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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.

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.

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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.

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The SE-18 18-lead electrocardiograph is intended 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.

The SE-18 acquires and displays an 18 leads waveforms, which can also be printed by an integrated thermal printer with effective recording width 216mm. Digital filtering techniques similar to those incorporated on the SE-1515 and SE-12 have been used in SE-18: including Anti-baseline drift filter, AC filter (50/60Hz), EMG Filter and Low pass Filter, which can help the user to record a higher quality ECG. The EDAN Instruments "Smart ECG Measurement and interpretation program" (SEMIP) is included in this machine. The SEMIP program is completely integrated and provides the clinician with a detailed analysis of the ECG signal to aid in the interpretation of the ECGs. The recorded ECG can be saved in flash memory or sent to a PC by Ethernet or WIFI. During the examination, there are no substances delivered to and/or extracted from the patient. SE-18's function block diagram is shown as Fig 1. It's made up of an external ECG Sampling Box, SE-18 Main Control Board with RAM, FLASH, Ethernet module, WIFI module and USB module, a thermal printer module, a power supply module, a keyboard, and 15' 1024*768 display module.

The provided text describes the 510(k) submission for the Edan Instruments, Inc. SE-18 Electrocardiograph. It establishes substantial equivalence to predicate devices (EDAN Instrument, Inc. Electrocardiograph, models SE-1515 and SE-12 Series) based on similar design features, performance specifications, and non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds against which device performance is directly measured. Instead, it compares the specifications of the proposed device (SE-18) against the predicate devices (SE-1515 and SE-12 Series) in a series of tables. The acceptance criteria are implicitly met if the proposed device's performance characteristics are "Same" as or demonstrate "minor differences" that "do not raise different questions of safety or effectiveness" compared to the predicate devices.

Below is a summary drawn from the provided comparison tables, focusing on a few key performance parameters. It consolidates information from Tables 1 and 2-2.

The document states that SE-18 has "minor differences" compared to the predicate devices and that these "do not raise different questions of safety or effectiveness." This implies that the observed differences are within acceptable limits or represent improvements that do not negatively impact safety or effectiveness.

2. Sample size used for the test set and the data provenance

The document explicitly states "Clinical data: Not applicable."
For non-clinical data, it mentions Bench Testing was conducted per IEC 60601-2-25: 2011, and "all the results show pass." However, specific sample sizes for this general bench testing are not provided. The data provenance is not mentioned beyond being part of the manufacturer's internal testing. It is retrospective, as it was submitted for a 510(k) premarket notification.

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 study or expert-based ground truth establishment is described for the device's performance other than that the device's interpretation statements are "offered to clinicians on an advisory basis only." For the safety and performance testing, standards like IEC 60601-1 and IEC 60601-2-25 are used, which do not typically involve human expert consensus for ground truth on device specifications like sampling frequency or input impedance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no described clinical study involving assessment by human readers requiring adjudication.

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

Not applicable. The document states "Clinical data: Not applicable" and describes an electrocardiograph, not an AI-assisted diagnostic tool requiring an MRMC study. The "EMIP" program for interpretation is mentioned, but its effectiveness or impact on human readers is not studied or presented here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device includes the "EDAN Instruments 'Smart ECG Measurement and interpretation program' (SEMIP)". While this is an algorithm, the document does not describe a standalone performance study of SEMIP's diagnostic accuracy. It states that "the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting it's not intended for standalone diagnostic use. The focus is on the device's hardware and basic signal acquisition/processing capabilities meeting predicate equivalence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance and safety specified, the ground truth is based on engineering specifications and adherence to international standards (e.g., IEC 60601-1, IEC 60601-2-25). For the SEMIP program, no explicit ground truth methodology for its interpretive statements is provided in this submission summary. Given its "advisory basis only" role, a rigorous ground truth validation for diagnostic accuracy might not have been required for this 510(k).

8. The sample size for the training set

Not applicable. The document does not describe a machine learning model that would require a training set. The SEMIP program is mentioned, but details on its development data or training set are not provided.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is described in the document.

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