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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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Indications for Use:
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.

• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

Intended Use:
The MAC 7 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult or pediatric populations. Basic system simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. Transmission and reception of ECG data and other clinical data to and from a central clinical information system is optional.

The MAC 7 Resting ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional's facility or wherever ECG testing is performed.

The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.

The device can capture 3, 6, 12 or 15 lead electrocardiograms, provide interpretive analysis, and print reports.

The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.

The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.

The FDA 510(k) clearance letter for the MAC 7 Resting ECG Analysis System (K251670) does not contain a specific study proving the device meets acceptance criteria. Instead, it establishes substantial equivalence to predicate devices (K203786, K173830, K210560) based on similarities in intended use, indications for use, technology, and performance, along with compliance with voluntary standards and non-clinical testing.

Therefore, the following information is extracted from the provided text to fulfill your request:

1. Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and compares them to predicate devices, demonstrating substantial equivalence rather than explicit acceptance criteria with numerical performance targets. The "Discussion of Differences" column often highlights that a change does not significantly affect substantial equivalence, implying that the performance remains acceptable.

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

The document states: "Summary of Clinical Tests: The subject of this premarket submission, MAC 7 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." This indicates that no specific test set data from clinical studies was used for performance evaluation in this submission. The "acceptance" is based on the device's technical characteristics aligning with or improving upon those of legally marketed predicate devices, supported by non-clinical testing and previous clearances for core components (like the 12SL™ analysis algorithm v24).

Therefore, details on sample size, country of origin, or retrospective/prospective nature of a clinical test set are not available in this document.

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

As no clinical studies were required for this submission to support substantial equivalence, there is no information provided regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Given that no clinical studies were performed, there is no adjudication method described for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention any MRMC comparative effectiveness study. The focus is on establishing substantial equivalence to existing devices, not on demonstrating improved human reader performance with AI assistance.

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

The document states that the "Interpretive Statements are provided by 12SL (v24) ECG Analysis Program which was previously cleared under K221321." This implies that the performance of the 12SL™ algorithm itself (a standalone interpretation algorithm) would have been assessed during its prior clearance (K221321). However, the details of that standalone performance study are not included in this K251670 submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Since no new clinical studies were performed for this submission, there is no mention of the type of ground truth used for a test set. For the 12SL™ analysis algorithm (v24) which provides interpretation statements, the ground truth would have been established during its prior clearance (K221321), but those details are not provided here.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for any training set. As noted, the approval is based on substantial equivalence and non-clinical testing rather than specific training data for a new algorithm.

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

The document does not provide information on how ground truth was established for any training set.

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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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The AccurECG® Analysis System v2.0 is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.

The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG® Analysis System v2.0 is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).

The AccurECG® Analysis System v2.0 is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.

The AccurECG® Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.

The AccurECG® Analysis System v2.0 does not interface with data management systems or hardware and is device independent.

The AccurKardia ECG Analysis System consists of: (1) A client-side web interface which provides tools to upload and review ECG recordings via a web application programming interface (API), and (2) A server-side automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.

AccurECG v2.0 is intended to analyze recordings performed on adults aged 22 and older and works in the following sequence:

i. The web interface allows the user to select files and upload to the AccurECG secure database.

ii. The proprietary AccurECG algorithm analyzes and labels the ECG:

• Delineation – detection of QRS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
• Abnormality labels – automated arrhythmia interpretation and statistical classification.

iii. AccurECG® Analysis System v2.0 displays the resulting analysis and original ECG signal with reviewing tools in the web interface.

iv. AccurECG® Analysis System v2.0 allows for preliminary comments summarizing the review before generating a report.

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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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