(15 days)
The MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.
The MobCardio System is comprised of an EKG acquisition module (connected via a PC-USB cable), a 12-lead EKG patient cable, a medical grade laptop, and the user software. The device is used to collect, transmit, and display resting 12-lead EKG data using FDA cleared disposable EKG electrodes and manufacturer supplied 12-lead EKG patient cable. The user software is pre-installed for the user and provides necessary menus and user interfaces for displaying and printing the acquired 12-lead EKG data. The MobCardio System is compatible with any desktop or notebook computer with a suitable USB port (1.0 or above) and Windows operating system. While we offer the EKG acquisition module and the medical grade laptop as a system, the user has the option to use a personal computer that fits the requirements listed in the device user manual. Without being connected to a computer, the EKG data acquired will not be displayed and no EKG prints out can be obtained.
The provided document describes the MobCardio System, an electrocardiography device. However, it does not contain information about studies proving the device meets specific performance acceptance criteria, nor does it mention any AI components, human-in-the-loop studies, multi-reader multi-case studies, or the establishment of ground truth as would be relevant for an AI/ML device.
The document is a 510(k) summary for a Class II Electrocardiography device and focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology, and basic functional and safety testing. It explicitly states, "No clinical interpretation of EKG is provided," indicating it's a data acquisition and display device, not one that performs analysis or requires complex validation as an AI/ML diagnostic tool would.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not present in the provided text because they are not applicable to the type of device described (a basic EKG data acquisition system without AI-driven interpretation).
Based on the provided text, here's what can be inferred and what information is missing:
Acceptance Criteria and Device Performance
Based on the provided 510(k) summary, the device is a standard electrocardiography system for acquiring, transmitting, and displaying 12-lead EKG data. It does not perform clinical interpretation or provide diagnostic outputs beyond displaying the raw EKG signals. Therefore, the "acceptance criteria" and "reported device performance" are primarily related to its ability to meet electrical safety, performance standards (like signal quality for display), and functional requirements rather than diagnostic accuracy metrics typically associated with AI.
The summary states: "Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results. No safety and effectiveness issues were raised." This is a general statement of compliance, not a quantitative table of specific performance metrics against acceptance criteria.
A table of acceptance criteria and reported device performance, as would be expected for an AI device, cannot be constructed from the provided text. The document focuses on demonstrating compliance with recognized standards (IEC, AAMI) for medical electrical equipment and essential performance for EKG acquisition and display.
Study Details (as related to the provided text)
Since this device is for data acquisition and display, and explicitly states "No clinical interpretation of EKG is provided," the types of studies mentioned in the prompt (e.g., those involving AI performance, human reader improvement, or specific diagnostic accuracy) are not described in the provided 510(k) submission. The document relies on demonstrating substantial equivalence to predicate devices and general functional/safety testing.
Here's an analysis based on the information provided, and what is explicitly not available:
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A table of acceptance criteria and the reported device performance:
- Not Available in a quantitative, AI-specific format. The document broadly states that "Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results. No safety and effectiveness issues were raised." This implies reaching general functional and safety acceptance criteria for EKG devices (e.g., signal fidelity for display, electrical safety, adherence to standards like IEC 60601 series and AAMI EC11). No specific quantitative performance metrics like sensitivity, specificity, or AUC are provided, as the device does not offer interpretation.
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Sample sizes used for the test set and the data provenance:
- Not Available. The document mentions "bench testing" and "safety testing" but provides no details on the sample size (e.g., number of EKG recordings or patients) or the provenance (country of origin, retrospective/prospective) of any data used for these tests. This is typical for a basic EKG acquisition device lacking interpretive algorithms.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Available. Since the device does not provide clinical interpretation, there is no "ground truth" establishment in the context of diagnostic accuracy for an AI/ML model. The ground truth for device performance would relate to the accuracy of signal acquisition (e.g., correctly capturing heart electrical activity) which is verified through engineering tests and compliance with standards rather than expert clinical consensus on interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Available. As there's no clinical interpretation and no expert panel for ground truth within the scope of this device, adjudication methods are not relevant or described.
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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. The document explicitly states: "No clinical interpretation of EKG is provided." Therefore, there is no AI assistance to compare human reader performance against, and no MRMC study would be applicable or described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. "No clinical interpretation of EKG is provided." There is no standalone algorithm for interpretation described. The device's "standalone performance" refers to its ability to acquire and display EKG data accurately according to engineering specifications and safety standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Described in terms of clinical interpretation. For a device that only acquires and displays, the "ground truth" relates to physical and electrical properties (e.g., a known, calibrated electrical signal input resulting in accurate representation on display, or verified electrical safety). It's not a clinical diagnostic ground truth.
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The sample size for the training set:
- Not Applicable/Not Available. This device does not have an AI/ML component that requires a training set for clinical interpretation.
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How the ground truth for the training set was established:
- Not Applicable/Not Available. As above, no AI/ML training set is described for clinical interpretation.
In summary, the provided 510(k) summary is for a basic EKG data acquisition and display system. It does not include details on AI/ML performance, diagnostic accuracy studies, human reader studies, or the rigorous ground truth establishment processes that would be required for a device offering automated clinical interpretation. The "studies" mentioned refer to functional and safety bench testing to ensure the device meets general medical device standards for its stated function of acquiring and displaying EKG data.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).