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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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The CardioBeeper® CB-12L is intended to condition an electrocardiograph signal so that it can be transmitted via a telephone line to a remote location. The CB-12L is designed to be used by a patient to transmit a rhythm strip or a 12 lead ECG signal in real time to a physician's office, hospital or other medical receiving center. Note that due to the discrete options for selecting the precordial electrode positions, the CB-12L transmission may only approximate a standard 12 lead ECG for some patients.

The CardioBeeper® CB-12L is a compact, hand-held, battery-powered, single channel transtelephonic ECG transmitter that is capable of transmitting a 24 second rhythm strip or a 45 second 12 lead ECG. The CB-12L consists of a transmitter/ electronics module (TEM), two limb electrodes (RA and LL) attached to the TEM via separate cables, and a chest belt containing the third limb electrode (LA) and thirteen silver silver-chloride electrodes. Prior to a patient using the CB-12L, the patient's physician must select the six most appropriate chest belt electrodes to function as the precordial V1-V6 electrodes according to the patient's chest size.

The provided text describes a 510(k) submission for the CardioBeeper® CB-12L, a telephone electrocardiograph transmitter. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense for the device's diagnostic capabilities. Instead, it frames the study as comparing the "diagnostic quality" of ECGs. The performance is reported in qualitative terms of "comparability."

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

• Sample Size: 97 patients
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it was a "clinical study," it implies a prospective data collection, but this is not explicitly confirmed.

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, their qualifications, or how they established the ground truth for the test set. It only mentions the comparison of diagnostic quality.

4. Adjudication Method for the Test Set:

The document does not provide any information about the adjudication method used for the 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:

This is not applicable. The CardioBeeper® CB-12L is a device for transmitting ECG signals, not an AI or diagnostic interpretation tool. The study focuses on the quality of the transmitted signal and the patient's ability to use the device, not on improving human reader performance with AI assistance.

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

This is not applicable in the context of an "algorithm only" performance because the device's primary function is signal transmission, not autonomous diagnostic interpretation. The study evaluates the device's functionality and the patient's ability to use it.

7. The Type of Ground Truth Used:

The "ground truth" for the diagnostic quality comparison was established by using "a standard 12 lead ECG system." The study compared the diagnostic content of the CB-12L's ECGs against these standard ECGs. The document doesn't specify if this "standard" was interpreted by expert consensus, or if there was subsequent pathology or outcomes data.

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of an algorithm or AI model development. The 97 patients appear to be the subjects of the clinical study, which evaluates the device's performance directly.

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

This is not applicable as there is no mention of a training set for an algorithm.

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