(359 days)
The ECG Acquisition Systems is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to vhECG Pro, which installed in iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12-lead ECGs.
The ECG Acquisition Systems is for use on adult and pediatic populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor.
The subject device is intended to be used for clinical use rather than home use. It can be used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.
The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.
The ECG Acquisition Systems is a hand-held, battery powered, 12-lead resting electrocardiograph system with vhECG Pro software. The ECG Acquisition Systems consists of ECG Acquisition Recorder, Patient Cable and vhECG Pro software. ECG data is transferred via Bluetooth® 4.0 Technology and displayed on mobile screen in real-time before, during and after acquisition. With vhECG Pro, resting ECGs can be recorded, viewed and printed in various formats. Besides, ECGs can also be uploaded to vhCloud ( cloud platform) by vhECG Pro, they can be reviewed by other medical staff authorized via its iPhone or iPad in which vhCloud is installed. The device is intended to provide reference for medical diagnosis, not intended for a replacement of diagnosis of clinicians.
The provided text is a 510(k) Summary for the "ECG Acquisition Systems" device. It describes the device, its intended use, comparison to a predicate device, and results of nonclinical tests. However, it explicitly states that clinical data is not applicable for this submission and does not contain any information about a study proving the device meets specific acceptance criteria based on clinical performance metrics (like sensitivity, specificity, or reader improvement with AI).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical performance study is described in the provided document. The document focuses on demonstrating substantial equivalence through nonclinical testing (electrical safety, EMC, QoS, wireless coexistence, ECG performance, patient cable performance, and software verification/validation) and comparison of technological characteristics to a predicate device, not on diagnostic accuracy or efficacy studies involving human readers or AI.
The response below reflects what could be extracted if such a study were present, but indicates the absence of this information in the provided text.
This document outlines the substantial equivalence of the "ECG Acquisition Systems" to a predicate device for FDA 510(k) clearance. It specifies the device's technical characteristics and nonclinical test results. However, it explicitly states that "Clinical data is not applicable for this submission." Therefore, the provided text does not contain information about acceptance criteria for clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI) or a study that proves the device meets such criteria through clinical evaluation.
The document primarily relies on nonclinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study.
Here's what can be gathered, alongside the confirmation that the requested clinical performance study details are absent:
1. Table of Acceptance Criteria and Reported Device Performance:
As no clinical performance study is described, there are no acceptance criteria for metrics like sensitivity, specificity, or other diagnostic performance indicators. The "acceptance criteria" discussed in this document pertain to adherence to technical standards and nonclinical test results.
| Category | Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| Electric Safety | IEC 60601-1: 2012 | Pass |
| EMC | IEC 60601-1-2: 2007; 47 CFR PART 15 Subpart C; ESTI EN (various) | Pass |
| QoS Testing | Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology in Medical Devices | Pass |
| Wireless Coexistence | 47 CFR PART 15 Subpart C; EN 300328 V1.8.1 | Pass |
| ECG Performance | IEC 60601-2-25 | Pass |
| Patient Cable Performance | AAMI ANSI EC53 | Pass |
| Software V&V Testing | Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Pass |
2. Sample size used for the test set and the data provenance:
No clinical test set data is described. The nonclinical tests refer to compliance with technical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical performance test set or ground truth establishment by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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:
No MRMC study was done, as the device provides "uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis" and does not involve AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device primarily acquires and displays raw ECG data, and does not provide automated interpretation (explicitly states: "The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical performance study requiring ground truth is described.
8. The sample size for the training set:
Not applicable, as the document does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).