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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.

Overall Conclusion: The document states that "almost all the performance parameters of the two different nebulizers were statistically identical for adult conditions and substantially equivalent in the therapeutic amount of medication delivered for pediatric conditions. The measured differences raise no new safety and efficacy issues; therefore, device equivalence is proved."

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

• Sample Size: The document does not specify the exact numerical sample size for the aerosol characterization testing (e.g., number of nebulizers tested, number of runs per condition). It reports mean and standard deviation, implying replicate measurements were performed.
• Data Provenance: The testing was conducted by an "independent source" according to the relevant CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). The country of origin of the data is not explicitly stated. The study appears to be prospective for the device testing itself, as it was performed to support the 510(k) submission.

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

This information is not applicable to this type of device and study. The testing for a compressor nebulizer involves objective physical and chemical measurements (e.g., particle size, dose delivery) rather than expert interpretation of images or patient data. The ground truth is established by the standardized measurement methods themselves.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device and study, as it did not involve expert review or consensus for establishing ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases, sometimes with and without AI assistance. The GUS831 Compressor Nebulizer is a therapeutic device (drug delivery), not a diagnostic one.

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

Yes, a standalone performance evaluation was done. The aerosol characterization and biocompatibility testing were conducted directly on the device (GUS831 Compressor Nebulizer) and compared to the predicate device, without involving human users in a clinical setting for performance assessment.

7. The Type of Ground Truth Used

The ground truth for the aerosol characterization was established through objective physical and chemical measurements obtained using a cascade impactor, following the methodology outlined in the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). This is a form of objective measurement data, not expert consensus, pathology, or outcomes data typically associated with diagnostic AI.

The ground truth for biocompatibility was established by testing against recognized international standards (ISO 10993-1, ISO 18562 family).

8. The Sample Size for the Training Set

This information is not applicable. The GUS831 Compressor Nebulizer is a physical medical device; it is not an AI/ML algorithm that requires a training set. The "testing" referred to in the document is for the physical performance and biocompatibility of the device compared to a predicate, not for training a model.

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

This information is not applicable, as the device is not an AI/ML algorithm requiring a training set.

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