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510(k) Data Aggregation
(89 days)
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
SE-3 Series (including SE-3, SE-300A, SE-300B, and SE-301) 3-channel electrocardiograph gathers ECG signals of 12 leads simultaneously. While all 12 leads are recorded and analyzed, printouts will only have 3 leads on a page, with 4 pages in series to output all 12 leads. It displays the operation menu, ECG parameters as well as electrocardiograms.
This document describes a 510(k) premarket notification for Electrocardiographs Models SE-3, SE-300A, SE-300B, and SE-301 by Edan Instruments, Inc. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative targets in terms of diagnostic accuracy metrics. Instead, the document relies on demonstrating that the proposed devices (SE-3, SE-300A, SE-300B, and SE-301) perform comparably to the predicate devices (SE-3, SE-300A, SE-300B - K091513, and reference devices SE-601C - K131503, SE-12 Series - K160876). The comparison is primarily focused on technical specifications and safety standards.
The closest to "performance" in a diagnostic sense relates to the ECG interpretation features.
| Acceptance Criteria Category | Specific Criteria (Implicitly "comparable to predicate") | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate (acquire ECG from adult and pediatric patients, analyze and diagnose heart disease on an advisory basis). | Same |
| Safety Specifications | Compliance with relevant IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25). | Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007 (for all models). SE-301 specifically mentions compliance to IEC 60601-1:2005/A1:2012 and EN 60601-1:2006/A1:2013, IEC 60601-1-2:2007, EN 60601-1-2:2007/AC:2010, IEC 60601-2-25:2011. |
| Biocompatibility | Compliance with ISO 10993-1 for surface-contacting devices (<24 hours). | Passes Cytotoxicity, Skin Sensitization, Skin Irritation tests. |
| Bench Testing | Pass tests per IEC 60601-2-25:2011. | All results show pass. |
| ECG Interpretation Features | Performance comparable to predicate devices' SEMIP algorithm (V1.6 and V1.7 versions). | V1.7 algorithms for SE-3 series were tested for pediatrics and results were comparable to V1.8. V1.8 in SE-301 is the same as SE-12 Series. Improvements in V1.7 for RVH, MI, T wave abnormal, and ventricular preexcitation measurement accuracy. |
| Software Verification & Validation | Compliance with FDA Guidance for "moderate" level of concern software. | Software verification and validation testing conducted, documentation provided, device considered "moderate" level of concern, demonstrating proper function. |
| Electrical Performance (e.g., HR Accuracy, Noise, CMRR) | Maintain or improve upon predicate specifications. | Many specifications are "Same" as predicate (e.g., HR range, accuracy, noise). Some are "Different" with improved values (e.g., A/D resolution, input circuit current, DC offset voltage, frequency response, CMRR, sampling frequency). |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "ECG interpretation features were also validated by database testing." However, no specific sample size for this test set is provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This detailed information is not provided in the document. It only mentions "ECG interpretation features were also validated by database testing" without elaborating on how the ground truth of that database was established or by whom.
4. Adjudication Method for the Test Set
The adjudication method for establishing ground truth from the test set is not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on demonstrating substantial equivalence based on technical specifications, safety, and a "database testing" for interpretation features, rather than human reader performance with and without AI assistance. Therefore, no effect size of human readers improving with AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The statement "ECG interpretation features were also validated by database testing" strongly suggests a standalone algorithm performance evaluation was conducted, where the algorithm's interpretations were compared against a database. However, details of this standalone study (metrics, specific results beyond "pass," sample size) are not provided.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used for the "database testing" of the ECG interpretation features. It can be inferred that it would be against a known or expert-adjudicated database of ECG recordings, but the specific nature of that ground truth (e.g., expert consensus, comparison to gold standard diagnoses, or other clinical data) is not detailed.
8. The Sample Size for the Training Set
The document does not report the sample size for the training set used to develop or train the SEMIP algorithm versions.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established. It mentions that "the criteria of some diseases are optimized to improve automatic diagnostic accuracy including RVH, MI, T wave abnormal and optimization of some terms and optimize ventricular preexcitation measure method to improve accuracy" for SEMIP V1.7, implying some form of optimization based on clinical data, but the method of ground truth establishment is not detailed.
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