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Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.

It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.

The provided text is a 510(k) summary for a Digital Electrocardiograph (ECG-2000) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical specifications. It does not contain information about acceptance criteria for device performance based on clinical studies, nor does it describe such a study.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.

The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and complied with relevant IEC and EN standards for electrical safety, EMC, and particular requirements for electrocardiographs. It also mentions "Software Verification Test was performed to verify the software functions against its intended use." However, these are engineering verification tests, not clinical performance studies for diagnostic accuracy.

The closest to "acceptance criteria" presented in the document are the technical specifications compared with predicate devices, such as:

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PM-2000XL Pro: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (Sp02), lovasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

PM-2000XL: The monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02 and Quick Temperature (Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

The PM-2000XL & PM-2000XL Pro Patient Monitors provide the following primary features:

PM-2000XL & PM-2000XL Pro Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, they are capable of storing, disnlaying, analyzing and controlling measurements, and they will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

PM-2000XL Patient Monitor can monitor parameters including SpO2, NIBP, EGG RESP, TEMP, C02, IBP

PM-2000XL Pro Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, C02, IBP, C.O. and AG

PM-2000XL is outfitted with a 8.4-inch display screen, PM-2000XL Pro is 15-inch, as well as an equal large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses.

PM-2000XL Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, EGG RESP, C02, IBP and Quick Temp.

PM-2000XL Pro Patient Monitor has parameter modules including SpO2 with EDAN-Sp02 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600. TEMP, EGG, RESP, C02, CO, IBP, AG.

The EDAN SpO2 module used in PM-2000XL Pro and PM-2000XL is also used by H1 100B Pulse Oximeter which has been cleared by FDA under K110922. The C02 module and Nellcor SpO2 module used in PM-2000XL Pro are the same to those used in M3B3, which has been cleared by K083821 in May 14, 2009.

PM-2000XL Pro could be configured with two different NIBP modules, one is EDAN NIBP module, the other one is Omron M3600 NIBP module; M3600 module used in PM-2000XL Pro is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003.

The C02 module and Nellcor SpO2 module used in PM-2000XL are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

Arrhythmia and ST Analysis used in PM-2000XL Pro is the same to that in PC EGG which has been cleared by FDA under K102854 and K092010.

This is a 510(k) summary for a patient monitor and, as such, typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed studies for device performance against specific acceptance criteria. The document explicitly states:

"This premarket notification submission demonstrates that PM-2000XL & PM-2000XL Pro Patient Monitor is substantially equivalent to the predicate device."

Therefore, the information you've requested regarding acceptance criteria, specific device performance studies, and ground truth establishment for a new device's algorithms (which would be necessary for AI/software-as-a-medical-device submissions) is not present in this document. This submission is for a patient monitor, which is a hardware device that incorporates various modules for physiological parameter monitoring. The performance of these modules is either cleared through previous 510(k)s (as explicitly stated for components like the EDAN SpO2 module, Nellcor SpO2 module, and Omron NIBP module) or is expected to meet established performance standards for such physiological monitors, without requiring a novel performance study to prove it for this specific integration.

Here's an analysis based on the provided text, explaining why much of the requested information is not available and what is stated:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria and reported device performance for the PM-2000XL & PM-2000XL Pro as a whole using new data. Instead, it relies on the substantial equivalence to a predicate device (M50 & M80 Patient Monitor K110922) and the prior clearance of its individual components/modules.

• Implied Acceptance Criteria: The implied acceptance criteria are that the device performs equivalently to the predicate device and that its individual modules meet their previously established performance standards.

The document mentions that:

• The EDAN SpO2 module is also used by H1 100B Pulse Oximeter cleared under K110922.
• The C02 module and Nellcor SpO2 module are the same as those used in M3B3 (cleared under K083821) and M3B (cleared under K083821).
• The Omron M3600 NIBP module is the same as that used in BX-10 (cleared under K032857).
• Arrhythmia and ST Analysis used in PM-2000XL Pro are the same as that in PC EGG (cleared under K102854 and K092010).

This signifies that the performance of these individual components has already been evaluated and deemed acceptable in their preceding 510(k) clearances.

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

Not applicable in this submission. The document relies on the existing clearances of its components and the substantial equivalence to the predicate device. New clinical performance data for the integrated system is not presented.

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

Not applicable. Ground truth establishment for a novel algorithm's test set performance is not part of this 510(k) submission, as it's not demonstrating the performance of a new algorithm.

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

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic or interpretative device requiring MRMC studies. It is a physiological monitoring device.

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

Not applicable in the context of a new, standalone algorithm. The "algorithms" present are for the interpretation of physiological signals (e.g., arrhythmia detection, ST segment analysis), which are noted to be the "same to that in PC EGG which has been cleared by FDA under K102854 and K092010." This implies their standalone performance was assessed in those prior submissions, not in this one.

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

Not applicable to this 510(k). The ground truth for the performance of the various physiological monitoring parameters (SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection accuracy, etc.) would have been established during the development and clearance of the individual modules or the predicate device, likely using recognized clinical standards and reference methods for each physiological parameter.

8. The sample size for the training set:

Not applicable. This submission is not for a new machine learning algorithm that requires a training set.

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

Not applicable.

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The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

iM50 :

The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature

( Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

iM50 /iM80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

iM50 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP.

iM80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP, C.O. and AG.

The above is the maximum configuration for iM50 and iM80, the user may select different monitoring parameters in according with the requirement.

iM50 is outfitted with a 8.4-inch display screen, iM80 is 15-inch, as well as an equal large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses. Besides, iM80 supports software upgrade online and networking.

iM50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, CO2, IBP and Quick Temp.

iM80 could be configured with three different NIBP modules, one is EDAN NIBP module, one is Omron NIBP module, the other is Suntech NIBP module; Omron NIBP module used in iM80 is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003. Suntech NIBP module is cleared by FDA in K032363

CO2 module and Nellcor SpO2 module used in iM50 and iM80 are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

Arrhythmia and ST segment Analysis used for ECG diagnoses in iM80 is the same to that in PC ECG which has been cleared by FDA under K102854 and K092010

The provided 510(k) summary for the Edan Instruments Patient Monitor (Models iM50 and iM80) does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and study proving device performance.

This document is a traditional 510(k) summary, which generally focuses on establishing substantial equivalence to predicate devices rather than providing exhaustive clinical study details. It refers to various internal tests but does not elaborate on their methodologies or results in a way that directly answers your questions.

However, I can extract the information that is present and note where the requested details are missing.

Here's what can be gathered from the provided text:

Acceptance Criteria and Device Performance Study for Edan Instruments Patient Monitor (Models iM50 and iM80)

The provided 510(k) summary does not explicitly state acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it broadly claims that the device has "the same or similar performance specifications" as its predicate devices, implying that it meets the performance established by those already cleared devices.

The document mentions that "Verification and validation testing was done on the Patient Monitor" to demonstrate substantial equivalence. This testing includes:

• Software testing
• Hardware testing
• Safety testing
• Environment test
• Risk analysis
• Final validation

However, no specific study details, quantitative results, or acceptance criteria for these tests are provided in this summary. The summary focuses on comparing the new device's features and operational principles to predicate devices.

Missing Information Details:

1. A table of acceptance criteria and the reported device performance:
* Not available in the provided text. The document states "have the same or similar performance specifications" as predicate devices, but does not list these specifications or the new device's performance against them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not available in the provided text. The summary mentions "testing," but no details on sample size, data type, or origin are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not available in the provided text. There is no mention of experts or ground truth establishment for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not available in the provided text. There is no mention of adjudication methods.

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 and not available in the provided text. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not explicitly detailed in the provided text for specific performance metrics. While "Software testing," "Hardware testing," "Safety testing," and "Final validation" are listed, the specifics of these tests and whether they constitute a "standalone" performance assessment (beyond basic functionality) are not explained. The general statement of "same or similar performance specifications" suggests standalone functions are expected to meet predicate device levels.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not available in the provided text. The document does not specify how ground truth was established for its testing.

8. The sample size for the training set:
* Not applicable and not available in the provided text. This is a traditional patient monitor, not an AI/machine learning device that would typically have a "training set" in the context of algorithm development for complex pattern recognition.

9. How the ground truth for the training set was established:
* Not applicable and not available in the provided text. (See point 8).

In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence through a comparison of features, operating principles, and general performance specifications to legally marketed predicate devices. It does not include the detailed clinical study data, performance metrics, and methodological specifics you've requested beyond general statements of testing being performed. Such detailed information would typically be found in the complete 510(k) submission, not necessarily in the summary intended for public disclosure.

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M80: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
MSO: The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

M50/M80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
M50 Patient Monitor can monitor parameters including SpO2, NIBP. ECG, RESP, TEMP, CO2, IBP.
M80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, CO2, IBP, C.O. and AG.
M50 is outfitted with a 8.4-inch display screen, M80 is 15-inch, as well as an equal large touch screen. which enables the operation by touching the screen, thus offering convenience for doctors and nurses.
M50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG RESP. CO2, IBP and Ouick Temp.
M80 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SpO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, CO2, CO, IBP, AG

The provided 510(k) submission for the Edan Instruments Patient Monitor (Models M50 and M80) describes the device and claims substantial equivalence to predicate devices. However, it does not contain the specific details required to answer all your questions regarding acceptance criteria and performance studies.

This type of 510(k) summary focuses on demonstrating equivalence to existing devices rather than presenting detailed scientific studies with acceptance criteria and specific performance metrics for the new device. The document mentions "Verification and validation testing" and "similar performance specifications" to predicate devices, but does not provide the results of these tests or explicit acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given document. The submission claims "similar performance specifications" to predicate devices, but no specific performance metrics or acceptance criteria are listed for the M50/M80 Patient Monitor itself. It only references that certain modules used within the M50/M80 were cleared under their own 510(k)s, implying that those modules met their respective performance criteria.

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

This information is not provided in the given document. The submission mentions "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Final validation," but does not detail the methodologies, sample sizes, or data provenance for these tests.

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

This information is not provided in the given document.

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

This information is not provided in the given document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the given document. This device is a patient monitor, not an AI diagnostic tool, so an MRMC study with human readers assisting AI would not be applicable.

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

This information is not explicitly provided in the given document. The "Verification and validation testing" and "Final validation" mentioned likely included testing of the device's algorithms and functions in a standalone capacity, as is typical for medical devices. However, no specific details of such studies are presented.

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

This information is not provided in the given document.

8. The sample size for the training set

This information is not provided in the given document. As this is a traditional patient monitor rather than a machine learning/AI device, the concept of a "training set" in the context of supervised learning algorithms might not directly apply in the same way. The device's internal algorithms would be developed and validated against established physiological models and sensor data, but these are typically not referred to as "training sets" in the context of a 510(k) for such devices.

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

This information is not provided in the given document. (See point 8 regarding the applicability of "training set" for this device type).

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison of indications for use, operating principles, testing modules, and general performance specifications to predicate devices. It does not present the detailed results of performance studies, specific acceptance criteria, or the methodologies for establishing ground truth or testing populations for the M50/M80 Patient Monitor itself. This level of detail is typically found in the full 510(k) submission, not just the summary.

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The intended use of SE-601 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-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. Device features include as follows: Portable, lightweight design Easy data input and operation Alphanumeric keyboard and one-touch operation Built-in rechargeable battery, AC/DC power supply Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics Two-step exercise test with periodic recording. Heart rate variability (HRV) analysis Internal thermal printer and external printer. Support external archiving: USB flash disk, card reader. Data transmission to PC via Ethernet or serial port

Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments SE-601 Series Electrocardiograph:

Based on the provided text, the device is an Electrocardiograph (ECG) and the submission is for modifying its indication for use to include the pediatric population. The information does not describe performance characteristics or a specific study proving the device meets particular acceptance criteria, in the way one might expect for an AI-powered diagnostic device. Instead, it focuses on regulatory clearance for an existing ECG device to expand its intended use.

Therefore, many of the requested categories for a study proving device performance are not explicitly present in the provided 510(k) summary. I will extract what is available and note where specific information is missing based on the context of an AI/algorithm-focused study.

Acceptance Criteria and Device Performance Study Analysis:

The provided document is a 510(k) summary for the Edan Instruments SE-601 Series Electrocardiograph, primarily focused on modifying its indication for use to include pediatric patients. It describes the regulatory clearance process rather than a detailed performance study with explicit acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) of an AI algorithm.

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

The document does not provide a table of acceptance criteria related to diagnostic performance or explicit reported performance metrics like sensitivity, specificity, or F1-score. The "Test Summary" section lists general quality assurance measures applied to the development of the device, rather than specific performance outcomes against predefined acceptance criteria for diagnostic output.

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

This information is not provided in the document. The text mentions "Verification and validation testing was done on SE-601 This premarket Series Electrocardiograph" but does not detail the sample size or data provenance for any specific performance study related to its diagnostic capabilities, especially regarding the advisory diagnostic software (SEMIP).

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

This information is not provided in the document. The document describes an ECG device with "Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics," but it does not detail any expert review process for establishing ground truth if such software's performance was evaluated.

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

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was performed or any reporting of an effect size for human reader improvement with AI assistance. The diagnostic software is described as "advisory basis only," suggesting it's an interpretive aid rather than a primary diagnostic tool.

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

The document mentions "Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics" which implies a standalone algorithmic function. However, no specific standalone performance metrics (e.g., sensitivity, specificity of SEMIP) are reported in this 510(k) summary. The statement that "interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only" reinforces that the algorithm's output is not intended as a definitive diagnosis without human review.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of Findings:

The provided 510(k) summary for the Edan Instruments SE-601 Series Electrocardiograph is a regulatory document focused on obtaining clearance for an expanded indication for use (pediatric patients) for an existing ECG device. It emphasizes the device's substantial equivalence to predicate devices and general quality assurance measures applied during development.

It does not contain the detailed information typically expected for a study evaluating the performance of an AI or algorithmic diagnostic component, such as specific acceptance criteria for diagnostic accuracy, test set sample sizes, data provenance, expert ground truth establishment, or comparative effectiveness studies. The interpretive software (SEMIP) is acknowledged, but its specific performance metrics are not detailed, and its role is explicitly stated as "advisory only."

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