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510(k) Data Aggregation
(205 days)
The MI-1000 is used to measure Wavelet Surface Residuan indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a graphical format for interpretation by a trained physician. The MI-1000 is also used for the measurement of SAECG indices. The MI-1000 should be used only as an adjunct to clinical history and the results of other noninvasive and/or invasive tests.
The device consists of an IBM compatible PC, nine skin surface ECG type electrodes, one electronics board, a patient interface module and software. Seven of the electrodes are used for sensing cardiac electrical activity. The remaining two electrodes are used to apply low level current pulses (maximum of 40 milliamps) to the patient. This technology uses noninvasive, externally applied, subthreshold (low amplitude) far-field stimulus while acquiring electrocardiogram data. The MI-1000 system is a tool used to identify heart cells that are significantly less stable than normal or conduct slower than normal and, thus, are an indication of cardiac electrical problems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Micro-Induction 1000 system:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance (e.g., sensitivity, specificity, accuracy thresholds). Instead, it describes a more general approach to demonstrating substantial equivalence for functional and safety testing.
| Acceptance Criteria Category | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Functional Performance | Conformance to product specifications under normal usage conditions. The device should "perform as designed" and "meet or exceed all product specifications." | "The results of the examination and testing were successful; the device performed as designed and met or exceeded all product specifications." |
| Safety Testing | Demonstrate a "low level of risk to the patient." Implied demonstration through clinical studies. | "low level of risk to the patient as demonstrated throughout the clinical studies." |
| Substantial Equivalence | Demonstrated similarity in functional design, materials, indications for use, and low level of risk compared to predicate devices (Cambridge Heart CH 2000 Cardiac Diagnostic System, Cambridge Heart Micro-V Alternans Sensor, Cambridge Heart Hi-Res ECG Electrode, Zymed Model 2010 Holter Scanner). | The device is "substantially equivalent to the Cambridge Heart CH 2000 Cardiac Diagnostic System... and the Cambridge Heart Micro-V Alternans Sensor... and Cambridge Heart Hi-Res ECG Electrode... [and] substantially equivalent to the Zymed Model 2010 Holter Scanner." This conclusion is based on "similarities in functional design, materials, indications for use and low level of risk to the patient as demonstrated throughout the clinical studies." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): "over 264 patients"
- Data Provenance: "two sites in the United States and one site in Europe." (Prospective, as it's a "clinical study" where data was "collected").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. The intended use states that data is "presented in a graphical format for interpretation by a trained physician," but this doesn't specify how ground truth for the study itself was established or adjudicated.
4. Adjudication Method for the Test Set
The document does not provide information on the adjudication method used for the test set (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not explicitly mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance. The study described focuses on the device's functional and safety performance and its substantial equivalence to predicate devices. It's a device that provides data for interpretation by a physician, rather than an AI assisting in the interpretation itself.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
The document does not describe a standalone performance study in the context of an algorithm's diagnostic accuracy. The device "is a tool used to identify heart cells," and the data is "presented in a graphical format for interpretation by a trained physician." This implies a human-in-the-loop system where the device provides information for a physician to interpret, rather than making a standalone diagnostic determination. The study focused on the device's ability to "perform as designed" and its "low level of risk."
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the clinical study. Given the device's function (measuring Wavelet Surface Residuan indices and SAECG indices to identify unstable heart cells), it's possible ground truth might have involved:
- Clinical outcomes (e.g., subsequent cardiac events).
- Correlation with findings from other established diagnostic tests.
- Expert consensus based on known clinical history and other test results.
However, this is inference, and the document provides no specific details.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This device pre-dates common AI/machine learning paradigms that explicitly use training and test sets in this manner. The "clinical study data" described seems to serve as a general validation/testing dataset rather than a distinct "test set" from a machine learning perspective, and there's no mention of a separate "training set" for an underlying AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the document does not provide information on how ground truth for a training set was established.
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