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The ECG3 is intended for use in a community hospital or at home and it is a dynamic electrocardiogram measurement system. It is designed to measure and record ECG data of an adult individual in the long term by using a technique in which an electrode was pasted on the chest.

The ECG3 Portable ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.

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This FDA letter acknowledges the clearance of the Portable ECG Monitor (model ECG3) but does not contain information about acceptance criteria or the study that proves the device meets those criteria. The provided text is a 510(k) clearance letter, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not include the detailed performance study results that would typically be found in the 510(k) submission itself.

Therefore, I cannot provide the requested information based on the given input. The document does not describe:

• Acceptance criteria and reported device performance in a table.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone performance study results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

To obtain this information, you would need to access the full 510(k) submission for K172862, which is typically a much more extensive document than the clearance letter.

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The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.

The product is not a conventional diagnostic tool.

The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.

The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, ORS interval and VEB measurement, print, etc.

The provided document is a 510(k) premarket notification for a Portable ECG Monitor (Model PM10) by Contec Medical Systems Co., Ltd. It declares substantial equivalence to a predicate device (Handheld ECG Monitor Model MD100, K093872).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically used in clinical studies for diagnostic accuracy. Instead, it relies on demonstrating compliance with non-clinical performance and safety standards, and technological characteristics similar to a predicate device.

However, we can extract the reported performance for specific parameters:

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

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no information regarding sample size for a test set, nor data provenance (country of origin, retrospective/prospective). The assessment of the device's performance for regulatory purposes is primarily based on non-clinical testing and comparison to a predicate device.

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

Since no clinical study was conducted, there is no information on the number of experts or their qualifications for establishing ground truth from a test set.

4. Adjudication Method for the Test Set

As there was no clinical study, there is no adjudication method described for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader, multi-case comparative effectiveness study was not done. The document states "No clinical study is included in this submission." Consequently, there is no information on the effect size of human readers improving with AI vs. without AI assistance, as the device is an ECG monitor and not an AI-assisted diagnostic tool described in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study of an algorithm's performance without human-in-the-loop was not done, as no clinical study was conducted. The device (Portable ECG Monitor) is described as recording and displaying ECG signals and heart rate, not as employing a complex algorithm that would typically undergo such standalone performance evaluation in a regulatory submission of this nature.

7. Type of Ground Truth Used

As there was no clinical study, no ground truth from expert consensus, pathology, or outcomes data was established or used for the purpose of demonstrating clinical performance. The "ground truth" implicitly referred to here is the accurate measurement of electrical signals and heart rate as per the device's physical and technical specifications, validated through engineering bench testing and compliance with relevant IEC and ISO standards.

8. Sample Size for the Training Set

Since no clinical study was performed and no AI/machine learning algorithm requiring a training set is explicitly described or implied beyond standard signal processing for ECG and heart rate, there is no information regarding a training set sample size.

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

Given that no training set is mentioned or implied for an AI/ML algorithm within the provided document, there is no information on how ground truth for a training set was established.

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The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.

The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.

The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, measurement etc.

The provided text is a 510(k) Summary for the Contec Medical Systems Co., Ltd Portable ECG Monitor, model PM10. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a novel device. As such, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format as it would for a performance study. Instead, it compares the proposed device's specifications to those of a predicate device to establish substantial equivalence. The "acceptance" in this context is that the device's measured performance aligns with or is sufficiently similar to the predicate's, and meets relevant voluntary consensus standards.

Here's a table based on the "Substantially Equivalent (SE) Comparison" in the document (Table 1):

Explanation of "Acceptance Criteria" for this submission: For a 510(k), the "acceptance criteria" largely involve demonstrating that the device meets recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 60601-2-47, IEC 60601-1-11, ISO 10993-5, ISO 10993-10) and has performance characteristics that are "substantially equivalent" to a legally marketed predicate device. The document explicitly states "The test results demonstrated that the proposed device complies with the following standards" for non-clinical tests.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set, nor any information on data provenance (country, retrospective/prospective). The assessment relies on non-clinical engineering and bench testing, and comparison to a predicate device.

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)

Not applicable, as no clinical study or test set with human data requiring expert ground truth was conducted or submitted (see point 2).

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

Not applicable, as no clinical study or test set was conducted that would require 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. This device is a "Portable ECG Monitor" for recording and displaying heart rate, not an AI-driven diagnostic tool that assists human readers. No MRMC study was conducted.

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

The device's core functions (recording ECG signals and displaying heart rate) are standalone in nature, as it processes the ECG signal and derives heart rate without human intervention in that specific computation. However, this is not an "algorithm-only" performance study in the sense of a complex AI diagnostic algorithm. The non-clinical tests verifying its compliance with standards and its stated heart rate accuracy (±1bpm or 1%) serve as the standalone performance verification.

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

For the non-clinical tests:

• Electrical safety and EMC: Ground truth is defined by the technical requirements and test procedures outlined in the specified IEC standards (IEC 60601-1, IEC 60601-1-2). Compliance with these standards is the "ground truth."
• Biocompatibility: Ground truth is established by the test procedures and acceptance criteria within ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization).
• Heart rate accuracy: The accuracy of ±1bpm or 1% would be verified against a known, precise input signal (e.g., using an ECG simulator or a reference standard). The known input signal acts as the "ground truth."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device, not a machine learning or AI device that requires a "training set."

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

Not applicable, as there is no training set for this device.

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