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Acute Cardiac Ischemia Time-Insensitive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals . TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue 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-TIP! 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 document is a 510(k) summary for the Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) Option. This document states that the ACI-TIPI Option is substantially equivalent to a predicate device, the Hewlett-Packard Model 1791A ACI-TIPI. However, it does not explicitly define specific acceptance criteria (e.g., sensitivity, specificity thresholds) or provide a detailed study report with device performance metrics against those criteria. Instead, it asserts equivalence based on developmental quality assurance measures.

Here's an analysis of the provided information:

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

The document does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or predictive values) for the ACI-TIPI Option. It states that "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 implies that the acceptance criterion was likely demonstration of substantial equivalence to the predicate device, rather than specific performance thresholds.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for a test set, data provenance (country of origin), or whether the data was retrospective or prospective. It generally refers to "software testing and field tests of the ACI-TIPI analysis," but no specifics are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for establishing ground truth for a 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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The intended use explicitly states that the device is "intended to supplement, not substitute for the physician's decision process," suggesting a physician-in-the-loop scenario, but no study details are provided to evaluate this.

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

The document does not explicitly state whether a standalone (algorithm only) performance evaluation was done. Given the context of a 510(k) for substantial equivalence to a predicate device, it's possible that internal testing would have included such an evaluation, but it is not reported in this summary.

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

The document does not specify the type of ground truth used for performance evaluation. It states that the device uses "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)." To establish ground truth for "acute cardiac ischemia," one would typically expect clinical outcomes data, such as cardiac enzyme levels, angiography results, or follow-up for adverse cardiac events, but this is not detailed.

8. The sample size for the training set

The document does not provide any information regarding the sample size of a training set. This is consistent with a pre-AI/machine learning era device, where "training" in the modern sense might not have been applicable. The device "employs the same technology as the predicate device," suggesting its design is based on established methods rather than a modern learning-based approach.

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

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

Summary of what is present:

• Acceptance Criteria: Implicitly, "substantial equivalence" to the predicate device (Hewlett-Packard Model 1791A ACI-TIPI).
• Reported Device Performance: "as safe, as effective, and performs as well as the predicate device" based on "Requirements specification review, software testing and field tests of the ACI-TIPI analysis."
• Device Description: Software option for Marquette MAC-series electrocardiographs.
• Intended Use: Aid physician decision-making in a chest pain setting, using patient age, gender, chest pain status, and ECG features to predict the probability of acute cardiac ischemia. Intended to supplement, not substitute, physician's decisions and for adult patient populations.
• Technology: Employs the same technology as the predicate device.

The provided 510(k) summary is from 1998, a period when regulatory expectations for demonstrating performance for software-based medical devices were less detailed compared to current standards for AI/ML devices. Therefore, it lacks the specific quantitative metrics, detailed study designs, and ground truth methodologies that are common in more recent submissions.

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The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that musche. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug, delivery. Once the physician is satisfied with the location, he/she injects a very. therein via the lumen of the needle.

Disposable Hypodermic Needle Electrode

The provided text is a 510(k) premarket notification letter from the FDA to TECA Corporation regarding their disposable monopolar needle electrodes and MyoJect disposable needle electrodes. This type of document is a regulatory approval, not a description of a scientific study that proves a device meets acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for the training set was established.

The letter simply states that the FDA has reviewed the 510(k) and found the devices to be substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory determination, not a scientific study report.

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Ask a specific question about this device