Search Results

The PRIME ECG® with enhanced Diagnostic Algorithm is intended to be used for the recording of electrocardiographic signals.

The PRIME ECG® with enhanced Diagnostic Algorithm is indicated for the recording of electrocardiographic signals on the body surface

The device consists of the following components and accessories: PRIME ECG Cart, PRIME ECG Algorithm, PRIME ECG Single-Use Patient Vest.

Data recording and analysis is contained within a durable medical device that is used to record, analyze and display electrocardiographic signals from the body surface. The system features a power supply with battery back-up, signal acquisitioning and processing hardware and firmware, a computer and a software, including automated analysis software, a flat panel color display and a color printer.

The PRIME ECG System incorporates computer processing that can present conventional ECG waveforms as color images displayed on a simulated torso. Each PRIME ECG recording captures body surface potentials for analysis. The PRIME ECG System translates the segments of the ECG waveform into ranges of color based on measured values. The range from vellow to red is assigned to positive values, with deep red assigned to the highest value. Green is assigned to neutral values and shades of blue are assigned to negative values with deep blue assigned to the highest negative value. This information allows physicians to identify areas of abnormality for interrogation.

The PRIME Diagnostic Algorithm is an adjunct to the color displays of the underlying ECG waveforms to assist the physician in coming to a conclusion on the patient's cardiac status. The Diagnostic Algorithm uses multiple parameters of ECG potentials and ECG morphology to make a recommendation on whether the patient has a Normal, Abnormal or Acute MI condition. An explanation window describes to the physician the basis of the Diagnostic Algorithm conclusion. Thus, the physician is at liberty to interrogate the recommendation and agree to or override it.

The PRIME ECG data recording and analysis system is attached to a single-patient electrode array (vest) that is placed on the patient in two parts consisting of a 64 lead anterior and a 16 lead posterior segment. Electrodes and signal conduction pathways are screen-printed onto a clear plastic substrate. The vest is secured to the patient with a pre-applied conductive adhesive gel. The vest is a single use device and cannot be re-used.

Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense as a target for the enhanced algorithm. Instead, it demonstrates improved comparative performance against a predecessor and the 12-lead ECG. The implication is that "improvement" is the de facto acceptance criterion.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Description: The "FDA Troponin" set.
• Sample Size (Positive Cases): 78 (True Positive cases for MI)
• Sample Size (Negative Cases): 147 (False Positive cases for MI, implying these were non-MI patients from the overall cohort)
• Total Test Set Size: 225 (78 + 147)
• Data Provenance: This sub-set was generated from the Company's IDE study (G990171), which gathered data from "a number of institutions." The text implies this data was historic, and the specific "FDA Troponin" set was created retrospectively from this larger dataset, as it was used to confirm previous algorithm versions. The context suggests the IDE study was prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated, though the MI diagnosis was "confirmed by Troponin as a Gold Standard," indicating a clinical diagnostic process. The involvement of "institutions" suggests clinical experts were involved in the initial diagnosis.

4. Adjudication Method for the Test Set:

• The document states that the original IDE study "allowed the institutions to follow their normal protocol in the treatment of suspect MI. As a result there were a number of methods of confirmation of the diagnosis, no one methodology had been mandated."
• For the "FDA Troponin" sub-set, the MI diagnosis was specifically "confirmed by Troponin as a Gold Standard." This implies a biomarker-driven adjudication, rather than a human expert consensus adjudication for the ground truth of MI.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was an MRMC study done? No. The study compares algorithmic performance to human interpretation and other algorithmic versions, but it does not describe an MRMC study where human readers interpret cases with and without AI assistance to measure improvement. The row "PRIME ECG, physician interpretation (K012414)" refers to a past evaluation of physician interpretation, not a concurrent AI-assisted reading study.

6. Standalone Performance Study:

• Was a standalone study done? Yes. The "Enhanced PRIME Algorithm (this application)" row in Table 1 represents the standalone performance of the algorithm itself without human intervention (as it reports algorithm sensitivity and specificity). The purpose of the algorithm is to make a "recommendation," which a physician can then agree to or override, implying standalone assessment followed by physician review in practice.

7. Type of Ground Truth Used:

• For the test set ("FDA Troponin" set): Biomarker (Troponin) confirmed MI was used as the "Gold Standard" for diagnosis.

8. Sample Size for the Training Set:

• The Company "created 3 training sets of cases (called Alpha, Beta and Charlie)."
• Specific sample sizes for Alpha, Beta, and Charlie are not provided.

9. How the Ground Truth for the Training Set Was Established:

• The training cases "have been drawn from Acute Coronary Syndrome patients attending a UK hospital."
• The exact method for establishing ground truth for these training sets is not explicitly stated, beyond being from diagnosed ACS patients. However, given the context of the "FDA Troponin" set, it is highly probable that clinical diagnoses, potentially involving biomarkers and other standard clinical assessments, were used to establish the ground truth for training.

Ask a specific question about this device