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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:

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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The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.

The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.

The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

The QardioCore ECG Monitor is composed of six main components: i) the QardioCore sensor with Bluetooth technology, ii) a chest strap that allows fitting of OardioCore sensor, iii) a USB charging cable, iv) the Qardio App (can be downloaded and installed from the respective App store) and runs on any iOS device with iOS version 10.0 or later, v) the cloud based server where the Qardio App stores and retrieves data, and vi) the ECG Viewer which provides a web interface to the doctor to view the data sent by the iPhone application.

The QardioCore device is a wearable device that captures information through a single-channel ECG. The data is then encrypted and transmitted via Bluetooth Low Energy to the Qardio App, installed on a compatible mobile platform. The OardioCore is supplied with chest straps accommodating chest sizes ranging from 27-5 to 43 inches. An optional XL chest strap is available from 41.7 to 59.8 inches. The device is provided with a USB Type-A cable to charge the device.

The Qardio App (which can be installed from the user's respective app store), can transmit the data, via Wi-Fi or standard data mobile telephony, to Qardio cloud based server for storage processing and transmission to an expert medical professional.

The ECG Viewer application provides a web interface to the doctor to view the ECG data collected from the iPhone Application. All data that a patient accumulates using the QardioCore device is stored in the central server. The ECG Viewer provides the doctor with ECG data and Heart Rate (BPM), which a doctor can use as additional information for forming a medical diagnosis. The doctor is able to see both the ECG data and Heart Rate (BPM) as soon as the data becomes available in the central server provided that the patient accepts the doctor's request for access. The device does not include automated analysis except for heart rate calculation. QardioCore is not suitable for physicians who need to perform ECG diagnoses such as myocardial ischemia, left ventricular hypertrophy or specific bundle branch blocks that require multiple and precise electrode placement and consistent wave amplitude.

The provided text describes the QardioCore ECG ambulatory monitoring device and its substantial equivalence determination by the FDA. Here's a breakdown of the requested information, specifically focusing on the clinical testing to establish acceptance criteria and prove its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the purpose of the clinical study was to demonstrate the non-inferiority of the QardioCore ECG Monitor in terms of signal quality compared to a conventional, FDA-cleared, 3-channel ECG-Holter monitor device over a 24-hour recording time with continuous recording. While specific numerical acceptance criteria for "non-inferiority" are not listed, the general acceptance can be inferred from the conclusion that the device "demonstrated the substantial equivalence with the predicate device."

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "a population consistent with the device indications for use," but does not give a numerical count of participants in the clinical study.
• Data Provenance: The study was a prospective clinical study conducted to demonstrate the accuracy of the QardioCore. The country of origin of the data is not specified beyond the device being from a US-based company (San Francisco, California).

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The text mentions that ECGs from both devices "were collected and analyzed in a blinded fashion," implying expert review, but does not detail their numbers or qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The text mentions that ECGs "were collected and analyzed in a blinded fashion," which is a common practice in clinical studies, but gives no specifics on how disagreements among experts (if multiple were used) were resolved.

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 document describes a device for capturing, storing, transmitting, and displaying ECG information. It specifically states: "The device does not include automated analysis except for heart rate calculation." Therefore, a comparative effectiveness study involving human readers improving with AI assistance would not be applicable, as the device's primary function is data acquisition and display for physician review, not AI-driven interpretation.

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

• No, a standalone algorithm-only performance study was not done. The device's current functionality, as described, is for presenting data to a physician for review, with only heart rate calculation being automated. The "reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience."

7. The Type of Ground Truth Used

• The ground truth was established by comparison with a reference device, specifically the ELA Medical, Inc., Spiderview Holter ECG recorder (K032466), which is an FDA-cleared 3-channel ECG-Holter monitor. The study aimed to demonstrate non-inferiority in signal quality against this established medical device.

8. The Sample Size for the Training Set

• Not applicable. The document describes a medical device for data acquisition and display, not a machine learning model that requires a training set in the conventional sense. The "training" in this context would refer to the development and testing of the device's hardware and software according to recognized standards.

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

• Not applicable, as there is no mention of a machine learning training set for this device.

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QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in)

QardioArm, model A100 measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.

The device includes a plastic enclosure and an integrated wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction.

This document describes the QardioArm, model A100, a non-invasive blood pressure monitoring system. It references regulatory standards, predicate devices, and performance claims but does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already cleared devices rather than providing a standalone clinical study report.

Thus, the following information is not present in the provided text:

• A table of acceptance criteria and the reported device performance with specific metrics like sensitivity, specificity, accuracy for a given disease or condition. The document primarily reports pressure and pulse accuracy as engineering specifications.
• Sample size used for a test set, data provenance, number of experts for ground truth, adjudication method, or details of a multi-reader multi-case study.
• Details of a standalone performance study as would be conducted if the device were completely novel.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical testing beyond the general statement of applying clinical test standards.
• Sample size for the training set or how ground truth was established for a training set (as this device is not an AI/ML device in the context of the question).

However, based on the provided text, here is an extraction of relevant information, focusing on the available performance specifications and the clinical testing mentioned:

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

The document mentions meeting specific accuracy criteria for blood pressure and pulse measurements. While not explicitly stated as "acceptance criteria" for a study, these are performance specifications that the device is stated to achieve and would likely be part of the product's design and validation requirements.

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

The document states under "3. PERFORMANCE & CLINICAL TEST" that the device was tested against "ANSI/AAMI ISO 81060-2:2009" and "EN 1060-4:2004". These are international standards for non-invasive sphygmomanometers. ISO 81060-2:2009 specifies requirements for the clinical investigation of non-invasive blood pressure measuring equipment. These standards typically define the population (e.g., age, sex, blood pressure ranges) and the number of subjects required for clinical validation (e.g., at least 85 subjects with specific distributions). However, the specific sample size, data provenance, or whether the study was retrospective or prospective are not detailed in this summary.

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)

This information is not provided in the summary. For blood pressure monitors, "ground truth" (or reference measurements) would typically be established using a auscultatory method by trained observers following a specific protocol, often with double or triple readings. However, details of observers' qualifications or number are not present.

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

This information is not provided in the summary. For clinical validation of blood pressure devices against a reference method, specific protocols for averaging or adjudicating reference readings are standard (e.g., two observers taking simultaneous readings, with a third if there is a significant discrepancy). However, the summary does not detail the methods used.

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 is not applicable to the QardioArm device as described. The QardioArm is a blood pressure monitor, not an AI-assisted diagnostic imaging or health analytics device that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The document does not suggest any AI components for interpretation or assistance.

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

This is not applicable in the context of "algorithm only" as typically applied to AI/ML devices. The device's performance is inherently "standalone" in the sense that it measures blood pressure and pulse rate automatically using an oscillometric method without human intervention in the measurement process itself, though it requires an external device for display and user interaction. The "Performance & Clinical Test" section implies validation of this automated measurement process.

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

For a blood pressure monitor, the "ground truth" would almost certainly be simultaneous or sequential auscultatory blood pressure measurements taken by trained observers using a calibrated sphygmomanometer, following a standard protocol (e.g., as defined by ISO 81060-2). The document implicitly references this by stating conformity to ISO 81060-2.

8. The sample size for the training set

This information is not provided. The concept of a separate "training set" for an algorithm is typically associated with AI/Machine Learning models. The QardioArm uses a fundamental oscillometric method, which is a well-established algorithm, not typically "trained" in the modern AI sense. Its development would involve engineering design and calibration, followed by validation.

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

As there is no mention of a training set in the AI/ML context, this information is not applicable to the provided summary.

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