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The HemoSphere Nano™ Monitor when used with a compatible non-invasive finger cuff is indicated for adult patients (≥ 18 years of age) in whom cardiac function parameters need to be evaluated as part of a patient's assessment. The HemoSphere Nano™ Monitor and compatible finger cuffs non-invasively measure blood pressure and associated hemodynamic parameters.

The HemoSphere Nano Monitor is a hand-held monitoring device that measures the arterial pressure waveform collected from a connected non-invasive finger cuff and displays blood pressure and derived hemodynamic parameters. These parameters are continuously displayed for up to a period of 10 minutes, serving as a series of spot-check or point-in-time measurements. As such, the device does not feature any physiological alarms. It is compatible for use with the single use Acumen IQ Plus finger cuff (AIQCA2; cleared via K243781).

The HemoSphere Nano Monitor utilizes the same principle of operation, algorithms, and mechanism for non-invasive monitoring hemodynamic parameters as the primary predicate, HemoSphere Advanced Monitoring Platform (K243781). When compared to the primary predicate, the subject device introduces a new hardware configuration with a smaller form factor. This new hardware configuration is powered by a rechargeable battery and features a smaller display to enable the product to be hand-held. Contrary to the predicate which incorporates a modular approach, the subject integrates all existing non-invasive technology (i.e., the ClearSight Module and Pressure Controller) into the HemoSphere Nano Monitor body itself to provide a unified and compact solution for non-invasive hemodynamic monitoring.

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

The CARTO™ 3 EP Navigation System V8.4, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electro anatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO™ 3 System V8.4 consists of the following hardware components:

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

All hardware components of the CARTO™ 3 system V8.4 are the same as those found in the predicate device.

The provided FDA 510(k) clearance letter and summary for the CARTO™ 3 EP Navigation System V8.4 details two new AI-powered features: the CARTOSOUND™ REVEAL Module and the LA FAM Module.

Based on the provided document, here's a breakdown of the acceptance criteria and the study information:

1. Acceptance Criteria and Reported Device Performance

The document states that the testing verified and validated that the new features perform according to specifications and that existing features were not negatively affected. However, specific quantitative acceptance criteria (e.g., a specific accuracy percentage, Dice coefficient, etc.) for the AI algorithms in the CARTOSOUND™ REVEAL Module or LA FAM Module are not explicitly provided in the public document. The reported performance is that "All system features were found to perform according to specifications" and "All tests were successfully completed."

Given the lack of specific quantitative metrics in the provided document, I cannot create a table with specific numeric acceptance criteria and reported performance values. The closest information is:

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

• CARTOSOUND™ REVEAL Module:
  • Sample Size: Not explicitly stated as a number. The document mentions "Data for... validation of the DL algorithm was collected from a representative range of LA and LV chamber volumes and geographical locations, using a variety of ultrasound system settings, ULS scanners, and catheters."
  • Data Provenance: "geographical locations" implies diverse data sources, but specific countries are not mentioned. The data was collected from "CARTO™ 3 System cases with ultrasound information," suggesting it's retrospective clinical data gathered during past procedures where the CARTO™ 3 system was used.
• LA FAM Module:
  • Sample Size: Not explicitly stated as a number. The document mentions "Data for... validation of the DL algorithm consisted of CT and CARTO™ 3 System cases with FAM and was collected from a representative range of LA chamber volumes, geographical locations, and catheters."
  • Data Provenance: "geographical locations" implies diverse data sources, but specific countries are not mentioned. The data was collected from "CT and CARTO™ 3 System cases with FAM," suggesting it's a mix of retrospective clinical CT data and retrospective clinical data from past CARTO™ 3 procedures.

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

Not explicitly stated in the provided document. The document describes the "anatomical labeling and automatic contouring algorithms" as "developed and tested using CARTO™ 3 System cases with ultrasound information." For the 3D shell model, it was "developed and tested using CT and CARTO™ 3 System cases with FAM." However, the exact number, qualifications (e.g., cardiologist, electrophysiologist, radiologist, years of experience), and process of expert involvement in establishing ground truth for the test set are not detailed.

4. Adjudication Method for the Test Set

Not explicitly stated in the provided document. The document does not describe any specific multi-expert adjudication method (e.g., 2+1, 3+1, none) used for the test set ground truth.

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

No MRMC comparative effectiveness study involving human readers assisting with AI vs. without AI assistance was mentioned. The testing described focuses on the standalone performance of the AI modules and regression testing of the overall system.

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

Yes, standalone performance was implied for the AI algorithms. The description of CARTOSOUND™ REVEAL and LA FAM modules specifically mentions "locked AI algorithms" for "Automatic identification," "Automatic 2D contours creation," and "Automatic 3D sell creation." The "Retrospective Validation Tests" were performed on "clinical recorded data" to "validate the clinical functionality and quality of the introduced modules," suggesting an evaluation of these automated features.

7. Type of Ground Truth Used

• CARTOSOUND™ REVEAL Module:
  • For anatomical labeling and automatic contouring: Ground truth was derived from "CARTO™ 3 System cases with ultrasound information." This likely implies expert consensus or manual annotation by experts reviewing these clinical images.
  • For 3D shell model: Ground truth was derived from "CT and CARTO™ 3 System cases with FAM." This suggests CT imaging, potentially combined with expert manual segmentation or annotation from CARTO™ 3 FAM data.
• LA FAM Module:
  • Ground truth was derived from "CT and CARTO™ 3 System cases with FAM." This also suggests CT imaging, potentially combined with expert manual segmentation or annotation from CARTO™ 3 FAM data.

In both cases, while not explicitly stated, the generation of "ground truth" for a medical imaging task typically involves expert manual annotation or comparison to a gold standard imaging modality (like CT for anatomical structures).

8. Sample Size for the Training Set

• CARTOSOUND™ REVEAL Module: Not explicitly stated as a number. The document mentions "Data for training... of the DL algorithm was collected from a representative range of LA and LV chamber volumes and geographical locations, using a variety of ultrasound system settings, ULS scanners, and catheters."
• LA FAM Module: Not explicitly stated as a number. The document mentions "Data for training... of the DL algorithm consisted of CT and CARTO™ 3 System cases with FAM and was collected from a representative range of LA chamber volumes, geographical locations, and catheters."

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

• CARTOSOUND™ REVEAL Module:
  • For anatomical labeling and automatic contouring: "The anatomical labeling and automatic contouring algorithms were developed and tested using CARTO™ 3 System cases with ultrasound information." This implies expert annotation or labeling of cardiac structures and contours within these ultrasound images.
  • For 3D shell model: "The 3D shell model was developed and tested using CT and CARTO™ 3 System cases with FAM." This implies expert segmentation or model creation/validation based on CT images and CARTO™ 3 FAM data.
• LA FAM Module:
  • "Data for training... of the DL algorithm consisted of CT and CARTO™ 3 System cases with FAM." This indicates the ground truth for training was established through expert analysis and annotation of CT scans and CARTO™ 3 Fast Anatomical Maps (FAM).

Similar to the test set, the establishment of ground truth for training data in medical AI typically relies on manual work by qualified experts to delineate structures or confirm labels.

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The IOPS Visionary System is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

The IOPS® Visionary system displays the position and orientation of sensor-equipped IOPS guidewires and IOPS catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously-acquired scan data (CT). IOPS Visionary tracks the location and orientation of the sensors in real time, superimposing navigation of the IOPS Catheter and IOPS Guidewire to the patient's vascular map.

The system consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact, reusable, multi-patient use device. The associated accessories are single use devices provided sterile (EtO).

The IOPS Visionary System is indicated for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic, and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS Visionary System does not make a diagnosis.

The associated accessories include:
• Guidewire
• Catheters
• Fiducial Tracking Pad
• Guidewire Handle

The system consists of three major sections: the cart, the tracking system (Interface Module, System Control Unit and Field Generator) and the accessories.

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The Holter ECG and ABP system is intended to acquire, analyze, display, edit and generate report of ambulatory ECG, ambulatory blood pressure and combined Holter ECG and ABP data. The analysis results are offered to doctors on an advisory basis only.

Data acquired may be used for the following indications:

• Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
• Evaluation of patients for ST segment changes.
• Evaluation of drug response in patients taking anti-arrhythmic medications.
• Evaluation of patients with pacemakers.

The ambulatory blood pressure function is intended for use in patients over 12 years of age from data collected from an FDA cleared ambulatory blood pressure cuff.

The ECG Analysis function is intended for use in adults and pediatric, but arrhythmia detection is intended for use in patients over 12 years of age.

The Holter ECG and ABP system is intended to be used only in hospital and healthcare facilities by physicians or trained healthcare professionals.

The Holter ECG and ABP system (Model: HolterABP) is a Windows-based application software. It is intended to acquire, analyze, display, edit and generate report of ambulatory ECG data, ambulatory blood pressure data and combined Holter ECG and ABP data that has been stored by the compatible recorders.

The Holter ECG and ABP system provides automatic QRS detection and classification, automatic arrhythmia detection, ST segment measurement and creates summary tables, trends.

The Holter ECG and ABP system display the ABP data, then form the summary table, and statistics information.

The final report can be previewed, printed and saved after the data analysis is completed.

All results obtained from automatic analysis and the resulting unconfirmed reports must be considered as suggestions only.

The subject device is intended only for retrospective analysis, and not for use in real-time monitoring or alarming.

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The SafeBeat Rx App analyzes ECG data recorded in compatible formats. This ECG signal may originate from a full 12-lead ECG or a reduced lead set ECG. The device provides ECG signal processing and provisional analysis, including interval measurements (QT interval, QTc, QRS duration, heart rate, and RR interval), along with visible display of QRS onset (Q-start), R-peak, and QRS offset (S-end). The SafeBeat Rx App can electronically interface with, and perform analysis of, data transferred from other computer-based ECG systems, such as an ECG management system. The SafeBeat Rx App does not provide real-time ECG display, continuous monitoring, or alarm functions. The device is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The SafeBeat Rx App ECG analysis is intended for adult patient populations (18 years and older).

SafeBeat Rx App provisional ECG analysis is not intended to be the sole means of diagnosis. The SafeBeat Rx App is not validated for use in lead I alone. The SafeBeat Rx App is intended to be used on an advisory basis only by qualified healthcare personnel to evaluate provisional ECG data. ECG data should be reviewed in conjunction with the patient's clinical history, symptoms, and/or other diagnostic tests, and the professional clinical judgement of the qualified healthcare provider.

The SafeBeat Rx App can be used in a professional healthcare environment such as a hospital, clinic or similarly equipped facility. The SafeBeat Rx App has an optional long term monitoring workflow intended for monitoring and evaluating a patient's home acquired ECG. The software workflow that is intended for use in the professional healthcare environment should not be used in the home environment to adjust QT prolonging medications as is contraindicated for applicable drugs.

The SafeBeat Rx App is a Software as a Medical Device (SaMD) that provides: (1) ML-based provisional ECG interval measurements of third-party ECG signals (e.g., HR, RR-interval variability, QT/QTc interval and QRS interval); and (2) optional non-device functions, including suggested antiarrhythmic drug (AAD) dosing consistent with manufacturer drug label for amiodarone, dofetilide, flecainide, sotalol and IV sotalol. The device analyzes ECG signals acquired by other ECG acquisition and storage devices. The device is only intended for traditional "wet" electrode inputs. The SafeBeat app does not directly acquire ECG data from patients. ECG data is obtained programmatically through an application programming interface (API) with the ECG acquisition and storage device, or manually via data upload through a secure web interface. The device is solely intended to analyze raw digital ECG data and does not allow the analysis of ECG signals imported by images.

Provisional ECG analysis is performed by the device. The device includes both beat-level feature identification and interval estimation. The beat-level parameters are:

• R-peak
• QRS onset
• ST onset
• T-wave offset

The interval estimation parameters:

• Heart rate
• RR interval variability
• QRS duration
• QT interval
• QT interval variability
• Heart rate corrected QT (e.g., QTcF)
• Heart rate corrected QT variability

Provisional ECG interval measurements are displayed on a user interface for review and interpretation by a qualified healthcare professional. The provisional ECG analysis can be viewed, edited, approved, or rejected by the qualified healthcare professional via the user interface.

The SafeBeat App does not provide continuous cardiac monitoring. The SafeBeat App does not provide rhythm interpretation or diagnosis cardiac arrhythmias (e.g. atrial fibrillation). The device does not include automated rhythm analysis. The device is intended for adult patient populations.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for the SafeBeat Rx App:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA letter does not explicitly state acceptance criteria in numerical targets (e.g., "accuracy must be > 90%"). Instead, the performance studies are designed to demonstrate "excellent agreement" with expert annotations and effective/accurate measurements. The key performance metrics reported are primarily related to agreement or error compared to a ground truth.

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

• SafeBeat Proprietary Validation Dataset: The exact sample size in terms of number of ECGs or patients is not explicitly stated, but it's described as a "retrospective testing using publicly available clinical datasets." It included a "broad spectrum of ECG morphologies" from "diverse patient populations collected across multiple geographically distinct locations, encompassing healthy individuals, patients in critical care settings, and patients with known arrhythmias."
  • Provenance: Retrospective, from "multiple independent sources" and "multiple geographically distinct locations." Race/ethnicity distribution included White (60.9%), Asian (3.8%), Black or African American (10%), Hispanic or Latino (4.8%), Other (4.1%), or Unknown (16.5%).
• Common Standards for Electrocardiography (CSE) Dataset: n=100 ECGs.
  • Provenance: Not explicitly stated, but it's a "CSE reference measurements" dataset.
• Standard ECG Test Databases (IEC 60601-2-47): Used the MIT-BIH Normal Sinus Rhythm dataset, AHA database, and MIT-BIH Noise Stress Test dataset.
  • Provenance: Well-known publicly available datasets.

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

• SafeBeat Proprietary Validation Dataset: Ground truth annotations were performed by an unspecified number of "board-certified cardiologists." Specific experience levels (e.g., "10 years of experience") are not provided.
• Common Standards for Electrocardiography (CSE) Dataset: "Manual CSE reference measurements" were used. The number and qualifications of the annotators for this reference dataset are not specified in the document.
• Standard ECG Test Databases (IEC 60601-2-47): These databases inherently contain established annotations, but the number and specific qualifications of the original annotators for these public datasets are not detailed within this FDA letter.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the SafeBeat proprietary dataset. It states annotations were "performed by board-certified cardiologists," which implies individual expert annotations were used as ground truth without further detail on how discrepancies (if multiple experts were involved) were resolved. For the CSE and IEC datasets, pre-existing reference measurements are used, so a separate adjudication method for the SafeBeat study is not mentioned.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or reported in this 510(k) submission. The study focuses on the standalone performance of the AI algorithm in measuring ECG intervals against expert annotations and established reference databases.

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

Yes, the studies described are primarily standalone performance evaluations of the SafeBeat Rx App algorithm. The software's measurements (QTc, QRS, HR, R-R) are compared directly against expert annotations and reference measurements, indicating algorithm-only performance. The device is intended "to be used on an advisory basis only by qualified healthcare personnel," meaning a human-in-the-loop will review and potentially adjust the output, but the validation itself is of the algorithm's initial output.

7. The Type of Ground Truth Used

• Expert Consensus/Annotation: For the SafeBeat Proprietary Validation Dataset, ground truth was established by "board-certified cardiologists" annotations.
• Reference Measurements/Established Datasets: For the CSE and IEC 60601-2-47 datasets, pre-existing "reference measurements" or established annotations from these standard databases were used as ground truth.

8. The Sample Size for the Training Set

The document states, "The training dataset consisted of broad distribution of cardiac rhythms and less common supraventricular rhythms." However, the sample size (number of ECGs or patients) for the training set is not provided.

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

The document only states that "The training dataset consisted of broad distribution of cardiac rhythms and less common supraventricular rhythms. QRS and QTc morphology were diverse. The dataset ensured generalization across age, sex, rhythm classes and ECG waveform variations." It does not specify how the ground truth for the training set was established (e.g., by experts, automated methods).

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

The CARTO™ 3 EP Navigation System V9.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO™ 3 System V9.0 consists of the following hardware components:

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

All hardware components of the CARTO™ 3 system V9.0 are the same as those found in the predicate device, with improved Patient Interface Unit (PIU Plus).

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STAR Apollo™ Mapping System assists users in the interpretation and manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial electrograms, of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The STAR Apollo Mapping System (v1.8) is a software driven system designed to assist operators in identifying Early Sites of Activation (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use with FDA cleared electroanatomic mapping systems specifically:

• CARTO™ 3 EP Navigation System (V8.1) (K252302) (Biosense Webster) and
  • OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253) (Biosense Webster)

for exporting geometry data, electrograms and electrode locations over ethernet connection during the electrophysiology procedure with CARTO 3 API (K231207) to provide input data for the STAR Apollo Mapping System.

• Ensite Precision Model EE 3000 Cardiac Mapping System (V2.6) (K201148) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• EnSite X EP System (V 1.1.1, V 2.0, V 3.0) (K213364) (K221213) (K231415) (Abbott Medical) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• Ensite X EP System (V 3.1) (K242016) (Abbott Medical) and either:
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
  • Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K242016) (Abbott Medical)

for exporting geometry data, electrograms and electrode locations via a portable external storage device or over ethernet data connection (Ensite X EP System (V 3.0, V 3.1) with LiveSync module) (K231415) (K242016) during the electrophysiology procedure to provide input data for the STAR Apollo Mapping System.

The principle of STAR Apollo Mapping System analysis is to use data on multiple individual wavefront trajectories to identify Repetitive Patterns of Activation (RPA) or regions of the atrium that represent Early Sites of Activation (ESA) which most often precede activation of neighboring areas, with the aim of helping clinicians to identify regions of the atria that may be the origins for AF activation. The system consists of proprietary STAR Apollo Mapping System software and a hardware component. STAR Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 11 Operating System. STAR Apollo Mapping System software is pre-installed onto the laptop.

The STAR Apollo Mapping System uses export data from the compatible Mapping System that has been collected with the compatible Mapping Catheter during the electrophysiology procedure. The Mapping Catheter is used to collect anatomy and electrogram data in the atria. Recordings are made for at least 30 seconds with the Mapping Catheter in a stable position and in contact with the atrial wall. These ≥30 second acquisitions are made in multiple, non-overlapping locations, to generate recordings over the entire atrial chamber. The data is exported via an external portable storage device or by streaming via an ethernet data cable connected to the data ethernet port of the EnSite X or CARTO 3 workstation. It is transferred to the laptop computer running the STAR Apollo Mapping System. The export data accepted from the Mapping Systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data is imported utilizing the portable external data storage device or via ethernet into the STAR Apollo Mapping System and then processed by the STAR Apollo Engine to generate a STAR Apollo Map visualized by the GUI. The STAR Apollo Map will highlight sites deemed to be Early Sites of Activation (ESA), as a red sphere at the endocardial locations corresponding to the recording electrode position. These sites are areas where the myocardium has initiated activation earlier than its neighboring sites on multiple occasions and therefore may be a potential site of AF initiation or maintenance. The more repetitive these sites are, the larger the red sphere appears on the STAR Apollo Map. The system will rank the ESA according to their repetition frequency and cycle length and identify the most relevant 3 sites. The system is designed to show the physician Repetitive Patterns of Activation (RPA). These are shown as colored arrows, which start from the leading electrode position, following the summarized activation sequence. The more repetitive or consistent that activation pattern is, the wider the white arrow. Based on this information the physicians may then use this as an additional guide for further mapping of the AF, using FDA cleared mapping system catheters.

The STAR Apollo Mapping System operates outside the sterile field and is only connected to the EnSite Precision, EnSite X EP or CARTO 3 workstation and not to the amplifier, patient, or any other devices used in the procedure. No data is transferred from the STAR Apollo Mapping System back to the EnSite Precision, EnSite X EP mapping system, or CARTO 3 i.e., data transfer is only in one direction. No modifications to the EnSite Precision, EnSite X EP mapping systems or CARTO 3 are made to accommodate the STAR Apollo Mapping System. The STAR Apollo Maps may be used to give physicians additional information about the AF activations. The physician may use them as an additional aid to identify areas within the atria that may warrant further and close examination using the mapping system, and the compatible Mapping Catheter. The STAR Apollo System is never directly connected to a patient, nor does it deliver therapy. It is used as a software tool that provides supplementary information to the physician in an electrophysiology procedure.

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

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

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

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

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Oximetry Cable

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

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

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the FloTrac™ Sensor, FloTrac Jr™ Sensor, Acumen IQ™ Sensor, and TruWave™ Disposable Pressure Transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Right Ventricular Pressure (RVP) parameters.

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

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

HemoSphere Alta Advanced Monitoring Platform with ForeSight™ Oximeter Cable

The non-invasive ForeSight™ Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The ForeSight™ Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight™ Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta™ Advanced Monitoring Platform.

• When used with large sensors, the ForeSight™ Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg.
• When used with medium sensors, the ForeSight™ Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
• When used with small sensors, the ForeSight™ Oximeter Cable is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

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

HemoSphere Alta™ Advanced Monitoring Platform with Non-invasive technology

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

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

HemoSphere Alta Advanced Monitoring Platform with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients.

It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary.

The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history symptoms and other diagnostic information.

DeepRhythmAI is a cloud-based software utilizing CNN and transformer models for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professionals with supportive information for review. DeepRhythmAI can be integrated into medical devices. The product supports downloading and analyzing data recorded in compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders used when assessment of the rhythm is necessary.

The DRAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI doesn't have User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for ECG visualization and analysis reporting.

DeepRhythmAI is not for use in life supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

DRAI consists of:

1. An API which allows the client to upload single- or two-lead ECG data and allows to download the results of the ECG analysis.
2. The automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.

DRAI works in the following sequence:

1. Accept uploading digital ECG files via secure API;

2. Analyze the uploaded ECG data using a proprietary algorithm, which detects cardiac beats/arrhythmias and intervals including:

   • QRS
   • Heart rate determination
   • RR Interval measurements
   • Non-paced supraventricular rhythm and arrhythmia calls as specified by product's Instruction for Use
   • Non-paced ventricular rhythm and arrhythmia calls: as specified by product's Instruction for Use
   • Atrioventricular blocks (second or third degree)

3. Analyze detected individual Ventricular ectopic beats also known as Premature Ventricular Contractions (PVCs) to form groups and subgroups of similar beat morphology if product is configured to do so.

4. The results of the ECG analysis can be downloaded via secure API by the external visualization software used by healthcare professionals for the ECG visualization and analysis reporting.

This document describes the acceptance criteria and the study proving the device meets these criteria for DeepRhythmAI, a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it states that the device's performance was evaluated against recognized consensus standards and a proprietary database, and that the PVC grouping algorithm meets "predefined requirements for accuracy." Without specific numerical targets, the table below will summarize the types of performance evaluations conducted and the reported outcomes as described.

2. Sample Size for the Test Set and Data Provenance

The 510(k) summary states that "the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population."

• Test Set Sample Size: The exact numerical sample size for the test set is not specified beyond "a large number of recordings."
• Data Provenance:
  • Country of Origin: Not explicitly stated. It refers to a "proprietary database (MDG validation db)."
  • Retrospective or Prospective: Not explicitly stated. Given it's a "validation db," it's likely retrospective data collected over time.

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

This information is not provided in the given 510(k) clearance letter. The document mentions "qualified healthcare professionals review and confirm the analytic result" in the context of the device's intended use and that the AI provides "supportive information for review." However, it does not detail how ground truth was established for the validation dataset, nor the number or qualifications of experts involved in that process.

4. Adjudication Method for the Test Set

The adjudication method used for establishing the ground truth for the test set is not provided in the document.

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

An MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, is not explicitly mentioned or described in the provided 510(k) summary. The device's indication for use states that "Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only," suggesting it functions as an assistive tool, but a formal MRMC study demonstrating improvement is not detailed.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The document states, "the algorithm was tested against the proprietary database (MDG validation db)" and that DeepRhythmAI "measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review." The performance assessment of the "automated proprietary deep-learning algorithm" and the "hierarchical Premature Ventricular Contraction (PVC) clustering algorithm" implies a standalone evaluation of the algorithm's capabilities.

7. Type of Ground Truth Used for the Test Set

The type of ground truth used is not explicitly stated. However, given the nature of ECG analysis for arrhythmias, it is highly probable that the ground truth was established through expert consensus or manual expert annotation of the ECG recordings in the "proprietary database (MDG validation db)."

8. Sample Size for the Training Set

The sample size for the training set is not provided in the document. The document mentions the use of "CNN and transformer models for automated analysis of ECG data," which implies a machine learning approach requiring a training set, but its size is not disclosed.

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

The method for establishing ground truth for the training set is not provided in the document. As with the test set, it is likely that expert consensus or manual expert annotation was used to label the data for training the deep learning algorithms.

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