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QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), End tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG. QMAPP® provides also clinical data acquisition, medical image/data processing and analytical assessment. QMAPP® is intended for use in the areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology. QMAPP® can be used standalone and in networked environments. The system is intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or send to other devices, such as physiological monitoring system, information management systems, image acquisition/storage devices and other medical devices.

The QMAPP® system offers a complete physiological/hemodynamic monitoring and reporting system. The system is built from three units: an Amplifier, Live Monitoring CPU and Reporting CPU. The Amplifier Unit has various sensors connected with the patient, e.g. ECG, SpO2 and NiBP. The Amplifier Unit is connected to the Live Monitoring CPU via a dedicated Ethernet connection. The acquired patient information can be visualized on a Live Monitoring CPU. Typically located in the technical room. A software application executed on the Live Monitoring CPU can visualize the patient information. Also the Amplifier Unit can be controlled, i.e. most importantly, to set acquisition and filtering parameters for the different sensors, by the Live Monitoring CPU. Optionally the Monitoring unit can be connected via a dedicated Ethernet connection to a Reporting CPU, typically located in the technical room. On the Reporting CPU a database is installed which facilitates data storage and retrieval. A software application executed on the Reporting CPU serves as a patient data management system. It can e.g. be used for analysis, calculation and reporting in various representations of patient information.
The QMAPP® system, can operate standalone or it can be part of a typical hospital network infrastructure. The latter offers the possibility to send or receive information from and to other devices. The software has several communication modules, based on HL7 or DICOM protocols to interface with third party equipment/systems.
• The QMAPP® system works with 3rd party 510(k) cleared SpO2 module (Covidien Nellcor, K083325), NiBP module (CAS Medical Systems, MAXNIBP ND+, e.g. used in FDA cleared device CAS Medical Systems, 740 Select, K150620) and EtCO2 sensors e.g. used in FDA cleared device CLEO Patient Monitor, K142244.

The provided FDA 510(k) Clearance Letter for the QMAPP® System describes the device, its intended use, and a summary of non-clinical tests conducted to support its substantial equivalence. However, the document does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study that proves the device meets them.

Here's a breakdown of what can and cannot be extracted from the provided text, and where the requested information is missing:

Information Present in the Document:

• Overall Device Performance: The "NON-CLINICAL TESTS" section lists various characteristics on which "Bench testing" was carried out, implicitly suggesting these are areas where performance was evaluated. The "Referenced Standards and Performance Testing" section explicitly states that the QMAPP® system "meets the requirements of following performance Standards."
• Study Type: The studies mentioned are "Bench testing," "Usability Testing," and "Software verification and validation testing." The clearance is based on a "Traditional 510(k)" and relies on "non-clinical data."
• Ground Truth Type (for non-clinical testing): For the performance characteristics listed (ECG, Heart rate, SpO2, NiBP, IBP, Cardiac Output, Intra cardiac ECG, Skin Temperature, ECG impedance for Rate of respiratory effort, Measurement accuracy), the "ground truth" would be established by the physical standards and reference systems used during bench testing for each specific measurement. For example, a calibrated heart rate simulator would provide the ground truth for heart rate accuracy.
• Sample Size for Training Set: Not explicitly mentioned, but the document refers to a "software verification and validation testing," implying a dataset (likely synthetic or previously collected) was used.
• How Ground Truth for Training Set was Established: Not explicitly mentioned.

Missing Information (Crucial for your request):

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to recognized standards. It does not present a detailed study report with specific acceptance criteria, reported performance against those criteria, or the methodology of how "ground truth" was established for clinical or test datasets in the manner you've requested for an AI/ML context.

The QMAPP® system is a physiological/hemodynamic monitoring system, not specifically an AI/ML device that requires a comparison of algorithmic output against expert consensus on a test set, multi-reader multi-case studies, or standalone algorithm performance. The "clinical data acquisition, medical image/data processing and analytical assessment" mentioned are functions of the system, but the document does not elaborate on an AI/ML component with associated performance metrics.

Based on the provided text, here is what can be inferred and explicitly stated, with clear indications of missing information for your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the QMAPP® system was tested against and "meets the requirements of following performance Standards." These standards themselves contain detailed acceptance criteria for various parameters. The table below excerpts the performance characteristics mentioned in the "SUBSTANTIAL EQUIVALENCE SUMMARY TABLE" and "NON-CLINICAL TESTS" sections. Crucially, the document does not provide the specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum deviations) or the actual measured performance values against those criteria in a consolidated table. Instead, it states that the device "meets the requirements" of the listed standards and has "Accuracy" values which are the specifications for the device itself, not acceptance criteria of a study.

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

• Sample Size for Test Set: Not specified. The document only mentions "Bench testing," "Usability Testing," and "Software verification and validation testing." These are typically performed in a lab environment.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. Given it's bench testing, actual patient data provenance is not directly relevant for the stated tests, but the data used for software verification and validation testing (if involving patient data) is not detailed.

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

• Number of Experts & Qualifications: Not applicable/not specified. For bench testing of physiological monitoring devices, the "ground truth" comes from calibrated testing equipment and reference signals, not expert human interpretation in the way, for example, a radiology AI would be evaluated. The "Software verification and validation testing" is also not described as relying on expert review of a patient dataset for ground truth.

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

• Adjudication Method: Not applicable/not specified. This methodology is typically used when comparing an algorithm's output to human expert interpretations, which is not the type of testing described for this physiological monitor.

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

• MRMC Study: Not applicable. The QMAPP® system is described as a physiological/hemodynamic monitoring, data acquisition, and analytical assessment system. It is not presented as an AI-assisted diagnostic tool designed to improve human reader performance in interpreting images or complex clinical scenarios.

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

• Standalone Performance: The described "Bench testing" and "Software verification and validation testing" can be considered "standalone" in the sense that they evaluate the device's inherent measurement and processing capabilities without a human in the loop for interpretation, but for a physiological monitor, the ultimate "human-in-the-loop" is the clinician using the displayed information. The document does not describe an AI algorithm that operates entirely independently to make a diagnosis or prediction in the same way an AI for image analysis might.

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

• Type of Ground Truth: For the "Bench testing" of physiological parameters, the ground truth would be established by calibrated reference standards and simulated physiological signals. For instance, a signal generator provides a known ECG waveform or blood pressure reading, and the device's measurement is compared to this known input.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. The document mentions "Software verification and validation testing," which would involve a dataset, but its size is not detailed. There is no mention of a "training set" in the context of an AI/ML model, as the device is not presented as such.

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

• How Ground Truth for Training Set was Established: Not specified. If a "training set" was used for software validation (e.g., for signal processing algorithms), the ground truth would likely be established through
  • Synthetic data: Ground truth is known by design.
  • Previously validated physiological data: Data collected with highly accurate reference devices, where the "truth" for various physiological parameters is established by the reference device's measurements.

In summary: The FDA 510(k) clearance document for the QMAPP® System confirms that the device meets relevant performance standards through non-clinical bench testing and software validation. However, it does not provide the detailed acceptance criteria and study particulars, particularly those related to expert-adjudicated test sets, MRMC studies, or specific AI/ML training/testing methodologies, because the device is presented as a traditional physiological monitor, not an AI-powered diagnostic system.

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The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO™ 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

The CARTO™ 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO™ 3 System V8.1 consists of the following hardware components:

• Patient Interface Unit (PIU)
• Workstation with Graphic User Interface (GUI)
• Wide-Screen monitors, keyboard, and mouse
• Intracardiac In Port
• Intracardiac Out Port
• Power Supply
• Patches Connection Box and Cables (PU)
• Pedals
• Location Pad (LP)
• Signal Processing Unit (SPU)

All hardware components of the CARTO™ 3 system V8.1 are the same as those found in the predicate device.

The provided FDA 510(k) clearance letter for the CARTO™ 3 EP Navigation System V8.1 does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device (CARTO™ 3 EP Navigation System V8.0) and outlines the V&V testing performed at a high level.

Specifically, the document does not report specific quantitative acceptance criteria or reported device performance metrics in a readily extractable table format. It states that "All tests were successfully completed and met the acceptance criteria" for various testing phases, but the acceptance criteria themselves are not provided. Similarly, actual performance metrics (e.g., accuracy values, false positive rates, etc.) are not listed.

Regarding the "study that proves the device meets the acceptance criteria," the document describes verification and validation testing, but this is not presented as a single, comprehensive "study" with a specific design (like an MRMC study or a standalone performance study) and reported results in the same way one might describe a clinical trial. Instead, it's a summary of different types of engineering and software testing.

Given these limitations, I will extract and infer information where possible based on the provided text, and explicitly state when information is not available in the document.

Overview of Device Acceptance and Performance (Based on Available Information)

The acceptance of the CARTO™ 3 EP Navigation System V8.1 is broadly based on the successful completion of various verification and validation (V&V) tests, ensuring the device meets its design specifications and performs as intended, especially with new features and existing functionalities. The primary "proof" of acceptance is the statement that "All tests were successfully completed and met the acceptance criteria," even if those criteria are not quantitatively detailed.

Since quantitative acceptance criteria and reported numerical performance are not explicitly provided, a table with specific metrics cannot be generated. The document focuses on conceptual and functional "acceptance."

Detailed Breakdown of Available Information:

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

Not explicitly provided in the document in a quantitative, tabular format.

The document states:

• "All tests were successfully completed and met the acceptance criteria" for "Proof of Design."
• "All system features were found to perform according to specifications and met the tests acceptance criteria" for "Functional verification."
• "All tests were successfully completed and met the acceptance criteria" for "Unit Tests."
• "All testing performed were successfully completed and met the acceptance criteria" for "Retrospective Validation Tests."
• "All test protocol steps were successfully completed and expected results were achieved" for "Animal Testing."

While these statements confirm the device met its internal acceptance criteria, the specific numerical values of these criteria (e.g., "accuracy > X mm," "sensitivity > Y%") and the actual measured performance values are not disclosed in this 510(k) letter.

Inferred Performance Claims:

• The device maintains "identical magnetic location sensor and ACL location accuracy" as the predicate device (V8.0). However, the specific accuracy values are not stated for either version.

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

• Test Set Sample Size: Not explicitly stated.
  • For "Retrospective Validation Tests," it mentions "clinical recorded data from historic EP procedures." The number of procedures or specific data points is not provided.
  • For "Animal Testing," it indicates "animal testing was conducted," but the number of animals or specific test cases is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated. The company Biosense Webster has facilities in Irvine, CA, USA, and Yokneam, Israel. The data could originate from clinical sites globally.
  • Retrospective or Prospective:
    • "Retrospective Validation Tests" explicitly used "clinical recorded data from historic EP procedures." This indicates retrospective data.
    • "Animal Testing" would be considered prospective in the context of controlled experimental animal studies.

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

Not explicitly stated. The document does not describe the process of establishing ground truth for any of the V&V tests, nor the involvement or qualifications of experts for this purpose.

4. Adjudication method for the test set

Not explicitly stated. Given that expert involvement for ground truth is not detailed, an adjudication method is also not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No, an MRMC comparative effectiveness study was NOT done or reported. The document focuses on demonstrating substantial equivalence through technical V&V testing and software feature improvements, not on comparative effectiveness with human readers. The CARTO™ 3 System is a navigation system, not an AI for image interpretation that typically undergoes MRMC studies.

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

Yes, aspects of standalone performance were evaluated, though not explicitly labeled as such.

• "Proof of Design" and "Unit Tests" would inherently involve evaluating the device's (or its software components') performance against design specifications in a standalone manner, without direct human-in-the-loop interaction beyond setup and execution of the tests.
• The statement "identical magnetic location sensor and ACL location accuracy" implies a standalone assessment of the system's core navigational accuracy.

However, specific quantitative metrics for this standalone performance (e.g., location accuracy in mm, precision, etc.) are not provided.

7. The type of ground truth used

Not explicitly stated for specific tests.

Inferred types of ground truth based on the nature of the device and tests:

• Engineering Specifications/Reference Standards: For "Proof of Design," "Functional verification," and "Unit Tests," the ground truth would likely be defined by internal engineering design specifications, simulated environments, and established reference measurements. For accuracy testing of location, highly precise physical measurement systems or phantoms would be used as ground truth.
• Retrospective Clinical Data: For "Retrospective Validation Tests," ground truth would presumably come from existing clinical records of "historic EP procedures," although how this ground truth was established within those records (e.g., confirmed diagnoses, procedural outcomes, expert review) is not detailed.
• Direct Observation/Measurement in Animal Models: For "Animal Testing," ground truth would be based on direct measurements and observations within the animal during the simulated procedures.

8. The sample size for the training set

Not applicable/Not mentioned. The CARTO™ 3 System is described as a navigation system with improved software features (e.g., catheter support, legacy feature enhancements). It is not presented as an AI/ML model that undergoes a distinct "training set" development phase in the typical sense of deep learning models requiring large datasets for training. The changes appear to be more in line with traditional software development and feature integration.

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

Not applicable/Not mentioned (as it's not described as an AI/ML system with a training set).

Summary of Limitations of the Document for this Request:

The provided FDA 510(k) clearance letter serves its purpose of demonstrating substantial equivalence based on the provided V&V testing summary. However, it is not a detailed technical report or clinical study publication that would typically include the specific quantitative acceptance criteria, full performance metrics, detailed sample sizes, expert qualifications, or ground truth methodologies you are requesting for a comprehensive analysis of a device's proven performance. The document implies successful adherence to internal specifications without detailing those specifications or the resultant performance values.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

The provided FDA 510(k) clearance letter for the EnSite™ X EP System (K251234) details the device's regulatory pathway and general testing conducted. However, it does not contain the specific information required to populate a table of acceptance criteria and reported device performance. It focuses on the regulatory aspects, substantial equivalence to a predicate device, and the general types of testing performed (e.g., software verification, amplifier design verification, system design validation) to demonstrate that the device meets user requirements and its intended use.

The document states: "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy or precision) and the reported device performance values against those criteria are not presented in this public clearance letter.

Similarly, the letter does not provide details regarding:

• Sample sizes used for test sets (beyond stating "design verification" and "system design validation" were performed).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for any test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found within the confidential 510(k) submission itself, not routinely published in the public clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter for the EnSite™ X EP System, the following information can be extracted regarding the device's acceptance criteria and the study that proves it meets those criteria:

Key Takeaway: The provided FDA 510(k) clearance letter asserts that acceptance criteria were met through various design verification and validation activities, demonstrating substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of the device's performance against those criteria. The details below are based on what is stated or can be inferred from the document.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific numerical acceptance criteria and reported device performance data are not explicitly stated or detailed. The document generally states:

"Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."

And

"System Design Validation to confirm the system could meet user requirements and its intended use after modifications"

Without specific numerical cut-offs or performance metrics (e.g., accuracy, precision, error rates), a table cannot be populated as requested. The clearance indicates that internal testing demonstrated the device met pre-defined acceptance criteria, but those criteria and the actual performance results are not publicly available in this document.

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

• Sample Size Used for Test Set: Not specified in the provided document. The document mentions "Design verification activities" and "System Design Validation" but does not give the number of cases, patients, or data points used for these tests.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • (It's common for electrophysiology systems that ground truth would be established by electrophysiologists, but this document does not confirm that.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none)

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

• MRMC Study: No indication that an MRMC comparative effectiveness study was performed or required for this 510(k) clearance. The focus of this submission is on substantial equivalence to a predicate device, which often relies on non-clinical testing for software updates or minor changes, rather than clinical efficacy studies comparing human readers with and without AI assistance.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable/Not provided, as an MRMC study is not mentioned.

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

• Standalone Performance: The document describes "Software Verification at unit, software and system level" and "Amplifier Design Verification," which are types of standalone-like algorithmic or component-level testing. However, the exact metrics and results for pure "algorithm-only" performance (e.g., for automated mapping or analysis features if present) are not detailed. The system is described as a "diagnostic tool" that "provides information" and "displays catheter location," implying human interaction is integral.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. Given the nature of an EP system, ground truth would likely involve a combination of:
  • Validated phantom models: For physical accuracy of catheter tracking and mapping.
  • Clinical expert consensus: For validating the interpretation of electrical activity and the accuracy of generated 3D maps or anatomical models.
  • Reference measurements: From other validated systems or direct measurements during testing.
  • The document implies ground truth was used for "Design verification" and "System Design Validation," which "confirm the system could meet user requirements."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) is for a software update (v5.0) to an existing system (EnSite™ X EP System, predicate K242016). The document describes changes related to compatibility with new catheters and ultrasound systems, rather than the development of entirely new AI/ML algorithms requiring a "training set" in the conventional sense of deep learning. While software is involved, the primary testing discussed is verification and validation, not model training.

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

• Ground Truth for Training Set Establishment: Not applicable/Not specified, as the document does not indicate the use of a "training set" in the context of machine learning model development. The 'ground truth' concept would apply more to the test and validation steps, as discussed in point 7.

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• HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter and Swan-Ganz Jr catheter indications for use statements for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, FloTrac Jr sensor, Acumen IQ sensor, and TruWave disposable pressure transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used. The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients >=18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions. The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.

• HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable: The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

  • When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >=40 kg.
  • When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >=3 kg.
  • When used with small sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects

The HemoSphere Advanced Monitor was designed to simplify the customer experience by providing one platform with modular solutions for all hemodynamic monitoring needs. The user can choose from available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

The provided FDA 510(k) clearance letter and summary for the Edwards Lifesciences HemoSphere Advanced Monitor (HEM1) and associated components outlines the device's indications for use and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed acceptance criteria or the specific study results (performance data) in the format typically required to answer your request fully, especially for acceptance criteria and performance of an AI/algorithm-based feature like the Hypotension Prediction Index (HPI) or Assisted Fluid Management (AFM).

The document states:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation. Additionally, system integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing was conducted, and documentation was provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed."

This indicates that internal performance specifications were met, but the specific metrics, thresholds, and study designs for achieving those specifications are not detailed in this public summary.

Therefore, I cannot populate the table with specific numerical performance data against acceptance criteria for the HPI or AFM features, nor can I provide details on sample size, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The text primarily focuses on:

• Substantial equivalence to predicate devices.
• Indications for Use for various HemoSphere configurations and modules.
• Description of software and hardware modifications (e.g., integration of HPI algorithm, new finger cuffs).
• General categories of testing performed (Usability, System Verification, Electrical Safety/EMC, Software Verification) with a blanket statement that "All tests passed."

Based on the provided document, here's what can and cannot be stated:

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

Cannot be provided with specific numerical data or thresholds from the given text. The document only states that "all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." No specific acceptance criteria values (e.g., "Accuracy > X%", "Sensitivity > Y%", "Mean Absolute Error

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ZBPro Diagnostic is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in Holter ECG data in the adult, non-paced population.

The product supports downloading and analyzing Lead II, CM5 (Ch 1), or Modified-MLII (Ch 2+) on retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings collected using standard Ag/AgCl wet electrodes in adult, non-paced patients. ZBPro is not intended for use with multi-lead analysis, wearable patches, or pediatric/paced recordings.

ZBPro Diagnostic can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.

ZBPro Diagnostic provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis.

ZBPro Diagnostic is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

ZBPro Diagnostic interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

ZBPro is cloud-based Software as a Medical Device which aids healthcare professionals in interpreting ambulatory ECG recordings. The software comprises a secure web interface and a backend server hosted on Amazon Web Server (AWS). Authenticated users upload compatible 24-48 hour Holter ECG recordings via a web browser through an Application Programming Interface (API). ZBPro's proprietary ECG interpretation algorithm analyzes and annotates ECGs to provide supportive information for ECG and arrhythmia analysis.

ZBPro provides beat-by-beat ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate and Heart Rate Variability measurement, and rhythm analysis.

ZBPro consists of:

1. A web interface which provides tools to upload data, measure, analyze and review numerous ECGs and patient diary logs, make manual annotation and generate ECG reports.
2. An automated proprietary ECG interpretation algorithm which measures and analyzes ECGs to provide adjunct information for ECG diagnosis.

The backend application is established in Amazon Web Services (AWS) and accessed through an Internet connection and a web browser to perform ECG analysis and generate reports.

The provided FDA 510(k) clearance letter and summary for ZBPro Diagnostic contains information related to the device's acceptance criteria and the study conducted to prove it meets them. However, it does not provide explicit details for all the requested points, particularly numerical metrics for acceptance criteria and specific performance results. Instead, it refers to compliance with standards and successful completion of validation.

Here's an extraction of the available information, with notes on what is not explicitly stated:

Acceptance Criteria and Reported Device Performance

The document states that "All clinical input requirements were validated against a gold standard," and "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database in accordance with ANSI/AAMI EC57 and IEC 60601-2-47 reporting conventions." This implies the acceptance criteria were defined by these standards. However, the exact numerical thresholds for sensitivity, specificity, accuracy, etc., for each specific arrhythmia or beat type, are not explicitly stated in the provided text. Similarly, the reported numerical device performance (e.g., specific percentages for sensitivity or specificity) is also not given.

The table below reflects what can be inferred or is directly mentioned regarding the device's performance against its expected functions, without specific quantitative results.

Study Details:

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

   • Test Set Sample Size: The document mentions "an adjudicated database" for performance validation testing but does not specify the sample size (number of patients or recordings) used for this test set.
   • Data Provenance: The document does not specify the country of origin of the data. It states the testing was done on "retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings." This confirms the data was retrospective.

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

   • The document states "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database." This implies that experts were involved in adjudication to establish ground truth. However, the number of experts used and their specific qualifications (e.g., radiologist with X years of experience) are not explicitly stated.

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

   • The term "adjudicated database" is used, indicating that a formal process was followed to establish ground truth. However, the specific adjudication method (e.g., 2+1, 3+1) is not explicitly described in the provided text.

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 MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned. The study described focuses on the standalone performance of the algorithm against an adjudicated ground truth and user interface usability.

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

   • Yes, a standalone performance evaluation of the algorithm was conducted. The document states: "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database." This refers to the algorithm's performance independent of a human-in-the-loop scenario.

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

   • The ground truth was established through expert consensus/adjudication, as indicated by the phrase "adjudicated database."

7. The sample size for the training set:

   • The document does not provide any information regarding the sample size of the training set used for the ZBPro Diagnostic algorithm.

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

   • The document does not provide any information on how the ground truth for the training set was established. It only refers to the "adjudicated database" for performance validation testing (typically the test set).

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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes.

The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed monitors B105M, B125M, B155M, B105P and B125P are new version of multi-parameter patient monitors developed based on the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490) to provide additional monitored parameter Bispectral Index (BIS) by supporting the additional optional E-BIS module (K052145) which used in conjunction with Covidien BISx module (K072286).

In addition to the added parameter, the proposed monitors also offer below several enhancements:

• Provided data connection with GE HealthCare anesthesia devices to display the parameters measured from anesthesia devices (Applicable for B105M, B125M and B155M).
• Modified Early Warning Score calculation provided.
• Separated low priority alarms user configurable settings from the combined High/Medium/Low priority options.
• Provided additional customized notification tool to allow clinician to configure the specific notification condition of one or more physiological parameters measured by the monitor. (Applicable for B105M, B125M and B155M).
• Enhanced User Interface in Neuromuscular Transmission (NMT), Respiration Rate and alarm overview.
• Provided Venous Stasis to assist venous catheterization with NIBP cuff inflation.
• Supported alarm light brightness adjustment.
• Supported alarm audio pause by gesture (Not applicable for B105M and B105P).
• Supported automatic screen brightness adjustment.
• Supported network laser printing.
• Continuous improvements in cybersecurity

The proposed monitors B105M, B125M, B155M, B105P and B125P retain equivalent hardware design based on the predicate monitors and removal of the device Trim-knob to better support cleaning and disinfecting while maintaining the same primary function and operation.

Same as the predicate device, the five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options. There is no change from the predicate in the display size.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters which include CO2 and Gas parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardiac Output parameter provided by the E-COP module (K052976), Neuromuscular Transmission (NMT) parameter provided by E-NMT module (K051635) and thermal recorder B1X5-REC.

The proposed monitors B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes. Do not attempt to use these devices to detect sleep apnea.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P also can interface with a variety of existing central station systems via a cabled or wireless network which implemented with identical integrated WiFi module. (WiFi feature is disabled in B125P/B105P).

Moreover, same as the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P include features and subsystems that are optional or configurable, and it can be mounted in a variety of ways (e.g., shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided FDA 510(k) clearance letter and summary for K242562 (Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P) do not contain information about specific acceptance criteria, reported device performance metrics, or details of a study meeting those criteria for any of the listed physiological parameters or functionalities (e.g., ECG or arrhythmia detection).

Instead, the documentation primarily focuses on demonstrating substantial equivalence to a predicate device (K213490) by comparing features, technology, and compliance with various recognized standards and guidance documents for safety, EMC, software, human factors, and cybersecurity.

The summary explicitly states: "The subject of this premarket submission, the proposed monitors B105M/B125M/B155M/B105P/B125P did not require clinical studies to support substantial equivalence." This implies that the changes introduced in the new device versions were not considered significant enough to warrant new clinical performance studies or specific quantitative efficacy/accuracy acceptance criteria beyond what is covered by the referenced consensus standards.

Therefore, I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists numerous standards and tests performed, but not specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not explicitly stated for performance evaluation, as clinical studies were not required. The usability testing mentioned a sample size of 16 US clinical users, but this is for human factors, not device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance studies requiring expert ground truth are not described.
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 device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "Bench testing related to software, hardware and performance including applicable consensus standards," which implies standalone testing against known specifications or simulated data. However, specific results or detailed methodologies for this type of testing are not provided beyond the list of standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated for performance assessment. For the various parameters (ECG, NIBP, SpO2, etc.), it would typically involve reference equipment or validated methods as per the relevant IEC/ISO standards mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that would require explicit training data in the context of this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating that the new monitors are substantially equivalent to their predicate through feature comparison, adherence to recognized standards, and various non-clinical bench tests (e.g., hardware, alarms, EMC, environmental, reprocessing, human factors, software, cybersecurity). It does not contain the detailed performance study results and acceptance criteria typically found for novel diagnostic algorithms or AI-driven devices.

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The Globe PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.

The Globe Pulsed Field System (Globe PF System) comprises the following components and accessories to support anatomical and electrophysiological mapping, and pacing stimulation of cardiac tissue:

• Globe Controller: Used for the acquisition and processing of signals for cardiac anatomical and electrophysiological mapping, generation of mapping energy and stimulation pulses.

• Globe Workstation: A PC workstation configured with the Globe Software, which the clinician uses to assess contact between the mapping catheter electrodes and the atrial wall, map the atrial electrical activity, and apply stimulation pulses for diagnostic purposes.

• Globe Positioning System (GPS™) Electrodes and GPS Cable: Surface electrodes and cables for localization of the mapping catheter.

The provided FDA 510(k) clearance letter and summary for the Globe® Pulsed Field System do not contain the detailed information required to answer all parts of your request. This document primarily focuses on establishing substantial equivalence to a predicate device based on intended use, indications for use, and a high-level comparison of technological characteristics.

Specifically, the document does not include:

• Specific acceptance criteria values (e.g., minimum sensitivity, specificity, or accuracy targets).
• The reported device performance against such criteria.
• Detailed information about the study design for clinical or performance evaluation (e.g., test set sample size, provenance, expert qualifications, ground truth establishment methods, or whether MRMC studies were conducted).
• Training set details.

Therefore, I can only provide information directly extractable from the given text.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: NOT PROVIDED. The document mentions "performance testing" but does not specify the sample size for any clinical or test data used to evaluate the device.
• Data Provenance: NOT PROVIDED. No information is given regarding the country of origin of data or whether it was retrospective or prospective.

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

• NOT PROVIDED. The document does not detail any expert involvement for ground truth establishment in performance testing.

4. Adjudication method for the test set

• NOT PROVIDED. No information is available regarding any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results.

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 PROVIDED. The document does not mention any MRMC comparative effectiveness study or any evaluation of human reader improvement with AI assistance. The device description focuses on its mapping and stimulation capabilities, not AI-assisted interpretation.

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

• NOT PROVIDED. While software verification and validation were performed, the document does not specify whether "standalone" performance (without human-in-the-loop) was a distinct part of the performance evaluation, or what specific algorithms were evaluated in such a manner. The device is a "Programmable diagnostic computer" that aids clinicians.

7. The type of ground truth used

• NOT PROVIDED. The general "performance testing" and "software verification and validation" are mentioned, but the specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for evaluation is not described. For the CONTACT and FLOW maps, it mentions they are "based on the same principles of operation as the reference device (Swan-Ganz catheter, K160084)" and that "the scientific methods used to evaluate the safety and effectiveness... are adequate." This suggests a comparison to established methods or a reference standard, but not explicit "ground truth" as you might see for diagnostic classifications.

8. The sample size for the training set

• NOT PROVIDED. The document does not mention a "training set" or any details about it. This submission is for a medical device that includes software, but it doesn't specify if it employs machine learning or requires a distinct "training set" in the common understanding of AI/ML development.

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

• NOT PROVIDED. As no training set is mentioned, naturally, no information on its ground truth establishment is available.

Summary of Device and Study Information (based on available text):

• Device Name: Globe® Pulsed Field System
• Intended Use/Indications for Use: Catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.
• Study Type: Performance testing (bench, biocompatibility, usability, electrical safety, EMC, software V&V, cybersecurity, packaging validation) to demonstrate substantial equivalence to a predicate device.
• Predicate Device: Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828)
• Reference Device: Swan-Ganz Catheter (K160084) (for CONTACT and FLOW maps)
• Key Finding for Equivalence: "The Globe PF System meets the performance criteria for its intended use and does not raise new questions on safety or effectiveness compared to the predicate device."

The FDA 510(k) clearance letter and summary are high-level documents focused on regulatory substantial equivalence. They typically do not delve into the granular details of performance study designs, such as specific sample sizes, expert qualifications, or ground truth methodologies, to the extent that you are asking. Such detailed information would typically be found in the full 510(k) submission itself, which is not publicly released in its entirety.

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The PhysCade System is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.

The clinical significance of utilizing the PhysCade System to help identify areas with intra-cardiac atrial electrograms exhibiting local early activated potentials and other features of interest during atrial arrhythmias has not been established by clinical investigations.

The PhysCade™ System (PhysCade) is an artificial intelligence (AI) enabled device intended to assist clinicians in their management of patients with heart rhythm disorders (arrhythmias). PhysCade is a medical decision support system which post-processes electrograms (EGMs) collected inside the heart during electrophysiology (EP) mapping procedures using compatible diagnostic EP catheters. The PhysCade software has advanced algorithms that analyze the collected EGMs to provide information on regions of interest in the heart that may be useful to the clinician to support clinical decisions together with other available patient-related information.

PhysCade provides specialized analyses of data from a compatible multipolar catheter. The primary output (coPILOT) indicates the predominant earliest site of activation relative to the catheter electrode array. Supporting outputs include determining activation times of successive beats in the EGM signal on each electrode (coMAP), voltage at each electrode, signal quality, and sequences of propagation over multiple beats of the arrhythmia on the catheter.

The PhysCade System consists of a computer workstation, display, and custom software and is not connected to other devices or medical equipment.

The provided FDA 510(k) Clearance Letter for the PhysCade System gives some information about the device's development and testing, particularly regarding its AI algorithms. However, it does not explicitly detail the acceptance criteria or the specific results of a study proving the device meets those criteria, nor does it provide the requested levels of detail for the ground truth establishment, expert qualifications, or MRMC study results.

Based on the information provided, here's what can be extracted and inferred for the requested points. Where information is not present, it is explicitly stated.

Acceptance Criteria and Device Performance Study

The document states, "Design Validation confirmed that the AI/ML system is accurate for its intended use." This indicates that performance testing was conducted. However, the specific quantitative acceptance criteria (e.g., a specific F1 score, accuracy, sensitivity, or precision threshold) and the resulting performance metrics the device achieved are not explicitly stated in this document.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • Test Set Sample Size:
     • Number of electrograms: ~5 Million
     • Number of patients: 109
   • Data Provenance: The document does not explicitly state the country of origin.
   • Retrospective or Prospective: The document does not explicitly state whether the data was collected retrospectively or prospectively. It references "datasets with the following characteristics" suggesting pre-collected (likely retrospective) data.

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

   • Number of Experts: NOT PROVIDED.
   • Qualifications of Experts: NOT PROVIDED. The document only mentions that the device is for "analysis by a physician" and is "intended to be operated by nurses, technicians, physicians, or other personnel who are trained and approved by each treating facility." It does not specify who established the ground truth or their qualifications.

3. Adjudication method for the test set:

   • Adjudication Method: NOT PROVIDED. The document does not describe how disagreements, if any, among experts establishing ground truth were resolved.

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:

   • MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The performance testing described focuses on the device's accuracy ("Design Validation confirmed that the AI/ML system is accurate for its intended use"), rather than human performance improvement.
   • Effect Size: NOT APPLICABLE as no MRMC study is mentioned.

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

   • Standalone Performance: While not explicitly stated as "standalone performance," the phrase "Design Validation confirmed that the AI/ML system is accurate for its intended use" strongly implies a standalone performance evaluation of the algorithm's output against established ground truth. The device "provides information on regions of interest in the heart that may be useful to the clinician to support clinical decisions," suggesting the AI's output is evaluated directly.

6. The type of ground truth used:

   • Type of Ground Truth: The document states the device "analyzes the collected EGMs to provide information on regions of interest in the heart that may be useful to the clinician." It further notes the "primary output (coPILOT) indicates the predominant earliest site of activation relative to the catheter electrode array." The ground truth would therefore pertain to the identification of these "regions of interest" or the "earliest site of activation" based on expert interpretation of electrophysiological data. The exact method of establishing this ground truth (e.g., expert consensus on EGM analysis, correlation with other diagnostic modalities, or clinical outcomes) is NOT EXPLICITLY STATED.

7. The sample size for the training set:

   • Training Set Sample Size:
     • Number of electrograms: ~15 Million
     • Number of patients: 174

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

   • Ground Truth Establishment for Training Set: The document does not explicitly state how the ground truth for the training set was established. It only describes the characteristics of the training, tuning, and test cohorts. It is commonly understood that ground truth for training data is established by similar means to test data (e.g., expert annotation), but this is not detailed here.

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The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.

The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.

The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.

The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.

The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.

The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Devices with Masimo technology are only indicated for use with Masimo accessories.

Radius VSM Accessories:

Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.

Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and accessories are an FDA cleared (K223498), wearable, battery-operated, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of different monitoring technologies based upon the hospital and clinician's assessment of what technologies are appropriate.

As part of this submission, a MAP feature is being added to the Radius VSM. The feature is a software feature that uses the previously cleared systolic and diastolic measurement capabilities to automate the calculation of MAP using the following formula: MAP = 1/3* Systolic + 2/3*Diastolic.

The MAP is calculated by the Radius VSM NIBP Module and displayed on the Radius VSM Wearable Monitor. There were no other features added as part of this submission.

The provided 510(k) clearance letter and summary discuss the addition of a Mean Arterial Pressure (MAP) feature to the previously cleared Radius VSM and Accessories device. The primary focus of the performance data section is on validating this new MAP feature.

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

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criterion for Blood Pressure (including MAP) is:

"Meets ISO 81060-2 (Mean difference of ≤5 mmHg with a standard deviation of ≤8 mmHg)"

The document directly states that the results of the clinical testing supported the clinical performance of the MAP in accordance with ISO 81060-2. While specific numerical results (e.g., the exact mean difference and standard deviation achieved) are not explicitly provided in the summary table, the clearance implies that these metrics fell within the specified ISO 81060-2 limits for the MAP feature.

Table 1: Acceptance Criteria and Reported Device Performance for MAP Feature (as inferred from the document)

Study Details for MAP Feature Validation

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not explicitly state the numerical sample size (number of subjects/patients) used for the clinical test set. It only mentions "clinical study data."
   • Data Provenance: The document does not specify the country of origin. It indicates it was a "clinical study" and implies it was prospective ("clinical testing is provided to support its performance" for the added feature).

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

   • Not applicable as the ground truth was established by an objective reference device, not human experts.

3. Adjudication Method for the Test Set:

   • Not applicable, as the method for ground truth establishment was comparison to a reference device.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. The study was a comparison of the device's calculated MAP to invasively measured MAP from a reference device. This is a technical performance validation, not a study assessing human reader improvement with AI assistance.

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

   • Yes, this was a standalone performance study. The Radius VSM automatically calculates the MAP based on the NIBP measurements (Systolic and Diastolic Pressure). The clinical testing validated the accuracy of this calculation against a reference standard, without human intervention in the MAP calculation or interpretation for the test itself.

6. The Type of Ground Truth Used:

   • Reference Ground Truth: Invasively measured MAP values from a 510(k) cleared reference device (K171801). This reference device is identified as "IntelliVue Multi-Measurement Module X3." This constitutes a device-based reference standard or instrument-based ground truth.

7. The Sample Size for the Training Set:

   • The document does not provide information about a training set since the MAP feature appears to be a direct calculation using a standard formula (MAP = 1/3* Systolic + 2/3*Diastolic) rather than a machine learning model that requires a training phase. While the device as a whole (Radius VSM) likely had training and validation phases for its other parameters, the specific "addition of a Mean Arterial Pressure (MAP) feature" is described as a software feature that "automates the calculation" using a known formula. Therefore, a separate training set for this specific MAP feature is unlikely to have been required or used in the conventional machine learning sense.

8. How the Ground Truth for the Training Set was Established:

   • As inferred above, a specific training set and ground truth establishment for this isolated MAP calculation feature are not described, given its nature as a direct formulaic calculation.

Summary of Key Information:

The core of this submission revolves around adding a simple, formula-based calculation for MAP. The primary study presented is a clinical validation confirming that the device's computed MAP aligns with a known industry standard (ISO 81060-2) when compared against an invasive reference device. This is a technical performance validation rather than a complex AI-driven diagnostic study.

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The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor.

The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias.

The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle.

The provided text is a 510(k) Clearance Letter and a 510(k) Summary for the OptiMap™ System. While it details the device, its intended use, and substantial equivalence to a predicate, it does not contain the specific performance study results, acceptance criteria, or details regarding the methodologies of testing (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

The relevant section, "VII. Summary of Non-Clinical Performance Testing," states:

"Software verification and validation testing was completed on the subject device demonstrating that the OptiMap System with Version 1.3 Software (including ACP functionality) successfully performed at the unit, integration and system levels. All open issues from the verification and validation activities have been resolved or documented as unresolved anomalies. The OptiMap System met the acceptance criteria listed in the test protocols, performs as designed, and is suitable for its intended use."

This statement confirms that testing was performed and acceptance criteria were met, but it does not provide the specific criteria or the quantitative results of these tests. Therefore, I cannot populate the requested tables and information based solely on the provided text.

To answer your request, the necessary information (specific performance metrics, acceptance thresholds, sample sizes, ground truth details, etc.) would typically be found in the actual validation study report, which is not part of this 510(k) clearance letter or summary.

If such a document were available, the information would likely be organized as follows:

Acceptance Criteria and Device Performance Study

Since the provided text does not contain the specific performance study details, the following tables and sections are illustrative, showing what information would be required to fulfill the request. This information was not found in the provided 510(k) document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: (Not provided in the document. Would typically specify number of patient cases, EGM recordings, or arrhythmias analyzed.)
• Data Provenance: (Not provided in the document. Would specify country of origin, if retrospective or prospective data collection, and if multi-center.)

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: (Not provided in the document. Would specify the count of experts.)
• Qualifications of Experts: (Not provided in the document. Would specify their medical specialization, board certifications, and years of experience, e.g., "3 Board-Certified Electrophysiologists, each with >10 years of experience in cardiac arrhythmia diagnosis and treatment.")

4. Adjudication Method for the Test Set

• Adjudication Method: (Not provided in the document. Common methods include:
  • 2+1: Two experts review independently, and a third adjudicates disagreements.
  • 3+1: Three experts review independently, and a fourth adjudicates if necessary, or majority agreement is used.
  • Consensus: All experts discuss and reach a consensus.
  • None: A single expert's reading is considered ground truth, or adjudicated by a pre-defined process.)

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

• MRMC Study Conducted?: (Not provided in the document. Typically stated if human-in-the-loop performance with and without AI assistance was evaluated.)
• Effect Size (if applicable): (Not provided in the document. Would quantify the improvement in human reader performance, e.g., "Radiologists' diagnostic accuracy improved by X% (from Y% to Z%) when using OptiMap™ System assistance compared to without assistance.")

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Conducted?: Yes, the summary for "Software verification and validation" implies that the system's performance was evaluated independently, as it describes the system successfully performing at unit, integration, and system levels. However, the specific metrics and results are not detailed.

7. Type of Ground Truth Used

• Type of Ground Truth: (Not provided in the document. For cardiac arrhythmia diagnosis, this could be:
  • Expert Consensus: Agreement among multiple expert electrophysiologists based on clinical data.
  • Electrogram Analysis: Detailed analysis of raw EGM signals by experts, potentially correlated with clinical outcomes.
  • Clinical Outcomes Data: Correlation with patient outcomes (e.g., successful ablation, recurrence of arrhythmia).
  • Pathology/Histology: Less common for electrophysiology mapping, but relevant for some cardiac conditions.)

8. Sample Size for the Training Set

• Training Set Sample Size: (Not provided in the document. This is distinct from the test set and crucial for machine learning model development.)

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: (Not provided in the document. Similar methods to the test set ground truth would apply, but often with a larger scale and potentially more automated or semi-automated labeling steps initially, followed by expert review.)

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