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Digital Electrocardiographs, iE 12A / iE 15S, are intended to acquire ECG signals from adult and pediatric 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.

Digital Electrocardiographs, iE 12A / iE 15 / iE 15S, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models. iE 12A / iE 15 / iE 15S, of the proposed device. Digital Electrocardiographs, follow · the same design principle and similar technical specifications.

The provided text describes a 510(k) premarket notification for Digital Electrocardiographs (models iE 12A, iE 15, iE 15S). The submission focuses on demonstrating substantial equivalence to a predicate device (iE 12) rather than presenting a study with specific acceptance criteria related to clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test and training sets for an AI algorithm, expert qualifications, adjudication methods, or MRMC study results, are not available in this document. This document primarily details the technical specifications and safety/EMC standards met by the device.

Here's a breakdown of what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to verifiable technical specifications and compliance with international standards for safety and electrical performance. The "reported device performance" in this context refers to the device meeting these technical specifications and standards.

Study Proving Acceptance Criteria Met:
The document states: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: EN 60601-1, EN 60601-2-25, EN 60601-1-2, IEC60601-2-51."

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, which is verified by meeting technical specifications and compliance with relevant safety and performance standards. The differences in frequency response and lead type for the proposed devices compared to the predicate were addressed by conducting relative standard tests to demonstrate compliance.

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

Not applicable/Not provided within the scope of this document. This submission focuses on technical specifications and substantial equivalence, not a clinical study with a patient test set for diagnostic algorithm performance.

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

Not applicable/Not provided. No diagnostic algorithm performance study is described.

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

Not applicable/Not provided. No diagnostic algorithm performance study 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

No. This document pertains to the hardware and basic signal acquisition capabilities of an electrocardiograph, not an AI-assisted diagnostic system.

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

No. This document describes the ECG acquisition device itself, not a standalone diagnostic algorithm.

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

Not applicable/Not provided. The "ground truth" here is compliance with engineering standards and technical specifications shown via bench testing.

8. The sample size for the training set

Not applicable/Not provided. No machine learning algorithm is described.

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

Not applicable/Not provided. No machine learning algorithm is described.

In summary: This 510(k) submission is for a traditional Digital Electrocardiograph hardware device. The "acceptance criteria" and "study" described are focused on engineering specifications, electrical safety, and electromagnetic compatibility (EMC) through bench testing, to demonstrate substantial equivalence to a predicate device. It does not involve a clinical study to evaluate diagnostic performance of an AI algorithm.

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Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs, ECG-8080/ IE 3S/ iE 12/ iE 12P, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paperthrough thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models, ECG-8080/ iE 3S/ iE 12/ iE 12P, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.

The provided document is a 510(k) summary for Digital Electrocardiographs. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods.

The document indicates "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, it does not provide specific performance criteria or results from these bench tests beyond compliance with general safety and EMC standards (IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2).

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.

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Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are intended to acquire ECG signals from adult and pediatric 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.

Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.

The provided text does not contain information about specific acceptance criteria, detailed device performance metrics, or a comprehensive study design proving the device meets acceptance criteria. The document is primarily a 510(k) summary for Digital Electrocardiographs, focusing on their substantial equivalence to a predicate device and adherence to general safety and EMC standards.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth methods as this information is not present in the provided text.

The text does state:

• "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• "The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1: 1988 +A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety. IEC 60601-1-2: 2001 +A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests"

This indicates that the "acceptance criteria" were the design specifications and compliance with the mentioned IEC standards, and the "study" was "bench tests" to verify these. However, no specific performance metrics or detailed study results are given.

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Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire ECG signals from adult and pediatric 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.

Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data and patient information could be stored in the memory of the device. All the models, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, of the proposed device, Digital Electrocardiographs, follow the same design principle and same technical specifications: They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

The provided text describes a 510(k) premarket notification for Digital Electrocardiographs (ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010). However, the document does NOT contain the detailed information required to answer all the questions about acceptance criteria and the specific study proving the device meets them. The text primarily focuses on the regulatory submission, intended use, device description, and the determination of substantial equivalence to a predicate device.

Here's what can be extracted and what is missing:

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

The document states: "Performance testing was conducted to validate and verify that the proposed devices met all design specifications and was substantially equivalent to the predicate device." However, it does not provide the specific acceptance criteria (e.g., accuracy, sensitivity, specificity for specific ECG features) or the reported performance metrics.

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

This information is not provided in the document.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

There is no indication that an MRMC comparative effectiveness study involving AI or human reader improvement was conducted. The device is a Digital Electrocardiograph, which is a signal acquisition and display device, not an AI-powered diagnostic tool. The document focuses on hardware performance and substantial equivalence to a predicate ECG device.

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

The device itself is a standalone electrocardiograph. The "algorithm" in this context refers to the device's ability to acquire, amplify, filter, display, and record ECG signals. The performance testing would inherently be assessing the device's standalone functionality. However, specific performance metrics for this standalone functionality are not detailed. It's not an AI algorithm in the common sense of the term for this type of device.

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

This information is not provided in the document. For an ECG device, ground truth for performance testing would typically involve a reference standard for signal accuracy, frequency response, common mode rejection, etc., which might be established by calibrated equipment or known physiological signals.

8. The sample size for the training set

This is not applicable as the device is not described as using a machine learning model that requires a training set. It's a standard medical device for signal acquisition.

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

This is not applicable for the same reason as point 8.

Summary of available information:

The document confirms that performance testing was conducted to ensure the device met design specifications and was substantially equivalent to the predicate device (Smart ECG (SE) Series Electrocardiograph, SE-12, K091513). However, it lacks the specific details of these tests, including acceptance criteria, performance results, sample sizes, and how ground truth was established, which would typically be found in a more detailed study report, not a 510(k) summary.

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FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.

Doppler fetal heart rate detector is a portable equipment to detect the heart rate of fetus in Obstetrics & Gynecology and delivery room. It can also be used at home or in public place for prenatal diagnosis on pregnant women. Doppler fetal heart rate detector is composed of the parts used for ultrasonic signal emitting and receiving, simulating signal processing, fetal heart rate calculation and display control.

The provided document is a 510(k) summary for the Shenzhen Biocare Electronics Co., Ltd's Doppler Fetal Heart Rate Detector (Model FM-200). It focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a clinical or standalone study report would.

Based on the provided text, the device's performance was validated through laboratory testing to ensure it met "all design specifications, including electrical safety, EMC, specification." However, it does not explicitly state quantitative acceptance criteria for fetal heart rate detection accuracy or sensitivity/specificity, nor does it provide a detailed study with specific performance metrics against such criteria.

Here's an attempt to extract and synthesize the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present quantitative acceptance criteria or detailed performance metrics for the FM-200 Doppler Fetal Heart Rate Detector in the typical sense of a clinical performance study (e.g., accuracy against a gold standard, sensitivity, specificity).

Instead, it states:

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "laboratory testing" but does not detail the number of subjects or data points used to validate the device's core function of detecting fetal heart beats.
• Data Provenance: Not specified. The testing described is "laboratory testing," which typically means controlled environments. It does not provide information on whether human subjects were involved, their country of origin, or if the data was retrospective or prospective.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

The document refers to "design specifications" and "consensus standards" as the basis for evaluation, implying a compliance-based assessment rather than an expert-driven ground truth establishment for a diagnostic performance study.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of the testing described (compliance to electrical safety, EMC, and design specifications), a traditional adjudication method for diagnostic performance would likely not be relevant or documented in this type of submission summary.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or reported in this submission summary. The device is a "Doppler Fetal Heart Rate Detector," which is typically used by a single operator to detect heartbeats. Its primary function is direct measurement/detection, not interpretation by multiple readers of complex images or signals requiring AI-assisted analysis.

6. Standalone Performance Study

• Standalone Performance Study: The "laboratory testing" described is a form of standalone testing, as it evaluates the device's ability to meet its design specifications and comply with standards. However, it is not a standalone diagnostic performance study (e.g., yielding sensitivity, specificity, accuracy against a clinical gold standard) that you might find for an AI algorithm. The document emphasizes technical compliance rather than diagnostic efficacy quantified in typical clinical metrics for standalone performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the "laboratory testing" appears to be defined by adherence to design specifications (e.g., measuring heart rate within a certain range, performing specific functions) and consensus standards (e.g., electrical safety, EMC limits). It does not mention clinical outcomes data, pathology, or expert consensus on fetal heart rate diagnosis. The device "detects fetal heart beats," implying its 'ground truth' is the actual presence and rate of the fetal heart beat during testing, likely validated using reference measurement equipment.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This device is a traditional hardware-based Doppler fetal heart rate detector, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process.

Summary Limitations:

It is crucial to understand that the provided text is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a predicate device based on technical specifications and safety standards. It is not a detailed clinical study report and therefore does not contain the in-depth performance metrics, study designs, and ground truth methodologies typically found in submissions for AI/ML-driven devices or those requiring extensive clinical efficacy trials. The "Test Conclusion" confirms technical compliance rather than diagnostic accuracy against a clinical gold standard.

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