(105 days)
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.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance (Not explicitly stated for diagnostic performance) |
|---|---|---|
| Software Testing | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Risk Analysis | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Safety Testing | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Performance Testing | (General, not specific performance metrics; likely refers to electrical, signal integrity, and functionality) | "[Performed]" (Implied by submission) |
| Environmental Testing | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Substantial Equivalence | Device is "substantially equivalent" to predicate devices. | Verified through "Verification and validation testing." |
| Pediatric Use | (Not explicitly stated, but implied by the submission requesting this expanded indication) | Device is suitable for pediatric patients. |
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."
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).