(148 days)
Digital Electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs, iE 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The provided text is a 510(k) summary for Digital Electrocardiographs (models iE 3, iE 6) and a letter from the FDA determining their substantial equivalence to a predicate device (iE 12). This document does not contain information about specific acceptance criteria, device performance metrics, or details of a study demonstrating the device meets such criteria.
The core of this document is a comparison between the proposed devices and a predicate device to establish "substantial equivalence," meaning that the new devices are as safe and effective as a legally marketed device. This is a regulatory pathway, not a clinical study demonstrating performance against specific benchmarks.
Therefore, many of the requested details cannot be extracted from this document.
Here's what can be inferred or directly stated from the provided text, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy for disease detection). The acceptance criteria, in the context of this 510(k), are primarily related to meeting design specifications and demonstrating substantial equivalence to the predicate device, especially regarding safety and intended use.
- Reported Device Performance: No specific numerical performance metrics are reported in this document. The document states a "Non-Clinical Test Conclusion" that "Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1, IEC 60601-1-2." This refers to electrical safety and electromagnetic compatibility standards, not clinical performance for diagnosing heart disease.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not mentioned, as a clinical study with ground truth established by experts is not detailed here.
4. Adjudication Method
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- If done: No, an MRMC comparative effectiveness study is not described or referenced in this document. This submission focuses on establishing substantial equivalence to a predicate device based on technical characteristics and intended use, not on demonstrating improved human reader performance with AI assistance.
- Effect size of human readers improvement: Not applicable, as no such study is presented.
6. Standalone (Algorithm Only) Performance Study
- If done: No, a standalone performance study of an algorithm is not described or referenced. The device is a "Digital Electrocardiograph" which acquires, displays, and records ECG signals for users (doctors/trained professionals) to analyze and diagnose. While it "can help users to analyze and diagnose heart disease," the document does not detail an inherent diagnostic algorithm's performance.
7. Type of Ground Truth Used
- Not mentioned, as no clinical study requiring a ground truth is detailed.
8. Sample Size for the Training Set
- Not mentioned, as this document does not describe the development or training of an AI algorithm.
9. How Ground Truth for the Training Set Was Established
- Not mentioned, as this document does not describe the development or training of an AI algorithm.
Summary of what the document does provide:
- Device Models: iE 3, iE 6
- Intended Use: To acquire ECG signals from adult and pediatric patients through body surface ECG electrodes, with obtained records helping users to analyze and diagnose heart disease. To be used in healthcare facilities by doctors and/or trained healthcare professionals.
- Predicate Device: Digital Electrocardiographs, iE 12 (K122712)
- Regulatory Basis for Acceptance: Substantial Equivalence (SE) to the predicate device, demonstrated through non-clinical tests verifying compliance with design specifications and international safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
- Key Comparison Points for SE: Intended use, technological characteristics, principles of operation, patient contact material, sterile/single use status, energy source, safety standards, and accessories are deemed equivalent to the predicate device.
§ 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).