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The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.

The product is not a conventional diagnostic tool.

This product is single channel, standard 12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in family ,hospital consultation, doctor's diagnosis, physical check-up, social medical organizations etc. it can implement real time continuous records of clear and exact single-channel ECG waveform using thermo sensitive printer at the same time. waveforms also can be freezed at any time. it has manual and automatic modes to be chosen and Chinese/English operation interface, it is easy to be used.

The provided text is a 510(k) summary for the Contec Medical Systems Co., Ltd. ECG80A Single-Channel Handheld Electrocardiograph. This document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and technical specifications. Unfortunately, it does not contain the detailed information necessary to answer the questions about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert involvement as requested.

The document states: "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications." However, it does not provide the details of these design specifications as acceptance criteria or the performance results against them.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, expert involvement, and ground truth in detail based solely on the provided text.

The information that can be extracted and inferred is limited:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "met all design specifications, including electrical safety, EMC, specifications."
• Reported Device Performance: Not explicitly stated in terms of specific metrics against criteria. The conclusion is that the device "is substantially equivalent (SE) to the predicate device Cardiette microtel (K082124) and CARDIOLINE AR1200 (K051534)."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not mentioned.
• Qualifications of experts: Not mentioned.
• Role of Experts: Not mentioned.

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

• Not mentioned.

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 is mentioned. This device is an electrocardiograph, not an AI-assisted diagnostic tool as described. It "records and displays ECG waveform." It does not appear to involve AI assistance for interpretation.

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

• Not applicable as this is a device for recording and displaying ECG waveforms, not an algorithm for interpretation. The text states it "provides to the treating physician with relevant data on the cardiac rhythm" but does not indicate automated diagnostic interpretation. Furthermore, it explicitly states "The product is not a conventional diagnostic tool."

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

• Not mentioned.

8. The sample size for the training set

• Not applicable/mentioned, as no algorithm training is indicated for this device.

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

• Not applicable/mentioned, as no algorithm training is indicated for this device.

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The Cor12+ Holter Recorder is intended to acquire, record and store ECG data of patients that have been connected to the Cor12+ recorder and are undergoing Holter monitoring. The Cor12+ acquires, digitizes and stores data to be analyzed on a computer with special software.

The Cor12+ is indicated for use:

in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours.

The Cor12+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.

The digital Holter ECG recorder Cor12+ is a portable battery operated ECG amplifier with build in data storage on memory card (Mini SD size):

• Single dual color (green/yellow) LED .
• Button control (one Button) to activate communication interface, event . recording
• Two standard size AA batteries .
• Speaker for voice output for alarm messages .
• PC program to set-up recorder via blue-tooth communication interface 0

Here's a breakdown of the acceptance criteria and study information for the Cor12+ Holter Recorder based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, the device's performance is established through substantial equivalence to predicate devices, particularly the H12+ Holter Recorder. The "acceptance criteria" here are implied by meeting or exceeding the performance characteristics of the predicate device, or by demonstrating that differences do not raise new questions of safety or effectiveness.

Therefore, the table below highlights key performance characteristics compared to the primary predicate device, the H12+. Where performance is improved, it is noted.

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

The provided document does not describe a clinical study with a "test set" in the traditional sense for evaluating device performance against pre-defined clinical endpoints or ground truth.

Instead, the submission relies on:

• Bench testing: "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards."
• Compliance with standards: "The EMC testing was performed according EN 60601-1-2 and EN 60601-2-47. Electrical Safety testing was performed according IEC 60601-1 and IEC 60601-2-47."
• Substantial equivalence arguments: Comparing technical specifications to predicate devices.

Therefore, there is no specific sample size for a clinical "test set" or information about data provenance (e.g., country of origin, retrospective/prospective) for a study directly proving the device meets performance claims through patient data. The evaluation methodology is primarily non-clinical.

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

Since there was no clinical "test set" with ground truth established on patient data, this information is not applicable and not provided in the document. The evaluation focuses on engineering, safety, and performance characteristic comparison.

4. Adjudication Method for the Test Set

As no clinical "test set" requiring ground truth and expert adjudication was conducted, this information is not applicable and not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses the impact of an AI algorithm on human reader performance, which doesn't apply here as the Cor12+ is a data acquisition device, not an analytical AI system.

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

The Cor12+ is described as a "Holter Recorder" that "performs no cardiac analysis by itself; it solely records the ECG signals." Therefore, there is no standalone algorithm performance to evaluate. Its function is data acquisition, digitization, and storage, not diagnostic analysis.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on demonstrating compliance with recognized electrical safety and EMC standards and showing technical equivalence or improvement over predicate devices in terms of physical and performance specifications for ECG signal recording, rather than clinical outcomes or expert consensus on diagnostic accuracy.

8. The Sample Size for the Training Set

Since the device does not employ machine learning or AI algorithms requiring a training set for analysis, this information is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm, this information is not applicable and not provided.

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