(413 days)
The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.
The Heart Force Ballistocardiograph senses and analyzes the mechanical movement of the heart. This is accomplished with 2 or 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion.
The provided text describes the 510(k) summary for the dBG 300 Digital Ballistocardiograph, but it does not contain acceptance criteria or detailed study results that prove the device meets specific performance metrics.
The document discusses substantial equivalence to a predicate device (Seismed SCG-2000 Seismocardiograph) and mentions clinical data collected to compare cardiac event timings with an echocardiograph. However, it does not provide the specifics of this clinical data in a way that allows for a comprehensive description of acceptance criteria and a study proving their fulfillment.
Therefore, I cannot fulfill all parts of your request with the information provided. I can, however, extract what is available regarding clinical data and ground truth establishment:
Missing Information
The provided text does not contain the following information:
- A table of acceptance criteria or specific reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity, agreement thresholds).
- Sample size used for the test set.
- Number of experts used to establish ground truth for the test set or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers with/without AI assistance.
- If a standalone (algorithm only) performance study was done with specific results.
- Sample size for the training set.
- How the ground truth for the training set was established.
Available Information Related to Studies and Ground Truth
While specific acceptance criteria and detailed study results are absent, the document does mention a clinical study and the type of ground truth used:
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A table of acceptance criteria and the reported device performance:
- Information not available: Specific acceptance criteria (e.g., "timing measurements must be within X ms of echocardiograph measurements") and quantitative reported device performance against such criteria are not provided.
- The document implies that "equivalent intended use, manufacturing materials, operating principles, physical and operational specifications" to the predicate device (Seismed SCG-2000) serve as a basis for substantial equivalence, rather than direct performance metrics against specific criteria.
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Sample size used for the test set and the data provenance:
- Information not available: The exact sample size for the clinical data is not specified.
- Data provenance: "clinical data collected to compare the subjects device's finding of the times of occurrence of cardiac events such as aortic valve opening or closing with that of an echocardiograph." This implies prospective data collection for comparison. The country of origin is not explicitly stated for the clinical data itself, though the submitter is from Canada and the regulatory correspondent from the US.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information not available: This detail is not provided.
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Adjudication method for the test set:
- Information not available: This detail is not provided.
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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:
- Information not available: The device is described as a tool to measure timing events; there is no mention of an "AI" component or human-in-the-loop performance improvement study in the context of MRMC. The document predates widespread AI in medical devices (2009).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied: The comparison to echocardiograph measurements suggests a standalone performance evaluation of the device's ability to measure cardiac event timings. However, specific performance metrics or detailed study design for this "standalone" evaluation are not provided.
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The type of ground truth used:
- Ground truth type: The clinical data compares the dBG 300's findings with "that of an echocardiograph." Therefore, echocardiography serves as the ground truth for measuring the timing of cardiac events (e.g., aortic valve opening or closing).
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The sample size for the training set:
- Information not available: No explicit mention of a separate "training set" or its size is made, suggesting a traditional device validation approach rather than an AI/machine learning model.
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How the ground truth for the training set was established:
- Information not available: Given the lack of an explicit training set, this information is not provided.
§ 870.2320 Ballistocardiograph.
(a)
Identification. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.(b)
Classification. Class II (performance standards).