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Indications for Use: This device is intended for use in patients who are morbidly obese and have failed to lose weight with diet and exercise.

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Here's a breakdown of the acceptance criteria and study details for the Hypertension Prediction Index (HePI) Algorithm, based on the provided FDA 510(k) letter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance is for the overall datasets (N=1813 for Minimally Invasive, N=1351 for Non-invasive). All sub-categories (surgical/non-surgical) also met the acceptance criteria.

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

• Minimally Invasive Sensor:
  • US Patients: 1615 subjects
  • OUS Patients: 198 subjects
  • Total N: 1813 subjects
• Non-Invasive Finger Cuff:
  • US Patients: 464 subjects
  • OUS Patients: 887 subjects
  • Total N: 1351 subjects

Data Provenance: The study used retrospective clinical data from multiple independent datasets. Data was collected from both US and OUS (Outside United States) patients.

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

The provided document does not specify the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The provided document does not specify an adjudication method. The ground truth definition of a "hypertensive event" is clearly stated (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg), suggesting an objective, pre-defined criterion rather than expert consensus on individual cases that would require adjudication.

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

The provided document does not indicate that an MRMC comparative effectiveness study was done. The focus is on the standalone performance of the algorithm.

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

Yes, a standalone performance study was done. The results presented in Table 2 (AUC, Sensitivity, Specificity, PPV, NPV) are direct measures of the algorithm's performance in predicting hypertensive events based on retrospective clinical data, without human interaction.

7. The Type of Ground Truth Used

The ground truth used is defined by objective physiological measurements and thresholds:
A "hypertensive event" is defined as:

• Mean Arterial Pressure (MAP) greater than 115 mmHg for at least 1 minute OR
• A MAP increase of more than 20% when current MAP is greater than 95 mmHg.

8. The Sample Size for the Training Set

The provided document does not explicitly state the sample size for the training set. It mentions that "Algorithm performance was tested using retrospective clinical data" and "Prospective analyses of retrospective clinical data from multiple independent datasets...were analyzed to verify the safety and performance of the subject device," referring to the test sets.

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

The provided document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device and the ground truth definition for the test set, it is highly likely that the same objective physiological measurements and thresholds (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg) were used to establish ground truth labels for the training data.

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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 Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.

The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.

It appears there might be a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device: the Fogarty Thru-Lumen Embolectomy Catheter.

This document is not about an AI/software-as-medical-device (SaMD) or a device that relies on complex algorithms requiring a study to prove its performance against acceptance criteria like sensitivity, specificity, or AUC based on a test set, ground truth, or expert readers.

Instead, this device is a physical catheter used to remove emboli and thrombi. The "acceptance criteria" and "study" proving its performance in this context relate to engineering and biocompatibility testing, not to AI model performance or interpretation of medical images.

Here's why the questions about AI/software-related study methodologies are not applicable to the provided document:

• No mention of AI, algorithms, or software: The document describes a physical medical device. There is no indication that it incorporates AI, software, or image analysis to function.
• "Study that proves the device meets the acceptance criteria" refers to bench testing: The document explicitly states under "Device Testing": "Bench testing was performed in accordance with Edwards' current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria." This refers to mechanical, material, and sterilization performance, not diagnostic accuracy or AI performance.
• Comparison to a predicate device: The basis for clearance is "substantial equivalence" to a predicate device (Fogarty Thru-Lumen Embolectomy Catheter cleared in K892410). The comparative analysis states, "The subject device is identical to the predicate device in terms of the intended use, indications for use, and technological characteristics (including design, material, chemical composition, principle of operation)." This reinforces that it's a physical device, not an AI system that would typically undergo MRMC studies or performance validation against a ground truth dataset of patient images.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) because the provided FDA document pertains to a physical medical device and does not involve AI or software development with the type of validation methodology you are asking about.

To summarize, the document is about the FDA clearance of a conventional medical device, not an AI-powered one. The "acceptance criteria" and "study" refer to engineering and biological safety tests, not the performance metrics of an AI model.

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The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) Software Feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM Software Feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM Software Feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.

The Acumen AFM Software Feature (core AFM algorithm + AFM Graphical User Interface) was originally granted in De Novo, DEN190029, on November 13, 2020, to inform clinicians about a patient's fluid responsiveness. The performance of the AFM Software Feature in predicting a patient's fluid responsiveness is measured using response rate and is calculated by reporting the percentage of followed AFM recommendations ("Fluid Bolus Suggested" and "Test Bolus Suggested" prompts) that have the desired change in stroke volume (SV), divided by the total number of AFM recommendations.

With this submission, Edwards is seeking clearance for the AFM Prompt Reclassifier algorithm (AFM PR algorithm) to the Acumen AFM Software Feature. The AFM Prompt Reclassifier algorithm is intended to be used in conjunction with the core AFM algorithm to re-assess the fluid bolus recommendations provided by the core alqorithm. It analyzes the patient's current hemodynamics for either confirming (corroborating) the original prompt or reclassifying the prompts (i.e., reclassify a "Test Bolus Suggested" prompt to a "Fluid Bolus Suggested" prompt or vice versa). In doing so, it acts as a secondary check for the fluid bolus prompts such that a greater number of the "Fluid Bolus Suggested" prompts lead to the desired change in stroke volume. Through refined prompt adjustments informed by real-time hemodynamic data, the AFM PR algorithm aims to improve patient responsiveness, thereby optimizing the impact of the AFM Software Feature on patient hemodynamics.

The FDA 510(k) summary for the Acumen Assisted Fluid Management (AFM) Software Feature describes the acceptance criteria and the study conducted to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The algorithm performance was analyzed on an archived dataset consisting of 1229 data points from 307 patients.
• Data Provenance: The data came from the US IDE Study, G170204. The study involved 9 independent U.S. sites. The data is retrospective as it was an "archived dataset."

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

• This information is not provided in the document. The study uses physiological response (change in stroke volume) as the outcome measure, implying a physiological ground truth rather than expert interpretation of images or other data.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Given the nature of the ground truth (physiological response), a traditional adjudication method for subjective assessments might not be directly applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• A MRMC comparative effectiveness study was not explicitly mentioned or described.
• The study focuses on the algorithm's performance in improving the response rate of its suggestions, rather than comparing human reader performance with and without AI assistance. The device offers "suggestions" and the "decision to administer a fluid bolus is made by the clinician."

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

• Yes, a standalone algorithm performance study was done. The document states, "Algorithm performance was analyzed on the archived dataset... The validation was to demonstrate the impact on the response rate of the AFM Software Feature's fluid bolus prompts due to the addition of AFM Prompt Reclassifier algorithm." This implies evaluating the algorithm's predictions against the measured physiological outcomes.

7. The Type of Ground Truth Used

• The ground truth used is physiological response/outcomes data. Specifically, the "desired change in stroke volume (SV)" following AFM recommendations was used to measure the "response rate."

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set. It only mentions the "archived dataset from the US IDE Study, G170204" used for algorithm performance analysis/validation.

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

• The document does not explicitly describe how the ground truth for the training set was established. It focuses on the validation of the AFM Prompt Reclassifier algorithm using an existing dataset. Given that the core AFM algorithm was granted in De Novo DEN190029, the ground truth for its original training would likely have involved similar physiological outcome data from clinical studies where fluid administration decisions were made and subsequent stroke volume changes were observed.

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The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

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.

The provided text is an FDA 510(k) clearance letter and summary for the Swan-Ganz catheter. It primarily details the regulatory process, device description, and indications for use.

Crucially, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of proving device performance against specific metrics. The document explicitly states:

"The subject Swan-Ganz Base and Advanced catheters are identical to the predicate devices cleared in K160084 and K222117 in terms of design, performance specifications, and technological characteristics with the exception of the indications for use statement and other portions of the labeling. The are no changes to the design, technology, performance, materials, or specifications of the devices in this 510(k). The modifications to the subject devices are limited to labeling changes."

This indicates that the current submission (K233824) is for a labeling change only, and therefore, the performance of the device itself (its ability to accurately monitor hemodynamic pressures) would have been established during the clearance of the predicate devices (K160084 and K222117), not in this particular submission.

Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria or a study proving the device meets acceptance criteria related to its performance.

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Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.

Fogarty venous thrombectomy catheters are specifically designed for the performance of venous thrombectomy in adult patients. Fogarty venous thrombectomy catheters have a long, soft tip which is intended to facilitate advancement past the venous valves while minimizing trauma. The flexibility required for the venous procedure is supplied by the spring-wound body. The spring is covered with a braiding for additional strength. The gate valve is designed for single-handed operation and to minimize the possibility of leakage. The gate valve has an arrow to indicate the "open" and "closed" positions. There are three available catheter sizes (6 French (2.0 mm), 8 French (2.7 mm), and 8/10 French (2.7/3.3 mm)). Each may be quickly identified by the color-coded body. The size and filling capacity are printed on each catheter.

This document is a 510(k) summary for the Fogarty Venous Thrombectomy Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. Importantly, it focuses on demonstrating substantial equivalence to a preamendment predicate device through bench testing, biocompatibility testing, shelf-life, packaging, and sterilization validations. It does not present a study proving the device meets acceptance criteria related to AI/software performance or human-in-the-loop improvements, nor does it discuss ground truth establishment, expert consensus, or MRMC studies.

Therefore, I cannot extract the information required to answer your prompt because the provided text pertains to a traditional medical device (catheter) and does not contain information about AI, software, or the types of studies you are asking about (e.g., MRMC studies, standalone algorithm performance).

The document explicitly states: "Bench testing inclusive of design verification, packaging, sterilization, and biocompatibility testing all demonstrate that the subject devices are substantially equivalent to the predicate devices." This highlights that the device's performance is demonstrated through physical and biological testing, not through AI/software evaluation.

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The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and non-invasive ForeSight sensors (large) in cerebral locations.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for use as an adjunct monitor of relative and total hemoglobin concentration of blood in individuals at risk for reduced-flow or no-flow ischemic states in surgical and ICU settings.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for continuously and non-invasively monitoring the relative and total hemoglobin values in the blood of patients requiring advanced hemodynamic monitoring in a critical care environment. The outputs of the algorithm include the relative changes in total hemoglobin in blood ( $\Delta$ tHb) and total hemoglobin in blood (tHb) parameters and are derived from the relative change in concentration of total tissue hemoglobin ( $\Delta$ ctHb parameter) measured by the ForeSight Oximeter Cable on the HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022).

The subject algorithm provides relative blood hemoglobin ( $\Delta$ tHb; measured in g/dL of blood) values continuously as a change over time from 0 g/dL. It can also be calibrated using an optional input of reference blood hemoglobin measurements such as ones obtained in vitro from a blood gas analyzer. When calibrated, it provides the value of total blood hemoglobin (tHb).

Additionally, the algorithm also provides three secondary output flags:
o DoNotCalibrate Flag: This flag is intended to indicate when a calibration should not be performed.
o Recalibrate Flag: This flag is intended to indicate when a new calibration is recommended.
o Unstable Flag: This flag is intended to indicate when the input signal ( $\Delta$ ctHb) is unstable.

The provided text describes the Edwards Algorithm for Measurement of Blood Hemoglobin, an algorithm intended for continuously monitoring changes to hemoglobin concentration. Here's a breakdown of the acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results demonstrated that the subject device subject device met the acceptance criteria of 1g/dL with a bias close to 0 and precision less than 1g/dL". While it mentions meeting the criteria, the exact numerical values for bias and precision are not explicitly provided in the text beyond "close to 0" and "less than 1g/dL". The 1g/dL criteria appears to be for RMSE/ARMS.

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

• Sample Size: 83 patients
• Data Provenance:
  • Country of Origin: Data was collected from 5 sites across the US and EU.
    • Amsterdam, The Netherlands (European Union) - 27 patients (32.53%)
    • Santander, Spain (European Union) - 8 patients (9.64%)
    • Greenville, North Carolina, USA - 18 patients (21.69%)
    • Sacramento, California, USA - 11 patients (13.25%)
    • Chicago, Illinois, USA - 19 patients (22.89%)
  • Retrospective or Prospective: Retrospective analyses were performed on data already collected, independent of the device development.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. However, it indicates that the device's performance was compared against a "laboratory co-oximeter," which implies a gold standard measurement method rather than expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory co-oximeter measurements, not through expert adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the algorithm's direct performance against a laboratory co-oximeter. The text states, "No clinical trial was performed in support of the subject 510(k) submission."

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

Yes, a standalone performance study was done. The performance data was assessed by comparing the device's output to laboratory co-oximeter measurements, without human interaction with the algorithm's output during the measurement process. The algorithm's outputs are numerical values for hemoglobin concentration.

7. The Type of Ground Truth Used

The ground truth used was laboratory co-oximeter measurements of total hemoglobin values in blood. This is considered a highly accurate and objective reference method for hemoglobin quantification.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. The descriptions provided are solely for the retrospective analysis performed for validation (the test set).

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

The document does not provide information regarding how the ground truth for the training set was established, as details about the training phase are not included in the provided text.

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The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and pediatic critical care patients requiring of cardiac output (continuous [CO] and intermittent [CO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

HemoSphere Alta monitor with HemoSphere Oximetry Cable

The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Alta Monitor with HemoSphere Pressure Cable

The HemoSphere Alta monitor when used with the HemoSphere pressure cable is indicated for use in 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 Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

The HemoSphere Alta™ Advanced Monitoring Platform is Edwards' next-Device generation platform that provides a means to interact with and visualize Description: hemodynamic and volumetric data on a screen. The HemoSphere Alta™ Monitoring Platform provides an improved user interface utilizing the existing Edwards technologies and algorithms commercially available in the HemoSphere Advanced Monitoring Platform.

This FDA 510(k) summary for the Edwards Lifesciences HemoSphere Alta Advanced Monitoring Platform (K232294) primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance validation. It explicitly states that "No new clinical testing was performed in support of the subject 510(k)." As such, the document does not provide specific acceptance criteria for AI/algorithm performance or details of a study proving the device meets such criteria through clinical data.

Instead, the submission emphasizes the device's functional and safety aspects, along with the integration of existing, previously cleared technologies and algorithms into a new hardware and software platform with an improved user interface.

Therefore, many of the requested sections below cannot be fully answered based on the provided text, as the focus was on non-clinical verification and substantial equivalence rather than new clinical performance studies for AI/algorithm features.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific acceptance criteria and detailed device performance metrics for individual AI/algorithm features (like HPI, GHI, AFM, RVP) are not detailed as part of a new clinical study for this 510(k) submission. The submission states, "No new clinical testing was performed in support of the subject 510(k)." The "Performance Data" section primarily discusses non-clinical verification.

The document states:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation."
• "System integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing were conducted... All tests passed."

This indicates that internal performance specifications were met, but these specifications themselves are not provided, nor is the performance against them quantified in this public summary.

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

No test set for clinical performance of AI/algorithm features is described, as "No new clinical testing was performed." The device leverages existing, previously cleared algorithms.

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

Not applicable, as no new clinical test set for AI/algorithm performance is described. The AI/algorithm features leverage ground truth established in prior clearances for the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set for AI/algorithm performance is described.

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

No MRMC comparative effectiveness study is mentioned, as "No new clinical testing was performed." The submission focuses on the HemoSphere Alta platform being a new generation integrating existing Edwards technologies and algorithms with an improved user interface and hardware.

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

The document does not describe new standalone performance studies for the AI/algorithm features. The AI/algorithm features (HPI, GHI, AFM, RVP) themselves were likely evaluated in standalone fashion during their original predicate clearances (e.g., K231038 for GHI). This 510(k) integrates these existing algorithms into a new platform.

7. Type of Ground Truth Used

The type of ground truth for the AI/algorithm features (HPI, GHI, AFM, RVP) would have been established during their original clearances. For this 510(k) submission, this information is not provided. Typically, hemodynamic algorithms like HPI or GHI rely on physiological measurements (e.g., direct arterial pressure, SvO2 from Swan-Ganz catheter, outcomes data related to hypotension or hypoperfusion events) as ground truth.

8. Sample Size for the Training Set

No details regarding training set sample sizes for the AI/algorithm features are provided in this 510(k) summary, as it covers the integration of existing algorithms. The training data would have been described in the original 510(k) submissions for those predicate algorithms (e.g., for Acumen HPI feature, Global Hypoperfusion Index, Right Ventricular Pressure algorithm, Acumen Assisted Fluid Management).

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

As with the training set size, the method for establishing ground truth for the training set of the AI/algorithm features is not detailed in this 510(k) summary because it pertains to existing algorithms. This would have been covered in their individual predicate 510(k) submissions.

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The Acumen™ IQ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the HemoSphere advanced monitoring platform.

The Acumen IQ finger cuff is intended to noninvasively measure blood pressure and use the information to derive hemodynamic parameters when connected to an Edwards' HemoSphere Advanced Monitoring platform.

The provided text describes a 510(k) premarket notification for the Acumen IQ finger cuff, which is a modified version of a previously cleared device (K190130). The modification involves expanding the finger circumference size range and removing a finger sizing aid. The submission states that the device is identical to the predicate device in terms of design, intended use, and technology.

The document mentions that usability testing was conducted in accordance with ANSI/AAMI HE75 and that clinical performance testing was completed to ensure the finger cuffs perform as intended, and that the Acumen IQ finger cuff has successfully passed all testing. However, the actual acceptance criteria and device performance results from these studies are not explicitly provided in the given text. The text only broadly states that the device "successfully passed all testing."

Without the specific details of the clinical performance testing, a comprehensive table of acceptance criteria and reported device performance cannot be generated. Similarly, concrete information regarding sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone performance is not available in the provided document.

Therefore,Based on the provided text, a complete answer to your request is not possible. The document states that clinical performance testing was completed and successfully passed, but it does not provide the specific acceptance criteria or the numerical results of this performance testing.

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

1. Table of Acceptance Criteria and the Reported Device Performance: This information is not provided in the document. The text only states that "clinical performance testing was completed to ensure the finger cuffs perform as intended" and that the device "has successfully passed all testing." No specific criteria (e.g., accuracy, precision) or numerical performance values are given.

2. Sample size used for the test set and the data provenance: This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.

4. Adjudication method for the test set: This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided in the document. The device is a "noninvasive blood pressure measurement system," not an AI diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is a measurement device. Its "performance" would inherently be standalone in its measurement capability once the cuff is applied. However, specific methodology (e.g., comparison to invasive measurements) and results are not provided.

7. The type of ground truth used: Given that the device non-invasively measures blood pressure, the ground truth for clinical performance testing would typically be established using a reference method for blood pressure measurement, such as invasive arterial line measurements or a highly accurate non-invasive oscillometric device that meets specific standards (e.g., ISO or BHS protocols). However, this is not explicitly stated in the document.

8. The sample size for the training set: This information is not provided in the document. (Note: For a device like a blood pressure monitor, there might not be a "training set" in the same sense as an AI algorithm that learns from data. It's more about calibration and validation against ground truth.)

9. How the ground truth for the training set was established: This information is not provided in the document.

In summary, the provided FDA clearance letter and 510(k) summary confirm that usability and clinical performance testing were conducted and passed, but they do not detail the specific acceptance criteria, performance results, or methodologies of those studies.

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When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.

The Smart Wedge algorithm is designed to provide the value at end-expiration of the pulmonary artery occlusion pressure (PAOP) signal, also called pulmonary wedge pressure, pulmonary capillary wedge pressure (PCWP), or pulmonary artery wedge pressure (PAWP), and to assess the quality of the pulmonary artery occlusion pressure measurement.

The Smart Wedge algorithm is intended to be used with a Swan-Ganz pulmonary artery catheter connected to a pressure cable and pressure transducer.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The device performance is reported for two main aspects: PAOP (Pulmonary Artery Occlusion Pressure) Identification and PAOP Measurement. The acceptance criteria can be inferred from the reported performance results and the comparison to the predicate device, especially the statement: "Results for the Smart Wedge algorithm met or exceeded predicate device performance." While explicit numerical acceptance criteria aren't listed as "targets," the provided performance values serve as the acceptable outcomes.

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