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The Globalcare GUS610 automatic Blood Pressure Monitor is indicated for home use for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 52 cm.

The Globalcare GUS610 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate.

The device is powered by batteries or by a mains-connected power adapter and is designed for home use.

The Globalcare GUS610 Blood Pressure Monitor is supplied complete with the following components:

• Blood pressure monitor main device - 1
• Upper arm cuff 22-42 cm - 1
• 1.5 V LR03 AAA batteries - 4
• Storage bag - 1
• Instructions for use - 1
• 100-240 VAC 50/60 Hz power supply (optional) - 1

None of the parts included with the device are supplied in a sterile condition.

The Globalcare GUS610 Blood Pressure Monitor main unit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter and is designed for home ('OTC') use.

The clinical outputs from the GUS610 Blood Pressure Monitor are:

• Systolic pressure (mm Hg)
• Diastolic pressure (mm Hg)
• Pulse rate (1/min)
• Cardiac arrhythmia (Irregular heartbeat (IHB)) symbol
• Level of risk
• Hemodynamic Rest Condition (HSD) indication

The GUS610 Upper Arm Cuff, with a circumference range of 22 cm to 42 cm, is manufactured by Globalcare China. The cuff is manufactured from gray color Polyester 200D (CAS n. 80595-68-2), supplied by Anhui Wuyixing Fabric and Weaving. This is identical to the cuff provided with the predicate device cited in K222160.

The purpose of this Special 510(k) is to add to the availability of an accessory for the GUS610, this being an optional Upper Arm Cuff with an increased circumference range of 42 to 52 cm. The testing undertaken for the predicate device in accordance with ISO 81060-2:2018, 'Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type', has been repeated with the new larger cuff, with 88 subjects having upper arm circumferences between 42 and 52 cm screened, from which 259 effective analysis datasets were obtained from 87 subjects. Gender distribution met the requirements of the standard (M: 55.2 % / F 44.8 %), arm size distribution met the requirements of the standard, and blood pressure measurements met the requirements of the standard clause 5.2.4.1.2 for Criterion 1 'mean difference' and 'standard deviation' for SBP and DBP, and also for Criterion 2 for SBP and DBP 'standard. deviation'. The accuracy of the BP and pulse rate measurements also met the manufacturer's specifications for accuracy.

There were no adverse incidents during the investigation and no failed measurements. There were no protocol deviations or violations.

A third party test house (TUV SUD China) has assessed the continued compliance of the GUS610 subject device when used together with the new optional XL cuff in accordance with IEC 80601-2-30 and found that the combination continues to meet the requirements of this standard.

The FDA 510(k) clearance letter details the acceptance criteria and the study that proves the Globalcare Blood Pressure Monitor (GUS610) with the new larger cuff meets these criteria. The study focuses on adding an optional upper arm cuff with an increased circumference range (42 to 52 cm) to an already cleared device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new cuff, as per ISO 81060-2:2018, pertain to the accuracy of blood pressure and pulse rate measurements. The standard has two main criteria for accuracy, focusing on the mean difference and standard deviation of measurements compared to a reference.

Table 1: Acceptance Criteria and Reported Device Performance (Based on ISO 81060-2:2018)

Study Details

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

   • Sample Size: 88 subjects were screened, from which "259 effective analysis datasets were obtained from 87 subjects." This implies 87 successful participants contributed data to the final analysis, with multiple readings per subject.
   • Data Provenance: The document does not explicitly state the country of origin where the clinical study was conducted for the new cuff, but the applicant is Globalcare Medical Technology Co., Ltd in China. It is implied to be a prospective clinical investigation as it describes the process of "testing undertaken" with new subjects.

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

   • The document does not specify the number or qualifications of experts used to establish the ground truth. For non-invasive sphygmomanometers, the ground truth is typically established by trained observers using a reference measurement method (e.g., auscultation with a mercury sphygmomanometer or validated reference device) as defined by the ISO 81060-2 standard.

3. Adjudication Method for the Test Set:

   • The document does not describe a formal adjudication method (like 2+1 or 3+1). For blood pressure measurement validation, ground truth is typically established by multiple independent observers taking simultaneous reference measurements, with the average or consensus being the ground truth. The ISO 81060-2 standard outlines procedures for this, but the specific adjudication within this study is not detailed here beyond mentioning "effective analysis datasets."

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

   • No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.

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

   • Yes, the performance evaluated was the standalone performance of the device (Globalcare GUS610 Blood Pressure Monitor) with the new larger cuff. It measures blood pressure automatically without human interpretation being part of its core function, other than the user applying the cuff and reading the display. The "clinical investigation" assessed the device's accuracy against a recognized standard (ISO 81060-2:2018).

6. The Type of Ground Truth Used:

   • The ground truth was established through a "clinical investigation" following ISO 81060-2:2018, 'Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type'. This standard typically requires concurrent, independent reference measurements (e.g., using a reference sphygmomanometer and trained observers) against which the device's readings are compared. Therefore, the ground truth is expert-derived reference measurements as per a recognized international standard.

7. The Sample Size for the Training Set:

   • This document describes a clinical validation study for a hardware device (blood pressure monitor with a new cuff), not an AI/ML algorithm. Therefore, there is no "training set" in the sense of machine learning. The device's internal algorithms for blood pressure measurement would have been developed and "trained" during its initial design phase, prior to this specific study for the new cuff accessory. This study is solely for validation of the new cuff.

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

   • As this is not an AI/ML algorithm, the concept of ground truth for a training set does not apply in the context of this 510(k) submission. The device's measurement algorithms are established through engineering design and calibration, not typically by "training" on a labeled dataset in the same way an AI model would be.

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The Globalcare GUS610 Automatic Blood Pressure Monitor is indicated for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.

The Globalcare GUS610 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power supply. The Globalcare GUS610 Blood Pressure Monitor comprises the following parts: Blood pressure monitor main device x1, Upper arm cuff x1, 1.5 V LR03 AAA batteries x4, Storage bag x1, Instructions for use x1, 100-240Vac 50/60Hz power supply (optional) with USB cable x1. None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS610 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter and is designed for home ('OTC') use. The clinical outputs from the GUS610 Blood Pressure Monitor are: Systolic pressure (mm Hq), Diastolic pressure (mm Hq), Pulse rate (1/min), Cardiac arrhythmia (Irregular heartbeat (IHB)) symbol, Risk indicator (WHO color scale), Hemodynamic Rest Condition (HSD) indication. The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff inflation. Irreqular heartbeat (IHB) is detected by measuring the interval time between each heartbeat and comparing these values with the average heartbeat interval (heartbeat per minutes shown on the display). If the difference between any heartbeat interval and the average is higher or lower than 25 %, the device shows the irregular heartbeat (IHB) symbol on the display. The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous. The GUS610 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during inflation. The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heartbeat is occurring.

The provided text describes the regulatory clearance of a blood pressure monitor, the Globalcare GUS610, and its substantial equivalence to a predicate device. The primary study presented focuses on the clinical accuracy of the device rather than the performance of an AI algorithm or human reader improvement.

Here's an analysis of the acceptance criteria and the study, addressing your specific points:

Acceptance Criteria and Reported Device Performance

The device, Globalcare GUS610 Blood Pressure Monitor, is subject to the ISO 81060-2:2018/AMD1:2020 standard for clinical accuracy of non-invasive automated sphygmomanometers. The study aims to demonstrate compliance with this standard.

Note: The document explicitly states: "The clinical results indicated that the subject device meets the requirements of ISO 81060-2:2018+A1: 2020." The specific numerical accuracy metrics (e.g., mean difference and standard deviation of differences between the device and reference method) which are central to ISO 81060-2 are not directly presented in this summary, but the conclusion states that the requirements were met.

Study Details

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

   • Sample Size: 255 blood pressure datasets from 85 adult subjects.
   • Data Provenance: The document states "A clinical investigation was performed to validate the clinical accuracy of the subject device... The investigation was performed on Globalcare model GCE610 blood pressure monitor, a device that is technologically identical to the subject device, but which is cleared for marketing in a non-US regulatory jurisdiction." This implies the data originates from a clinical study conducted for a similar device, likely outside the US (given "non-US regulatory jurisdiction"). The method described is a prospective clinical accuracy study.
   • The demographic breakdown of the 85 subjects is provided in Table 1 (e.g., gender, limb size, SBP/DBP ranges), demonstrating adherence to the ISO 81060-2 standard's requirements for subject distribution.

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

   • The ground truth was established using an auscultatory reference sphygmomanometer. Per ISO 81060-2, this typically involves two trained observers simultaneously and independently taking readings. The document does not specify the number or qualifications of these observers, but good clinical practice for such studies requires highly trained individuals to minimize observer bias.

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

   • The method used is the arm sequential method described in subclause 5.2.4.1 of ISO 81060-2:2018+A1:2020. This method involves sequential measurements by the test device and the reference standard(s) on the same arm, with a specific protocol for timing and number of repetitions. ISO 81060-2 generally requires two independent observers for the reference measurement, with a pre-defined threshold for disagreement (e.g., within 4 mmHg); if they disagree by more than this, a third observer might be involved or the measurement discarded. The document does not explicitly detail the observer adjudication process but implies adherence to the ISO standard.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This study is for a standalone medical device (blood pressure monitor) that accurately measures blood pressure, not an AI-powered diagnostic tool that assists human readers.

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

   • Yes, a standalone performance evaluation was done. The GUS610 Blood Pressure Monitor itself, an automated device, operates without continuous human input during the measurement process. The "performance data" and "clinical performance" sections directly describe the accuracy of the device's algorithm in measuring blood pressure and pulse rate. The device's software is described as controlling the pneumatic components, collecting data from the pressure sensor, and calculating results (systolic, diastolic, pulse rate, IHB, HSD). This is a direct assessment of the device's algorithmic performance against a clinical reference.

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

   • The ground truth used was auscultatory reference measurements obtained using a legally available sphygmomanometer, aligning with the "gold standard" for blood pressure measurement in clinical validation studies as specified by ISO 81060-2.

7. The sample size for the training set:

   • Not applicable / Not specified. This document describes the validation study for a medical device (blood pressure monitor) against an established international standard. It's not a submission for an AI/ML device where a separate "training set" would be typically documented as part of the regulatory submission process. The device's algorithm for calculating blood pressure is pre-programmed, refined during development processes, but not typically "trained" in the machine learning sense with a discrete training set that requires specific regulatory submission.

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

   • Not applicable. As above, the concept of a "training set" for the type of device described (non-invasive blood pressure monitor) is not relevant in the context of this regulatory summary. The device's underlying algorithm is based on established oscillometric principles and calibration/design processes, not on a machine learning training dataset established with ground truth in the way AI/ML systems are developed.

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GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.

GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol.

Here's a breakdown of the acceptance criteria and study information for the GUS831 Compressor Nebulizer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (U-RIGHT Compressor Nebulizer, K121969) rather than explicitly stating pre-defined acceptance criteria with pass/fail thresholds against a specific standard for all performance parameters. However, the aerosol characterization section presents quantitative data for both the subject and predicate devices, implying those values serve as comparative criteria.

Note: The "acceptance criteria" here are implicitly defined by the predicate device's performance, with the goal being "statistically identical" or "substantially equivalent" performance.

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The Globalcare GUS622 automatic Blood Pressure Monitor is indicated for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.

The Globalcare GUS622 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power supply. The Globalcare GUS622 Blood Pressure Monitor comprises the following parts: Blood pressure monitor main device x1, Upper arm cuff x1, 1.5 V LR03 AAA batteries x4, Storage bag x1, Instructions for use x1, 100-240Vac 50/60Hz power supply (optional) x1. None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS622 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter, and is designed for home ('OTC') use. The clinical outputs from the GUS622 Blood Pressure Monitor are: Systolic pressure (mm Hg), Diastolic pressure (mm Hg), Pulse rate (1/min), Cardiac arrhythmia (Irregular heart beat (IHB)) symbol, Level of risk, Hemodynamic Rest Condition (HSD) indication. The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff deflation. Irregular heart beat (IHB) is detected by measuring the interval time between each heart beat and comparing these values with the average heart beat interval (heart beat per minutes shown on the display). If the difference between any heart beat interval and the average is higher or lower than 25 %, the device shows the cardiac arrhythmia (IHB) symbol on the display. The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous. The GUS622 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during deflation. The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements, and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heart beat is occurring.

The provided document is a 510(k) summary for a blood pressure monitor, not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects (such as training data, expert adjudication, MRMC studies, standalone algorithm performance, etc.) are not directly applicable to the information contained in this document.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets those criteria, as described for a non-AI/ML medical device like a blood pressure monitor.

Here's the breakdown based on the provided text, focusing on the performance and validation of the Globalcare GUS622 Blood Pressure Monitor:

Acceptance Criteria and Device Performance for Globalcare GUS622 Blood Pressure Monitor

The acceptance criteria for this vital signs monitoring device are primarily based on established international standards for noninvasive sphygmomanometers, specifically ISO 81060-2:2013 and EN 1060-3:1997+A2:2009 for clinical performance. These standards define the accuracy requirements for blood pressure measurements.

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

Note: The document explicitly states that the GUS622 has been tested and found to be in compliance with ISO 81060-2:2013 and EN 1060-3:1997+A2:2009 for clinical performance. These standards inherently define the accuracy requirements. The "Accuracy" row in Table 1 directly reflects the performance against these criteria.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states "Clinical performance: ISO 81060-2:2013". ISO 81060-2 specifies requirements for the clinical investigation of non-invasive sphygmomanometers, including patient population size. While the exact number of subjects for the clinical study is not explicitly stated in this 510(k) summary, compliance with ISO 81060-2:2013 implies that the study was conducted with a sufficient number of subjects (typically a minimum of 85 subjects with specific demographic distribution as per the standard).

• Test Set Sample Size: Not explicitly stated, but compliance with ISO 81060-2:2013 implies a sample size that meets the standard's requirements (typically a minimum of 85 subjects).
• Data Provenance: Not explicitly stated. Clinical studies for compliance with international standards are generally prospective. The manufacturer is Globalcare Medical Technology Co., Ltd in China.

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

For blood pressure monitors, the "ground truth" during clinical validation is typically established by trained observers (often two or more) taking simultaneous auscultatory measurements using a mercury reference sphygmomanometer, in accordance with the protocols outlined in standards like ISO 81060-2.

• Number of Experts: Not explicitly stated, but clinical validation for blood pressure monitors generally involves multiple trained observers. ISO 81060-2, for example, specifies the use of multiple observers (e.g., at least two) for reference measurements.
• Qualifications of Experts: Not explicitly stated, but they would be trained according to the requirements of the standard, typically involving specific training in auscultatory blood pressure measurement.

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

For blood pressure monitor validation studies (e.g., under ISO 81060-2), ground truth is established through simultaneous measurements by multiple trained observers. The method is often a comparison of the device's readings against the average or reconciled readings from these observers.

• Adjudication Method: Not explicitly detailed, but ISO 81060-2 outlines procedures for agreement between observers and handling discrepancies, implying a form of "adjudication" through simultaneous, blinded 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

• N/A. This is a traditional medical device (blood pressure monitor), not an AI/ML device. MRMC studies are not applicable.

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

• This device is a standalone algorithm-driven device (it operates on the oscillometric method with a software algorithm). The performance data cited (compliance with ISO 81060-2) reflects the overall device performance, which is the standalone performance in this context. The human "in the loop" is the user taking the measurement, but the measurement itself is produced by the device's internal algorithm.

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

• Type of Ground Truth: Paired and simultaneous (or sequential in close proximity) reference measurements taken by trained observers using a validated reference method (e.g., mercury sphygmomanometer) in a clinical setting. This is considered the "expert consensus" or "reference measurement" gold standard for blood pressure validation.

8. The sample size for the training set

• N/A. This information is for an AI/ML device's training data. For a traditional device like this, there isn't a "training set" in the AI/ML sense. The device's algorithm would have been developed and tested internally, but not based on a "training set" of patient data that is then distinct from a "test set" in the way an AI model is trained and validated.

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

• N/A. See point 8.

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