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The intended use of ECG301 is to acquire ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.

Electrocardiograph, models: ECG301, is to acquire multi-channel ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The device can gather and record ECG signals of 12 leads simultaneously. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.

Electrocardiograph, models: ECG301, has LCD display with touchscreen and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal dot-matrix recorder for ECG report printing. The Electrocardiograph includes main unit and an AC power cord.

The provided document is a 510(k) premarket notification for an ECG device. It outlines the device's technical characteristics and compares them to a predicate device to demonstrate substantial equivalence. However, it explicitly states in Section 8: "There was no clinical testing performed."

Therefore, I cannot provide the information requested in points 1 through 7, or 9, as no clinical study or performance testing against acceptance criteria was conducted for this specific submission to establish clinical accuracy or improvement with AI assistance. The document focuses on non-clinical tests (safety, EMC, software verification) to demonstrate substantial equivalence to a predicate device.

The requested information regarding acceptance criteria and study data would typically be found in a clinical study report or a different section of a more extensive submission for a device that relies on clinical performance data for clearance.

Here's what I can extract and explain based on the provided document:

8. The sample size for the training set:
Not applicable. The document states, "There was no clinical testing performed." This implies no training set was used for performance validation in a clinical context for this submission. The device, an "Electrocardiograph," as described, does not appear to incorporate AI or machine learning that would typically require a training set for its core functionality of acquiring ECG signals. It explicitly states, "ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements."

9. How the ground truth for the training set was established:
Not applicable, as no training set (for clinical performance evaluation) was used or mentioned.

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The SE-1200 Pro&SE-1201 Pro 12-lead electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiographs are only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

SE-1201 Pro&SE-1200 Pro (2 models: SE-1201 Pro and SE-1200 Pro) features a LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC.

The provided document is a 510(k) premarket notification for Electrocardiograph models SE-1200 Pro and SE-1201 Pro. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document makes a clear statement regarding clinical data: "Clinical data: Not applicable." This indicates that no clinical study was conducted to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy. Instead, the submission relies on non-clinical data, including electrical safety, electromagnetic compatibility (EMC), and performance testing (bench).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or MRMC studies, as the submission explicitly states that clinical data was not applicable.

The device's performance demonstration relies on:

1. Electrical safety and electromagnetic compatibility (EMC): Conformity to standards like ANSI AAMI ES 606601-1:2005/(R) 2012, IEC 60601-1-2:2014, and IEC 60601-2-25 Edition 2.0 2011-10.
2. Performance testing (bench): Functional and system-level testing to validate accuracy specifications and compliance with relevant consensus standards (e.g., IEC 60601-2-25).
3. Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance for software in medical devices.

The conclusion states that "The bench testing data and software verification and validation demonstrate that Electrocardiograph SE-1201 Pro&SE-1200 Pro is substantially equivalent to the predicate devices." This substantial equivalence is based on the technical and non-clinical performance characteristics, not on a clinical effectiveness study involving human subjects or interpretation.

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The iSE series electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.

iSE-1210 and iSE-1810 Electrocardiograph can support ECG Data Sampling of maximum 12 leads and maximum 18 leads separately. iSE series electrocardiograph uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.

The provided text is a 510(k) Premarket Notification summary for the Edan Instruments, Inc. Electrocardiograph (iSE series). It focuses on establishing substantial equivalence to previously cleared devices.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Key Takeaway: This 510(k) summary does not include a clinical study with real patient data to prove the device's diagnostic performance against a ground truth for conditions like heart disease. Instead, it relies heavily on non-clinical bench testing, electrical safety, EMC, human factors, and software verification/validation to demonstrate that the new device (iSE series) is as safe and effective as its predicate devices, primarily in its ability to acquire and process ECG signals according to established industry standards. The interpretation of ECGs with measurements and interpretive statements is explicitly stated as advisory only.

Therefore, the acceptance criteria and study described will pertain to the technical performance and safety of the ECG acquisition and processing rather than the diagnostic accuracy of an AI algorithm in interpreting ECGs for specific heart conditions.

Acceptance Criteria and Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in the format requested for diagnostic performance. Instead, it states that the device meets "accuracy specification" and "relevant consensus standards" through non-clinical bench testing.

Based on the "Performance Specifications" table (Table 1) and the "Performance testing-Bench" section, we can infer some performance aspects that were likely tested against standards.

Inferred Acceptance Criteria and Reported Device Performance (based on technical specifications and implied testing):

Study Details (Based on the provided document)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified for any performance testing beyond "Functional and system level testing" and "usability testing." No specific number of patient ECGs are mentioned for any diagnostic validation.
   • Data Provenance: The document does not specify the country of origin for any data (if patient data was used implicitly in some "accuracy specification" bench testing, which is unlikely given the context). The studies mentioned (Electrical safety, EMC, performance bench testing, human factors, software verification) are non-clinical bench and lab-based studies. There is no mention of prospective or retrospective patient data collection.

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

   • Not Applicable. For non-clinical bench testing, the "ground truth" is typically defined by engineering specifications, calibration standards, and validated test equipment rather than expert human interpretation of medical data.
   • The interpretative statement for the ECGs is offered "on an advisory basis only," indicating that the device's interpretation is not intended to replace a physician's diagnosis.

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

   • Not Applicable. The studies described are technical performance tests against standards, not human reader studies requiring adjudication of medical diagnoses.

4. 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. An MRMC study was not conducted or reported. The device's interpreted ECGs are advisory, and there's no claim of AI assistance for human readers in the diagnostic process. The "algorithm" mentioned (SEMIP V1.92) generates measurements, data presentations, graphical presentations, and interpretative statements, but its performance is not assessed in a comparative effectiveness study with human readers.

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

   • Partially Yes, for technical performance. The bench testing (e.g., meeting accuracy specifications, sampling frequency, frequency response) can be considered a standalone performance assessment of the device's ability to acquire and process ECG signals according to engineering and industry standards. However, this is distinct from a standalone diagnostic performance study typically seen for AI/CADe devices. The document explicitly states "Clinical data: Not applicable." This confirms that no standalone clinical diagnostic performance study was performed or needed for this 510(k) submission, as the device's interpretations are advisory.

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

   • Technical Specifications/Industry Standards. For the non-clinical tests, the "ground truth" for the device's performance is compliance with established electrical safety, EMC, and ECG technical performance standards (e.g., IEC 60601 series). There is no "ground truth" of patient diagnosis (e.g., pathology, outcomes, expert consensus on disease states) used as this device is broadly an ECG acquisition and processing device, with its interpretive statements being advisory.

7. The sample size for the training set:

   • Not applicable / Not specified. The document makes no mention of AI model training or a training set. The "algorithm" (SEMIP V1.92) is mentioned as generating interpretive statements, but its development process (e.g., use of a training set, machine learning) is not described or evaluated in this 510(k) summary. Given the nature of a foundational ECG device and the "advisory basis only" statement for interpretations, it's highly likely this algorithm is rule-based or statistical rather than a deep learning model requiring a large training set of annotated ECGs for diagnostic purposes.

8. How the ground truth for the training set was established:

   • Not applicable. As no training set is mentioned or evaluated in the provided document, the process for establishing its ground truth is not described.

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The SE-1202 12-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements is offered to clinicians on an advisory basis only.

CONTRAINDICATIONS:
SEMIP algorithm is not intended for interpretive statements of neonatal patients from birth to 28 days.

The SE-1202 electrocardiograph features a 10.1" LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC.

The provided document is a 510(k) Premarket Notification from Edan Instruments, Inc. for their Electrocardiograph SE-1202. It establishes substantial equivalence to a predicate device (Edan Instruments, Inc, Electrocardiograph: SE-12, SE-12 Express, SE-1200, and SE-1200 Express, K171942).

The document does not contain details about a study addressing specific acceptance criteria for an AI/algorithm's performance as typically required for devices with interpretive or diagnostic AI functionalities. Instead, it focuses on the performance of the electrocardiograph hardware and its ability to meet general electrical safety, EMC, and basic functional standards (e.g., heart rate range, noise, filter specifications).

The device's software includes an algorithm (SEMIP or Glasgow) that generates measurements, data presentations, graphical presentations, and "interpretative statements." However, the document explicitly states that these interpretations are "offered to clinicians on an advisory basis only." Furthermore, it contraindicates the SEMIP algorithm for neonatal patients.

Given that the core of the request is about acceptance criteria and a study that proves the device meets specific acceptance criteria related to its performance, and the document explicitly states "Clinical data: Not applicable," it indicates there wasn't a clinical study designed to test the interpretive algorithm's performance against detailed criteria for accuracy, sensitivity, or specificity in a diagnostic context. The "Performance validation via EDAN proprietary database" is mentioned, but no specifics about this validation, its acceptance criteria, or its results are provided.

Therefore, many of the requested details cannot be extracted from this document, as it describes a device where the interpretive statements are advisory and clinical data showing performance of these interpretive features in a diagnostic capacity was not deemed necessary for this 510(k) clearance.

However, I will extract what is available and clearly state what information is not present.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating equivalence to a predicate device through technical specifications and compliance with general medical device standards, rather than defining and meeting specific analytical or clinical performance acceptance criteria for an AI/algorithm's diagnostic accuracy. The "acceptance criteria" here are more about meeting safety, EMC, and basic functional parameters of the ECG device itself, and showing the interpretive algorithm's presence but framing its output as advisory.

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

• Sample Size: Not specified for any performance testing related to the interpretive algorithm. The document mentions "Performance validation via EDAN proprietary database" but does not give details on the size or characteristics of this database.
• Data Provenance: Not specified (e.g., country of origin). The document indicates it's an "EDAN proprietary database," suggesting it's internal.
• Retrospective or Prospective: Not specified.

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

• This information is not provided in the document. Given that the interpretive statements are "advisory" and no clinical data was submitted, detailed ground truth establishment by experts for evaluative purposes is not described.

4. Adjudication Method 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

• No. The document explicitly states "Clinical data: Not applicable." Therefore, an MRMC study was not performed or submitted for this 510(k). As a result, no effect size of human readers improving with AI vs. without AI assistance is reported.

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

• The document mentions "Performance validation via EDAN proprietary database" for the algorithm. However, specific details of this "standalone" performance (e.g., metrics like sensitivity, specificity, accuracy for specific arrhythmias or findings) are not provided, nor are the acceptance criteria for these metrics. The focus of the submission is on substantial equivalence of the overall device, not on analytical performance of the interpretive algorithm in isolation for diagnostic claims.

7. The Type of Ground Truth Used

• For the "Performance validation via EDAN proprietary database," the type of ground truth is not specified. Given the nature of ECG interpretation, it would typically involve cardiologist consensus or perhaps correlation with other diagnostic modalities for specific findings, but this document does not describe it.

8. The Sample Size for the Training Set

• This information is not provided. The document notes the use of "SEMIP or Glasgow" algorithms. These tend to be well-established, rule-based or statistical algorithms, rather than deep learning models that would have a distinct "training set" in the modern sense. If newer machine learning components were integrated, their training data size is not disclosed.

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

• This information is not provided. For established algorithms like SEMIP or Glasgow, their development likely involved expert consensus and large ECG databases over time, but the specific method for their training data's ground truth is not detailed here.

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The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and disease. However, the interreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

The SE-12/12 Express/1200/1200 Express Electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms, and be powered by the mains supply or battery. And the system has advanced performance and high reliability due to high resolution thermal recorder, 32-bit processor and a large-capacity memorizer. Design of the system took much consideration on ergonomics so the size is suitable for clinic and hospital uses.

There are four selectable modes in the system, including manual, auto, rhythm, R-R analysis or VCG, and VCG is configured with SE-12 Express & SE-1200 Express.

SE-12 and SE-1200 share the same single-color LCD screen of which the resolution is 320×240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800×600 multicolor LCD screen.

Moreover, SE-12 Express is configured with stress ECG function, which will allow to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before leaving hospital, and assess the effect of the treatment.

The provided text describes a 510(k) premarket notification for an Electrocardiograph device (models SE-12, SE-12 Express, SE-1200, and SE-1200 Express). It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/algorithm's performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical data and comparisons of technical specifications.

Therefore, many of the requested items related to an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not available in the provided text.

However, I can extract the acceptance criteria and performance information that is available, which pertains to the device's general technical specifications and safety/EMC standards.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Same" or "Different" comparison to the predicate device for various specifications, as well as compliance with relevant standards. The reported device performance is either identical to the predicate (marked as "Same") or an improved/different specification (marked as "Different").

Note: The "Comparison Result" column indicates if the proposed device's specification is "Same" or "Different" from the predicate. When "Different," the proposed device's performance is listed.

Study Details (Information Not Available in the Provided Text)

The document is a 510(k) summary for a medical device (Electrocardiograph) seeking substantial equivalence to a previously cleared predicate device. It primarily focuses on hardware specifications, safety, EMC, and software verification/validation. It does not describe a study involving an AI or algorithm's diagnostic performance beyond stating that "ECG interpretation features were also validated by database testing." As such, the following requested information is not explicitly detailed in the provided text:

2. Sample size used for the test set and the data provenance: Not explicitly stated for specific diagnostic performance of the interpretation features, beyond "database testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not stated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not stated.
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. The device's interpreted ECG with statements is "offered to clinicians on an advisory basis only," indicating it's an assistive tool, but no comparative effectiveness study with human readers is described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "ECG interpretation features were also validated by database testing," which suggests standalone algorithm testing, but details on its specific performance metrics (e.g., sensitivity, specificity, accuracy) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not stated for the "database testing" of interpretation features.
8. The sample size for the training set: Not stated.
9. How the ground truth for the training set was established: Not stated.

The document primarily demonstrates that the updated hardware and software of the Electrocardiograph maintain the safety and effectiveness profile of its predicate device, rather than providing a detailed study of an AI's diagnostic performance against specific acceptance criteria.

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The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

SE-3 Series (including SE-3, SE-300A, SE-300B, and SE-301) 3-channel electrocardiograph gathers ECG signals of 12 leads simultaneously. While all 12 leads are recorded and analyzed, printouts will only have 3 leads on a page, with 4 pages in series to output all 12 leads. It displays the operation menu, ECG parameters as well as electrocardiograms.

This document describes a 510(k) premarket notification for Electrocardiographs Models SE-3, SE-300A, SE-300B, and SE-301 by Edan Instruments, Inc. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in terms of diagnostic accuracy metrics. Instead, the document relies on demonstrating that the proposed devices (SE-3, SE-300A, SE-300B, and SE-301) perform comparably to the predicate devices (SE-3, SE-300A, SE-300B - K091513, and reference devices SE-601C - K131503, SE-12 Series - K160876). The comparison is primarily focused on technical specifications and safety standards.

The closest to "performance" in a diagnostic sense relates to the ECG interpretation features.

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

The document states, "ECG interpretation features were also validated by database testing." However, no specific sample size for this test set is provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

This detailed information is not provided in the document. It only mentions "ECG interpretation features were also validated by database testing" without elaborating on how the ground truth of that database was established or by whom.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth from the test set is not specified.

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

No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on demonstrating substantial equivalence based on technical specifications, safety, and a "database testing" for interpretation features, rather than human reader performance with and without AI assistance. Therefore, no effect size of human readers improving with AI assistance is reported.

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

The statement "ECG interpretation features were also validated by database testing" strongly suggests a standalone algorithm performance evaluation was conducted, where the algorithm's interpretations were compared against a database. However, details of this standalone study (metrics, specific results beyond "pass," sample size) are not provided.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for the "database testing" of the ECG interpretation features. It can be inferred that it would be against a known or expert-adjudicated database of ECG recordings, but the specific nature of that ground truth (e.g., expert consensus, comparison to gold standard diagnoses, or other clinical data) is not detailed.

8. The Sample Size for the Training Set

The document does not report the sample size for the training set used to develop or train the SEMIP algorithm versions.

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

The document does not describe how the ground truth for the training set was established. It mentions that "the criteria of some diseases are optimized to improve automatic diagnostic accuracy including RVH, MI, T wave abnormal and optimization of some terms and optimize ventricular preexcitation measure method to improve accuracy" for SEMIP V1.7, implying some form of optimization based on clinical data, but the method of ground truth establishment is not detailed.

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The SE-18 18-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

The SE-18 acquires and displays an 18 leads waveforms, which can also be printed by an integrated thermal printer with effective recording width 216mm. Digital filtering techniques similar to those incorporated on the SE-1515 and SE-12 have been used in SE-18: including Anti-baseline drift filter, AC filter (50/60Hz), EMG Filter and Low pass Filter, which can help the user to record a higher quality ECG. The EDAN Instruments "Smart ECG Measurement and interpretation program" (SEMIP) is included in this machine. The SEMIP program is completely integrated and provides the clinician with a detailed analysis of the ECG signal to aid in the interpretation of the ECGs. The recorded ECG can be saved in flash memory or sent to a PC by Ethernet or WIFI. During the examination, there are no substances delivered to and/or extracted from the patient. SE-18's function block diagram is shown as Fig 1. It's made up of an external ECG Sampling Box, SE-18 Main Control Board with RAM, FLASH, Ethernet module, WIFI module and USB module, a thermal printer module, a power supply module, a keyboard, and 15' 1024*768 display module.

The provided text describes the 510(k) submission for the Edan Instruments, Inc. SE-18 Electrocardiograph. It establishes substantial equivalence to predicate devices (EDAN Instrument, Inc. Electrocardiograph, models SE-1515 and SE-12 Series) based on similar design features, performance specifications, and non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds against which device performance is directly measured. Instead, it compares the specifications of the proposed device (SE-18) against the predicate devices (SE-1515 and SE-12 Series) in a series of tables. The acceptance criteria are implicitly met if the proposed device's performance characteristics are "Same" as or demonstrate "minor differences" that "do not raise different questions of safety or effectiveness" compared to the predicate devices.

Below is a summary drawn from the provided comparison tables, focusing on a few key performance parameters. It consolidates information from Tables 1 and 2-2.

The document states that SE-18 has "minor differences" compared to the predicate devices and that these "do not raise different questions of safety or effectiveness." This implies that the observed differences are within acceptable limits or represent improvements that do not negatively impact safety or effectiveness.

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

The document explicitly states "Clinical data: Not applicable."
For non-clinical data, it mentions Bench Testing was conducted per IEC 60601-2-25: 2011, and "all the results show pass." However, specific sample sizes for this general bench testing are not provided. The data provenance is not mentioned beyond being part of the manufacturer's internal testing. It is retrospective, as it was submitted for a 510(k) premarket notification.

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

Not applicable, as no clinical study or expert-based ground truth establishment is described for the device's performance other than that the device's interpretation statements are "offered to clinicians on an advisory basis only." For the safety and performance testing, standards like IEC 60601-1 and IEC 60601-2-25 are used, which do not typically involve human expert consensus for ground truth on device specifications like sampling frequency or input impedance.

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

Not applicable, as there is no described clinical study involving assessment by human readers 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

Not applicable. The document states "Clinical data: Not applicable" and describes an electrocardiograph, not an AI-assisted diagnostic tool requiring an MRMC study. The "EMIP" program for interpretation is mentioned, but its effectiveness or impact on human readers is not studied or presented here.

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

The device includes the "EDAN Instruments 'Smart ECG Measurement and interpretation program' (SEMIP)". While this is an algorithm, the document does not describe a standalone performance study of SEMIP's diagnostic accuracy. It states that "the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting it's not intended for standalone diagnostic use. The focus is on the device's hardware and basic signal acquisition/processing capabilities meeting predicate equivalence.

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

For the non-clinical performance and safety specified, the ground truth is based on engineering specifications and adherence to international standards (e.g., IEC 60601-1, IEC 60601-2-25). For the SEMIP program, no explicit ground truth methodology for its interpretive statements is provided in this submission summary. Given its "advisory basis only" role, a rigorous ground truth validation for diagnostic accuracy might not have been required for this 510(k).

8. The sample size for the training set

Not applicable. The document does not describe a machine learning model that would require a training set. The SEMIP program is mentioned, but details on its development data or training set are not provided.

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

Not applicable, as no training set for a machine learning model is described in the document.

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Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection. Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Carewell Digital Electrocardiographs, ECG-1101G(I) / ECG-1103G(I)/ ECG-1103LW(I) / ECG-1106L /ECG-1112 / ECG-1112D, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, fittered and analyzed, the ECG signal waveforms and analysis results are displayed on the LCD and recorded on the paper through thermal printer. ECG data, result and patient information could be stored in the memory of the device.

All the models, ECG-1101G(1) / ECG-1103G(1) ECG-1103LW(1) / ECG-1106L /ECG-1112 / ECG-1112D of the proposed device, Carewell Digital Electrocardiographs, have difference in appearance. but follow the same design principle and similar technical specifications:

They consist of three modules, which are power module and control module, and they have three operation modes, including AUTO Mode (automatic mode), MAN Mode (manual mode) and ANA Mode (analysis mode).

They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads. And they are using the same accessories.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document references adherence to several standards but does not explicitly state quantitative acceptance criteria or detailed performance results in terms of accuracy or specific metrics for QRS detection, Heart Rate, VEB, SVEB, or ST Segment Deviation. The statement "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device" is a general claim rather than a detailed performance report.

However, the "Intended Use Statement" lists the capabilities that the device is designed to perform, which implies expected performance for these metrics. Based on the mention of ANSI/AAMI EC57:2003, Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms, it can be inferred that the device was tested against the performance requirements outlined in this standard. Without direct access to the full test report or the specific criteria within EC57 for this submission, we can only list the intended functionalities as the implied performance areas.

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

The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation of the ECG measurement algorithms (QRS, HR, VEB, SVEB, ST Segment). It only mentions "Bench tests were conducted to verify that the proposed device met all design specifications."

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

The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for the test set.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed according to the provided text. The submission focuses on device equivalence and performance against standards, not on human reader improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone study was indicated. The document states, "Bench tests were conducted to verify that the proposed device met all design specifications." The purpose of these tests was to demonstrate that the device's algorithms (for QRS detection, Heart Rate, VEB, SVEB, and ST Segment Deviation) performed according to established standards (specifically referencing ANSI/AAMI EC57:2003), enabling the device to be considered "Substantially Equivalent" to a predicate device. This implies testing of the algorithm's performance independent of human-in-the-loop interaction.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the performance evaluation of the algorithms. However, given the reference to ANSI/AAMI EC57:2003, Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms, it is highly probable that a standard, meticulously annotated ECG database (potentially with expert consensus annotations or derived from clinical events) would have been used to establish the ground truth for evaluating the algorithm's performance against the specified metrics.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set.

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

The document does not provide any information on how the ground truth for the training set was established, as no details about a training set are mentioned.

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The intended use of SE-1201 12-channel electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

SE-1201 is 12-channel electrocardiograph, it's configured with a 7inch Multi-color screen with 800*480 dots resolution. SE-1201 is mainly composed of the ECG board, the power supply board, the Key board and the main board. SE-1201 can acquire 12 channel waveforms simultaneously, which can also print out 12 channel electrocardiograph wave simultaneously by a 216mm wide thermal printer, and the waveforms also can be displayed in LCD and stored in flash memory or send to PC by Ethernet. SE-1201 has the features as follows: Supporting barcode scanner Supporting multi-language ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves are displayed and recorded simultaneously Full alphanumeric keyboard (touch screen is optional) Real-time uploading to PC ECG Multiple file formats: DAT, PDF, SCP, FDA-XML High resolution thermal recorder, recording frequency response ≤150Hz Flexible printing formats The auto, manual, rhythm, R-R analysis and off modes can be chosen freely Automatic baseline adjustment for optimal printing Convenient operation of system setup and file management Measurement function and interpretation function Hint information of lead off, lack of paper, low battery capacity etc. Built-in rechargeable lithium battery with large capacity ECG data can be transmitted to the PC software through the net cable, or wireless AP (optional).

Here's an analysis of the provided text regarding the acceptance criteria and study for the SE-1201 device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly define acceptance criteria as quantitative metrics for specific performance parameters of an interpretive ECG algorithm (e.g., sensitivity, specificity for certain heart conditions). Instead, the "Test Summary" and "Conclusion" indicate a broader approach to demonstrating substantial equivalence for the entire device, which includes software functionality like "measurement function and interpretation function."

The acceptance criteria implied are that the device's overall performance and safety are comparable to the predicate device (MAC 5000 ECG Analysis System K014108). The study merely states that "Verification and validation testing was done on SE-1201" and concludes "This pre-market notification submission demonstrates that SE-1201 is substantially equivalent to the predicate device."

Therefore, a table of specific quantitative acceptance criteria and reported performance cannot be generated from the given text. The relevant parts are:

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

The document does not provide details on the sample size used for the test set, nor the data provenance (e.g., country of origin, retrospective/prospective nature). The "Test Summary" broadly states "Verification and validation testing was done," but no specifics about the dataset used for this testing are included.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for any testing, particularly for the "interpretation function." Given that this is a 510(k) summary for an electrocardiograph, and not a detailed clinical study report for an AI diagnostic algorithm, such granular information is typically not included. The interpretation function is offered "on an advisory basis only," suggesting that human experts are ultimately responsible for diagnosis.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set. This level of detail is absent.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not indicate that an MRMC comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, nor any effect size. This device is an electrocardiograph that includes an interpretation function, not explicitly an AI-assisted diagnostic platform in the contemporary sense that would warrant an MRMC study from this document.

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

The document does not explicitly state that a standalone performance study was done for its interpretation algorithm. The "interpretation function" is listed as a feature, but its standalone diagnostic accuracy metrics are not presented. The overall "substantial equivalence" is for the entire device.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for evaluating the "interpretation function" (e.g., expert consensus, pathology, outcomes data). For an ECG interpretation algorithm of this era, ground truth would most commonly involve expert cardiologist interpretation or potentially correlation with patient outcomes or other diagnostic tests, but this information is not provided.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. The process described is for a predicate device comparison for an electrocardiograph, not an AI model requiring a distinct training phase.

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

Since no training set is mentioned (see point 8), there is no information provided on how ground truth for a training set was established.

Summary of Missing Information:

This 510(k) summary is for a more traditional medical device (electrocardiograph) that includes an "interpretation function." It is not structured like a submission for a modern AI/ML diagnostic software, which would typically contain detailed performance metrics, ground truth establishment, sample sizes, and study designs for the algorithm itself. The focus of this document is on establishing substantial equivalence of the entire device, including its electrical, mechanical, and basic software functions, to a predicate device. Therefore, much of the specific information requested in the prompt regarding AI model evaluation is not present in this 2011 document.

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SE-12 series is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-12 series is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-12 series can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

SE-12 series is 12-channel electrocardiograph, it contains four models:SE-12/SE-1200/SE-12Express/SE-1200Express. These four models include the same ECG board, power supply board and main controlling board. The software and function of these four models are similar, except that SE-12Express has the optional function which include stress exercise test. SE-12 series can acquire 12 channel waveforms simultaneously, which can also print out 12 channel electrocardiograph wave simultaneously by a 216mm wide thermal printer, and the waveforms also can be displayed in LCD and stored in flash memory or send to PC by RS232 or Ethernet.

This document is a 510(k) summary for the Edan Instruments SE-12 series Electrocardiograph, a Class II medical device. It outlines the device's description, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed performance metrics, or a dedicated study section that directly addresses the acceptance criteria in the manner requested. The document primarily focuses on establishing substantial equivalence to previously cleared devices.

Based on the provided text, here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The provided 510(k) summary does not explicitly list acceptance criteria with corresponding performance statistics. Instead, it relies on a "Test Summary" stating: "The following quality assurance measures were applied to the development of the SE-12 series: Software testing, Risk analysis, Safety testing, Environment test." It concludes: "Verification and validation testing was done on SE-12 series. This premarket notification submission demonstrates that SE-12 series is substantially equivalent to the predicate device."

To fulfill this request fully, detailed performance specifications and acceptance criteria would typically be found in the full 510(k) submission, not just the summary. Without that, we can only infer that the acceptance criteria revolved around meeting safety, performance, and functional requirements comparable to the predicate devices.

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

The document does not specify the sample size used for any test sets, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective nature).

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)

The document does not mention the number or qualifications of experts used to establish ground truth for any test set. The intended use states that the interpreted ECG is "offered to clinicians on an advisory basis only," implying human expert review is still central to diagnosis, but it doesn't detail how ground truth was established for testing the device's interpretation function itself.

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

The document does not describe any adjudication method for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device, an electrocardiograph, pre-dates widespread AI interpretation in medical devices, dating back to 2010. Its interpretation function is likely rule-based rather than AI-driven.

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

The document states that the "interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only." This clearly indicates that the device's interpretation function is not intended for standalone use in diagnosis and requires human-in-the-loop performance. Therefore, a standalone performance study in the context of diagnostic interpretation is not implied or described. The "Test Summary" only mentions general software, risk, safety, and environment testing.

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

The document does not specify the type of ground truth used for any testing. Given the "advisory basis" for interpretation, it's highly likely that if interpretation accuracy was assessed, it would have been against expert consensus readings, but this is not explicitly stated.

8. The sample size for the training set

The document does not provide information regarding a training set sample size. This is consistent with the device being from 2010 and its interpretation likely relying on rule-based algorithms rather than machine learning models that require explicit training sets in the modern sense.

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

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

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