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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 Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatic populations. The basic system delivers three (3), six (6) or twelve (12) channels of ECG parameters (waveform, arrhythmia and rhythm measurements, interpretation and heart rate). The device is indicated in situations where an instantaneous display of ECG information or a hard copy record may be required. The device is intended to be used under the direct supervision or a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is meant to acquire and record cardiac action potentials from patients. The device is design to be used in Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be applied. Waveforms, heart rate and analysis data from these patients are available to the diagnostic or may be recorded.

The FX-8322 is an Electrocardiograph. The main part consists of the Main Control Board (model: PCB-7285), the Operation Board (model: PCB-7234), the AMP Board (model: PCB-6731), the LCD Module (model: TX17DO1VM2CAA / FD-42-3D), the Power Supply Unit (model: APAU003-07), the Recorder Unit. In addition, the Patient Cable (model: CP-105L), the Chest Electrode (model: TEE-01 / TEE-01RA) and the Limb Electrode (model: TEE-43 / TEE-43RG). Furthermore, the device is designed so it can be connected to USB, LAN cable, Serial cable, SD Card and an external monitor. There are two (2) types of the external monitors depending on the display size desired:

17 inch LC monitor L-560T-C: 19 inch LC monitor MX-191:

The user interfaces, touch screen panel and key panel are located on the top surface of the device. The touch screen display has a variable number of keys that are activated by software and depends on the display/function that the user selects. In addition, there are sixty-five (65) fixed keys on the bottom of the LCD display.

The Fukuda Denshi Model CardiMax FX-8222 provides acquiring and recording ECG (standard 12 lead), heart rate along with the standard 12-Lead ECG analysis software module.

The Fukuda Denshi Model CP-105L Patient Cable provides the ECG signal through Electrocardiograph Electrodes.

Additional standard features include the LAN connection, which is a proprietary network system through either a built in Ethernet LAN connector for connection to the hospital system. Standard features include a USB connection and SD Card connection, which is intended to store the ECG data and connect the USB Wireless LAN adaptor, and the Serial Connection, which is intended to connect to an External Monitor connection and the R-sync connection available when an R-Wave synchronized signal is needed.

The provided document is a 510(k) summary for the Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph. It describes the device, its intended use, and its technological characteristics, stating that it incorporates identical technology to predicate devices. It also mentions compliance with various safety and performance standards.

However, the document does not provide details about acceptance criteria, specific device performance metrics, or study designs that would enable the completion of the requested table and information points. The summary only broadly states that the device has been "subjected to extensive safety, environmental and performance testing" and that "Final testing for the device included various performance tests for the device designed to insure that all functional and performance specifications were met."

Therefore, based solely on the provided text, I cannot fill out the requested table or answer most of the specific questions.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document only mentions the device's ability to provide "interpretation" but doesn't detail the ground truth establishment process for testing this interpretation.

4. Adjudication method for the test set

• Not specified.

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 specified. The document states the device performs "interpretation" but does not detail human reader studies or AI assistance. This device is an electrocardiograph, and the "interpretation" likely refers to automated ECG interpretation, not an AI assisting human readers.

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

• The document implies standalone performance for the "12-Lead ECG analysis software module" by stating it's the "same as that used in the Fukuda Denshi CardiMax model FX-4010 Multi Channel Electrocardiograph cleared under 510(k) # K981066 and the Nihon Kohden Cardiofax model ECG-1350A cleared under 510(k) #K072217." However, it does not detail a specific standalone study for this particular 510(k) application.

7. The type of ground truth used

• Not specified. For ECG interpretation, common ground truths might include expert cardiologist over-reads, clinical outcomes, or pathology reports for specific conditions. This information is not present.

8. The sample size for the training set

• Not specified.

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

• Not specified.

Summary of Document Information:

• Device Name: Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph
• Intended Use: To acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Delivers 3, 6, or 12 channels of ECG parameters (waveform, arrhythmia and rhythm measurements, interpretation and heart rate).
• Predicate Devices: Fukuda Denshi Cardiograph Model FX-4010 Electrocardiograph (K981066) and Nihon Kohden Cardiofax model ECG-1350A (K072217). The "12-Lead ECG analysis software module" is noted as being the same as in the predicate devices.
• Testing Mentioned: "Extensive safety, environmental and performance testing." Compliance with IEC 60601-1, IEC 62304, IEC 62366, ISO 14971, ANSI/AAMI EC53, IEC 60601-2-25, ISO 15233-1, and IEC 60601-1-2. These are general and particular safety and performance standards for medical electrical equipment and software, not specific clinical performance studies.
• Conclusion: The device is substantially equivalent to predicate devices based on laboratory testing, validation, and risk analysis.

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

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

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

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

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

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

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

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

Power system: provide power supply for each system module;

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

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

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

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

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

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

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

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

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

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The intended use of 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

The proposed device can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal. The ECG electrical signals from patient body surface are acquired by disposable ECG electrodes; after been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper via an external printer.

The provided text is a 510(k) Summary for a Digital Electrocardiograph. It contains information about the device's substantial equivalence to a predicate device, focusing on non-clinical tests and technical specifications. However, it does not include any details about clinical studies, acceptance criteria for an algorithm's performance, or the specific information requested about human reader performance, ground truth establishment for a test set or training set, or sample sizes related to clinical efficacy evaluation.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with electrical safety and performance standards for the hardware, not the diagnostic performance of an interpretive algorithm against specific clinical benchmarks.
• Sample sized used for the test set and the data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: None of this information is available in the provided text, as it describes a non-clinical assessment for substantial equivalence, primarily focusing on hardware characteristics and safety standards.

The document mentions "automated analysis" and "interpretive statements offered to clinician on an advisory basis only," but it does not provide any data or studies related to the performance or validation of this interpretive function from a clinical accuracy perspective. It primarily verifies that the proposed device met design specifications and complied with relevant safety standards (IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2) which are non-clinical requirements.

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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.

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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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