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The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or 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 and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. Device features include as follows: Portable, lightweight design, Easy data input and operation, Alphanumeric keyboard and one-touch operation, Built-in rechargeable battery, AC/DC power supply, Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics, Two-step exercise test with periodic recording, Heart rate variability (HRV) analysis, Internal thermal printer and external printer, Support external archiving: USB flash disk, card reader, Data transmission to PC via Ethernet . WIFI or serial port.

The provided text is a 510(k) summary for the SE-601 Series Electrocardiograph, indicating that the submission is to modify the intended use to include pediatric patients. The document outlines general testing performed but does not provide specific acceptance criteria or a detailed study proving the device meets those criteria based on clinical performance metrics for the diagnostic software.

Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:

1. Table of acceptance criteria and reported device performance:

This information is not present in the provided document. The summary mentions "Software testing," "Performance testing," "Safety testing," and "Environmental testing" were applied, and that "Verification and validation testing was done," leading to the conclusion of substantial equivalence. However, no quantitative acceptance criteria or performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for ECG interpretation) are given.

2. Sample size used for the test set and data provenance:

This information is not present in the provided document. The text does not detail any clinical test set used for evaluating the device's diagnostic software for adults or the newly added pediatric population.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not present in the provided document.

4. Adjudication method for the test set:

This information is not present in the provided document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance:

This information is not present in the provided document. The device offers "Automatic analysis and diagnostic software (SEMIP)," but there's no mention of a comparative effectiveness study involving human readers. The interpretive ECG with measurements and statements is explicitly advisory only and not intended for pediatric patients, suggesting it's not designed to replace human interpretation, especially for diagnosis.

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

While the device has "Automatic analysis and diagnostic software (SEMIP)," the document does not provide details of any standalone performance study (e.g., sensitivity, specificity, accuracy) for this software, either for adults or for its (not yet approved for diagnosis) use in pediatrics. It only states that the interpreted ECG is advisory and only for adult patients.

7. The type of ground truth used:

This information is not present in the provided document. Given the lack of a detailed clinical study, the type of ground truth used to evaluate the diagnostic software's performance (e.g., expert consensus, pathology, outcomes data) is not specified.

8. The sample size for the training set:

This information is not present in the provided document. The document mentions the SEMIP software but does not detail how it was developed or trained.

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

This information is not present in the provided document.

In summary:

The provided 510(k) summary is primarily focused on demonstrating substantial equivalence to predicate devices for the device itself (acquiring ECG signals, physical characteristics, general software functionality like display and saving) and modifying its intended use to include pediatric signal acquisition. It does not present the detailed clinical performance data, acceptance criteria, or study methodologies that would be necessary to answer your specific questions regarding the diagnostic capabilities of the device's interpretive software. The interpretive software is explicitly noted as "advisory basis only" and "only intended to be used on adult patients." This strongly suggests that its diagnostic performance was not the primary focus of this specific 510(k) submission, or at least such detailed data is not included in this summary.

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The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or 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 and interpretive statements is offered to clinicians on an advisory basis only.

SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. Device features include as follows: Portable, lightweight design Easy data input and operation Alphanumeric keyboard and one-touch operation Built-in rechargeable battery, AC/DC power supply Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics Two-step exercise test with periodic recording. Heart rate variability (HRV) analysis Internal thermal printer and external printer. Support external archiving: USB flash disk, card reader. Data transmission to PC via Ethernet or serial port

Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments SE-601 Series Electrocardiograph:

Based on the provided text, the device is an Electrocardiograph (ECG) and the submission is for modifying its indication for use to include the pediatric population. The information does not describe performance characteristics or a specific study proving the device meets particular acceptance criteria, in the way one might expect for an AI-powered diagnostic device. Instead, it focuses on regulatory clearance for an existing ECG device to expand its intended use.

Therefore, many of the requested categories for a study proving device performance are not explicitly present in the provided 510(k) summary. I will extract what is available and note where specific information is missing based on the context of an AI/algorithm-focused study.

Acceptance Criteria and Device Performance Study Analysis:

The provided document is a 510(k) summary for the Edan Instruments SE-601 Series Electrocardiograph, primarily focused on modifying its indication for use to include pediatric patients. It describes the regulatory clearance process rather than a detailed performance study with explicit acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) of an AI algorithm.

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

The document does not provide a table of acceptance criteria related to diagnostic performance or explicit reported performance metrics like sensitivity, specificity, or F1-score. The "Test Summary" section lists general quality assurance measures applied to the development of the device, rather than specific performance outcomes against predefined acceptance criteria for diagnostic output.

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

This information is not provided in the document. The text mentions "Verification and validation testing was done on SE-601 This premarket Series Electrocardiograph" but does not detail the sample size or data provenance for any specific performance study related to its diagnostic capabilities, especially regarding the advisory diagnostic software (SEMIP).

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)

This information is not provided in the document. The document describes an ECG device with "Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics," but it does not detail any expert review process for establishing ground truth if such software's performance was evaluated.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was performed or any reporting of an effect size for human reader improvement with AI assistance. The diagnostic software is described as "advisory basis only," suggesting it's an interpretive aid rather than a primary diagnostic tool.

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

The document mentions "Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics" which implies a standalone algorithmic function. However, no specific standalone performance metrics (e.g., sensitivity, specificity of SEMIP) are reported in this 510(k) summary. The statement that "interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only" reinforces that the algorithm's output is not intended as a definitive diagnosis without human review.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of Findings:

The provided 510(k) summary for the Edan Instruments SE-601 Series Electrocardiograph is a regulatory document focused on obtaining clearance for an expanded indication for use (pediatric patients) for an existing ECG device. It emphasizes the device's substantial equivalence to predicate devices and general quality assurance measures applied during development.

It does not contain the detailed information typically expected for a study evaluating the performance of an AI or algorithmic diagnostic component, such as specific acceptance criteria for diagnostic accuracy, test set sample sizes, data provenance, expert ground truth establishment, or comparative effectiveness studies. The interpretive software (SEMIP) is acknowledged, but its specific performance metrics are not detailed, and its role is explicitly stated as "advisory only."

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The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or 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 and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. Device features include as follows:

• Portable, lightweight design .
• Easy data input and operation .
• Alphanumeric keyboard and one-touch operation .
• Built-in rechargeable battery, AC/DC power supply .
• Automatic analysis and diagnostic software (SEMIP) for . adults
• Heart rate variability (HRV) analysis
• Internal thermal printer and external printer
• Support external archiving: USB flash disk, card reader .
• Data transmission to PC via Ethernet or serial port .

The provided text does not contain detailed information about specific acceptance criteria for the SE-601 Series Electrocardiograph, nor does it describe a detailed study proving the device meets particular performance metrics. The summary focuses on regulatory compliance, outlining the device description, intended use, and substantial equivalence to a predicate device.

However, based on the limited information available and making some inferences about standard regulatory practices for ECG devices, I can construct a response. Please note that many fields will be marked as "Not provided" because the document does not offer that level of detail.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Acceptance Threshold" and specific "Specific Metric" are largely inferred based on typical regulatory requirements for ECG devices seeking 510(k) clearance, as the document only generally states that "Verification and validation testing was done" and that the device is "substantially equivalent."

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

• Sample Size for Test Set: Not provided. The document mentions "Verification and validation testing" but does not specify the number of patients or ECGs used in any performance evaluation.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not provided.

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

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.
  • Inference: For ECG interpretation software, ground truth is typically established by board-certified cardiologists or physicians experienced in ECG reading.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided.
  • Inference: If multiple experts were used, common methods include 2-out-of-3 consensus, 3-out-of-5 consensus, or a lead expert adjudicating disagreements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The submission focuses on substantial equivalence, implying a comparison to a predicate device rather than an evaluation of human reader improvement with AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was described.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Study: Yes, an implicit standalone performance evaluation of the "Automatic analysis and diagnostic software (SEMIP)" was likely performed as part of the "Verification and validation testing" and "Performance test." The document states this software provides "analysis and diagnostic software (SEMIP) for adults" and that the "interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only." This suggests the algorithm's output was evaluated, even if the specific metrics are not detailed.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated.
  • Inference: For ECG interpretation software, ground truth is typically established by:
    • Expert Consensus: Independent review by a panel of cardiologists.
    • Clinical Outcomes/Follow-up: Though less common for individual ECG features, clinical correlation might be used for certain diagnoses.
    • Pathology: Not directly applicable to ECG interpretation.
    • Given the "advisory basis only" statement, it's highly probable that expert consensus was the primary method for establishing ground truth for the interpretive statements.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not provided. The document does not describe the development or training of the SEMIP algorithm, only its existence and intended use.

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

• Ground Truth Establishment for Training Set: Not provided.
  • Inference: Similar to the test set, ground truth for training data would typically be established by expert cardiologists reviewing ECG waveforms and clinical data.

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