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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.

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The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.

The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest. The electrodes are screen-printed onto a clear plastic substrate. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.

The PRIME software also contains a diagnostic algorithm that may be used as an aid in diagnosing AMI. The algorithm provides an explanation of the measurements that were interpreted to reach the suggested diagnosis.

Acceptance Criteria and Study Details for PRIME ECG System with Diagnostic Algorithm

The provided 510(k) summary for the PRIME ECG System with Diagnostic Algorithm (K030104) offers limited details on specific acceptance criteria and the comprehensive study that proves the device meets them. However, it does state that a clinical study was performed to demonstrate the algorithm's utility in diagnosing AMI. Based on the available information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not specify quantitative metrics for the "assistance in diagnosis of AMI" nor does it provide a specific performance target or range for this criterion. It merely states that the study "demonstrated" this capability.

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

The 510(k) summary does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the clinical study validating the diagnostic algorithm.

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

The 510(k) summary does not provide details on the number of experts used to establish ground truth or their qualifications for the clinical study.

4. Adjudication Method for the Test Set

The 510(k) summary does not provide details on the adjudication method used for the test set in the clinical study.

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

The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The study described appears to focus solely on the algorithm's ability to "provide information that may assist in the diagnosis of AMI," rather than a comparative study with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study appears to have been conducted. The description "a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction" suggests that the algorithm's performance in providing diagnostic information was evaluated. There is no mention of human-in-the-loop performance in the context of this specific clinical study for the diagnostic algorithm.

7. Type of Ground Truth Used

The 510(k) summary does not explicitly state the type of ground truth used for the clinical study demonstrating the diagnostic algorithm's utility for AMI. Given the nature of AMI diagnosis, it is highly probable that a combination of clinical assessment (symptoms, physical exam), biomarkers (cardiac enzymes), follow-up outcomes, and potentially expert consensus on other diagnostic tests (e.g., echocardiography, coronary angiography) would have been used to establish the ground truth for AMI. However, this is an inference and not explicitly stated in the document.

8. Sample Size for the Training Set

The 510(k) summary does not provide details on the sample size for the training set used for the diagnostic algorithm.

9. How Ground Truth for the Training Set Was Established

The 510(k) summary does not provide details on how the ground truth for the training set was established for the diagnostic algorithm.

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The PRIME ECG is indicated for the recording of electrocardiographic signals on the body surface.

The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest or harness. The electrodes are screen-printed onto a clear plastic substrate. The section of the vest applied to the anterior side of the patient (anterior harness, applied to chest area) contains channels 1 to 55 and 59 to 64. The section applied to the posterior side of the patient (posterior harness, applied to the patient's back) contains channels 65 to 80. Channels 56, 57 and 58 are applied to the right arm, left arm and left leg, respectively. Signals are conducted along pathways that are also printed, eliminating the need for conventional lead wires. The electrode array or " vest" features pre-applied gel to assure good conductivity and secure attachment. Anatomical markers provide for consistent location on different size patients. The vest can be applied in less than 5 minutes. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored. The system measures the ECG recordings simultaneously for all 80 channels. For practical reasons only eight channels are displayed at one time, so the operator may scroll through 10 screens to visualize all active channels. The system contains an algorithm that identifies (with color, words and symbols) any individual electrode that may be suspect, allowing the operator to make adjustments before recording. Once satisfied, the operator activates the recording and the system retains 10.0 seconds of data. If the recording contains any poor signals, the algorithm alerts the operator who must determine whether to accept the recording. The number of poor quality leads may not exceed 6 on the anterior harness. If the signals from any 2 adjacent electrodes, or any posterior electrode, are bad, the maps are not accepted. It is possible for the operator to accept a recording which contains channels that have low quality, but resulting maps contain the legend "Unacceptable Quality" and each poor quality channel is marked in red. Because the electrode vest covers most of the torso, electrode locations include those for a standard 12-lead ECG. This means that among the 80 leads individual locations are consistent with required placement necessary to result in a conventional 12-lead recording and display. There is a user-selected option for displaying these leads, (e.g., the channels are automatically selected and displayed which correspond to a Lead II ECG), although the operator may designate specific electrodes to reflect preferred locations for display. Once the 80-lead recording is accepted, the system creates a series of isopotential and isointegral images (maps) for specific segments of a single beat. Measuring signal strength at a specific time interval of the beat creates Isopotential maps. The resulting strengths and locations of these signals are plotted against an "unwrapped" image of the torso. For example, the unwrapped torso image can be oriented with an x and y axis. At a given point in time, an voltage measurement in millivolts is collected at each location (x,y). This voltage can be plotted along the z axis. If lines are drawn on this plot to connect points with the same voltage z, isopotential contour maps are created. Isopotential maps can be created at any point in time during the cardiac cycle to reflect the cyclic polarization and repolarization of the heart. Isointegral maps are an attempt to provide a look at what is happening over the cycle, as a body surface distribution of the ventricular gradient. At each location (x,y) the potential z changes over the time of the cardiac cycle. Integrating the areas under the QRST of each lead gives the gradient at each point. The gradient at each point is then mapped. Joining points on the plot with the same calculated gradient produces the isointegral contour map. The isointegral map allows evaluation of repolarization properties.

This document describes the PRIME ECG™ System, an 80-lead electrocardiograph, and its FDA 510(k) submission. However, the provided text does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the document states: "a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems." However, it does not provide the results, metrics, acceptance criteria, study design details (like sample size, ground truth, expert qualifications), or specific effect sizes from this clinical study.

Therefore, the following response will reflect the information that is present in the provided text.

Acceptance Criteria and Study for PRIME ECG™ System

Based on the provided 510(k) summary, the PRIME ECG™ System's acceptance criteria primarily revolve around its equivalence to a predicate device and its compliance with relevant industry standards. While a clinical study is mentioned for improved AMI diagnosis, the details of its acceptance criteria and results are not included.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: The document mentions that "a clinical study was performed," but it does not specify the sample size for this study or any test set.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective).

3. Number of Experts and Qualifications for Ground Truth for the Test Set

• The document does not specify the number of experts used or their qualifications for establishing ground truth in the "clinical study."

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the clinical study.

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

• The document mentions "a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems."
• However, it does not provide details on whether this was an MRMC study, nor does it specify an "effect size of how much human readers improve with AI vs. without AI assistance." The PRIME ECG is described as an ECG system itself, not necessarily an AI-assisted interpretation tool in the context of human reader improvement. It provides more data (80-leads) to aid diagnosis.

6. Standalone Performance Study (Algorithm Only)

• The document does not explicitly state if a standalone (algorithm only without human-in-the-loop performance) study was done for the "improved diagnosis of AMI" claim. The nature of an ECG system typically involves a clinician interpreting the output.

7. Type of Ground Truth Used

• The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the "clinical study" related to AMI diagnosis.

8. Sample Size for the Training Set

• The document does not mention any training set or its sample size. This suggests the primary demonstration of equivalence was based on predicate device comparison and standard compliance, with the clinical study serving as supportive evidence for improved diagnostic capabilities, rather than a deep learning model requiring a distinct training and test set in the modern sense.

9. How Ground Truth for the Training Set Was Established

• As no training set is mentioned (see point 8), the method for establishing its ground truth is not applicable based on the provided text.

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