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510(k) Data Aggregation
(154 days)
QardioArm 2
The QardioArm 2 is a fully automatic, wireless blood pressure monitor intended to measure the systolic and diastolic blood pressures and pulse rate of adult individuals. It utilizes an inflatable cuff that is wrapped around the upper arm. The arm circumference is limited to 8.7 - 18.5 inches (22 - 47 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is not intended to be used as a diagnostic device and users are instructed to contact their physician if hypertensive values are indicated.
The QardioArm 2 is an over-the-counter (OTC) non-invasive blood pressure monitor intended for spot-checking in adults. It uses a detachable inflatable cuff that is wrapped around the upper arm to determine blood pressure based on the oscillometric method. Two cuff sizes are available: standard size for an arm circumference of 8.7 to 14.6 inches or large size for an arm circumference of 14.6 to 18.5 inches.
The QardioArm 2 is a non-invasive blood pressure measurement system. The acceptance criteria and the study that proves the device meets them are detailed below.
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not contain a specific table of acceptance criteria or reported device performance in the format of a direct comparison table. However, it states that the device "met all the requirements of the standard" and "passed all tests" for various criteria.
Based on the general information provided, we can infer some key performance criteria and the reported performance:
| Acceptance Criteria Category | Specific Criteria (Inferred from standards) | Reported Device Performance |
|---|---|---|
| Accuracy (Blood Pressure) | As per ISO 81060-2:2018 (Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type), which is a recognized standard for blood pressure monitor accuracy. This standard typically requires a mean difference between the device and reference standard of ≤ ±5 mmHg, and a standard deviation of differences ≤ 8 mmHg. (Implicit) | "The device met all the requirements of the standard [ISO 81060-2:2018]." This implies the accuracy criteria of ISO 81060-2 were met. The technological comparison section explicitly states an accuracy of "+/-3mmHg or 2% reading for blood pressure." |
| Accuracy (Pulse) | As per ISO 81060-2:2018 or similar standards for pulse measurement. (Implicit) | The technological comparison section explicitly states an accuracy of "+/-5% for pulse." |
| Electrical Safety | Compliance with IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance. | "The device passed all tests, including the US deviations." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests. | "The QardioArm 2 passed all tests." |
| Battery Safety | Compliance with IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems. | "found to comply with all relevant sections." |
| Wireless Coexistence | Compliance with AAMI TIR69:2017 and ANSI C63.27:2017. | "All tests passed." |
| Software Verification & Validation | Adherence to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," for a "Moderate" level of concern. | "Software verification and validation testing were conducted, and documentation was provided as recommended... The software for this device was considered as a 'Moderate' level of concern." While not explicitly stating "passed," meeting the guidance for a moderate level of concern implies successful validation. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11:2015, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. | "The device passed all tests." |
| Automated Non-Invasive Sphygmomanometer Performance | Compliance with IEC 80601-2-30:2018, Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. | "The device passed all tests." |
| Human Factors | Adherence to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices," demonstrating the device is safe and effective for its intended users, uses, and use environments. | "The QardioArm 2 was found to be safe and effective for its intended users, uses, and use environments." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Clinical Data (Test Set): 86 subjects.
- Data Provenance: The study was a "prospective, single arm paired comparison study." The document does not specify the country of origin of the data, but it was conducted to demonstrate performance in accordance with ISO 81060-2:2018 and FDA's requirements for 510(k) submissions, suggesting a standard clinical study environment.
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 study description mentions a "same arm sequential method with dual auscultators." This implies that the ground truth for blood pressure measurements was established by two human observers (auscultators) using a reference sphygmomanometer. The document does not specify the number of experts beyond "dual auscultators" or their specific qualifications (e.g., years of experience, medical role). However, for such studies, these individuals are typically trained and validated healthcare professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The method used was a "same arm sequential method with dual auscultators." While not explicitly stated as "2+1" or "3+1" (which are typically used for imaging assessments), the use of dual auscultators suggests a comparison or consensus method between the two observers for establishing reference measurements. Differences between the dual auscultators would typically be adjudicated or the reading discarded according to the ISO standard's protocol, though the specific adjudication method is not described in detail.
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 non-invasive blood pressure monitor, not an AI-assisted diagnostic imaging device that involves human interpretation of images. The study focused on the device's accuracy compared to a reference standard, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, a standalone performance assessment was done. The QardioArm 2 measures blood pressure automatically (oscillometric method) and provides a reading. The clinical study directly compared these device-generated readings against reference measurements obtained by human auscultators. The device operates autonomously to produce the blood pressure and pulse rate values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for blood pressure measurements was established using a reference sphygmomanometer via a same arm sequential method with dual auscultators. This constitutes an expert consensus or expert-derived reference standard for physiological measurements, rather than pathology or outcomes data.
8. The sample size for the training set
The document does not provide information about a separate "training set" or its sample size. This type of device's core functionality (oscillometric measurement) is based on established principles and algorithms, often developed and refined internally. For a 510(k) submission of a blood pressure monitor, the primary focus is on the performance of the final device as compared to a reference standard in a clinical test set, rather than detailing the training data for an AI algorithm.
9. How the ground truth for the training set was established
As no specific training set data is mentioned for an AI algorithm, the method for establishing ground truth for a training set is not applicable or detailed in this document. The device's operation is based on physical measurement principles rather than a deep learning model requiring a large labeled training dataset in the same way an image analysis AI would.
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