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FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

FibriCheck is medical device software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation. It makes use of optical sensing from a mobile device to collect photoplethysmogram data (PPG data). The recordings can be shared optionally with a physician or monitoring service.

The FibriCheck web application, an online tool, has the sole intention to display data. Professional users can use the web application for managing patients and reviewing FibriCheck data.

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided FDA submission:

Device: FibriCheck (Atrial Fibrillation Monitor)
Intended Use: Self-testing by patients diagnosed with, or susceptible to, atrial fibrillation to monitor and record heart rhythms intermittently.

1. Acceptance Criteria and Reported Device Performance

The submission implicitly defines acceptance criteria through its clinical performance comparison. While explicit numerical thresholds for sensitivity/specificity/PPV/NPV/accuracy are not stated as "acceptance criteria," the comparison aims to demonstrate that FibriCheck's diagnostic performance is comparable to a legally marketed reference device (Kardia/AliveCor). The key performance metrics are presented as actual results.

Note: The submission states, "This means that both methods have comparable diagnostic results," implying that meeting or exceeding Kardia's performance was the implicit acceptance goal.

2. Sample Size and Data Provenance

• Test Set Sample Size: 223 subjects
• Data Provenance: The document does not explicitly state the country of origin or if the study was retrospective or prospective. It is a "clinical performance study" where subjects participated, which typically implies a prospective design.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. It mentions that the devices were "compared towards a gold-standard 12-lead ECG device." This implies that the interpretation of the 12-lead ECG (which serves as the "gold standard") would have been done by qualified medical professionals (e.g., cardiologists or electrophysiologists), but specifics are not provided in this excerpt.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described in the provided text. The reliance on a "gold-standard 12-lead ECG device" suggests that the 12-lead ECG readings were used as the definitive diagnosis, but how those readings themselves were confirmed (e.g., single expert, consensus of multiple experts) is not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described. The study compared the device's performance (FibriCheck vs. Kardia) against a gold standard (12-lead ECG), not the improvement of human readers with or without AI assistance. This was a standalone performance comparison.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done for FibriCheck. The provided performance metrics (sensitivity, specificity, PPV, NPV, accuracy) for FibriCheck are its algorithm-only performance when compared against the 12-lead ECG ground truth.

7. Type of Ground Truth Used

The type of ground truth used was gold-standard 12-lead ECG device. This is a clinical diagnostic standard for cardiac rhythm analysis.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set used for FibriCheck's algorithm development. The performance data presented refers to the test set performance.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established.

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Accutension Smartphone Auscultatory Blood Pressure Kit is intended for professionals or home users to nonautomatically measure systolic and diastolic blood pressure on adults by detecting Korotkoff sounds and measure pulse rate on adults by detecting oscillometry. This device is not indicated for children, heart failure patients and critical patients.

The Accutension Smartphone Auscultatory Blood Pressure Kit (Model XYZ-110) is a non-invasive blood pressure measurement system for professionals and home users to nonautomatically measure systolic and diastolic blood pressure and pulse rate. It utilizes advanced pressure sensing module to transfer cuff pressure value to an iOS App via established Bluetooth connection between the module and the iOS device during measurement, meanwhile a stethoscope detects Korotkoff sounds and transfers the sound signal to the smartphone via its earphone jack. Both the cuff pressure and auscultatory sounds are visualized in the app and a user can determine the systolic and diastolic blood pressure by finding the cuff pressures on the first and last Korotkoff sounds. It automatically calculates the pulse rate based on cuff pressure oscillometry. This device consists of 5 parts, arm cuff, pressure sensing module, hand pump (bulb) with airflow valve, stethoscope with earphone plug and charging cable.

This document describes the 510(k) premarket notification for the Accutension Smartphone Auscultatory Blood Pressure Kit (Model XYZ-110). It demonstrates the device's substantial equivalence to predicate devices for blood pressure and pulse rate measurement. The core of the evidence relies on clinical and non-clinical testing, particularly adherence to ISO 81060-2:2013 for blood pressure accuracy.

Here's a breakdown of the requested information based on the provided text:

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

The document states that the device's accuracy was assessed against the criteria specified in ISO 81060-2:2013. While specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure are not explicitly tabulated in the provided text, the conclusion section confirms that the device "satisfies the criteria specified in ISO 81060-2:2013" and is "as safe and effective (accurate) in a clinical environment".

For pulse rate, the document states: "Testing to demonstrate pulse rate accuracy" was performed, and the Conclusion claims the device demonstrates "the same level of safety, effectiveness and performance" as predicate devices. However, explicit numerical acceptance criteria for pulse rate accuracy are not provided.

2. Sample size used for the test set and the data provenance

• Sample Size for Clinical Test (Blood Pressure Accuracy): "255 pairs of data from 85 valid subjects were achieved following the clinical study protocol defined in ISO 81060-2:2013."
• Data Provenance: The text does not explicitly state the country of origin of the data. Since the submitting company is Shanghai Hulu Devices Co., Ltd, it is highly probable the data originated from China. The study is described as a "clinical study," which implies a prospective collection of data.

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

The document mentions that a "manual Mercury Sphygmomanometer was used as a reference device in the clinical testing." For the primary blood pressure determination, the device relies on a human user "listening to the Korotkoff sounds with human ear." However, the text does not specify the number of expert readers, their qualifications (e.g., radiologists, physicians with X years of experience), or if they were involved in establishing the "ground truth" beyond performing the reference measurements with the mercury sphygmomanometer. The ISO 81060-2 standard usually details requirements for reference measurements and observers.

4. Adjudication method for the test set

The document describes a "Same arm simultaneous method" used during the clinical validation, with a manual Mercury Sphygmomanometer as a reference. This usually implies a direct comparison, rather than an adjudication process between multiple readers. No mention of an adjudication method (e.g., 2+1, 3+1) is made for determining the ground truth for the test set.

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

There is no mention of a multi-reader, multi-case (MRMC) comparative effectiveness study. The device is not an AI-assisted diagnostic tool in the typical sense where AI provides an interpretation and human readers improve with its assistance. Instead, it digitizes and visualizes blood pressure and Korotkoff sounds for a human user to interpret. The study focuses on the accuracy of the device itself compared to a reference standard (manual mercury sphygmomanometer).

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

No, the device is explicitly designed for human-in-the-loop performance. The core method for blood pressure determination is "By listening to the Korotkoff sounds with human ear". The device visualizes the sounds and cuff pressure, which "provides an extra feature to help capture the first and last Korotkoff sounds for blood pressure determination." Therefore, no standalone algorithm-only performance was conducted or is applicable given the device's function. The pulse rate is "automatically calculates based on cuff pressure oscillometry," which is a standalone algorithm component for that specific measurement.

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

The ground truth for blood pressure measurement was established using a "manual Mercury Sphygmomanometer" as a reference device in the clinical testing, following the protocol of ISO 81060-2:2013. This implies a direct, real-time comparison to a well-accepted clinical standard performed by human observers.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI models. Given that the device's primary method for blood pressure determination relies on human auscultation supplemented by visualization, and pulse rate is calculated via oscillometry (a known physiological method), there isn't an explicit "training set" for an AI algorithm for these core functions. The term "training set" is usually relevant for AI/ML devices that learn from data, which doesn't appear to be the case for the primary blood pressure determination function here.

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

As there is no explicit mention of a "training set" for a machine learning model for blood pressure determination, this question is not applicable to the provided information.

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The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.

The Stealth™ Monitor is a small, lightweight, patch-style, single-use cardiac monitor designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 168 hours (7 days) and ECG signal characterization. It is worn on the patient's chest similar to an adhesive bandage. The housing is constructed of a foam material making the device very lightweight (less than 9 grams). A software application is installed at a physician's office to receive the data from the monitor using a direct connection. Data retrieved from the monitor may be printed or saved and stored for later viewing. The DSD software has the ability to generate reports as well as the ability to save a full disclosure ECG file for viewing.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and studies:

Device Name: Stealth™ Monitor (S200, K142468)

Device Type: Prescription only single-use, continuous recording ECG monitor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for the device's performance in terms of diagnostic accuracy or specific metrics (e.g., sensitivity, specificity for detected arrhythmias). Instead, it focuses on the performance of the device's components and system in meeting regulatory standards and functional requirements.

The "Summary of Performance Testing" section lists various documentation provided, indicating that general safety and functional performance were evaluated. However, specific numerical acceptance criteria for arrhythmia detection or other clinical performance metrics are absent from this summary.

Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance related to clinical accuracy cannot be constructed. The document primarily addresses the substantial equivalence to predicate devices based on indications for use and technological characteristics, along with adherence to software and safety standards.

Further analysis of the document indicates: No clinical studies demonstrating diagnostic performance (e.g., sensitivity, specificity for specific arrhythmias) with specific acceptance criteria are presented or referenced in this 510(k) summary. The "Stealth™ System S200" is listed with "Arrhythmias and/or statistics" of "Normal, fastest heart rate, slowest heart rate, average heart rate, pauses, bradycardia (run), tachycardia (run)," but there are no performance metrics provided for these detections. This 510(k) seems to rely on substantial equivalence to predicate devices for its claims, rather than new clinical performance data for arrhythmia detection.

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