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This device is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.

The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic noninvasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric technique. The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The subject 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 two models, which are W05, W1101L. All models contain the same software, measurement principle and NIBP algorithm. The main differences are product appearance, specification of pump and specification of the battery. W05 is alkaline battery driven device and W1101L is lithium battery driven device.

Here's a breakdown of the acceptance criteria and the study details for the Shenzhen Jamr Technology Co., Ltd. Wrist Type Blood Pressure Monitor (W05, W1101L):

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 95 patients.
• Data Provenance: The document does not explicitly state the country of origin. The study was a clinical investigation performed to verify accuracy according to ISO 81060-2:2018, which is a standard for clinical investigation of intermittent automated measurement type for non-invasive sphygmomanometers. It describes patients with "adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site." It is a prospective clinical test, as new measurements were taken for the study.

3. Number of Experts and Qualifications for Ground Truth:

• The document implies that the ground truth was established by the standard auscultation method, which is performed by trained medical professionals. However, the exact number of experts and their specific qualifications (e.g., number of years of experience) used to establish the ground truth for this particular test set are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set:

• The document states, "Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2 Third edition 2018-11." This indicates a direct comparison approach, but no specific adjudication method (like 2+1 or 3+1 for resolving discrepancies) is mentioned.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by humans.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The clinical test summarized in the document directly evaluates the device's accuracy in measuring blood pressure and pulse rate against a reference standard (auscultation) without human-in-the-loop assistance. The device's measurement principle is described as "oscillometric technique," which is an automated process.

7. Type of Ground Truth Used:

• Expert consensus (indirectly through a standard method): The ground truth was established using the standard auscultation method. This method relies on the auditory interpretation of Korotkoff sounds by trained human observers, which can be considered an expert-derived ground truth.

8. Sample Size for the Training Set:

• The document does not provide information about a separate training set or its sample size. Blood pressure monitors typically rely on established algorithms for oscillometric measurements, rather than machine learning models that require a distinct training set in the same way an AI diagnostic tool would.

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

• As a training set is not explicitly mentioned or implied for this type of device (a traditional blood pressure monitor using an oscillometric algorithm), the document does not explain how ground truth for a training set was established.

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This device is intended to measure the systolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.

The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric technique. The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The subject 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 three models, which are W02S. W1102. W1102A. All models contain the same software. measurement principle and NIBP algorithm. The main differences are product appearance and the specification of solenoid Valve.

The provided text describes the acceptance criteria and the study that proves the device (Wrist Type Blood Pressure Monitor) meets those criteria, primarily focusing on its clinical accuracy.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's clinical accuracy was evaluated according to ISO 81060-2:2018 (Third edition 2018-11). This standard sets the clinical acceptance criteria for automated non-invasive sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation limits) from ISO 81060-2 are not explicitly detailed in the provided text, the summary states:

"The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device W1102 in the group of 95 adult subjects (56 male and 39 female) with qualified distribution."

And under Accuracy in the comparison table:

This is a direct comparison to the predicate device's accuracy, which the subject device matches. The clinical study further supports that these accuracy limits were met according to the ISO standard.

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

• Sample Size: 95 patients (56 males and 39 females)
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "Clinical Test report" and mentions "95 patients were invited for the study." The manufacturer is based in Shenzhen, China, so it is highly probable the study was conducted there.
• Retrospective or Prospective: The wording "95 patients were invited for the study" strongly suggests a prospective clinical study.

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

The ground truth for the clinical accuracy study was established using the standard auscultation method as the reference blood pressure monitor. This method typically involves trained medical professionals (e.g., nurses, doctors) taking manual blood pressure measurements. However, the document does not specify the number of experts or their qualifications.

4. Adjudication Method for the Test Set

The document mentions that blood pressure measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2 Third edition 2018-11." This standard outlines specific protocols for comparing automated devices to a reference method, often involving multiple measurements and averaging. However, it does not explicitly describe an adjudication method in the sense of resolving discrepancies between multiple expert readers for image interpretation (which is common for AI/ML device studies). For blood pressure measurement, the auscultation method itself serves as the direct reference.

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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI/ML-assisted diagnostic tool that would typically involve human readers interpreting AI output. The study focused on the device's accuracy compared to a gold standard (auscultation).

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 accuracy study assessed the device's ability to accurately measure blood pressure on its own, comparing its readings directly to those obtained via the auscultation method. This is a "standalone" evaluation of the device's measurement algorithm.

7. The Type of Ground Truth Used

The type of ground truth used was comparative measurement against a recognized gold standard: the standard auscultation method for blood pressure measurement.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For traditional medical devices like blood pressure monitors, the "training" (i.e., development and calibration) is typically done internally by the manufacturer during the product design phase, and the document focuses on the test set used for regulatory submission and clinical validation. There's no indication of an AI/ML model that would require a distinct training set in the context of this FDA submission.

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

As there's no mention of a distinct training set for an AI/ML algorithm in the context of this blood pressure monitor, the question about "ground truth for the training set" is not applicable in the way it typically applies to AI/ML devices. The device's underlying algorithm for oscillometric measurement is part of its design, calibrated through internal processes. The submitted study focuses on the validation of the final device's performance against clinical standards.

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BPM16B automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging 125 ~ 210 mm (approx. 4.9 ~ 8.3 inch) and for home use

Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate.

This document is a 510(k) Premarket Notification for a Wrist Type Blood Pressure Monitor (BPM16B). The core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

The information provided does not describe an AI/ML device, nor does it detail a study proving the device meets acceptance criteria related to AI/ML or human augmentation. Instead, it focuses on the performance testing required for a non-invasive blood pressure measurement system.

Therefore, many of the requested criteria regarding AI/ML studies, expert adjudication, MRMC studies, and ground truth establishment for training sets are not applicable to this document. The document primarily focuses on compliance with established medical device standards for blood pressure accuracy and safety.

Here's a breakdown of the relevant information from the document as it pertains to acceptance criteria and performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to compliance with ISO 81060-2 and IEC 80601-2-30 for performance. While it states that the device "meets the performance specifications for its intended use" and "the required limits for mean difference and standard deviation are fulfilled," it does not provide a specific table with numerical acceptance criteria and reported device performance values for blood pressure accuracy.

However, in the comparison table (Table 1 predicate device) in Section 6, "Technological Characteristics and Substantial Equivalence Comparison with Predicate," it lists the following for "Accuracy":

Note: This table only shows that the claimed accuracy of the new device is the same as the predicate and the general industry standard for non-invasive blood pressure monitors. It does not present the specific results from the clinical validation study proving these accuracies beyond stating "the required limits for mean difference and standard deviation are fulfilled."

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

• Sample Size: The document mentions "clinical investigation" but does not specify the sample size used for the performance testing (test set).
• Data Provenance: Not explicitly stated, but the submission is from Taiwan (Avita Corporation, New Taipei City, Taiwan). The testing would presumably be conducted in Taiwan. The study is a prospective clinical validation study, as it's testing the performance of the device against clinical standards.

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

• Not Applicable in the context of expert review for AI/ML ground truth. For a blood pressure monitor, the "ground truth" for blood pressure measurements is established by a reference method, typically auscultation by trained medical professionals, not by expert review of images or data in the way one might establish ground truth for an AI diagnostic algorithm. The ISO 81060-2 standard outlines the methodology for clinical validation, which involves direct comparison to a reference method. The document does not specify the number or qualifications of the individuals performing the reference measurements.

4. Adjudication Method for the Test Set:

• Not Applicable for a blood pressure monitor in the context of expert adjudication. The "adjudication" for a blood pressure monitor pertains to how the reference measurements are taken and compared to the device measurements according to the ISO standard. This does not involve an adjudication panel for discordant readings in the way an AI diagnostic study might.

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

• No, this was not done. This type of study is relevant for diagnostic AI tools where human readers interpret medical images or data, and the AI assists or replaces them. This is a blood pressure monitor, not an AI diagnostic algorithm.

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

• Yes, in spirit. The performance testing (compliance to ISO 81060-2) is essentially a standalone performance assessment of the device's accuracy in measuring blood pressure compared to a reference method, without human intervention in the measurement process of the device itself. The device is "automated" and provides readings directly.

7. Type of Ground Truth Used:

• Comparator Measurement / Clinical Reference Standard: The ground truth for blood pressure accuracy is established by a reference method (e.g., auscultation with a sphygmomanometer by trained observers) as defined by the ISO 81060-2 clinical validation standard. It is not expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML study for diagnosis.

8. Sample Size for the Training Set:

• Not Applicable. This is a medical device, not an AI/ML algorithm that requires a "training set." The device's measurement algorithm is based on oscillometric principles and is likely deterministic or uses fixed, non-AI algorithms, not machine learning that would require a distinct training set for model development.

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

• Not Applicable. See point 8.

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The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home. The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.

The proposed device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. The Wrist Type Blood Pressure Monitor can automatically complete the inflation, deflation and measurement of systolic and diastolic blood pressure as well as the pulse rate of adult person. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data; User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result; User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure. diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.

The provided document is a 510(k) premarket notification for a Wrist Type Blood Pressure Monitor (K162616). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving stand-alone safety and effectiveness through extensive, detailed clinical trials with the rigor typically seen for novel devices.

Therefore, the information available is primarily related to demonstrating equivalence to the predicate device, particularly regarding adherence to relevant performance standards for blood pressure monitors. It does not contain the granular detail about acceptance criteria, test set characteristics, expert qualifications, or multi-reader studies that would be present in a submission for a novel AI device with complex image analysis or diagnostic capabilities.

Here's an attempt to extract and interpret the information based on the provided document, addressing the requested points. Please note that many points cannot be fully answered due to the nature and scope of this 510(k) submission for a blood pressure monitor.

Acceptance Criteria and Device Performance (as demonstrated for a blood pressure monitor)

The primary acceptance criteria for a blood pressure monitor, as indicated by compliance with ISO 81060-2:2013, relate to the accuracy of blood pressure measurements.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Table 2 shows a general "BP Accuracy: ±3 mmHg" which typically refers to the device's inherent precision, not the clinical validation results against a gold standard as per ISO 81060-2. The clinical conclusion on page 6 is more relevant for the acceptance criteria. |
| Pulse Rate (PR) Accuracy (not explicitly detailed in acceptance criteria, but measured) | PR Range: 40-199 bpm (Table 2) |
| Non-Clinical Test Compliance | IEC 60601-1:2012 (General safety)
IEC 60601-1-2:2007 (EMC)
ISO 80601-2-30:2013 (Specific for automated non-invasive sphygmomanometers)
ISO 10993-5:2009 (Biocompatibility - cytotoxicity)
ISO 10993-10:2010 (Biocompatibility - irritation/sensitization) (Page 5-6) |
| Substantial Equivalence to Predicate Device | Demonstrated through comparative tables for product code, regulation, class, intended use, application site, patient population, measurement items, principle, main components, BP/PR ranges, operation/storage conditions, data storage, performance standard, cuff size, power supply, voltage, electrical safety, EMC, biocompatibility, labeling, and software level of concern. (Pages 6-8) |

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

• Sample Size: "There were 150 subjects been selected to participate in the trial." (Page 6)
• Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. It can be inferred that it was likely conducted in China, given the manufacturer's and submission correspondent's locations.
• Retrospective or Prospective: Not explicitly stated, but clinical validation studies for device accuracy are typically prospective to ensure controlled measurement conditions per the standard.

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

• The ground truth was established by "Auscultation... with the qualified calibrated mercurial sphygmomanometer used as control group." (Page 6).
• The document does not specify the number or qualifications of the individuals (experts or clinicians) who performed the auscultation measurements. For ISO 81060-2:2013, typically two independent observers (clinicians trained in auscultation) are required to take measurements.

4. Adjudication Method for the Test Set

• Not explicitly described. For ISO 81060-2:2013, the standard dictates how the reference measurements are obtained and compared, often involving simultaneous auscultation by multiple observers. An explicit adjudication method beyond this standard protocol is not mentioned.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools (e.g., in radiology) where human-in-the-loop performance is being evaluated. This device is a standalone measurement device (blood pressure monitor), not an AI-assisted diagnostic tool.

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

• Yes, the primary clinical validation was a standalone performance test of the device's accuracy. The device (Wrist Type Blood Pressure Monitor, YK-BPW1) operated autonomously to measure blood pressure, and its readings were compared against the established gold standard (auscultation). This is inherent to the type of device.

7. The Type of Ground Truth Used

• Clinical Measurements via Auscultation: The ground truth was established by human auscultation using a qualified calibrated mercurial sphygmomanometer (a medical standard for manual BP measurement). This represents expert consensus/clinical gold standard.

8. The Sample Size for the Training Set

• This document describes a clinical validation study and non-clinical tests for a medical device (blood pressure monitor), not a machine learning or AI algorithm in the sense of needing a distinct "training set." The device's underlying algorithm is pre-programmed based on known oscillometric principles. Therefore, there is no explicit "training set" sample size mentioned or implied for this type of device submission.

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

• As there is no "training set" in the context of an AI algorithm being trained, this question is not applicable to the information provided for this blood pressure monitor. The device's design and internal algorithms are based on established biometric measurement principles.

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The AVITA BPM1x Series device automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125 mm to 210 mm (approx. 4.9 ~ 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

AViTA BPM1x series Wrist Type Blood Pressure Monitor

The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information required to answer your questions about acceptance criteria, study design, ground truth establishment, or performance metrics.

Specifically, the document:

• Declares the device substantially equivalent to a predicate device. This means the new device performs similarly to an existing, legally marketed device.
• Lists the indications for use (wrist blood pressure monitor for adults, 125-210 mm wrist circumference, home use, detects irregular heartbeats).
• Outlines regulatory requirements for the manufacturer (registration, labeling, MDR, GMP, etc.).
• Identifies the product code and regulatory class.

It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or expert qualifications.
• Information on ground truth methods, training/test set sizes, or how ground truth was established for these sets.
• Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

To answer your questions, one would need access to the actual 510(k) submission, which would include the performance study reports and data. The provided letter is the FDA's decision based on that submission, not the submission itself.

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Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The theoretical range of cuff circumference is limited to 14-19.5cm.

Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series

The provided text is a 510(k) premarket notification letter from the FDA for a Wrist Type Blood Pressure Monitor. It does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.

Therefore, I cannot provide the requested information from the given input. The letter primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory compliance requirements. It does not delve into the specific technical performance or study results.

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