Search Results

The Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card.

The Cardy302Max Compact Digital Holter Recorder System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.

The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data.

The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.

Device Description

The Cardy302Max Compact Digital Holter System is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for up to 48 hours. The device stores the acquired ECG data on its removable memory card.

The Cardy Controller02 downloads patient demographic information into the Cardy302Max Compact Digital Holter Recorder and allows the user to check the signal quality of the ECG data at hookup time. At the end of recording, the ECG data can be transferred to the controller by removing the SD memory card from the recorder and installing it into the Cardy Controller02.

AI/ML Overview

The provided document describes the acceptance criteria and study for the Kenz® Cardy302Max Digital Holter System.

This device is a digital ambulatory Holter recorder that acquires ECG signals but does not perform any analysis of the ECG data. Therefore, the acceptance criteria and studies focus on the hardware's safety, performance, and compliance with relevant standards, rather than the diagnostic accuracy of an AI algorithm.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety	Complies with IEC 60601-1 (General requirements for safety).
Electromagnetic Compatibility	Complies with IEC 60601-1-2.
Particular Requirements for Safety (including Essential Performance)	Complies with IEC 60601-2-47 (Ambulatory electrocardiographic systems for medical electrical equipment).
Water Ingress Protection	Successfully conducted independent water ingress testing in accordance with IEC 60529:2001 for IPX5, X8H.
Software Functionality	Software verification and validation testing demonstrated that all modes and functions operated as designed and in accordance with the indications for use.

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

Not applicable for an AI algorithm test set. The testing described focuses on hardware and software functional verification against engineering standards. The document does not specify a "test set" in the context of clinical data for AI performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The device does not perform analysis, so clinical ground truth (e.g., diagnosis by experts) is not relevant for its mechanical and electrical performance verification.

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

Not applicable, as there's no clinical "test set" 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

No. This device is not an AI analysis system. It is a data acquisition device, and therefore, an MRMC study comparing human readers with AI assistance is not relevant or described.

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

No. This device is a hardware system for recording ECG data. It does not contain an "algorithm" for independent diagnostic performance without human-in-the-loop intervention. The software verification confirmed the device's operational functionality, not diagnostic accuracy.

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

The "ground truth" for this device's performance is based on regulatory and engineering standards compliance. This includes:

Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-47 for safety and essential performance.
Compliance with IEC 60529:2001 for water ingress protection.
Software verification and validation outputs demonstrating that the software operates "as designed" and "in accordance with the indications for use."

8. The sample size for the training set

Not applicable. This device is a data acquisition hardware system and does not employ machine learning or AI algorithms requiring a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Ask a Question

Ask a specific question about this device

K Number

K092389

Device Name

DISPOSAL ECG ELECTRODES, MODEL EASYRODE

Manufacturer

SUZUKEN CO., LTD.

Date Cleared

2009-10-13

(69 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K970796

Predicate For

N/A

Intended Use

The Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.

Device Description

Easyrode is a self-adhesive, non-sterile, single use disposable electorode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a pressure sentive adhesive non-woven tape which hold the conductive elements of the electrodes in place on the patient's skin for short or long term ECG procedures.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with statistical results proving the device meets said criteria for the "Easyrode Disposal ECG Electrodes, Model Easyrode." The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with performance metrics.

However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study":

The "acceptance criteria" in this context are primarily informal, focusing on demonstrating that the Easyrode performs "as well as" the predicate device in fundamental ECG monitoring functionalities and meets general safety and effectiveness standards for such devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Safe and effective for ECG monitoring.	The conclusion states: "The results of these measurements demonstrated that the Easyrode is as safe, as effective, and performs as well as the predicate device." This is a qualitative statement of equivalence. No specific quantitative performance metrics (e.g., impedance, signal-to-noise ratio, artifact levels) are provided in the summary. The comparison focuses on similar intended use and general technological characteristics.
Suitable for short-term and long-term (up to 2 days) monitoring.	Easyrode: Intended for use in ECG Monitoring, for short-term and long-term (2 Days) monitoring. This matches the intended use of the predicate devices. Predicate device (3M Red Dot 2560): Used for short time and long time (2 day). The document explicitly states "Easyrode is used for 2day and below," confirming alignment with the predicate's duration of use.
Functional equivalence to predicate device in ECG applications.	The device description and intended use state: "The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used." Under "Technological Characteristics," it indicates both Easyrode and the predicate are "Used for short time and long time (up to 2day)." The primary difference noted is the material (Non-woven tape for Easyrode vs. Foam tape for predicate), with the claim that "Non-woven is allow air pass through easily than foam. That means non-woven is more adhesive to patient skin." This implies performance is at least equivalent, potentially better in adhesion for the Easyrode, without compromising ECG signal quality or patient safety. The approval letter confirms "substantially equivalent."
Meets general requirements for disposable ECG electrodes.	This is implicitly met through the 510(k) clearance process, which reviews if the device adheres to general controls, including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Study Information (Based on Available Text):

The document does not describe a clinical trial or a specific standalone study with statistical results to prove performance against pre-defined acceptance criteria in the way one might expect for a novel device. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "study" mentioned abstractly ("The results of these measurements demonstrated...") refers to comparative testing and analysis against the predicate device to support this equivalence. No details of these "measurements" are provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "The results of these measurements," implying some form of testing was done, but no specifics on the number of electrodes tested, number of subjects, or duration of testing are provided.
Data Provenance: Not specified. The manufacturer is based in Japan (SUZUKEN CO, LTD.). The context implies tests were likely conducted by the manufacturer or on their behalf, but the location and whether it was retrospective or prospective data are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. Given the nature of a 510(k) for an ECG electrode, ground truth likely pertains to technical performance measurements (e.g., impedance, adhesion, signal quality) rather than expert clinical interpretation of ECGs produced by the electrodes. If human evaluation was part of the "measurements," no details are included.

4. Adjudication Method for the Test Set

Not applicable/Not specified. There is no mention of a human adjudication process for establishing ground truth, as the 'measurements' likely pertain to technical specifications rather than diagnostic output requiring clinical consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically associated with diagnostic imaging or interpretation where multiple readers evaluate medical cases. This type of study is not relevant or described for a disposable ECG electrode, which is a physical component, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/No. This device is a passive, disposable ECG electrode. It does not involve an algorithm or AI. Performance is inherently "standalone" in the sense that it's the electrode's physical properties being measured, but not an algorithm's.

7. The Type of Ground Truth Used

Inferred Technical Performance Data/Comparison to Predicate: The "ground truth" (or basis for comparison) was the performance characteristics of the legally marketed predicate device (3M Red Dot 2560 Monitoring Electrode). "Measurements" were conducted to demonstrate that the Easyrode performs "as safe, as effective, and performs as well as" the predicate. This would typically involve measuring electrical characteristics (e.g., impedance, DC offset, AC impedance, defibrillation recovery), adhesion properties, and biocompatibility, all compared against established standards or the predicate's known performance. No specific details on which data types were collected are in the summary.

8. The Sample Size for the Training Set