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HemoSphere Alta™ Advanced Monitoring Platform with Swan-Ganz™ Technology

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere Alta Swan-Ganz™ Patient Cable and 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 be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Swan-Ganz™ Catheter and Swan-Ganz Jr™ Catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz™ Catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

When used in combination with a Swan-Ganz™ Catheter connected to a pressure cable and pressure transducer, the Smart Wedge™ Algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressure measurement. The Smart Wedge™ Algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge™ Algorithm 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 Smart Wedge™ Algorithm parameters.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Oximetry Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Oximetry Cable and 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 oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor - Pressure Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – 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 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 Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) 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™ Parameter.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm 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 Right Ventricular Pressure (RVP) parameters.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical or non-surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac Output provides a continuous cardiac output and derived parameters.

The Cerebral Autoregulation Index (CAI) algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere™ Pressure Cable and StO2 is acquired by the ForeSight™ Oximeter Cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) algorithm.

HemoSphere Alta Advanced Monitoring Platform with 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 Alta™ Advanced Monitoring Platform.

• 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 <8 kg and non-cerebral use on pediatric subjects <5kg.

The algorithm for measurement of blood hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight™ Oximeter Cable and noninvasive ForeSight IQ™ Sensors in cerebral locations.

HemoSphere Alta™ Advanced Monitoring Platform with Non-invasive technology

The HemoSphere Alta™ Monitor when used with the pressure controller and a compatible finger cuff are indicated for adult and pediatric patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere Alta™ Advanced Monitor and compatible finger cuffs non-invasively measures blood pressure and associated hemodynamic parameters. Refer to the non-invasive finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) 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™ Parameter.

HemoSphere Alta Advanced Monitoring Platform 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 HemoSphere Alta Advanced Monitoring Platform is the next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates existing hemodynamic monitoring technologies into a unified platform.

The HemoSphere Alta Advanced Monitoring Platform's FDA 510(k) clearance letter and associated 510(k) summary (K252533) primarily focus on software modifications and the integration of previously cleared hardware components to an existing platform (K242451). The document states that no new clinical testing was performed in support of the subject 510(k). Therefore, the information provided mainly pertains to performance verification studies rather than standalone clinical performance studies involving ground truth establishment by experts for a novel algorithm.

However, based on the provided text, we can infer the acceptance criteria and study information as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several verification activities without providing specific numerical acceptance criteria for each, except implicitly stating "All tests passed" or "All acceptance criteria were met."

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

• For Usability Study: The document mentions "the intended users." It does not specify the numerical sample size of users or the provenance of the data (e.g., retrospective or prospective, country of origin).
• For Non-Clinical Performance (Bench Simulation): "Measured and derived parameters were tested using a bench simulation." No sample size in terms of patient data or data provenance is applicable here, as it's a bench test.
• For Software Verification: "Extensive software verification testing was conducted." No specific sample size of test cases or data provenance is provided.
• For Clinical Performance: "No new clinical testing was performed in support of the subject 510(k)." This indicates no patient-level test set data was used for this specific submission. The algorithms within the device (e.g., GHI, Smart Wedge, HPI, CAI, RVP, RVCO, AFM) likely had clinical performance studies for their initial clearances, but those details are not provided in this 510(k) for the HemoSphere Alta platform updates.

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

• As "no new clinical testing was performed" for this 510(k) submission, there is no mention of experts establishing ground truth for a new clinical test set.
• For the Usability Study, "intended users" participated, implying clinical professionals, but their specific qualifications or their role in establishing "ground truth" (beyond identifying usability issues) are not detailed.

4. Adjudication Method for the Test Set

• Since no new clinical test set data with expert adjudication is described in this submission, no adjudication method is mentioned.

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

• The document does not mention any MRMC comparative effectiveness study comparing human readers with and without AI assistance for this 510(k) submission.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

• While the device contains various algorithms (e.g., GHI, HPI, Smart Wedge, CAI, RVP, RVCO, AFM), this 510(k) primarily addresses software updates and hardware integration to an existing platform. It doesn't detail standalone performance studies for these specific algorithms within this document. The description of these algorithms (e.g., "additional information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions") implies a non-standalone, assistive role, but explicit standalone performance studies are not part of this submission's provided information.

7. Type of Ground Truth Used

• "No new clinical testing was performed." Therefore, for this specific 510(k) submission, no new patient-level ground truth (expert consensus, pathology, outcomes data, etc.) was established for performance evaluation of new algorithms or features. The verification activities relied on bench simulations and usability testing, not clinical ground truth.

8. Sample Size for the Training Set

• The document pertains to the clearance of a device (HemoSphere Alta Advanced Monitoring Platform) with software modifications and hardware integration, not the development or training of new AI algorithms. Therefore, no information on the sample size of a training set is provided. The algorithms included in the HemoSphere Alta system (e.g., GHI, HPI, CAI) would have been developed and trained using data sets prior to their initial clearance. This current 510(k) does not detail those previous training sets.

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

• Similar to the training set sample size, this information is not provided in this 510(k) document, as it focuses on software updates and hardware integration to an already cleared platform, not the initial development and training of novel algorithms.

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The N10, N12, N15, N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (O2) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:

• Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
• NIBP measurement continual mode is not applicable to neonates.
• When using COMEN SpO2, the monitor is intended to be used on adult patient only.
• PAWP is intended for adult and pediatric patients only.
• C.O. measurement is intended for adult patients only.
• BIS monitoring is intended for adult patients only.
• RM is intended for adult and pediatric patients only.
• NMT monitoring is intended for adult and pediatric patients only.

The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.

The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.

The monitors are not intend for use as apnea monitors.

The monitors are not intended for use in MRI or CT environments.

The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

There are six (6) models under evaluation, namely N10, N12, N15, N10MPro, N12MPro, N15MPro. All models share the same intended condition of use, the same intended patient population and operator profile, biological safety characteristic and principle of operation. All these models are the same on electric and electrical circuit and components, mechanical construction, software and alarm system. The only difference lies on the screen and configuration of with/without plug-in module slot and the number of battery packs.

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Withings BeamO is intended to record, display (when prescribed or used under the care of a physician), store, and transfer single-channel electrocardiogram (ECG) rhythms. It is indicated for use with individuals 22 years and older.

Withings BeamO is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages.

Withings BeamO is also an electronic stethoscope that enables the recording and transmission of auscultation sound data. Withings BeamO is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages. The electronic stethoscope is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

Withings BeamO, model name SCT02, is a multi-function handheld battery powered device with ECG, stethoscope, temperature capabilities. Withings BeamO can record a 1-lead ECG using two stainless steel electrodes. It analyzes the data collected by the integrated two stainless steel electrodes to generate an one-lead ECG waveform and provides the ECG recording to the user for a given 30 second measurement.

Withings BeamO is also a contactless thermometer that can measure body temperature in adjusted mode.

Withings BeamO is also a digital stethoscope that can be used to auscultate heart and lung sounds. The sensor generates an electric charge when subjected to mechanical vibrations. The charge variations are amplified and digitized by an audio codec. Sound filters are applied to the resulting sound wave in order to listen to the patient's heart and lung sounds with clarity.

Withings BeamO consists of hardware and embedded software. Withings BeamO works in conjunction with a companion software on the Withings App. Withings BeamO communicates with the companion software via Bluetooth Low Energy (BLE). The device measurement results and recordings are synchronized with the companion software using Wi-Fi/Cellular data via the Withings servers.

Withings BeamO does not include ECG analysis or ECG-derived heart rate functionalities.

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Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.

F15A series fetal and maternal monitors mainly provide following primary feature:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do 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 focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.

Specifically, the document does not include information on:

• A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
• Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
• Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
• Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
• Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
• Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.

Therefore, based solely on the provided text, I can only address what is present or infer what is missing.

Here's a breakdown based on the available information:

Analysis of Acceptance Criteria and Performance Testing based on Provided Document

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.

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

The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:

• IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
• ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
• ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
• IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).

Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.

Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not provided in this summary.

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

The document mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:

• Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
• Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance validation.

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 is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:

• Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
• Physical standards/phantoms: e.g., temperature baths at known temperatures.
• Known physical properties: e.g., precise weights for pressure transducers.

Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.

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

This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.

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

This is not applicable and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.

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

The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.

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

As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.

8. The sample size for the training set

This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.

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

This is not applicable and not provided for the same reasons as point 8.

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The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), and cardiac output (C.O.).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatric patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

The CX&UX series Patient Monitor including CX10/CX12/CX15/UX10/UX12/UX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.

Minor differences from the predicate device are limited to some modifications of monitoring parameter specifications. These updates do not change the fundamental scientific technology of the cleared predicate device and thus do not raise any questions about the safety and effectiveness of the subject device.

The provided FDA 510(k) clearance letter details the device's technical specifications and comparisons to predicate devices, along with the non-clinical performance data and adherence to various IEC and ISO standards. However, it explicitly states: "Clinical data: The subject device did not require new clinical studies to support substantial equivalence."

This means that the submission for this Patient Monitor device (CX10, CX12, CX15, UX10, UX12, UX15) relies on demonstrating substantial equivalence to a legally marketed predicate device (Edan Instruments, Inc., Patient Monitor Model iX10, iX12, iX15, K232962) through non-clinical performance testing and software verification/validation, rather than new clinical trials or studies involving human patients.

Therefore, the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria through clinical performance (e.g., sample size for test set, expert involvement, MRMC studies, ground truth establishment for test/training sets, effect size of human reader improvement with AI) cannot be extracted from this document, as such clinical studies were explicitly not required for this 510(k) submission.

The document focuses on demonstrating that the new device's technical specifications and performance are similar to the predicate device, and that it complies with relevant safety and performance standards through bench testing.

Here's what can be extracted from the provided text regarding acceptance criteria and the type of study performed, specifically focusing on the non-clinical aspects:

Device: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

The acceptance criteria for this device are implicitly tied to its performance meeting the standards and accuracy specifications of the predicate device and relevant international standards. Since no new clinical studies were conducted, the "proof" comes from non-clinical bench testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

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

• Sample Size: Not applicable in terms of human subjects or patient data test sets, as "new clinical studies" were not required. The "test set" refers to bench testing and functional system-level validation. The specific number of test cycles or a detailed breakdown of test cases for bench testing is not provided in this summary.
• Data Provenance: The data primarily originates from Edan Instruments Inc. (Shenzhen, Guangdong, China) through internal engineering and quality assurance processes for non-clinical bench testing and software validation. It is not patient data, so concepts like "retrospective or prospective" do not apply.

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

• Not applicable for clinical ground truth: Since no clinical studies were performed requiring human interpretation or diagnosis for a test set, no medical experts (e.g., radiologists) were used to establish ground truth in this context.
• Internal experts: Bench testing and software validation would have involved engineers and quality assurance professionals, whose qualifications are implicit in the quality system (21 CFR Part 820) but not specified in detail here.

4. Adjudication Method for the Test Set:

• Not applicable: Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving multiple readers. This was not a clinical study. Bench testing relies on established technical specifications and standard compliance.

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

• No: No MRMC study was performed as no new clinical studies were required or conducted. Therefore, there's no effect size of human readers improving with AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

• Yes (for the technical components): The "performance testing-Bench" effectively represents a standalone evaluation of the device's functional components (ECG, NIBP, SpO2, etc.) and software against defined technical specifications and standards. The "software verification and validation testing" also represents a standalone evaluation of the algorithm and software functions. The specific algorithms (e.g., iCUFS, iFAST for NIBP, arrhythmia analysis logic) are tested independently for their accuracy against known inputs or reference standards as part of bench testing.

7. The Type of Ground Truth Used:

• Technical/Reference Standards: For the bench testing, the "ground truth" would be derived from:
  • Reference standards/simulators: Calibrated medical equipment, physiological simulators, and test signals (e.g., known ECG waveforms, simulated blood pressure readings, temperature standards) are used to provide the "true" values against which the device's measurements are compared.
  • Defined specifications: The device's internal design specifications and the requirements of the referenced IEC/ISO standards serve as the "ground truth" for compliance testing.
• Not clinical ground truth: No expert consensus, pathology, or outcomes data from real patients were used for establishing ground truth for this submission.

8. The Sample Size for the Training Set:

• Not applicable: The device is a patient monitor, not a machine learning/AI algorithm that typically undergoes a distinct "training" phase with a large dataset. Its functionality is based on established physiological measurement principles and programmed algorithms. Any internal calibration or algorithm refinement would be part of the product development process, not a dedicated "training set" in the AI/ML sense.

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

• Not applicable: As there was no "training set" in the context of an AI/ML model, the concept of establishing ground truth for it does not apply to this 510(k) submission.

In summary, this 510(k) clearance relies on demonstrating that the new Patient Monitor is substantially equivalent to a previously cleared predicate device, primarily through robust non-clinical bench testing and software validation, proving compliance with established medical device standards and functional specifications. No new clinical studies with patient data were required or conducted for this specific submission.

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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 <8 kg and non-cerebral use on pediatric subjects <5kg.

  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 ClearSight Module: The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller or Smart Pressure Controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. The Edwards Lifesciences Acumen Hypotension Prediction Index 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 Hypotension Prediction Index (HPI) parameter.

• Indication for Acumen IQ Plus and VitaWave Plus finger cuffs: The Acumen IQ Plus and VitaWave Plus finger cuff adult indicated for patients over 18 years of age to continuously blood pressure and associated hemodynamic parameters when used with a compatible Edwards monitoring platform.

• Smart Pressure Controller: The Smart Pressure Controller is intended for use with an Edwards compatible noninvasive monitoring system - composed of compatible monitor, pressure source (pump), compatible Edwards finger cuff(s) and pressure controller - for continuous noninvasive measurement of blood pressure and associated hemodynamic parameters. Refer to the operator's manual of the compatible Edwards monitor being used for specific information on the intended use environment and patient population.

• Intended Use: The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The Viewfinder remote mobile application can be used for supplemental near real-time remote display of monitored hemodynamic parameter data as well as faults, alerts and notifications generated by the HemoSphere advanced monitoring platform. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, Swan-Ganz Jr catheters, FloTrac sensors, FloTrac Jr sensors, Acumen IQ sensors, TruWave disposable pressure transducers, ForeSight/ForeSight Jr sensors, Acumen IQ fluid meter, and ClearSight/ClearSight Jr/Acumen IQ/Acumen IQ Plus/VitaWave/VitaWave Plus finger cuffs

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 < Z") or reported performance values are publicly disclosed in this summary for any parameter, including HPI or AFM. For measured and derived parameters (like CO, MAP, etc.), it states they were tested using bench simulation, and "All tests passed," implying they met internal accuracy specifications for physical measurements, but these are not detailed.

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

Cannot be provided from the given text. The document mentions "bench simulation" for measured and derived parameters, but does not provide sample sizes for these, or the type/provenance of data for testing the HPI or AFM algorithms.

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)

Cannot be provided from the given text. The document doesn't describe the process of establishing ground truth for the algorithms, nor does it mention the number or qualifications of experts involved in such a process.

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

Cannot be provided from the given text. There is no mention of adjudication methods for any test sets.

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

Cannot be provided from the given text. The document does not describe any MRMC studies or human-in-the-loop performance evaluation regarding the HPI or AFM features. The HPI and AFM features are described as providing "physiological insight" and "suggestions," not as tools requiring reader interpretation in a comparative effectiveness study as typically seen with imaging AI.

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

Likely yes, based on the nature of the algorithms, but no specific performance metrics are provided. The HPI and AFM features are stated to provide "quantitative information" and "suggestions." The text indicates "System Verification (Non-Clinical Performance)" and "Software Verification" were performed, suggesting standalone evaluation against internal specifications, but no detailed results are provided. The HPI algorithm itself was "previously cleared in K230057," implying its standalone performance would have been evaluated during that prior clearance, but those details are not in this document.

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

Cannot be definitively stated from the given text. For the HPI feature, which predicts future hypotensive events, ground truth would typically involve actual patient outcomes (e.g., observed hypotensive events). For AFM, which suggests response to fluid therapy, ground truth might involve observed physiological responses to fluid boluses. However, the document does not specify how these ground truths were established for the purpose of testing the algorithms.

8. The sample size for the training set

Cannot be provided from the given text. The document does not mention details about the training data for the algorithms.

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

Cannot be provided from the given text. The document does not mention details about the training data or its ground truth establishment.

Summary of Device Features Mentioned in Relation to Performance/Testing (General):

• HemoSphere Advanced Monitor and various modules/accessories: The document primarily describes this as a monitoring platform for various hemodynamic parameters (CO, SvO2, MAP, etc.). Performance for these measured and derived parameters was tested via "bench simulation," and "All tests passed," implying they met internal benchmarks for accuracy and reliability.
• Acumen Hypotension Prediction Index (HPI) software feature: This feature provides "physiological insight into a patient's likelihood of future hypotensive events." It was integrated from a previously cleared device (K230057). The document states "There are no changes to the Acumen HPI algorithm from what was cleared in K230057." This implies that the acceptance criteria and supporting studies for the HPI algorithm itself would be found in the K230057 clearance documentation, not typically resubmitted in detail for integration into another platform unless the integration process significantly altered its functionality or intended use.
• Acumen Assisted Fluid Management (AFM) software feature: This feature provides "physiological insight into a patient's estimated response to fluid therapy" and "suggestions." It also mentions "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." This language suggests it's a supportive, advisory tool, rather than a diagnostic one requiring strict accuracy metrics in the same way. No performance specifics for AFM are given.
• Usability Study: Conducted to ensure primary operating functions and critical tasks can be performed without patient or user harm. Determined that "intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm." This is an acceptance criterion for human factors, but not for algorithmic performance.
• Electrical Safety and EMC, Software Verification: All tests passed. These are general product safety and quality criteria, not specific to the performance of the predictive algorithms.

To obtain the detailed performance data, acceptance criteria, sample sizes, and ground truth information for the HPI or AFM algorithms, one would typically need to refer to the original 510(k) submission for the HPI algorithm (K230057) and potentially separate documentation for the AFM feature, which are not included in this general clearance letter for the HemoSphere platform update.

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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 Ear Thermometer is intended to measure human body temperature of people over three months from surface of eardrum. It applies to both professional use and home use.

The ear thermometer is a handheld device that displays the temperature of the measured patient by measuring the thermal radiation of the eardrum. Measurement unit: °C or °F. The results can be displayed on LCD. The thermometers are powered by 1.5V×2 (AAA or AA) alkaline batteries, which can be used for people over three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum, which is converted into temperature measurement with the unit of °C or °F. All the models share the same critical components, intended use, working principle and similar product design, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, unit switch, low battery detection and high temperature indicator.

The FDA 510(k) clearance letter and accompanying 510(k) Summary for the Ear Thermometers (EAR-E101, EAR-E102, EAR-E103) provide information on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Jiangsu Yuyue Medical Equipment & Supply Co., Ltd, Infrared Ear Thermometers YHT101 and YHT200, K203583). Thus, the "acceptance criteria" are largely framed as demonstrating equivalence or adherence to relevant standards. The performance data is presented in comparison to the predicate and overall compliance with standards.

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

• Non-clinical Data (Bench Testing): The document does not specify a "sample size" in terms of number of devices for bench testing. It states that "The device has been tested according to the following standards," implying tests were performed on representative samples to ensure compliance.
• Clinical Data: The summary states, "The clinical testing has been conducted per ISO 80601-2-56 Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement." However, the specific sample size (number of patients/measurements) and data provenance (e.g., country of origin, retrospective/prospective) for this clinical study are NOT provided in the given document.

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

• Clinical Data: The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. As it's an ear thermometer, the "ground truth" would typically come from a reference temperature measurement method (e.g., rectal thermometry) rather than expert interpretation of an image or signal.

4. Adjudication method for the test set:

• Clinical Data: Given that the device measures a quantitative value (temperature), an adjudication method in the context of expert consensus (like multiple readers for an image) is generally not applicable. The comparison would be between the device's reading and the reference method's reading. The document does not describe any specific adjudication method for the clinical test set.

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

• No, an MRMC comparative effectiveness study was NOT done. This type of study (MRMC) is relevant for diagnostic imaging devices where human interpretation plays a significant role, sometimes aided by AI. This document is for an ear thermometer, a direct measurement device, not an AI-assisted diagnostic tool.

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

• Yes, a standalone performance was done for the ear thermometer. The device itself is designed to provide temperature readings directly, without requiring human interpretation or input to calculate the core measurement. The bench and clinical testing described aim to quantify this standalone performance in terms of accuracy and adherence to standards.

7. The type of ground truth used:

• Clinical Data: While not explicitly stated, for a clinical thermometer, the ground truth for performance testing is typically established by comparison against a standardized, highly accurate reference thermometer (e.g., a rectal thermometer or an oral thermometer with known accuracy) or a specialized blackbody calibrator in a controlled environment as specified by standards like ISO 80601-2-56. The document mentions "clinical accuracy test" and "performance test," strongly implying such a comparative methodology.

8. The sample size for the training set:

• Not applicable / Not provided. The device is an ear thermometer, which is a sensor-based measurement tool, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's performance is determined by its design, calibration, and adherence to physical principles and engineering specifications, which are validated through bench and clinical testing.

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

• Not applicable. As noted above, the concept of a "training set" and its associated ground truth establishment is not relevant for this type of medical device submission.

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Celsi Warmer is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates.

a. Maintain pre-set body temperature as determined by the physician.
b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg.
c. Monitoring and controlling patient temperature.

The Celsi Warmer is a portable, non-invasive thermal regulating system, indicated for continuous temperature monitoring and thermal treatment of neonates that require extra warmth to maintain normal body temperature. It uses a non-invasive thermometer (using direct mode) that measures the temperature of an infant's skin via a temperature probe placed on their abdomen to provide input into a physiological control loop that controls the mattress temperature. The Celsi Warmer is intended for use in hospitals under a clinician's supervision and is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. The Celsi Warmer is comprised of the following components:

• Warming Mattress
• Controller Tower
• Celsi Temperature Probe and Celsi Belt
• Power Supply and Cables

I apologize, but the provided text from the FDA 510(k) Clearance Letter for the Celsi Warmer does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.

The document focuses on:

• Formal FDA clearance: Confirmation of the 510(k) submission, product classification, and general regulatory requirements.
• Device description and indications for use: What the Celsi Warmer is and what it's intended for.
• Comparison to a predicate device: Highlighting similarities in intent, technology, and use environment.
• Summary of non-clinical testing: A list of standards and types of testing performed (Biocompatibility, Software V&V, EMC/Electrical Safety, Usability).

However, it does not include:

1. A table of specific acceptance criteria and reported device performance: While it mentions testing, it doesn't provide the quantifiable metrics or the results of those tests.
2. Sample sizes for a test set, data provenance, ground truth establishment, or expert details for performance studies.
3. Details about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Information on training set sample sizes or ground truth for training data.

The 510(k) summary typically provides a high-level overview. Detailed performance data, acceptance criteria, and study methodologies (like those involving expert human readers or specific statistical analyses) are usually found in the full 510(k) submission document, which is not publicly available in this format from the clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions based solely on the provided text.

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Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.

The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable

The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.

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

The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.

The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.

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

This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.

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

No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.

7. Type of Ground Truth Used

The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:

• Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
• International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
• Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require a "training set."

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

This information is not applicable. As there is no training set for an AI/ML algorithm involved, no ground truth was established for a training set.

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