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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

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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.

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The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.

The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.

The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and central venous invasive pressure monitoring line. The LogiCal® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System. The LogiCal® monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a vented cap on the zeroing stopcock; this vented cap will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the vented cap should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and venous invasive pressure monitoring line. The TranStar® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Closed Blood Sampling Set with TranStar® Pressure Monitoring System. The TranStar® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a porous plug on the zeroing stopcock; this porous plug will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the porous plug should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics and acceptance criteria in the way a clinical trial might.

Therefore, many of the requested details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific efficacy or accuracy metrics, and details on training sets) are not applicable or not provided within this type of regulatory submission. The submission is primarily concerned with bench testing and validation against established engineering standards and existing regulatory guidance.

Here's a breakdown of the information that can be extracted or deduced from the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For the type of device (Extravascular Blood Pressure Transducer) and the nature of this 510(k) submission (design update and labeling changes), the "acceptance criteria" are primarily based on demonstrating compliance with relevant international standards and ensuring that the minor changes do not compromise the safety and effectiveness established by the predicate device. Specific quantitative performance metrics with defined acceptance thresholds (e.g., accuracy, sensitivity, specificity) for the device as a whole are not explicitly presented as they would be in a clinical study report for a diagnostic device.

The reported device performance is that "All testing met pre-established specifications."

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

• Sample Size: Not specified in the provided document. The testing described is primarily bench testing against engineering standards for components and system integrity, not a clinical trial with a "test set" of patient data.
• Data Provenance: The document refers to "Bench Testing" and "Validation" conducted by Smiths Medical. There is no mention of country of origin for patient data or retrospective/prospective data collection, as this is not a study involving patient data.

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

• This concept is not applicable here. The "ground truth" for demonstrating substantial equivalence and meeting safety/effectiveness standards in this context comes from adherence to established international standards (e.g., ISO, AAMI) and internal company specifications, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

• Not applicable, as there isn't a "test set" of cases requiring adjudication by experts.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging AI systems and is not relevant for a blood sampling and pressure monitoring system's safety and effectiveness evaluation for a 510(k) submission.

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

• Not applicable. This device is a physical medical device, not an AI algorithm. "Standalone performance" in this context refers to the device's functional performance as evaluated through bench testing and validation against engineering specifications, which was indeed done.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is defined by established international engineering standards (e.g., ISO 594-1, ISO 594-2, ISO 11135, AAMI TIR28, ISO 11747, ISO 62366, ISO 10993-1) and the manufacturer's internal specifications derived from these standards and the predicate device's performance. There is no reference to pathology, outcomes data, or expert consensus on patient cases for determining the device's fundamental safety and performance characteristics in this submission.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a "training set."

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

• Not applicable (see point 8).

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The HemoDraw@ Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system. This device is for use in adults only.

The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system. This device is for use in adults only.

The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and central venous invasive pressure monitoring line. The LogiCal® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System. The LogiCal® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a vented cap on the zeroing stopcock; this vented cap will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the vented cap should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and venous invasive pressure monitoring line. The TranStar® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Closed Blood Sampling Set with TranStar® Pressure Monitoring System. The LogiCal® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a porous plug on the zeroing stopcock; this porous plug will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the porous plug should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

The provided document is a 510(k) summary for the HemoDraw® Plus Closed Blood Sampling Set with LogiCal®/TranStar® Transducer System. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. This type of document generally focuses on engineering and bench testing rather than clinical study data involving human interpretation of medical images or data. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

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

The document states that "All testing met pre-established specifications," but it does not detail the specific quantitative acceptance criteria or the exact reported performance values for each test. It only lists the categories of evaluations performed.

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 does not specify sample sizes for each non-clinical test. It states "a worst case packaging configuration" for packaging tests, implying at least one configuration was tested. The data provenance is internal testing by Smiths Medical ASD, Inc. (the applicant), based on the context of a 510(k) submission. These are non-clinical bench and lab tests, not clinical data with provenance like country of origin.

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. The evaluations described are non-clinical engineering and biological tests (e.g., leakage, pressure containment, cytotoxicity), not expert-interpreted medical images or data. Ground truth is established by objective measurements against engineering specifications and standard biological testing protocols.

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

This is not applicable. Adjudication methods like 2+1 are used for human expert interpretation in clinical studies, typically for creating a consensus ground truth. The tests performed are objective bench and lab tests.

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. MRMC studies are clinical trials used to compare the performance of human readers, often with and without AI assistance, on medical cases. The provided document details non-clinical bench and lab testing of a blood sampling and pressure monitoring system.

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

This is not applicable. The device is a physical medical device (closed blood sampling set and pressure transducer system), not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests described is established by:

• Engineering Specifications: For device performance tests like leakage, pressure containment, cycle test, vacuum, frequency response, and assembly, the device's performance is measured against pre-defined engineering design specifications.
• Standardized Biological Testing: For biocompatibility tests, the ground truth is determined by the results of tests performed according to ISO 10993 standards, which dictate acceptable levels of toxicity, sensitization, etc.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI or machine learning system 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.

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The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.

The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory).

The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical.

The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device:

1. Wireless Pressure Receiver - GE Monitor (CWMG001-5)
2. Wireless Pressure Receiver Philips Monitor (CWMP001-5)

The provided text describes information about the submission of the "Compass Cast and MAP System" for FDA clearance. However, it does not contain explicit acceptance criteria and device performance data in a tabular format, nor does it detail a study that proves the device meets specific performance criteria related to its core function of physiological pressure measurement beyond stating adherence to existing standards.

The document focuses heavily on demonstrating substantial equivalence to a predicate device (Compass CT Port) by highlighting the technological characteristics and the modifications made (addition of Bluetooth capability and a reusable Monitor Accessory Plug - MAP). Performance data mentioned primarily concerns safety aspects due to these modifications, such as sterility, EO residuals, and electromagnetic compatibility.

Therefore, many of the requested items cannot be fully answered from the provided text.

Based on the available information:

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

The document does not explicitly state a table of new acceptance criteria established for the Compass Cast and MAP system itself in terms of pressure measurement performance. Instead, it states that the device's fundamental pressure accuracy and functional performance are "identical" to the predicate device and "Meet or exceed ANSI/AAMI BP22:1994(R)2006".

The only "acceptance criteria" and "reported performance" directly stated are for safety and compatibility tests related to the new wireless functionality and sterilization.

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The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.

The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.

The provided text describes a 510(k) premarket notification for a Disposable Blood Pressure Transducer (DBPT). It does not contain information related to the acceptance criteria or study results for AI/ML-based devices. The discussion of non-clinical testing refers to traditional medical device testing standards (biocompatibility, product performance, safety) and a predicate device (Transpac® Disposable Straight Pressure Transducer (DSPT)), which are typical for non-AI medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on the provided text. The document is for a traditional medical device, not an AI/ML-driven one.

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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 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 Edwards Lifesciences FloTrac and VolumeView sensors are sterile, single use devices that monitors pressures when attached to pressure monitoring catheters. The FloTrac and VolumeView sensors are also capable of providing cardiac output measurements when connect to compatible Edwards monitoring systems.

The provided text describes a 510(k) premarket notification for the FloTrac Sensor and VolumeView Sensor. While it lists performance specifications and mentions functional safety testing, it does not contain a detailed study with acceptance criteria, sample sizes, ground truth establishment, or specific reported device performance data in the way a clinical study report would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K043065 and K142749) through performance testing. The information provided is primarily related to the device's technical specifications and the conclusion that it is safe, effective, and substantially equivalent.

Here's an attempt to extract the requested information based on what is available, noting where information is explicitly not provided:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified. The document states "Performance testing was conducted" and "functional performance testing post MRI exposure" but does not give the number of devices or data points tested.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• This information is not provided. The testing described appears to be technical performance testing against engineering specifications, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

• This information is not provided. As the testing appears to be technical performance validation against specifications, an adjudication method for ground truth in the context of clinical interpretation would not be 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

• No. This device is a sensor for intravascular pressure monitoring and cardiac output measurement. It is not an AI-assisted diagnostic imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

• The device itself is a standalone sensor. The document states "Performance testing was conducted to compare the proposed device(s) to the predicate device(s)" and "The Flotrac and VolumeView Sensors have successfully passed functional performance testing post MRI exposure. This testing included pressure accuracy (nonlinearity and hysteresis)." This implies standalone technical performance testing of the device.

7. The type of ground truth used

• The "ground truth" for the performance testing described would be the established engineering specifications or reference measurements for pressure accuracy, flush rate, and operating pressure range. For example, a calibrated pressure source would serve as the ground truth for pressure accuracy measurements.

8. The sample size for the training set

• Not applicable / Not provided. This device is not an AI/ML device that requires a training set.

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

• Not applicable / Not provided. This device is not an AI/ML device that requires a training set.

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The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring of the blood and/or intra-abdominal pressure of the critically ill patients.

The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravasular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder.

The device is for single and short term use.

The Art-Line™ Disposable Pressure Transducer (Art-Line™ DPT ) set is a disposable pressure transducer device that interfaces between a catheter and a monitoring equipment by converting changes in pressure into electrical signals. The Art-Line™ DPT (see Table 1.) is offered in different configurations to fit physicians' needs: with one, two or three channel lines. Also it may be offered as a closed system which assist to prevent blood loss and minimize a cross contamination risk. The complete configuration may be pole or patient mounted. The set is sterile and non-pyrogenic.

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

Disclaimer: The provided text is a 510(k) summary for a medical device submitted to the FDA. It details a determination of substantial equivalence, not a standalone clinical study report. Therefore, some information typically found in a detailed study report (e.g., highly granular acceptance criteria, specific effect sizes for human improvement with AI) may not be present or directly applicable.

Acceptance Criteria and Device Performance Study

The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) aims to measure blood pressure and/or intra-abdominal pressure. The demonstration of its performance relies on functional performance tests and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "functional performance tests" and "biocompatibility tests" performed on the Art-Line™ DPT. However, it does not specify the sample size (e.g., number of devices tested, number of patients, number of data points) for these tests.

The data provenance is implicitly from laboratory/bench testing and potentially in-vitro biocompatibility testing, given the standards cited. There is no mention of human clinical data or patient data (retrospective or prospective) being used to assess the functional performance against the cited standards.

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

This information is not applicable or not provided in the context of this 510(k) summary. The acceptance criteria are based on established international and national standards for medical devices (IEC 60601-2-34, ANSI/AAMI BP22-1994, ISO 10993-1), which define objective performance benchmarks. These standards themselves are developed by expert committees, but the document does not detail individual expert involvement in establishing ground truth for this specific device's test set.

4. Adjudication Method for the Test Set:

This information is not applicable or not provided. Since the performance assessment is against objective standards set for devices (functional and biocompatibility), typical clinical adjudication methods (like 2+1 or 3+1 expert consensus) are not relevant.

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

No MrMC study was mentioned or performed. This device is an extravascular blood pressure transducer, a physical measurement device, not an AI/software-based interpretive tool that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

Not applicable. This device is not an algorithm or AI system. Its performance evaluation is based on its physical properties and ability to accurately convert pressure into electrical signals according to established medical device standards.

7. Type of Ground Truth Used:

The ground truth for assessing performance was based on established industry standards and objective measurements prescribed by:

• IEC 60601-2-34: Specifies performance requirements for invasive blood pressure monitoring equipment.
• ANSI/AAMI BP22-1994: Standard for blood pressure transducers.
• ISO 10993-1: Standard for biological evaluation of medical devices.

These standards define the acceptable range of physical and biological characteristics, which serve as the "ground truth" for evaluating the device's compliance.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware component and does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable for the same reason as in point 8.

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The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.

The Mirador Compass™ CT and CT Port are disposable pressure measurement and monitoring devices with an integrated digital display. The devices are intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics like "Accuracy: X mmHg". Instead, it states that "The subject Compass CT and CT Port incorporate new software that allows for an extended pressure range. Therefore, all verification tests related to the software and pressure accuracy that were completed to support the substantial equivalence of the predicate Compass devices were re-executed for the subject Compass CT and CT Port. Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed."

Without the specific results from the re-executed pressure accuracy testing, a direct table of acceptance criteria vs. reported performance cannot be created from the given text. However, the implicit acceptance criterion is adherence to the performance standards specified in ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed for pressure accuracy.

The text states: "The results from this in vitro testing demonstrate that the technological and performance characteristics of the subject Compass CT and CT Port meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring physiological pressure." This implies that the device did meet the internal design requirements and the standards cited.

Implicit Acceptance Criteria & Reported Performance:

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

The document states "Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed." These are in vitro testing standards.

• Sample size: The specific number of devices or measurements used in the pressure accuracy testing is not provided in the given text.
• Data provenance: The testing was in vitro (laboratory-based), rather than from a clinical setting. The country of origin of the data is not explicitly stated, but the manufacturer is Mirador Biomedical, Inc. in Seattle, Washington, USA, suggesting the testing likely occurred in the US or at a certified lab. The study is prospective in the sense that these specific tests were re-executed for the new software version.

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

This type of information (experts, ground truth establishment) is typically not applicable or reported for in vitro device performance testing where the ground truth is established by a calibrated reference standard (e.g., a highly accurate pressure calibrator). The performance is assessed against these known, precise values, not expert interpretation.

4. Adjudication method for the test set

Not applicable for in vitro performance testing against a calibrated reference standard.

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 MRMC study was done. This device is a direct pressure measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI.
• No AI component requiring human-in-the-loop performance measurement is described. The device incorporates an "integrated pre-programmed diagnostic computer" but this refers to its internal processing and display of pressure, not an AI for interpretation or assistance to a human reader.

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

Yes, the pressure accuracy testing conducted ("re-executed for the subject Compass CT and CT Port") is a form of standalone performance assessment. The performance of the device's internal pressure measurement and display system was evaluated independently (without human intervention in the measurement process itself, beyond operating the test equipment). The "algorithm" here refers to the software that processes the pressure sensor's input and drives the display.

7. The type of ground truth used

The ground truth for the pressure accuracy testing would be established by calibrated reference standards. This typically involves highly accurate, independently verified pressure transducers or calibrators against which the device's measurements are compared.

8. The sample size for the training set

The concept of a "training set" is not relevant here as this is not an AI/machine learning device that learns from data. It's a measurement device with a pre-programmed diagnostic computer.

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

Not applicable as there is no training set mentioned or implied for this type of device.

Ask a specific question about this device

Medine Blood Pressure Transducer is intended for direct measurement and monitoring of blood pressure. This disposable transducer is intended for single use only. Indications for use include: - . Direct arterial blood pressure monitoring - central and peripheral - Pulmonary artery monitoring (PA distal) . - Venous pressure monitoring (RA Proximal) ● - Left atrial monitoring when used with an air eliminator . - Cardiac catheterization .

Medline Blood Pressure Transducer

This document is a 510(k) premarket notification letter from the FDA regarding the Medline Blood Pressure Transducer. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically be found in the 510(k) summary or the full submission, which are not provided here.

Therefore, I cannot answer the questions based on the provided text.

Ask a specific question about this device