Search Results

The SE-1202 12-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements is offered to clinicians on an advisory basis only.

CONTRAINDICATIONS:
SEMIP algorithm is not intended for interpretive statements of neonatal patients from birth to 28 days.

The SE-1202 electrocardiograph features a 10.1" LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC.

The provided document is a 510(k) Premarket Notification from Edan Instruments, Inc. for their Electrocardiograph SE-1202. It establishes substantial equivalence to a predicate device (Edan Instruments, Inc, Electrocardiograph: SE-12, SE-12 Express, SE-1200, and SE-1200 Express, K171942).

The document does not contain details about a study addressing specific acceptance criteria for an AI/algorithm's performance as typically required for devices with interpretive or diagnostic AI functionalities. Instead, it focuses on the performance of the electrocardiograph hardware and its ability to meet general electrical safety, EMC, and basic functional standards (e.g., heart rate range, noise, filter specifications).

The device's software includes an algorithm (SEMIP or Glasgow) that generates measurements, data presentations, graphical presentations, and "interpretative statements." However, the document explicitly states that these interpretations are "offered to clinicians on an advisory basis only." Furthermore, it contraindicates the SEMIP algorithm for neonatal patients.

Given that the core of the request is about acceptance criteria and a study that proves the device meets specific acceptance criteria related to its performance, and the document explicitly states "Clinical data: Not applicable," it indicates there wasn't a clinical study designed to test the interpretive algorithm's performance against detailed criteria for accuracy, sensitivity, or specificity in a diagnostic context. The "Performance validation via EDAN proprietary database" is mentioned, but no specifics about this validation, its acceptance criteria, or its results are provided.

Therefore, many of the requested details cannot be extracted from this document, as it describes a device where the interpretive statements are advisory and clinical data showing performance of these interpretive features in a diagnostic capacity was not deemed necessary for this 510(k) clearance.

However, I will extract what is available and clearly state what information is not present.

Here's an analysis of the acceptance criteria and the study as described in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating equivalence to a predicate device through technical specifications and compliance with general medical device standards, rather than defining and meeting specific analytical or clinical performance acceptance criteria for an AI/algorithm's diagnostic accuracy. The "acceptance criteria" here are more about meeting safety, EMC, and basic functional parameters of the ECG device itself, and showing the interpretive algorithm's presence but framing its output as advisory.

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

• Sample Size: Not specified for any performance testing related to the interpretive algorithm. The document mentions "Performance validation via EDAN proprietary database" but does not give details on the size or characteristics of this database.
• Data Provenance: Not specified (e.g., country of origin). The document indicates it's an "EDAN proprietary database," suggesting it's internal.
• Retrospective or Prospective: Not specified.

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

• This information is not provided in the document. Given that the interpretive statements are "advisory" and no clinical data was submitted, detailed ground truth establishment by experts for evaluative purposes is not described.

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

• No. The document explicitly states "Clinical data: Not applicable." Therefore, an MRMC study was not performed or submitted for this 510(k). As a result, no effect size of human readers improving with AI vs. without AI assistance is reported.

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

• The document mentions "Performance validation via EDAN proprietary database" for the algorithm. However, specific details of this "standalone" performance (e.g., metrics like sensitivity, specificity, accuracy for specific arrhythmias or findings) are not provided, nor are the acceptance criteria for these metrics. The focus of the submission is on substantial equivalence of the overall device, not on analytical performance of the interpretive algorithm in isolation for diagnostic claims.

7. The Type of Ground Truth Used

• For the "Performance validation via EDAN proprietary database," the type of ground truth is not specified. Given the nature of ECG interpretation, it would typically involve cardiologist consensus or perhaps correlation with other diagnostic modalities for specific findings, but this document does not describe it.

8. The Sample Size for the Training Set

• This information is not provided. The document notes the use of "SEMIP or Glasgow" algorithms. These tend to be well-established, rule-based or statistical algorithms, rather than deep learning models that would have a distinct "training set" in the modern sense. If newer machine learning components were integrated, their training data size is not disclosed.

9. How the Ground Truth for the Training Set was Established

• This information is not provided. For established algorithms like SEMIP or Glasgow, their development likely involved expert consensus and large ECG databases over time, but the specific method for their training data's ground truth is not detailed here.

Ask a specific question about this device

For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) The use of EASI leads implies that the results may not be of diagnostic quality.

The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.

Acceptance Criteria and Device Performance Study for MIDA™ Algorithm Rev. B.

The Acceptance Criteria and the study proving the device meets these criteria for the MIDA™ Algorithm Rev. B are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be met through a demonstration of "substantial equivalence" to a predicate device, specifically regarding the ability to measure ST-segment shifts using a 5-lead EASI system compared to a system using Frank electrode placement.

The "reported device performance" is framed as the ability of the MIDA™ Algorithm Rev. B to calculate ST-segment shifts when using the EASI lead system, and its comparability to the results obtained from Frank electrode placement.

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

• Sample Size for Test Set: The text states, "Testing involved acquirement of data for patients that was undergoing PTCA." It does not specify the exact number of patients or the size of the test set.
• Data Provenance: The patients were "undergoing PTCA" (Percutaneous Transluminal Coronary Angioplasty), indicating a medical procedure associated with cardiac conditions. The country of origin is not explicitly stated. The study appears to be prospective as it involved "acquirement of data for patients" during a procedure, suggesting real-time data collection or at least data collected specifically for this testing.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The comparison was made between ST-segment shifts calculated by the MIDA algorithm using different lead placements, not against an expert-adjudicated ground truth for the presence of ischemia or ST-elevation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for establishing ground truth. The comparison was directly between the calculated ST-segment shifts from two different electrode placements (Frank vs. EASI) within the MIDA™ Algorithm, not against an external "ground truth" adjudicated by multiple experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on the algorithm's performance in calculating ST-segment shifts with different lead systems, not on its impact on human reader performance or diagnostic accuracy.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The study involved comparing the ST-segment shifts calculated by the MIDA™ Algorithm Rev. B using EASI lead placement against the ST-segment shifts calculated by the same algorithm using Frank electrode placement. The conclusion is based on a "Software Test Report MIDA Algorithm Rev B. ID: P-593-062." This clearly indicates an assessment of the algorithm's output without direct human intervention in the interpretation or diagnostic process for the comparison.

7. Type of Ground Truth Used

The "ground truth" in this context was the ST-segment shifts calculated by the MIDA™ Algorithm using Frank electrode placement. The study aimed to demonstrate that using EASI leads with the MIDA™ Algorithm produced comparable results to the established Frank lead system within the same algorithm. It was not based on pathology, clinical outcomes, or expert consensus regarding the presence of a condition, but rather on the consistency of a measurement between two different input methods for the same algorithm.

8. Sample Size for the Training Set

The document does not provide information regarding a specific training set size. The description focuses on the verification and validation of the device, which typically involves a test set. It is possible that the MIDA™ Algorithm itself was developed using a separate dataset, but details are not provided in this 510(k) summary.

9. How Ground Truth for the Training Set Was Established

Since information on a training set is not provided, the method for establishing its ground truth is also not mentioned.

Ask a specific question about this device