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This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.

Bluetooth Blood Pressure Monitor, BPW1 is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method, including irregular heartbeats (IHB) from the wrist. The device is powered by a rechargeable Lithium battery. The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement. The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0. An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.

The provided text describes the submission of a 510(k) premarket notification for a "Bluetooth Blood Pressure Monitor, BPW1" and its substantial equivalence to a predicate device. It details various performance tests conducted, including safety, EMC, reliability, and biocompatibility. However, it does not contain the specific acceptance criteria for the device's performance (e.g., blood pressure accuracy in mmHg or pulse accuracy in bpm), nor does it provide the detailed study results that prove the device meets these criteria in a quantitative manner.

Instead, the document states that the device was tested according to relevant standards (e.g., IEC 80601-2-30, ISO81060-2:2013) and that it "met all relevant requirements" or "achieved the requirements." It also states "The evaluation of these results present no new issues related to safety or effectiveness." This indicates that the study was performed, and the results were deemed acceptable, but the specific numerical performance data and detailed acceptance thresholds are not included in this summary.

Therefore, for aspects requiring quantitative data (like specific accuracy tolerances and achieved performance), the information is implicitly covered by conformance to standards, but not explicitly stated.

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

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

Note: The "Accuracy" values (Static Pressure: ± 3mmHg, Pulse: ± 5% reading value) are explicitly stated in the "Comparison of Technological Characteristics" table under the "Accuracy" row for both the predicate and modified device. This implies they are the expected performance standard and likely the acceptance criteria for those specific parameters. The broader "Reported Device Performance" for other categories is a general statement of compliance with standards, as detailed numerical results are not included.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The text clearly mentions "Clinical Validation: ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type." This standard specifies requirements for the number of subjects and measurements for clinical validation. While the exact number of subjects is not stated in this document, it implies that the sample size adhered to the ISO 81060-2:2013 standard. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a blood pressure monitor, the ground truth for clinical validation is typically established by trained observers using a reference measurement method (e.g., auscultation with a sphygmomanometer). The ISO 81060-2 standard outlines requirements for such observers, but the specific details are not in this text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. For blood pressure clinical validation, ground truth primarily relates to the reference measurement method (e.g., mercury sphygmomanometer with trained observers), rather than expert adjudication of AI output.

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:
This device is a blood pressure monitor, not an AI-based imaging diagnostic tool that typically involves human readers. Therefore, an MRMC study is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the clinical validation study conducted per ISO 81060-2:2013 is a standalone performance test of the device (its algorithm) against a reference standard. The document states, "The device has achieved the requirements of ISO18060-2:2013," which indicates its standalone performance against a clinical reference.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the clinical validation of the blood pressure monitor, the ground truth would be established through simultaneous or closely sequential measurements using a validated reference method, typically auscultation by trained observers with a mercury sphygmomanometer or another precisely calibrated and validated reference device, as specified by ISO 81060-2:2013. This is implicitly the "ground truth" against which the device's measurements are compared.

8. The sample size for the training set:
This device is a traditional oscillometric blood pressure monitor, not a machine learning/AI device requiring a separate "training set" in the conventional sense of AI model development. Therefore, this concept is not applicable in the context presented. The "training" for such devices is inherent in their design and calibration processes, not a distinct data set for algorithm training.

9. How the ground truth for the training set was established:
As explained in point 8, the concept of a separate "training set" with established ground truth as used in AI/ML is not applicable to this type of medical device based on the information provided.

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BW-BW1 Bluetooth Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and heart rate from the wrist using the oscillometric method, the measured data is transferred to a smart phone for the patient record archiving and/or measured data analysis purpose.

The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.

It can not be used while the wrist (arm) has bleeding or wound the blood flowing from the wound in pressurizing.

Not Found

This document is a 510(k) premarket notification for the BW-BW1 Bluetooth Blood Pressure Monitor. It primarily consists of regulatory correspondence and an "Indications for Use" statement, and does not contain the detailed study information needed to answer the request.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them, because this document does not include that data. This document only states that the device is "substantially equivalent" to predicate devices, which is part of the regulatory approval process but doesn't detail performance studies.

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PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.

The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen. Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.

The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.

It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

The cuff circumference is limited to 13.5cm - 21.5cm.

BP210 Wrist Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method is a well - known technique in the market called the "oscillometric method".

The device stores automatically 180 (2*90) sets of measurement values with the measuring date and time. You can read the stored data conveniently by pressing the memory button. If any irregular heartbeat is detected, the symbol IHB will be displayed on the LCD. Moreover, it has the function of averaging the last three measurement values. The memory data can be transferred to the PC by connecting the device with the PC via USB cable.

The provided text describes the non-clinical and "clinical" testing for the BP210 Wrist Blood Pressure Monitor. However, it explicitly states that no new clinical study was performed for the BP210 device. Instead, the manufacturer argues that the BP210 is substantially equivalent to the predicate device (BP201) and that the previous clinical testing for the BP201 is sufficient.

Therefore, for the BP210 device specifically, there is no direct study described that proves its own acceptance criteria were met through a new clinical trial. The justification for its performance relies on the substantial equivalence to the predicate device.

Based on the provided text for the BP210, here's a breakdown of the requested information, focusing on what is available and noting what is not for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or reported device performance in the format of a clinical validation study for the BP210. Instead, it refers to compliance with standards.

For blood pressure monitors, the primary performance standard referenced is ANSI/AAMI SP10: 2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers."
While the text states "The BP210 met all relevant requirements of this standard," it doesn't provide specific numerical performance metrics from a new clinical study for the BP210.

It should be noted that for a blood pressure monitor to meet ANSI/AAMI SP10, its accuracy requirements typically relate to the mean difference and standard deviation between the device readings and a reference measurement (e.g., auscultation by trained observers).

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

• Sample Size: Not applicable. No new test set for clinical validation was used for the BP210.
• Data Provenance: Not applicable, as no new clinical data was collected. The device's performance relies on the equivalence to the predicate device (BP201). The provenance of the predicate device's data is not detailed in this submission.

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

• Number of Experts: Not applicable. No new test set for clinical validation was used for the BP210.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No new test set for clinical validation was used for the BP210.

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

• MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, with or without AI assistance, for the BP210. This type of study is more common for diagnostic imaging AI devices, rather than a standalone blood pressure monitor.

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

• Standalone Performance: The BP210 is a standalone device that provides blood pressure and heart rate measurements using an oscillometric method. Its "performance" refers to its accuracy against a gold standard. The manufacturer asserts this performance remains identical to the predicate device (BP201). The text states, "the measurement algorithm and its program codes of the BP210 remain unchanged." This implies the algorithm's standalone performance is assumed to be the same as the predicate.

7. The Type of Ground Truth Used

• Ground Truth Type: Not applicable for a new clinical study of the BP210. For the predicate device (BP201) or any device validated under ANSI/AAMI SP10, the ground truth for blood pressure measurements is typically established through simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device), following a specific protocol.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document does not describe the development of a new algorithm that would require a separate training set. The existing "oscillometric method" algorithm is stated to be unchanged from the predicate device.

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

• Ground Truth Establishment for Training Set: Not applicable, as no new training set or algorithm development is described for the BP210.

Summary of the Study that Proves the Device Meets Acceptance Criteria (for BP210):

The manufacturer's argument for the BP210 meeting acceptance criteria relies entirely on substantial equivalence to the predicate device, BP201 (K083043).

• Rationale: The document states, "The BP210 is, from a technical point of view, identical to the predicate device, Model BP201. Moreover, the measurement algorithm and its program codes of the BP210 remain unchanged. The fundamental scientific technology of the modified BP210 device is the same as the predicate BP201 device."
• Conclusion: "Therefore the performance of the BP210 in terms of blood pressure measurement would be identical with performance of the predicate BP201 device. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject BP210 device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device."

In essence, the "study" proving the BP210 meets acceptance criteria is the original clinical validation study performed on the BP201 (predicate device), which satisfied the requirements of ANSI/AAMI SP10: 2002. The details of that study are not included in this 510(k) summary for the BP210. The changes in the BP210 (PC link, classification, memory) were deemed not to affect the core measurement performance by the manufacturer.

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It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.

The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.

It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

BP201 Wrist Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist.

BP201 Wrist Blood Pressure Monitor uses an inflated cuff which is wrapped around the wrist .The cuff is inflated by a built-in air pump. The systolic and diastolic blood pressures are determined by Oscillometric method. The inflation rate is controlled by MCU at a constant rate 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.

Here's an analysis of the provided text regarding the BP201 Wrist Blood Pressure Monitor, outlining the acceptance criteria and study details:

Acceptance Criteria and Device Performance for BP201 Wrist Blood Pressure Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for blood pressure monitors generally revolve around accuracy standards set by organizations like ANSI/AAMI, and the provided document confirms adherence to these.

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (number of subjects/measurements) used for the clinical comparison study. It only mentions that "A comparison study with a device that uses auscultatory method used by trained observers was performed".
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's location in Shenzhen, PR China, it is probable the study was conducted there, likely as a prospective study for regulatory submission.

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

• Number of Experts: The document states that the comparison study involved "trained observers" using an auscultatory method. It does not specify the number of these observers (experts).
• Qualifications of Experts: The experts are described as "trained observers" using an auscultatory method. Their specific qualifications (e.g., medical doctors, nurses, years of experience) are not detailed.

4. Adjudication Method for the Test Set

The document describes a "comparison study with a device that uses auscultatory method used by trained observers." This implies the auscultatory measurements served as the reference standard against which the BP201 was compared. It does not describe an explicit adjudication method for discrepancies between multiple readers, as the ground truth seems to have been established by the trained observers directly.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study described focuses on the comparison of the device against a reference method, not on human readers' improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The entire submission focuses on the performance of the BP201 Wrist Blood Pressure Monitor itself (the "algorithm only," in this context meaning the device's automated oscillometric measurement) compared against a recognized reference standard (auscultatory method). The device's automated measurements are validated against these established methods.

7. Type of Ground Truth Used

The type of ground truth used was expert concensus (implicitly, as "trained observers" using the "auscultatory method") measurements. The auscultatory method is a widely accepted clinical standard for blood pressure measurement, and its execution by trained observers serves as the ground truth.

8. Sample Size for the Training Set

The document does not provide information on a training set or its sample size. This is typical for medical devices that are not "AI/ML-enabled" in the modern sense but rather rely on established algorithms (like oscillometric) and hardware. Such devices are typically validated against standards rather than "trained" on data.

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

As there is no mention of a training set in the context of an AI/ML model, there is no information on how its ground truth was established. The device utilizes an oscillometric method, which is an established principle, and its performance is assessed through clinical validation against a reference standard.

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