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CONTEC™ Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and or trained healtheare professionals.

This product is an electrocardiograph collecting 12-lead ECG signal simultaneously and printing ECG waveform with thermal printing system, which features in, recording and displaying ECG waveform with manual or auto mode, measuring and diagnosing ECG waveform parameters automatically, prompting for "Lead off" and "Lack of paper", optional interface languages(Chinese/ English), case database management.

This product is used to assist doctors to analyze and print the ECG waveform of children and adults, which can be applied to ECG room, ward, hospital, etc.

The ECG machine provides medical department human ECG wave group for pattern and rhythm analysis that applied in clinical diagnosis and research.

Essential Performance:Sync collection and display of 12-lead ECG.Display of HR.Print ECG wave with different format,Filter settings,and Auto-measurement of ECG data.

ECG90A is divided into button system, printing system, power supply system, LCD display system, signal collection system, control system

Button system: to collect the user's key operation input, send the control system to process,

Printing system: print the print data sent by the control system, heat the printer head to record the waveform on the thermal printing paper, and feedback whether the lack of paper;

Power system: provide power supply for each system module;

The proposed device adopts two kinds of power supply modes: build-in lithium battery DC power supply and AC-DC adapter power supply.

AC-DC adapter power supply: after the external power adapter connecting with the proposed device, the AC voltage is reduced to 12V via the AC-DC power adapter. The 12V voltage is used to charge the lithium battery via the charging management chip;meanwhile the 12V voltage is reduced to 8.6V via a voltage converter, which is used to power the following circuit and printer. Then the 8.6V voltage is reduced again to 5.0V voltage via the voltage converter, and the 5.0V voltage pass through power isolation and is used to power the signal collection and processing module; meanwhile the 5V voltage will be reduces to 3.3 Vvoltage, which is used to power the control module. Build-in lithium battery DC power supply: when the proposed device is connected with AC-DC adapter power supply, the build-in lithium battery will be charged automatically. The charged battery will power the whole system as DC power supply when the proposed device is not connected with the external AC-DC adapter power supply

LCD display system: display various of settings of waveform information to the user for viewing :

Signal collection system: collect the waveform data,submit the final data to the control system to process; the signal acquisition and process module adopts floating and optical isolation to reduce the external disturbance to signal. After filtering and amplification, the A/C conversion of acquired ECG signal is completed on MCU (Micro Controller Unit); and then the data is transmitted to control system.

after processing the data will be displayed on the LCD screen and the waveform will be printed on the thermal paper. MCU can identify and response the key operation through connecting line, and MCU can connect and communicate with the SD card and USB through the signal line.

Control system: the MCU is used to control the whole system operation. The device parameters setting, the processing of acquired signal, the printing, screen display and charging are all controlled by this module.

The provided document is a 510(k) summary for the CONTEC™ Electrocardiograph (ECG90A). It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria for AI-related functions. The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or any details related to AI or MRMC studies, as these are not present in the provided text.

The information primarily focuses on establishing substantial equivalence to a predicate device (CONTEC™ Electrocardiograph, ECG300G) based on non-clinical tests and technical specifications.

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CONTECTM Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult 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.

The proposed device, CONTECTM Electrocardiograph, has three models: ECG100G, ECG300G and ECG1200G. The three models all have three design modules, which are power module, signal acquisition and processing module and control module. The proposed devices acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via single channel/ three channel/ twelve channel. The proposed device, model ECG100G, has two recording modes, including automatic mode and manual mode; the other two models, ECG300G and ECG1200G have three recording modes, including automatic mode, manual mode and rhythm mode. The proposed devices are designed to acquire, process, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed on the LCD screen and recorded on the paper through thermal printer. ECG data, waveform and patient information could be stored in the memory of the device;

The provided document K131900 is a 510(k) summary for the CONTECTM Electrocardiograph. It outlines the device's technical specifications and compares it to predicate devices to establish substantial equivalence. However, it does not describe a clinical study with acceptance criteria and reported device performance in the way a traditional clinical efficacy study would.

Instead, this document focuses on non-clinical tests to verify that the proposed device meets design specifications and complies with relevant international and national standards. The acceptance criteria are implicit in these standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with corresponding "reported device performance" in terms of clinical outcomes or diagnostic accuracy. Instead, the document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The "reported device performance" is the statement that it complies with the listed standards and its technical specifications match or are similar to the predicate devices.

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

The document does not describe a clinical "test set" in the context of diagnostic accuracy. The tests performed are non-clinical, related to electrical safety, electromagnetic compatibility, and performance according to engineering standards. There is no mention of patient data or its provenance (country of origin, retrospective/prospective).

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

Not applicable. No clinical test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication is described.

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. This device is an electrocardiograph, which acquires and displays ECG signals. It does not appear to incorporate AI for interpretation or assistance with human readers. The document does not mention any "Measurement/Analysis Function" for the proposed device, as shown in the comparison table where it explicitly states "No" for this function, contrasting with one of the predicate devices that has "Yes".

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

Not applicable. The device itself is an acquisition device, not an algorithm for interpretation. It explicitly states "No" for "Measurement/Analysis Function."

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

Not applicable. As described, the "ground truth" for this submission are the engineering and medical device standards (e.g., IEC 60601 series, ANSI/AAMI EC11) which define acceptable electrical and physical performance, rather than diagnostic accuracy against a clinical gold standard.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device with an interpretation algorithm.

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

Not applicable. As above, no training set or its ground truth establishment is mentioned.

Summary of the Study:

The "study" described in K131900 is a series of non-clinical bench tests designed to demonstrate that the CONTECTM Electrocardiograph adheres to established electrical safety, electromagnetic compatibility (EMC), and specific performance standards for electrocardiographs. The "acceptance criteria" are the requirements set forth in these international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ANSI/AAMI EC11) and the technical specifications listed in the comparison table, which are either identical or similar to legally marketed predicate devices. The "proof" is the statement that "The test results demonstrated that the proposed device complies with the following standards" and the detailed comparison table that shows its technical specifications meet or are equivalent to the predicate devices. This type of submission is common for medical devices that aim to show substantial equivalence based on technical and performance characteristics, without requiring new clinical efficacy data if the intended use and technology are sufficiently similar to approved predicate devices.

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