(88 days)
Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals utilizing recorded ECG data to produce a numerical score which is the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction). Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitute for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings. ACI-TIPI is intended for adult patient populations.
Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is a software option for Marquette MAC-series electrocardiographs to aid the physician's decision-making process in a chest pain setting by using patient age, gender, chest pain status and ECG features to provide the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction).
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets them. Instead, it focuses on the device's substantial equivalence to a predicate device and its intended use.
However, based on the information provided, we can infer some details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. The performance claim is a qualitative comparison to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | "ACI-TIPI analysis is as safe, as effective, and performs as well as the predicate device, Hewlett-Packard Model 1791A ACI-TIPI." |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
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 an MRMC comparative effectiveness study or the effect size of human reader improvement with AI assistance. The device is intended to supplement a physician's decision, not replace it, which suggests it might be used in conjunction with human readers, but no study details are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "software testing and field tests of the ACI-TIPI analysis," but it doesn't explicitly state whether a standalone performance study was conducted. The nature of the device as a "predictive instrument" producing a numerical score implies an algorithm-only component.
7. The type of ground truth used
The document does not specify the type of ground truth used for performance evaluation. It notes the device calculates "the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction)." The "ground truth" would presumably relate to the actual occurrence of these conditions.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of Study Information Provided in the Document:
The provided text primarily focuses on the regulatory submission for substantial equivalence. The "Performance" section briefly states that "The following quality assurance measures were applied to the development of ACI-TIPI: Requirements specification review, software testing and field tests of the ACI-TIPI analysis." It then concludes, "The results of these measurements demonstrated that ACI-TIPI analysis is as safe, as effective, and performs as well as the predicate device, Hewlett-Packard Model 1791A ACI-TIPI."
This statement indicates that some form of internal testing was conducted to demonstrate equivalence to the predicate device, but the details of these tests (sample sizes, ground truth establishment, expert involvement, specific metrics) are not disclosed in this summary. The regulatory approval is based on substantial equivalence, implying that the predicate device already had established performance.
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