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The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.

• Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
  The system provides 12-lead ECG and interpretive analysis.
  The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
  Sending and receiving ECG data to and from the Hospital Information System is optional.
  The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
  In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.

Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.

The provided document is a 510(k) summary for the Cardio Q50 and Cardio Q70 ECG Analysis System, which includes both ECG and spirometry functions. The document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner you've requested.

However, based on the information provided, I can infer some aspects related to acceptance criteria and how the device's performance is demonstrated:

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

The document does not provide a direct table of acceptance criteria with reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., for the diagnostic algorithms. Instead, it states that the device complies with certain international standards. Compliance with these standards implicitly serves as the acceptance criteria for various aspects of the device's functionality and performance.

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

The document does not provide details on sample size, data provenance (e.g., country of origin, retrospective/prospective), or demographic information for any test sets used to validate the performance of the Bionet or Glasgow ECG analysis algorithms. It mentions "Non-Clinical Test Summary" and "Clinical Test Summary" but states "Clinical testing is not required." This implies that the device's performance regarding the ECG interpretation algorithm itself was likely established based on prior validation of the algorithms (Bionet algorithm V 3.26 and Glasgow algorithm V 30.4) outside the scope of this specific 510(k) submission, or that the FDA did not require new clinical data for this particular clearance due to substantial equivalence.

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 document because no specific clinical study data is presented for the ECG analysis algorithm. The document mentions that the interpretive analysis "must be confirmed by a qualified medical professional along with other relevant clinical information." This highlights the human-in-the-loop nature of the device's intended use rather than providing details on ground truth establishment for an algorithm's validation.

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

This information is not provided as no specific clinical study data (including ground truth establishment) is detailed 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

The document does not indicate that an MRMC comparative effectiveness study was performed or refer to any such study demonstrating the effect size of human readers improving with AI assistance. The device's clearance is based on substantial equivalence to existing devices and compliance with relevant standards, not on a demonstrated improvement in human reader performance.

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

While the document states that the ECG interpretation algorithm provides analytical information that "must be confirmed by a qualified medical professional," it also includes the algorithm as a feature. The compliance with standards like ANSI AAMI EC53 (Ambulatory ECG Recorders) might implicitly cover some standalone algorithm performance metrics, but no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of the algorithms) are explicitly provided in this 510(k) summary. The document focuses on the safety and essential performance of the electrocardiograph system as a whole, rather than the isolated diagnostic performance of its interpretive algorithms.

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 the validation of the Bionet or Glasgow ECG analysis algorithms, as details of a specific validation study are not included in this submission. For ECG interpretation algorithms, ground truth is typically established through expert consensus by multiple cardiologists, often aided by correlation with other clinical data and patient outcomes.

8. The sample size for the training set

The document does not provide information on the sample size for the training set of the ECG analysis algorithms.

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. This information would typically be part of the algorithm's development and validation, which precedes the 510(k) submission for a device incorporating a previously developed or updated algorithm. The document only states the versions of the Bionet (V 3.26) and Glasgow (V 30.4) algorithms being used, implying their prior establishment and validation.

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The Cardio P1 Analysis System is intended to acquire, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be a qualified medical professional along with other relevant clinical information. Sending ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

Cardio P1 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its user-oriented design enables ECG examination with a single push of a button. The Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience.

The provided text is a 510(k) summary for the Cardio P1 device, which is a 12-channel ECG recording equipment. The summary states that clinical testing is not required and that the substantial equivalence is based on non-clinical testing demonstrating similar technological characteristics to the predicate device (Cardio10, K220535). Therefore, the document does not contain information regarding acceptance criteria and a study proving the device meets those criteria for clinical performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, target population, and technical specifications, along with compliance with electrical safety, EMC, usability, and software validation standards.

Specifically, it states:

• "Clinical testing is not required" (page 9)
• "The non-clinical testing demonstrates the subject device (Cardio P1) is substantially equivalent in terms of technological characteristics to the predicate device (K220535)." (page 9)

Given this, I cannot provide the requested table or details about a clinical study's sample size, ground truth, expert qualifications, or MRMC study results because such information is explicitly stated as not being required or performed for this submission. The device performance listed in the comparison table on page 5-6 refers to the technical specifications of the ECG device rather than diagnostic accuracy or clinical outcomes.

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The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Pediatric population is defined as patients between the ages from 3 and less than 16 years.

Basic systems deliver 12 lead ECG's, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients. 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.

Cardio 10 is a device to measure and record ECG of a patient as an ECG recording machine with 12 channels.

It provides parameters required for the diagnosis. ECG records of a patient, and automatic diagnosis and prints ECG records and output report if entering patient or user information and efficiently use them for the chart management. At the same time, it is possible to transmit saved data to the PC connected to the network and manage digital files.

In addition, it is possible to measure ECG by pressing the button only once in consideration of the convenience of a user as much as possible and save, transmit, and print data all at once after completing the automatic diagnosis.

Parameter and automatic diagnosis required on the spirometer record and diagnosis of patients are provided to users while printing the A4 size and Letter size report along with the spirometer records by entering the information of patients or users for the efficient management of chart. At the same time, saved data are delivered to the PC connected to the network managing digital files.

In addition, the battery can be internally saved as an optional component making it feasible to carry and use for checkup while moving.

The provided document is a 510(k) summary for the Cardio10 device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for device performance, the specific study design (beyond general non-clinical testing for safety and EMC), sample sizes for test sets where ground truth was established, expert qualifications, or multi-reader multi-case studies as you requested.

The document states: "Clinical testing is not required." This indicates that the manufacturer did not conduct a clinical study to prove the device meets specific performance acceptance criteria in human subjects for the purpose of this 510(k) submission.

However, based on the information provided, I can extract the following details regarding the non-clinical testing performed to support substantial equivalence:

Acceptance Criteria and Device Performance (Non-Clinical Testing Summary)

The Cardio10 device was tested to comply with several international and national standards related to electrical safety, electromagnetic compatibility, usability, and specific requirements for electrocardiographs and spirometers. The acceptance criteria essentially refer to meeting the requirements of these standards. The device is reported to comply with these standards.

Missing Information:

The document does not provide the following information as it was not a clinical study designed to demonstrate performance against specific clinical acceptance criteria:

1. Sample size used for the test set and data provenance: Not applicable for the non-clinical validation studies described.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable for the non-clinical validation studies described.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted. The document explicitly states "Clinical testing is not required."
5. Standalone (algorithm only without human-in-the-loop performance): While the device includes interpretive algorithms, the document does not provide a specific standalone performance study report for these components. The claim is substantial equivalence to a predicate device that also has interpretive analysis, and that algorithm analysis "must be confirmed by a physician."
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the non-clinical validation studies described.
7. Sample size for the training set: Not applicable, as this is not a study about an AI model's training performance, but rather a regulatory submission for a device incorporating software.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document does indicate regarding "studies":

The "study" that proves the device meets the (non-clinical) acceptance criteria consists of various engineering and validation tests to demonstrate compliance with recognized national and international standards for electrical safety, electromagnetic compatibility, usability, and specific device types (ECG and spirometer). Software validation was also performed, indicating that the firmware was developed, verified, and validated according to a software development process. Biocompatibility testing was also conducted. These are all non-clinical evaluations aimed at establishing safety and performance relative to predicate devices and recognized standards, but they are not clinical trials demonstrating diagnostic accuracy or effectiveness in human subjects with specific clinical endpoints.

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SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings. The general clinical applications include fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging.

The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a Tablet PC or Mobile Phone that utilizes the iOS, Android OS or Windows System.

The SonoMe Wireless Probe Type Ultrasound Scanner and SONOFINDER Wireless Probe Type Ultrasound Scanner are a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS, Android OS or Windows System, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and (iv) User Manual, USB charging cable and Wireless Charger (H5C10L only).

The Wireless Probe Type Ultrasound Scanner software can be downloaded to Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and utilizes an icon touch-based user interface.

The provided document is a 510(k) summary for the SonoMe and SONOFINDER Wireless Probe Type Ultrasound Scanners, indicating their clearance by the FDA based on substantial equivalence to predicate devices. It primarily focuses on demonstrating that the new devices meet established safety and performance standards through non-clinical testing and comparison with current ultrasound systems.

Crucially, the document explicitly states in Section 9. "Summary of Clinical Tests":

"The subject of this premarket submission, SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25), did not require clinical studies to support substantial equivalence."

Therefore, the following information regarding acceptance criteria, study design, and performance metrics for an AI-enabled device's clinical performance, as requested in the prompt, cannot be extracted from this document, because no clinical studies were performed or required for the 510(k) clearance of this ultrasound device. The device is purely a hardware ultrasound scanner, not an AI/ML software.

The document focuses on the equivalence of the device's technical specifications and safety standards (electrical, EMC, biocompatibility, acoustic output) to predicate devices, rather than on the performance of a diagnostic algorithm.

Despite the lack of clinical study information in the provided text, I will answer the questions based on the closest relevant information available regarding the device's characteristics and the general principles of medical device clearance, noting where specific details are not provided.

Acceptance Criteria and Device Performance (Based on provided information)

The acceptance criteria for this device are not framed as specific diagnostic performance metrics (e.g., sensitivity, specificity) derived from a clinical study for an AI algorithm. Instead, they are defined by compliance with recognized electrical, safety, and biocompatibility standards, and substantial equivalence in technical characteristics and intended use to legally marketed predicate ultrasound devices.

The "reported device performance" is implicitly that it successfully passed these non-clinical tests and was found substantially equivalent.

1. Table of acceptance criteria and the reported device performance

Regarding an AI-enabled device's clinical performance, the following answers reflect the absence of such information in this specific 510(k) summary, as it explicitly states clinical studies were not required.

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

• Not Applicable. No clinical test set or diagnostic study was performed. The evaluation was based on non-clinical engineering and bench testing, and comparison to predicate devices' specifications.

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

• Not Applicable. No clinical ground truth was established as no clinical study was performed for this device's clearance.

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

• Not Applicable. No clinical test set requiring adjudication was performed.

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. No MRMC study was conducted, as the device is an ultrasound scanner itself, not an AI-assisted diagnostic software affecting human reader performance.

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

• Not Applicable. This is a hardware ultrasound device, not a standalone diagnostic algorithm.

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

• Not Applicable. No clinical ground truth was used or established for this submission, as per Section 9. The "ground truth" for the device's clearance pertains to its adherence to established electrical, performance, and biocompatibility standards.

8. The sample size for the training set:

• Not Applicable. This is a hardware device; thus, it does not have a "training set" in the context of an AI/ML algorithm.

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

• Not Applicable. As above, this is a hardware device, so there is no training set or ground truth in the AI/ML sense.

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The SPM-300 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients in general practice, specialty physician, and hospital settings.

SPM-300 is a pulmonary function monitoring system consisting of a spirometry data acquisition unit (spirometer handle and mouthpiece) and a host device that provides data analysis and management, display and user interface functions.

This document describes the Bionet SPM-300 Spirometer and its performance testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SPM-300 are based on compliance with ATS (American Thoracic Society) standards for spirometry measurements. The reported device performance is that it meets these standards.

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

The document does not specify a distinct "test set" in the context of clinical trials with patient data. Instead, it refers to non-clinical testing to demonstrate compliance with ATS standards. This implies the use of calibrated equipment and simulated airflow patterns to assess accuracy and repeatability. The data provenance is non-clinical, likely generated in a laboratory setting by an independent testing organization.

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

Since the testing appears to be non-clinical and focused on adherence to technical standards rather than clinical diagnosis, the concept of "experts establishing ground truth" in the traditional sense of medical image interpretation or clinical diagnosis doesn't directly apply. The "ground truth" for the test set would be the known, precise values generated by calibrated spirometry simulation equipment, against which the SPM-300's measurements are compared to ensure they fall within ATS-defined tolerances. The ATS standards themselves are established by expert consensus in respiratory medicine.

4. Adjudication Method for the Test Set

Not applicable since the testing is described as non-clinical and based on objective measurements against established technical standards (ATS).

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

No. The document describes a non-clinical performance study and a comparison to a predicate device for substantial equivalence, not an MRMC comparative effectiveness study with human readers.

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

Yes, in the sense that the device's technical specifications and measurement accuracy were assessed independently. The performance information provided pertains to the device's ability to accurately measure pulmonary function parameters according to ATS standards. This is a standalone assessment of the device's core functionality.

7. The Type of Ground Truth Used

The ground truth used for the performance testing (specifically for accuracy and repeatability of FVC, FEV1, MVV, and PEF) would be known, precisely generated airflow and volume patterns from calibrated spirometry test equipment. For biocompatibility, the ground truth refers to established ISO 10993 standards for material safety.

8. The Sample Size for the Training Set

Not applicable. This device is a spirometer for measuring lung function, not an AI/ML algorithm that requires a training set of data.

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

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

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The Cardio7 electrocardiograph is one of the tools that clinicians can use to evaluate and diagnose patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

Cardio7 is an EKG monitoring system that provides standard EKG and (optional) pulmonary diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG and pulmonary monitoring, data analysis and data management functions.

The provided document is a 510(k) premarket notification for the Bionet Cardio7 electrocardiograph. It claims substantial equivalence to a predicate device (Bionet CardioXP, K102767) rather than providing a detailed performance study with established acceptance criteria and results.

Therefore, the document explicitly states: "Because Cardio7 complies with the EC11 standard, assessment of performance data is not necessary to determine of Substantial Equivalence for this type of device."

This means that a specific study demonstrating compliance against acceptance criteria, as typically seen for devices requiring clinical evidence for efficacy or safety, was not included or deemed necessary for this 510(k) submission. Instead, compliance with the EC11 standard for electrocardiographs was deemed sufficient to establish substantial equivalence to the predicate device.

Given this, I cannot fill out all the requested information as it is not present in the provided text.

Here's what can be extracted based on the document's content:

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

Since the document states performance data assessment was not necessary due to EC11 standard compliance, there is no explicit table of acceptance criteria or reported device performance against those criteria. The comparison table (Table 1) focuses on features and specifications, not performance outcomes against acceptance criteria.

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

Not applicable. No specific test set or performance study is detailed.

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

Not applicable. No specific test set or ground truth establishment is detailed.

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

Not applicable. No specific test set or adjudication method is detailed.

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

Not applicable. This device is an electrocardiograph with an "interpretive algorithm" for analysis, not an AI-assisted diagnostic tool that augments human readers in a comparative effectiveness study. The 510(k) does not mention such a study.

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

The device has a "12-lead ECG interpretive algorithm [that] provides a computer-generated analysis of potential patient cardiac abnormalities". However, the document explicitly states this analysis "must be confirmed by a physician with other relevant clinical information." This indicates it's an assistive tool, and no standalone performance study without human confirmation is detailed in this submission.

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

Not applicable. No specific performance study with ground truth is detailed.

8. The sample size for the training set:

Not applicable. No details about algorithm training are provided in this regulatory submission.

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

Not applicable. No details about algorithm training are provided.

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The CardioXP electrocardiograph is one of the tools that clinicians can use to evaluate and diagnose patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

CardioXP is an EKG monitoring system that provides standard EKG diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG monitoring, data analysis and data management functions.

This document describes the Bionet CardioXP, an electrocardiograph. The acceptance criteria and supporting study information are derived directly from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "CardioXP complies with the EC11 standard". EC11 (now ANSI/AAMI EC11:2007/(R)2017) is a standard for diagnostic electrocardiographic devices, specifying general safety and performance requirements. The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular condition) for an interpretive algorithm, nor does it present explicit performance metrics against such criteria. Instead, compliance with the EC11 standard is presented as the primary "performance information."

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

The document explicitly states: "Because CardioXP complies with the EC11 standard, assessment of performance data is not necessary to determine of Substantial Equivalence for this type of device."

Therefore, there is no specific test set sample size reported for evaluating the interpretive algorithm's performance, as a comparative clinical effectiveness study was deemed unnecessary for substantial equivalence based on standard compliance. The data provenance (country of origin, retrospective/prospective) is not applicable/not reported for an absent test set.

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

Since no specific test set data was provided or analyzed for the interpretive algorithm's performance against ground truth, the number and qualifications of experts involved in establishing such ground truth are not applicable/not reported.

4. Adjudication Method for the Test Set

As there was no specific test set and no performance data presented for the interpretive algorithm, an adjudication method for the test set is not applicable/not reported.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this submission. The device's substantial equivalence was based on compliance with the EC11 standard rather than such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study of the algorithm's diagnostic accuracy was not presented in the provided document. The claim is based on compliance with a standard, not on a direct performance evaluation of the interpretive algorithm's diagnostic capabilities.

7. The Type of Ground Truth Used

Given that no performance data for the interpretive algorithm was presented beyond compliance with a technical standard, the type of ground truth (expert consensus, pathology, outcomes data, etc.) used for such an evaluation is not applicable/not reported. The submission indicates that the interpretive algorithm provides "computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information," implying that the algorithm's output is not the definitive ground truth.

8. The Sample Size for the Training Set

The document does not report any information regarding a training set sample size for the interpretive algorithm.

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

The document does not report how the ground truth for any training set, if one was used for the interpretive algorithm, was established.

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EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device-CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.

The EKG-PLUS II Software is a program which receives, displays, stores and prints out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device.

The provided text describes a 510(k) submission for the EKG-PLUS II Software. However, it does not include detailed information regarding discrete acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or ground truth methodologies that would typically be found in a performance study section.

Based on the provided text, here's what can be extracted and what is missing:

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

The document states: "The performance of the EKG-PLUS If Software was comprehensively tested with the CardioCare-2000 and CardioTouch-3000. All functions as defined in the specifications were completely verified and validated."

This indicates that internal specifications for the software's functions served as the acceptance criteria. However, the document does not provide specific quantitative acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) or the reported performance metrics against those criteria. It only states that the functions were "completely verified and validated."

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 given text.

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 given text. The device is an ECG analysis system, implying it processes data from ECG devices. While it might perform some interpretive functions (like its predicate), the text does not detail a study where human experts independently establish a ground truth to evaluate the device's diagnostic accuracy.

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

This information is not provided in the given text.

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 mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as "EKG-PLUS II Software ECG Analysis System," an "algorithm only" product for displaying, storing, and printing ECG data, and performing analysis. It's not presented as an AI-powered assistive tool for human interpretation in the context of this submission.

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

Yes, the described "EKG-PLUS II Software" is a standalone algorithm as it is an "ECG Analysis System" intended to "receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device." The "Non-clinical tests" section focuses on the performance of the software itself in conjunction with the specified ECG devices. The conclusion states it is "as effective, and performs as well as the CARDIOVIEW ECG Interpretive Software" (predicate device), implying a standalone, algorithmic comparison.

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

The document states "All functions as defined in the specifications were completely verified and validated." This implies an engineering-centric verification and validation against internal functional and technical specifications, rather than a clinical ground truth like expert consensus on diagnostic interpretations, pathology, or outcomes data. If there were interpretive capabilities, the ground truth methodology for those specific functions is not detailed.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text. As a pre-2009 submission, it's less likely to extensively detail machine learning training sets in the way more recent AI/ML device submissions would. The "analysis" capabilities are likely based on established ECG interpretation algorithms rather than a trained machine learning model in the contemporary sense.

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The patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities.

Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.

The patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.

Bionet BM3Plus Patient Monitor ("BM3Plus" or the "subject device") is a multifunctional device that monitors vital signs of human patients from neonates to adults. Parameters monitored by BM3Plus include electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, noninvasive blood pressure (NIBP), temperature, and respiration. Data output is displayed in numeric and/or wave form(s) on a 7-inch color LCD screen. Selected parameters and waves can also be shown in print via a built-in 58 mm thermal printer. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.

BM3Plus is compact and can be used in either stationary mode or on the move in all professional medical facilities. Its energy source can come from AC input or lithium-ion battery. BM3Plus' LAN connection capability enables the device to be built into a monitoring system, so that one person can monitor several patients at a time.

This document describes the Bionet BM3Plus Patient Monitor, but it explicitly states that "Clinical test is not applicable to BM3Plus."

Therefore, a study demonstrating the device meets specific acceptance criteria based on clinical performance data is not provided in this submission. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized consensus standards and a comparison of technical specifications.

Here's an analysis based on the provided text, primarily addressing why many of the requested points cannot be answered:

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

• Acceptance Criteria: The document lists several IEC and EN standards (e.g., IEC 60601-1, IEC 60601-1-2, EN 865, EN 1060-1, etc.) that the BM3Plus meets. These standards themselves contain detailed performance and safety requirements, which serve as the acceptance criteria for the device's design, electrical safety, electromagnetic compatibility, and specific parameter monitoring capabilities (e.g., ECG, NIBP, SpO2).
• Reported Device Performance: The document states that the BM3Plus "meets" these standards. However, it does not provide a table of specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) for each monitored parameter (ECG, SpO2, NIBP, temperature, respiration) and how they measure up against a set of clinical acceptance criteria derived from a performance study. The statement "Clinical test is not applicable to BM3Plus" means such a table based on clinical data is not included.

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

• Not applicable / Not provided. Since no clinical performance study was conducted or presented, there is no test set, sample size, or data provenance from a clinical perspective. The "testing" referred to in the document pertains to adherence to recognized consensus standards, which typically involves bench testing, electrical safety testing, and EMC testing, not clinical data collection.

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

• Not applicable / Not provided. As no clinical performance study was conducted, there was no ground truth established by experts for a test set.

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

• Not applicable / Not provided. No clinical test set means no adjudication method was used.

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 / Not provided. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not applicable / Not provided. The BM3Plus is a patient monitoring device, not a standalone algorithm. Its performance is inherent in its hardware, firmware, and sensor technology, and its "standalone" performance is measured against the technical specifications within the consensus standards it claims to meet.

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

• Not applicable / Not provided for clinical performance. For the non-clinical testing against consensus standards, the "ground truth" would be the reference measurements and specifications defined within those standards and performed by calibrated testing equipment, not clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable / Not provided. Since this is not an AI/machine learning device requiring a training set, this question is not relevant.

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

• Not applicable / Not provided. As there is no training set mentioned, this question is not relevant.

In summary of what is provided:

The submission for the Bionet BM3Plus Patient Monitor establishes its safety and effectiveness through substantial equivalence to an existing predicate device (Goldway UT4000F Patient Monitor, K021154) and by demonstrating compliance with a list of recognized consensus standards (IEC, EN, ISO). The document explicitly states that "Clinical test is not applicable to BM3Plus," meaning that the acceptance criteria are primarily met through engineering design verification and validation against these standards, rather than through a clinical performance study with human subjects or patient data.

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FC-700 is the fetal monitor that measures, displays numerical value of measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus.

It intended to be used by trained healthcare personnel. It is not intended for home use.

FC-700 is the fetal monitor that measures the fetal heart rate and uterine contraction. FC-700 irradiates ultrasound wave to the abdomen of a pregnant woman and detects the Doppler frequency signal reflected from the heart of the fetus. FC-700 analyzes detected signal and displays the numerical values of the fetal heart rate by LED. FC-700 measures the uterine contraction values of a pregnant woman by pressure sensors, analyzes measured value and displays the numerical values of the uterine contraction by LED. FC-700 provides the sound from the heart of fetus. I C-700 prints graphically the heart rate of the fetus and the values of uterine contraction.

This is a 510(k) summary for a medical device and describes a comparison to a predicate device, not a study evaluating the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from this document.

The document states that the FC-700 is "substantial equivalent to predicated device COROMETRICS MONITOR (K991905)". This means that the device's safety and effectiveness are deemed equivalent to the predicate device based on its similarity in technological characteristics, rather than a new clinical study with specific acceptance criteria.

However, I can provide what's available and point out what's missing:

Acceptance Criteria and Reported Device Performance

Missing Information and Reasoning:

• 1. A table of acceptance criteria and the reported device performance: As explained above, the document doesn't provide specific quantitative acceptance criteria for the FC-700's performance (e.g., accuracy, precision for FHR or UC measurements) and corresponding reported performance metrics from a formal study. Instead, it relies on substantial equivalence to a predicate device. The performance characteristics listed are functions the device performs, not quantitative performance metrics against acceptance criteria.
• 2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study with a test set. The evaluation is based on technological characteristics comparison.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance study is described.
• 4. Adjudication method for the test set: Not applicable. No clinical performance study is described.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (fetal monitor), not an AI-based diagnostic tool. There is no mention of an MRMC study or AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a fetal monitor, not an algorithm, and its use inherently involves human interaction (trained healthcare personnel).
• 7. The type of ground truth used: Not applicable. No clinical performance study is described. The "ground truth" for this submission is the performance and safety profile of the predicate device.
• 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that involves a training set.
• 9. How the ground truth for the training set was established: Not applicable. No training set is involved.

Summary:
This 510(k) submission establishes substantial equivalence to a predicate device (COROMETRICS MODEL 171 AND 172 FETAL MONITOR, K991905) by comparing technological characteristics and adherence to recognized standards for safety and EMC. It does not present a standalone clinical performance study with specific acceptance criteria and detailed quantitative results as would be typical for more novel devices or those undergoing a PMA pathway.

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