaries.

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Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.

The proposed device, Wrist Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.

The proposed blood pressure monitor includes 5 models, which are BP165W, BP180W, BP186W and BP 188W. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.

The provided text describes the acceptance criteria and a clinical study for the Wrist Type Automatic Blood Pressure Monitor (Models: BP165W, BP180W, BP186W, BP188W) by Shenzhen Jiacom Technology Co., Ltd.

Here's a breakdown of the requested information:

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)

The document states that a clinical accuracy study was conducted according to ISO 81060-2:2013. This standard details the requirements for clinical validation of automated non-invasive sphygmomanometers. While the specific sample size, country of origin, and whether the data was retrospective or prospective are not explicitly stated in this document, adherence to ISO 81060-2:2013 generally implies:

• A minimum of 85 participants for clinical testing to ensure a statistically robust evaluation (as per the standard's requirements for phase II testing).
• A prospective study design, as the standard describes a protocol for conducting direct comparisons against a reference measurement.
• Data provenance would be from the site where the clinical validation was performed, but the specific country is not mentioned.

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)

Again, the document does not explicitly state the number or qualifications of experts. However, for a clinical validation study adhering to ISO 81060-2:2013, the ground truth (reference blood pressure measurements) is typically established by trained observers (experts) using a mercury or auscultatory sphygmomanometer. The standard requires the observers to be trained and qualified, often with specifications regarding their experience and successful completion of a training program to minimize inter-observer variability.

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

For clinical validation studies following ISO 81060-2:2013, the standard dictates that reference blood pressure measurements be taken simultaneously by at least two trained observers using an auscultatory method. If there is a significant discrepancy between the two observers' readings, a third observer might be involved (though the standard prioritizes agreement between the initial two). So, a 2 (two trained observers) method is implied, with potential for adjudication if specified by the study protocol compliant with the standard.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor is there any mention of "AI assistance" or "human readers" in the context of blood pressure measurement in this document. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool requiring human interpretation.

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

Yes, the primary clinical validation conducted was a standalone performance study of the device's algorithm. The document states that the "clinical accuracy of the proposed device was evaluated per... ISO 81060-2 Second Edition 2013-05-01." This standard specifically assesses the automated device's ability to measure blood pressure without human intervention (other than proper placement and initiation of the measurement), comparing its readings to simultaneously obtained reference measurements.

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

The ground truth used for the clinical validation would be expert reference measurements obtained using a validated auscultatory method (e.g., mercury sphygmomanometer) as mandated by the ISO 81060-2:2013 standard.

8. The sample size for the training set

The document does not provide any information about a "training set" or algorithm development. The information focuses on the clinical validation of an already developed device. Automatic blood pressure monitors based on oscillometric techniques often rely on established algorithms and calibration methods rather than machine learning "training sets" in the contemporary sense.

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

As no training set is described in the provided information, the method for establishing its ground truth is also not mentioned.

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Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

The proposed device, Arm Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.

The proposed blood pressure monitor includes 9 models, which are BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, and BP-JC312. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.

The provided document describes the acceptance criteria and a clinical study conducted for the Arm Type Automatic Blood Pressure Monitor to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical accuracy of the device was evaluated according to the standard ISO 81060-2:2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type." While the document states the device complies with the standard requirements, it does not explicitly list the detailed acceptance criteria and reported device performance from the ISO 81060-2:2013 standard within the provided text.

However, based on the general information provided for blood pressure monitors, the key performance metrics and their accuracies are stated:

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

The document states that a clinical investigation was conducted according to ISO 81060-2:2013. The ISO 81060-2 standard specifies a minimum of 85 subjects for clinical validation. Although the exact number used in this specific study is not explicitly mentioned, it can be inferred that at least 85 subjects were used to comply with the standard.

• Sample Size for Test Set: Not explicitly stated, but ISO 81060-2:2013 requires a minimum of 85 subjects.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "clinical investigation... has been conducted."

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

The ISO 81060-2 standard requires that the simultaneous auscultation method, performed by human observers, serves as the reference standard (ground truth). This typically involves multiple trained observers.

• Number of Experts: Not explicitly stated in the document, but ISO 81060-2:2013 generally requires at least two experts (trained observers) for simultaneous auscultation.
• Qualifications of Experts: Not explicitly stated. For ISO 81060-2, the observers must be trained and validated against a mercury sphygmomanometer.

4. Adjudication Method for the Test Set

The ISO 81060-2 standard (which this study followed) uses a simultaneous auscultation method where mercury sphygmomanometers are used in conjunction with the test device. This involves multiple observers (typically two) taking measurements simultaneously and independently. If there's a significant discrepancy between their readings, a third observer might be involved or the measurement discarded.

• Adjudication Method: Implicitly, the method follows the procedures outlined in ISO 81060-2 for simultaneous auscultation, which includes specific rules for reconciling or handling differences between observers' readings to establish the reference blood pressure. This could be considered akin to a 2-observer consensus (or 2+1 if required) process for establishing ground truth.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes the validation of a non-invasive blood pressure monitor, which is a standalone measurement device, not an AI-assisted interpretation tool for human readers.

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

Yes, a standalone performance evaluation was done. The clinical investigation directly assessed the accuracy of the automated blood pressure monitor against the reference standard (human auscultation) without human interpretation of the device's output influencing the measurement. The device's "algorithm only" performance (the oscillometric technique's ability to measure blood pressure) is what was validated.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation was expert consensus (or reference) measurements obtained via simultaneous auscultation using mercury sphygmomanometers, as mandated by the ISO 81060-2 standard.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set or its sample size. This type of blood pressure monitor relies on a pre-defined oscillometric algorithm. While the algorithm itself would have been developed and potentially refined using a dataset, information on this "training set" is not part of this medical device submission document, which focuses on the validation of the final product.

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

As no information is provided about a training set, the method for establishing its ground truth is also not available in this document.

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The Scian Automatic Digital Blood Pressure Monitor, Models LD-518 & LD-537, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

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The provided text is a 510(k) clearance letter from the FDA for the Scian Automatic Blood Pressure Monitor, Models LD-518 & LD-537. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or the specific data requested in your prompt.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of human readers with AI assistance.
6. Information on a standalone algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval letter, not a clinical study report. To obtain the information you're looking for, you would typically need to refer to the 510(k) submission summary or associated clinical validation studies that would have been part of the manufacturer's submission to the FDA.

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