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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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