Search Results

The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.

The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of age.

The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.

The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.

The FloTrac, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.

The provided FDA 510(k) summary for the FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the typical format requested for an AI/ML-based medical device.

This document describes a substantial equivalence determination for extravascular blood pressure transducers (sensors) manufactured by Edwards Lifesciences, LLC. The core of the submission is that the subject devices are identical to the predicate devices in terms of intended use, indications for use, and technological characteristics, EXCEPT for changed pressure tubing and IV set component materials.

Therefore, the "study" described here is primarily focused on demonstrating that these material changes do not introduce new safety or effectiveness concerns, rather than validating an AI/ML algorithm's diagnostic performance against established ground truth.

Here's a breakdown based on the provided text, addressing your questions where possible, and noting where the information is not applicable or not present:

Overview of the Device and Study's Focus:

The devices in question are FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors, which are intravascular pressure monitoring devices that also work with Edwards' arterial pressure-based cardiac output monitoring hardware. The 510(k) submission (K242909) is for modifications to these existing devices, specifically changes to the pressure tubing and IV set component materials. The premise of the submission is that these material changes do not alter the fundamental performance or safety in a way that would require new clinical performance studies typical for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states:

• "All testing met the existing predetermined acceptance criteria."
• "Based on the performance testing and the technological characteristics, the FloTrac sensors, Acumen IQ sensors, and VolumeView sensors meet the established performance criteria and are substantially equivalent to the predicate."

However, the specific quantitative acceptance criteria (e.g., accuracy +/- X mmHg, drift

Ask a specific question about this device

Swan-Ganz catheters:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
Models 096F6, 096F6P, TS105F5, 132F5, 131F7, 131F7P 831F75, 831F75P, 834F75, and 834F75P are intended for adult and pediatric patients:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of critically ill adult and pediatric patients ≥ 12 years of age including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

FloTrac sensors:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥ 12 years of age.

ClearSight finger cuffs:
The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.
The ClearSight finger cuffs are indicated for adult and pediatric patients ≥ 12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.

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. It may 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 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 (compatible with FloTrac sensors):
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, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

Swan-Ganz Catheters:
The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

FloTrac Sensors:
The FloTrac sensor is a sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. When connected to a compatible monitor, the FloTrac sensor minimally-invasively measures cardiac output and key hemodynamic parameters, which assist the clinician in assessing the patient's physiologic status and support clinical decisions related to hemodynamic optimization. The disposable sterile cable, with a red-connector interfaces, exclusively with an Edwards cable that is specifically wired for the pressure monitor being used. The disposable sterile cable, with a green-connector interfaces, exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware.
The FloTrac sensor has a straight, flow-through design across the pressure sensors with an integral flush device.

ClearSight finger cuffs:
The ClearSight finger cuffs, when used with an appropriate Edwards monitoring system, provide continuous, noninvasive hemodynamic monitoring. The ClearSight finger cuffs utilize the volume-clamp method to measure blood pressure with an inflatable bladder wrapped around the middle phalanx of the finger.

HemoSphere Advanced Monitor Platform:
The HemoSphere Advanced Monitoring Platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the 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.

This document is a 510(k) summary for Edwards Lifesciences' Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, and HemoSphere Advanced Monitoring Platform. The core of this submission is to expand the indications for use of these devices to include pediatric patients (≥12 years of age), in addition to their existing adult indications.

The information regarding acceptance criteria and the study that proves the device meets those criteria, as detailed in your request, is primarily found in the "Device Verification and Validation" and "Conclusion" sections. However, the FDA summary document only provides a high-level overview. It does not contain the detailed acceptance criteria table, precise performance metrics, sample sizes, ground truth establishment methods, or specific details about expert adjudication or MRMC studies, which are typically found in the full 510(k) submission or supporting clinical trial reports.

Based on the provided text, here's what can be extracted and what information is not present:

Key Takeaway from the FDA 510(k) Summary:

The primary purpose of this 510(k) submission is to expand the indicated patient population for the listed devices from adult-only to include pediatric patients aged 12 years and older. The submission claims that the devices perform similarly in this expanded pediatric population compared to adults, meeting predefined acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

Not Provided in this Document. The document states "within predefined acceptance criteria" but does not list these criteria or the specific reported device performance metrics against them.

Study Details (Based on available information):

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

   • Sample Size: Not explicitly stated. The document mentions "the target pediatric population in a clinical study" but does not provide the number of patients.
   • Data Provenance:
     • Country of Origin: Not specified in this summary. Clinical studies are often multi-center, but no specific locations are mentioned.
     • Retrospective or Prospective: Not explicitly stated, but the phrase "clinical study" typically implies prospective data collection for regulatory submissions, especially for expanding indications to a new population.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. Given the nature of these hemodynamic devices, ground truth would likely be established by clinical measurements and potentially other validated reference methods, rather than expert interpretation of images or signals in the same way a radiologist might interpret an X-ray. Clinical experts (e.g., intensivists, anesthesiologists, cardiologists) would be involved in patient selection, data collection, and overseeing the study.

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

   • Adjudication Method: Not specified. This type of adjudication (e.g., multi-reader consensus) is more common in image-based diagnostic AI studies. For device performance measurement, agreement with a reference standard is the typical method.

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: Not applicable/not performed for this type of device and study. MRMC studies are primarily for evaluating AI's impact on human interpretation tasks (e.g., radiologists reading images). This submission is for devices that directly measure physiological parameters and provide data, with one feature (Acumen HPI) providing "physiological insight" for reference. The study focuses on the device's performance in a new patient population, not on how it assists human readers in interpreting complex cases, except perhaps by providing accessible data. The Acumen HPI feature specifically states "no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter," indicating it's an informational tool rather than a definitive diagnostic AI assist requiring a MRMC study.

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

   • Standalone Performance: The study evaluated the devices' performance in the pediatric population. The devices themselves are "standalone" in that they acquire and process physiological signals to output parameters. The statement "The data demonstrate the performance in the expanded pediatric population ≥ 12 years of age and is substantially equivalent to their respective predicate devices for adult patient population ≥ 18 years of age" suggests an evaluation of the device's measurement accuracy and consistency.

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

   • Type of Ground Truth: Not explicitly stated, but for hemodynamic monitoring devices, ground truth is typically established by:
     • Reference Standards/Comparative Measurements: Comparing the device's measurements (e.g., cardiac output, blood pressure) against established, precise, and often more invasive or gold-standard methods (e.g., thermodilution, invasive arterial line measurements from validated transducers).
     • Clinical Outcomes/Safety Data: Demonstrating safety and effectiveness in the target population through clinical monitoring and observation.
   • The document states "clinical data presented in this 510(k) demonstrates the performance of hemodynamic parameters expanded to pediatric patients ≥ 12 years of age... are consistent and within predefined acceptance criteria," implying comparisons to a reference or expected range.

7. The sample size for the training set:

   • Training Set Size: Not applicable/not specified. These devices measure physiological parameters; they are not "AI algorithms" in the sense of needing a large training dataset to learn patterns for classification or prediction (except for the Acumen HPI feature, but no details on its development or training are provided here). The focus of this 510(k) is the application of existing technology to a new age group, not the development of a new pattern-recognition algorithm.

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

   • Ground Truth for Training Set: Not applicable, as there's no mention of a traditional AI training set. The devices likely use established physiological models and algorithms for calculating parameters. If the Acumen HPI feature involved machine learning, its training ground truth would likely be based on recorded physiological data and subsequent hypotensive events. However, the document does not elaborate on the development of this specific feature in the context of this 510(k).

Ask a specific question about this device

The EpiFinder is intended for use, in between a luer Loss of resistance (LOR) syringe and an epidural needle, to verify the needle tip placement in the epidural space as a secondary indicator adjunctive to the LOR technique.

The EpiFinder is intended to be used in conjunction with a standard epidural LOR technique as an independent secondary confirmatory indicator, giving the practitioner a clear visual signal that the needle tip has entered the epidural space. The EpiFinder is a sterile, single-use device that is used during epidural procedures. The device works with a standard loss of resistance (LOR) syringe and an epidural needle (18G) to verify that the needle tip placement is in the epidural space in patients ages 18 or older.

The EpiFinder consists of a blunt tip spring-loaded probe that is installed into a standard epidural needle, and a plastic housing that is composed of a linear actuator, a sensor, and a microcontroller that measures the probe spring's contraction. The EpiFinder is attached to a Tuohy needle that has been inserted into the patient. The device has built in "wings" to help advance the needle, if the practitioner wishes to use them. As the needle advances forward, there are LED indicator lights on the housing that give feedback to the operator as to when the epidural space is entered, as input to the user in conjunction with the standard LOR technique.

Here's an analysis of the acceptance criteria and study information for the EpiFinder device, based on the provided text:

Important Note: The provided text does not explicitly list acceptance criteria in a quantitative table format with pass/fail metrics. Instead, it describes various performance evaluations and concludes that the device's performance was "appropriate," "effective," and "similar to standard practice." Therefore, the table below will summarize the reported device performance based on the described studies, indicating what was evaluated and the general outcome.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Animal Study (Pigs): "Numerous test sites" (specific number not given) were randomly divided into two groups: Group 1 (EpiFinder + standard LOR technique) and Group 2 (standard LOR technique alone). The study was conducted in compliance with OECD principles of Good Laboratory Practice (GLP) ENV/MC/CHEM (98)17 (except for blood analysis).
   • Human Factors Evaluation: 16 anesthesiologists (physicians) and 10 student resident nurse anesthetists (sRNAs).
   • Clinical Evaluation: 31 adult subjects.
   • Data Provenance: The animal study was noted as GLP compliant, implying a controlled, prospective design. The human factors and clinical evaluations would also be prospective studies. The country of origin for the animal and clinical studies is not explicitly stated, but the company address is in Israel.

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

   • Animal Study: Ground truth was confirmed using X-ray and contrast medium. No specific number of experts or their qualifications are mentioned for interpreting these confirmations.
   • Human Factors: The "experts" were the participating 16 anesthesiologists (physicians) and 10 student resident nurse anesthetists (sRNAs) who evaluated usability. Their feedback contributed to assessing safety and usability.
   • Clinical Evaluation: Ground truth for epidural space identification during the clinical trial is implied to be clinical assessment by the performing physicians, potentially combined with the standard LOR technique used concurrently. The text mentions "The performance of the device was also established, demonstrating that the device is capable of correctly identifying the epidural space during the injection procedure." No specific number of independent experts or their detailed qualifications for establishing ground truth are explicitly stated beyond the clinical team performing the procedures.

3. Adjudication method for the test set:

   • The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in any of the studies.
   • In the animal study, confirmation was via X-ray and contrast medium, which typically involves interpretation by a radiologist or veterinary specialist, but a specific adjudication process isn't detailed.
   • In the clinical evaluation, the "correctly identifying the epidural space" implies the clinical judgment of the performing physician was the primary determinant, likely corroborated by the LOR technique.

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 is described where human readers' performance with and without AI assistance is compared. The EpiFinder is a physical device with an indicator (LEDs) and functions adjunctively to the standard LOR technique, rather than being an AI diagnostic tool primarily interpreted by human readers.

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

   • The EpiFinder is designed to be used "in conjunction with a standard epidural LOR technique as an independent secondary confirmatory indicator." It provides a "clear visual signal" via LEDs. Therefore, its performance is inherently "human-in-the-loop" as it provides feedback to the operator. The animal study did evaluate the device's signal in conjunction with the standard LOR technique, and its effectiveness was confirmed against X-ray and contrast.

6. The type of ground truth used:

   • Animal Study: Radiographic confirmation (X-ray and contrast medium).
   • Clinical Evaluation: Clinical identification of the epidural space by performing physicians, presumably leveraging the concurrent standard LOR technique. The device's ability to "correctly identify" the space refers to its agreement with this clinical assessment.

7. The sample size for the training set:

   • The document describes performance evaluation studies (validation studies) for the EpiFinder. It does not provide information about a "training set" as this device is a hardware product with a pre-programmed microcontroller/firmware, not a machine learning (AI) algorithm that undergoes a training phase with a distinct dataset. Software verification and validation were performed, but this typically involves testing inputs/outputs against specifications, not learning from a dataset.

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

   • Not applicable, as there is no mention of a "training set" in the context of an AI/machine learning model. The software is described as "pre-programmed software (firmware)," implying it's deterministic based on its design specifications, not trained on data.

Ask a specific question about this device

The Meritrans ECO Reusable Pressure Transducer is intended to be coupled with a disposable dome kit for converting hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals for invasive blood pressure monitoring when connected to a patient monitor or recording device.

The devices are intended for pediatric and adult patient populations.

The Meritrans ECO Reusable Pressure Transducer is a non-invasive, reusable device used primarily for blood pressure monitoring. The housing assembly interfaces the pressure sensor assembly to the fluid channel of patient by coupling the transducer to the Meritrans ECO Disposable Dome. The fluid channel of patient is isolated from the pressure sensor by diaphragms. As the pressure signal of patient carried via the saline solution presses against the surface of transducer, the diaphragm is deflected, and the physiological pressure signal is transformed from the dome to the sensor of the reusable pressure transducer. Subsequently, the physiological pressure signal is transformed into electrical signal and displayed in a monitor that is connected via transducer interface cable.

The Meritrans ECO Disposable Domes are disposable diaphragm domes which are coupled with the reusable transducer for invasive blood pressure monitoring. The disposable diaphragm dome has a transparent hemispherical hollow cavity. The domes have two ports; one port of the dome has a rotating Luer Lock fitting where the patient line is connected. Another port has an adaptor for connection to a pressurized IV fluid bag or an infusion pump. The disposable diaphragm dome has a diaphragm membrane that isolates the patient's fluid-filled system from the reusable transducer. For dome models with flush devices, an integral flow/flush device provides continuous flow of fluid to maintain catheter patency during the invasive blood pressure measurements.

The provided text describes the acceptance criteria and the studies performed to demonstrate the device's conformance, but it does not detail a study proving the device meets the acceptance criteria in the format typically used for AI/ML performance evaluation (e.g., specific metrics for accuracy, sensitivity, specificity, clinical outcome studies). Instead, it focuses on compliance with various engineering, safety, and biological standards through a battery of tests.

Here's an analysis of the provided information:

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

The document lists various standards that the device complies with, implying that meeting the requirements of these standards constitutes the acceptance criteria. The reported device performance is stated as "Results of the testing demonstrate that the subject devices met the acceptance criteria sufficient for their intended use." However, specific numerical performance metrics for each criterion against a defined acceptable range are not provided in this summary.

Generic Table based on the document's structure for Performance Bench Testing:

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 lists various standards and states that "A battery of tests was performed based on the requirements of the below FDA recognized / non-recognized consensus standards and guidance, as well as biocompatibility, sterilization, and labeling standards and guidance." However, it does not specify the sample sizes used for these tests or the data provenance (country of origin, retrospective/prospective). This information would typically be detailed in the test reports themselves, which are not included in this summary.

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

This information is not applicable in the context of this 510(k) summary. The device in question, a pressure transducer and disposable domes, is a hardware medical device with electrical and mechanical performance, biocompatibility, and sterility requirements. Its evaluation is based on engineering testing and biological assays against recognized standards, not on image interpretation or diagnostic performance with expert-established ground truth. Therefore, there are no "experts" in the sense of clinical reviewers establishing ground truth for a test set.

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

This is not applicable for the reasons stated above. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved to establish ground truth, typically in AI/ML performance evaluations.

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. The device is an extravascular blood pressure transducer, a piece of hardware for physiological monitoring. It does not involve AI assistance for human readers in any diagnostic or interpretive task.

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

This is not applicable. The device is a hardware product, not a software algorithm.

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

For this device, the "ground truth" is established by the specified requirements and test methods outlined in the recognized consensus standards (e.g., ANSI/AAMI BP22 for blood pressure transducers, ISO 10993 for biocompatibility). These standards define acceptable performance metrics, physical properties, and biological responses. The device's performance is measured against these established technical and biological benchmarks.

8. The sample size for the training set

This is not applicable. The device is a hardware medical device, and the evaluation described is for its physical and biological performance against standards, not for a trainable AI/ML algorithm that requires a "training set."

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

This is not applicable for the reasons stated above. There is no AI/ML training set mentioned or implied for this device's evaluation.

Ask a specific question about this device

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), 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.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• · BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult patients only;
• · C.O. monitoring and A-Fib are intended for adult patients only;
• · ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• · rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO₂), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• PAWP, PNP, and PNC are intended for adult and pediatric patients only;
• A-Fib is intended for adult patients only;

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment, whereas N1 configured with WMTS technology can be used inside the hospital only. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• . BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor ●
• BeneVision N19 Patient Monitor ●
• BeneVision N22 Patient Monitor ●
• BeneVision N1 Patient Monitor

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

This document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (K202405).

The information provided primarily details the device's technical specifications and comparisons to a predicate device, rather than a full study proving the device meets acceptance criteria for a specific medical condition or AI diagnostic output.

Therefore, I cannot fully answer all parts of your request as the document does not contain the detailed clinical study results (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or specific AI performance metrics) that would typically be found for a device requiring those types of studies (e.g., an AI-powered diagnostic tool).

However, I can extract the relevant information regarding the device's functional and technical performance as demonstrated in this 510(k) submission.

Here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in this context are related to meeting the performance specifications of the predicate device and relevant consensus standards. The "reported device performance" is demonstrated through functional and system-level testing, ensuring the device meets its accuracy specifications for the various physiological parameters it monitors.

Table of "Acceptance Criteria" (Implied Specifications) and "Reported Device Performance" (Conformance):

Detailed Study Information (Based on Document Content):

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

   • The document states that "functional and system level testing" and "bench testing" were conducted.
   • However, no specific sample sizes for test sets (e.g., number of patients, number of data recordings) are provided for any of the performance evaluations.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests described are generic "bench testing" to ensure compliance with technical specifications and standards, not clinical studies.

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

   • Not applicable / Not provided. This document describes engineering and bench testing against pre-defined technical specifications and industry standards for physiological measurement accuracy. It does not describe a clinical study involving human experts establishing ground truth for diagnostic interpretation (e.g., for an AI algorithm interpreting medical images).

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

   • Not applicable / Not provided. Same reason as above.

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. This device is a patient monitor. It detects physiological parameters and provides alarms, and some interpretations of ECG (e.g., 12-lead ECG interpretation, arrhythmia detection). It is not an AI-assisted diagnostic device in the sense of image interpretation for which MRMC studies are typically performed. The document details that "optimized auditory ALARM SIGNALS" and "alarm highlight" were added, suggesting improvements to the human-device interface, but not a formal MRMC study on diagnostic improvement.

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

   • The document implies that algorithms for ECG (Mindray or Mortara algorithm for arrhythmia and ST-segment analysis) are embedded in the device. The listed accuracy specifications for these measurements (e.g., HR, ST, QT) reflect the standalone performance of these measurement algorithms and sensors against established benchmarks. However, a formal "standalone study" with detailed methodology, distinct from the general bench testing, is not specifically described or provided with separate results. The performance data listed (e.g., accuracy for HR, ST, QT) serves as the "standalone" performance verification for these integrated functionalities.

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

   • For physiological measurements (ECG, SpO2, NIBP, etc.), the "ground truth" would typically refer to reference measurement devices or calibrated simulators used during bench testing to verify the accuracy of the monitor's readings against a known, accurate value.
   • For the ECG interpretation (e.g., 12-lead ECG interpretation, arrhythmia detection), the ground truth for the algorithms would have been established during their development and previous clearance processes (Mindray or Mortara algorithms). This document focuses on demonstrating that the integration and revised features maintain that established accuracy rather than re-proving the core algorithms.

7. The sample size for the training set:

   • Not provided. This document pertains to the 510(k) clearance of updates to an existing patient monitor series. It does not detail the development or training of new AI/ML algorithms, which would typically involve substantial training datasets. The ECG algorithms (Mindray or Mortara) were presumably "trained" (or developed and validated) previously as part of their initial predicate clearances.

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

   • Not provided. (See point 7). For existing algorithms like Mortara or Mindray ECG algorithms, ground truth for their original development would likely have been established using large, diverse ECG databases with expert cardiologist interpretations and/or correlation with clinical outcomes where relevant. This particular 510(k) document is concerned with demonstrating equivalence and continued performance with minor changes, not the original algorithm development.

Ask a specific question about this device

BeneVision N12/N15/N17/N19/N22

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), 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.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

· BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only:

· C.O. monitoring and A-Fib are intended for adult patients only;

• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

· rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.

BeneVision N1 Patient Monitor:

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• PAWP, PNP, and PNC are intended for adult and pediatric patients only;
• A-Fib is intended for adult patients only;

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor ●
• . BeneVision N19 Patient Monitor
• . BeneVision N22 Patient Monitor
• BeneVision N1 Patient Monitor ●

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

The provided document describes the BeneVision N Series Patient Monitors and their clearance by the FDA based on substantial equivalence to predicate devices, particularly focusing on changes and new features. The document details the device's intended use, technological comparisons, and performance data from various tests. However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. Instead, it states that "the results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device."

Specifically regarding "Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)" which is the relevant regulation name for the product code MHX (used by the BeneVision N Series Patient Monitors), the document states:
"Add arrhythmia detection for neonatal patients when used with the MPM 3.0 module." (Page 9, Table 2 ECG section; Page 22, Table 3 ECG section).
And references "K200015 - ePM series Patient Monitors...: provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors." (Page 6, Section 4).

Given the information in the document, here's a structured response:

Acceptance Criteria and Device Performance Study for Arrhythmia Detection in Neonates

The provided FDA 510(k) summary (K202405) for the BeneVision N Series Patient Monitors primarily focuses on demonstrating substantial equivalence to a predicate device (K192972) and a reference device (K200015) for the new feature of neonatal arrhythmia detection. While it explicitly states that the device meets its accuracy specifications, it does not provide a specific table of acceptance criteria or detailed reported performance metrics for neonatal arrhythmia detection. Instead, it relies on general statements about meeting specifications and compliance with standards.

However, based on the document's information and common regulatory expectations for such devices, we can infer the type of acceptance criteria and the nature of the study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table for the acceptance criteria and reported device performance for neonatal arrhythmia detection. It states that the device "meets its accuracy specification." For arrhythmia detection systems, typical performance metrics and acceptance criteria, often derived from standards like IEC 60601-2-27, would generally include:

Ask a specific question about this device

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and

The IntelliVue Patient Monitors MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located at the patient bedside vicinity and can also be used during patient transport inside hospitals.

The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

Here's a breakdown of the acceptance criteria and the study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided FDA 510(k) summary:

This submission is a 510(k) for modifications to an existing device, the IntelliVue Patient Monitors MX500 and MX550. The acceptance criteria and supporting studies primarily focus on demonstrating that the modifications do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an update to an existing device focusing on integrating new measurement modules (Masimo O3, IRMA CO2, ISA CO2) and updating EMC standards, the "acceptance criteria" are primarily related to meeting established performance standards for patient monitors and demonstrating that the new modules function as intended without compromising the overall device safety or efficacy. The document doesn't present specific numerical acceptance criteria for all physiological parameters of the overall monitor, but rather confirms compliance with recognized standards.

Ask a specific question about this device

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), 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.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: · The arrhythmia detection, BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only:

· C.O. monitoring is intended for adult patients only;

• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

· rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.

BeneVision N1 Patient Monitor:

The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection and PAWP is intended for adult and pediatric patients only

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors: BeneVision N12 Patient Monitor, BeneVision N15 Patient Monitor, BeneVision N17 Patient Monitor, BeneVision N19 Patient Monitor, BeneVision N22 Patient Monitor, BeneVision N1 Patient Monitor. Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

The provided text is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors. It mainly focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and specific performance metrics in the format requested.

The document discusses functional and system level testing and bench testing to validate performance and ensure specifications are met, but it does not provide a table of acceptance criteria alongside reported device performance data, nor does it detail the specifics of such a study.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

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

   • Not Available. The document states that "functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate" and "the subject device meets its accuracy specification." However, it does not provide the specific numerical acceptance criteria or the reported performance data in a table. It only lists measurement ranges and accuracies for various parameters (ECG, Respiration Rate, Temperature, SpO2, Pulse Rate, NIBP, IBP, C.O., CCO, SvO2/ScvO2, CO2, O2, AG, ICG, RM, NMT, EEG, rSO2) under the "Technological Comparison" tables (Table 2 and Table 3). These are presented as specifications rather than acceptance criteria for a study.

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

   • Not Available. The document mentions "functional and system level testing" and "bench testing" but provides no details on the sample size of data used for these tests, nor its provenance (country, retrospective/prospective nature).

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

   • Not Applicable / Not Available. This device is a patient monitor, and its performance is assessed against established physical measurement standards and algorithms, not typically against expert interpretation of data for ground truth in the way an AI diagnostic algorithm might be (e.g., radiologists for medical images). The document does not mention any expert review process for determining ground truth.

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

   • Not Applicable / Not Available. As mentioned above, the assessment appears to be against physical specifications and consensus standards, not an expert-adjudicated ground truth.

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, not done. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. This device is a patient monitor providing physiological parameters, not an AI-assisted diagnostic tool for human interpretation.

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

   • N/A (Implicitly standalone for most parameters against physical standards). The performance evaluation described largely implies standalone testing against specifications and standards. For example, for ECG, SpO2, NIBP, etc., the device's internal algorithms process signals and provide readings, which are then assessed for accuracy. The "reporting" is of the device's ability to measure parameters correctly, not its ability to assist a human.

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

   • Physical Standards and Reference Devices/Methods. The ground truth for the measurements would be established by validated physical standards, calibrated equipment, and comparison to reference methods (e.g., for invasive blood pressure, cardiac output). The document implies validation against these types of established standards and specifications.

8. The sample size for the training set

   • Not Applicable / Not Available. The document does not describe the development or training of AI algorithms that would require a "training set" in the context of machine learning. The patient monitor's algorithms are based on established physiological signal processing, not deep learning models.

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

   • Not Applicable. See point 8.

Ask a specific question about this device

The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), 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.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
• C.O. monitoring is intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection and PAWP is intended for adult and pediatric patients only
  The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor
• BeneVision N19 Patient Monitor
• BeneVision N22 Patient Monitor
• BeneVision N1 Patient Monitor

The BeneVision N Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.

The provided document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

Therefore, many of the requested elements for a detailed study description (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and ground truth establishment for training data) are not present in the provided text.

The document primarily highlights changes from predicate devices and states that functional and system-level testing, along with compliance with consensus standards, demonstrate equivalence.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for a new device's efficacy study. Instead, it compares the specifications of the subject device with those of predicate devices, implicitly indicating that the subject device's performance meets or exceeds the predicate's established performance or relevant cleared standards.

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

The document does not specify sample sizes for test sets. The testing mentioned is referred to as "functional and system level testing" and "bench testing." It also states Mindray conducted "clinical testing to demonstrate that the Mindray and Nellcor SpO2 modules meet relevant consensus standards."
There is no mention of data provenance (e.g., country of origin of data, retrospective or prospective).

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

Not applicable. The document does not describe the use of experts to establish ground truth for testing. The evaluation focused on meeting specifications and consensus standards, and demonstrating equivalence to predicate devices.

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

Not applicable. There is no mention of adjudication methods.

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

Not applicable. This is a patient monitor, not an AI-assisted diagnostic device, and no MRMC studies are mentioned.

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

The document describes performance in terms of functionality and adherence to technical specifications and consensus standards, not in terms of "algorithm-only" performance as would be relevant for an AI device. The tests performed are for the integrated device.

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

The term "ground truth" is not used. The performance evaluation is based on meeting engineering specifications, comparing against predicate device performance, and compliance with recognized consensus standards (e.g., IEC, ISO, AAMI standards for physiological measurement accuracy).

8. The sample size for the training set

Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a patient monitor, and no machine learning model training is discussed.

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

Not applicable, as no training set for a machine learning model is mentioned.

Ask a specific question about this device

Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians.

In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).

Star 65 is a multi-parameter modular patient monitoring system for continuous monitoring of the physiological parameters like ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, CO2, Cardiac Output (CO). & Anesthesia Gas Monitoring (AGM) Module (Optional). The modular parameters are IBP, CO and CO2.

Star 65 is a 8 channel monitor with 12.1" LED display with touch screen capable of displaying and monitoring ECG, Respiration, SpO2, CO2, IBP, and O2 digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic & Mean), Invasive Blood Pressure (Systolic, Diastolic & Mean), Temperature, EtCO2, FiCO2, IPI, CO, N2O, O2, EtAA, and FiAA readings.

Star 65 has 240 Hours tabular and graphical vital trend. Star 65 has a NIBP trend of last 240 readings. Star 65 has Alarm Recall facility with last 48 'Patient Alarms' details.

Star 65 has communication features like USB for Thumb drive, Printer, Bar code scanner interface, Ethernet for CNS & Bed to Bed connectivity, HDMI output for External monitor connectivity, External Port for AGM 55 interface, Wi-Fi for CNS, Bed to Bed & Network Printer connectivity. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals, high priority alarms are indicated by red colour, medium priority alarms are indicated by yellow colour & low priority alarms are represented by blue colour.

Star 65 has got Drug calculator software package to display drug dosage applied / to be applied for the standard Medicines.

The provided text describes the 510(k) premarket notification for the Skanray Technologies Pvt Ltd Star 65 patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, it is important to note that the document does not present a standalone clinical study to prove the device meets acceptance criteria. Instead, it relies on demonstrating that the subject device's performance, as measured through non-clinical (bench) testing against recognized standards, is comparable to its predicate devices, which are already legally marketed.

Here's an breakdown based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of a clinical study outcome. Instead, it details the performance specifications of the Star 65 and compares them to predicate devices. The "reported device performance" is essentially the listed specifications for the Star 65, and "acceptance criteria" can be inferred as being equivalent to or meeting the performance of the predicate devices and relevant consensus standards.

Since a strict "acceptance criteria" table from a dedicated study is not available, I will present the performance specifications of the Star 65 as its "reported performance," and the "acceptance criteria" is implied to be that these specifications are within acceptable ranges, similar to the predicate devices, and comply with the listed consensus standards.

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

The document does not specify a "test set" in the context of a patient-based study. The testing performed was non-clinical (bench testing), as stated in Section VII. "NON-CLINICAL STUDY." It refers to "Electrical, mechanical environmental safety and performance testing according to the following consensus standards" and "Performance testing- Accuracy, Environment cycling, Temperature Rise Test, wireless co-existence were performed according to Design Requirement specification and Validation plans."

Therefore, there is no patient sample size for a test set described. The data provenance is from bench testing results, not human data. The document does not specify the country of origin for the testing itself, but the device manufacturer (Skanray Technologies Pvt Ltd) is based in India.

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

This section is not applicable. Since no patient-based clinical test set was used, there was no ground truth establishment by experts in that context. The "ground truth" for the non-clinical performance validation was the specifications and performance outlined in the relevant consensus standards (e.g., IEC, ISO standards).

4. Adjudication method for the test set

This section is not applicable. No patient-based test set requiring expert adjudication was conducted.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any AI assistance in the provided document. The device is a patient monitoring system, not an AI-driven diagnostic tool that would typically involve human readers interpreting results with or without AI.

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

This section is not applicable in the sense of an "algorithm only" performance for a diagnostic task. The "standalone" performance shown is the inherent performance of the integrated hardware and software system (Star 65) measuring physiological parameters, as assessed through bench testing against standards.

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

For the non-clinical performance testing, the "ground truth" was defined by the technical specifications and accuracy requirements set forth in the international consensus standards (e.g., IEC 60601 series, ISO 80601 series) to which the device was tested for compliance. For example, for NIBP accuracy, the ground truth standard is +/-5mmHg with a standard deviation greater than 8 mmHg.

8. The sample size for the training set

This section is not applicable. The document does not describe the use of machine learning or AI models that would require a "training set." The device is a traditional multi-parameter patient monitoring system.

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

This section is not applicable, as there was no training set mentioned in the document.

Ask a specific question about this device